There is provided, inter alia, an aqueous solution comprising (i) an antibody protein; and (ii) a antibody protein stabilizing mixture of arginine, methionine, and a C3 polyol.
A61K 47/60 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p. ex. les supports ou les additifs inertesAgents de ciblage ou de modification chimiquement liés à l’ingrédient actif l’ingrédient non actif étant chimiquement lié à l’ingrédient actif, p. ex. conjugués polymère-médicament l’ingrédient non actif étant un agent de modification l’agent de modification étant un composé organique macromoléculaire, p. ex. une molécule oligomérique, polymérique ou dendrimérique obtenu par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyurées ou polyuréthanes le composé organique macromoléculaire étant un oligomère, un polymère ou un dendrimère de polyoxyalkylène, p. ex. PEG, PPG, PEO ou polyglycérol
C07K 16/22 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des facteurs de croissance
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
C07K 16/32 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des produits de traduction des oncogènes
There is provided inter alia an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant which is an alkyl glycoside; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a log K with respect to zinc ion binding of more than 12.3 at 25° C.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
A61M 5/142 - Perfusion sous pression, p. ex. utilisant des pompes
A61M 5/315 - PistonsTiges de pistonGuidage, blocage, ou limitation des mouvements de la tigeAccessoires disposés sur la tige pour faciliter le dosage
A61M 5/32 - AiguillesParties constitutives des aiguilles relatives au raccordement de celles-ci à la seringue ou au manchonAccessoires pour introduire l'aiguille dans le corps ou l'y maintenirDispositifs pour la protection des aiguilles
An aqueous solution composition of pH in the range 4.0-8.5 comprising:
an antibody construct comprising an Fc domain;
optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.5 and which pKa is within 2 pH units of the pH of the composition;
optionally one or more neutral amino acids; and
an uncharged tonicity modifier;
wherein the buffers are present in the composition at a total concentration of 0-5 mM; and
wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
C07K 14/705 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire
C07K 14/71 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des facteurs de croissanceRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des régulateurs de croissance
C07K 14/715 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des cytokinesRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des lymphokinesRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des interférons
There is provided inter alia a storage stable aqueous solution composition comprising vancomycin or a pharmaceutically acceptable salt thereof, at a concentration of 1-10 mg/mL; D-lactic acid or a pharmaceutically acceptable salt thereof; and a polyol selected from the group consisting of propylene glycol, sucrose, glycerol, trehalose, lactose, glucose, sorbitol and mannitol, or a mixture thereof; wherein the osmolarity of the composition is 400-1250 mOsm/L.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
5.
INJECTION PEN SYSTEM FOR THE DELIVERY OF AN INSULIN COMPOUND
There is provided inter alia an injection pen system comprising an injector mechanism and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said injector mechanism to a mammal wherein the composition comprises (i) an insulin compound, (ii) ionic zinc and (ii) an alkyl glycoside as a non-ionic surfactant.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A storage stable aqueous solution composition comprising vancomycin or a pharmaceutically acceptable salt thereof, at a concentration of 25-75 mg/mL; D-lactic acid or a pharmaceutically acceptable salt thereof; a cosolvent selected from propylene glycol and a mixture of propylene glycol and glycerol; and an inorganic salt containing a metal cation.
The present invention relates inter alia to an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a nicotinic compound (iv) a non-ionic surfactant; and (v) a salt selected from the salts formed between Group 1 metals and a mono or divalent anion. It also provides related methods, uses and pharmaceutical compositions.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
There is provided, inter alia, an aqueous solution composition of pH in the range 4.0-7.5 comprising: a peptide therapeutic agent; optionally one or more buffers being substances having at least one ionisable group with a pK a in the range 3.0 to 8.5 and which pk a is within 2 pH units of the pH of the composition; and a stabilizer; wherein the peptide therapeutic agent does not contain ionisable groups with pk a in the range 3.0 to 8.5, and wherein the buffers are present in the composition at a total concentration of 0-5 mM.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
A61K 47/22 - Composés hétérocycliques, p. ex. acide ascorbique, tocophérol ou pyrrolidones
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
9.
AQUEOUS SOLUTION COMPOSITIONS FOR INCREASING STABILITY OF ENGINEERED DIMERIC PROTEINS
The present application relates to aqueous solution compositions of engineered dimeric proteins comprising monomers that comprise at least one human serpin polypeptide operably linked to a human immunoglobulin Fc polypeptide or a polypeptide that is derived from an immunoglobulin Fc polypeptide, at low buffer concentrations and low ionic strength and containing a neutral amino acid. The aqueous solution compositions increase the stability of the an Fc domain in aqueous solution compositions, and in particular increase the stability of an engineered dimeric protein.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
There is provided inter alia a storage stable liquid solution composition comprising carfilzomib or a pharmaceutically acceptable salt thereof and a solvent consisting of (a) an organic solvent component comprising propylene glycol optionally together with polyethylene glycol (PEG), present at a total concentration of at least about 65% (v/v based on the total volume of the composition) and (b) water at a concentration of no more than about 15% (v/v based on the total volume of the composition); and a neutral amino acid, wherein the pH of the storage stable liquid solution composition is in the range 2.5 to 4.0.
There is provided inter alia a storage stable liquid composition concentrate comprising bendamustine or a pharmaceutically acceptable salt thereof and a liquid solvent in which said bendamustine or a pharmaceutically acceptable salt thereof is dissolved;
wherein said composition comprises:
(i) a mixture of two or more different polyethylene glycol (PEG) polymers, wherein each polyethylene glycol has an average molecular weight in the range 150-650 Da; and
(ii) 5-20% (v/v) of water.
There is provided inter alia an aqueous solution composition of pH in the range of about 4.0 to about 8.5 comprising: —an engineered protein construct comprising an Fc domain; —optionally one or more buffers being substances having at least one ionisable group with a pKa in the range of about 3.0 to about 9.5 and which pKa is within 2 pH units of the pH of the composition; —optionally one or more neutral amino acids; and—an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration in the range of about 0 mM to about 10 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/22 - Composés hétérocycliques, p. ex. acide ascorbique, tocophérol ou pyrrolidones
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
There is provided, inter alia, an aqueous solution comprising an antibody protein and a stabilizing amount of (i) a chelating agent which is a multi-anion; and (ii) a C3 polyol.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
C07K 14/705 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
C07K 16/22 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des facteurs de croissance
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
A61K 47/60 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p. ex. les supports ou les additifs inertesAgents de ciblage ou de modification chimiquement liés à l’ingrédient actif l’ingrédient non actif étant chimiquement lié à l’ingrédient actif, p. ex. conjugués polymère-médicament l’ingrédient non actif étant un agent de modification l’agent de modification étant un composé organique macromoléculaire, p. ex. une molécule oligomérique, polymérique ou dendrimérique obtenu par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyurées ou polyuréthanes le composé organique macromoléculaire étant un oligomère, un polymère ou un dendrimère de polyoxyalkylène, p. ex. PEG, PPG, PEO ou polyglycérol
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
There is provided inter alia a storage stable aqueous solution composition comprising vancomycin or a pharmaceutically acceptable salt thereof, at a concentration of 1-10 mg/mL; D-lactic acid or a pharmaceutically acceptable salt thereof; and a polyol selected from the group consisting of propylene glycol, sucrose, glycerol, trehalose, lactose, glucose, sorbitol and mannitol, or a mixture thereof; wherein the osmolarity of the composition is 400-1250 mOsm/L.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 38/14 - Peptides contenant des radicaux saccharideLeurs dérivés
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A storage stable aqueous solution composition comprising vancomycin or a pharmaceutically acceptable salt thereof, at a concentration of 25-75 mg/mL; D-lactic acid or a pharmaceutically acceptable salt thereof; a cosolvent selected from propylene glycol and a mixture of propylene glycol and glycerol; and an inorganic salt containing a metal cation.
inter aliainter alia a storage stable aqueous solution composition comprising vancomycin or a pharmaceutically acceptable salt thereof, at a concentration of 1-10 mg/mL; D-lactic acid or a pharmaceutically acceptable salt thereof; and a polyol selected from the group consisting of propylene glycol, sucrose, glycerol, trehalose, lactose, glucose, sorbitol and mannitol, or a mixture thereof; wherein the osmolarity of the composition is 400-1250 mOsm/L.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 38/14 - Peptides contenant des radicaux saccharideLeurs dérivés
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A storage stable aqueous solution composition comprising vancomycin or a pharmaceutically acceptable salt thereof, at a concentration of 25-75 mg/mL; D-lactic acid or a pharmaceutically acceptable salt thereof; a cosolvent selected from propylene glycol and a mixture of propylene glycol and glycerol; and an inorganic salt containing a metal cation.
There is provided, inter alia, an aqueous solution comprising (i) an antibody protein; and (ii) a antibody protein stabilizing mixture of arginine, methionine, and a C3 polyol.
A61K 47/60 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p. ex. les supports ou les additifs inertesAgents de ciblage ou de modification chimiquement liés à l’ingrédient actif l’ingrédient non actif étant chimiquement lié à l’ingrédient actif, p. ex. conjugués polymère-médicament l’ingrédient non actif étant un agent de modification l’agent de modification étant un composé organique macromoléculaire, p. ex. une molécule oligomérique, polymérique ou dendrimérique obtenu par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyurées ou polyuréthanes le composé organique macromoléculaire étant un oligomère, un polymère ou un dendrimère de polyoxyalkylène, p. ex. PEG, PPG, PEO ou polyglycérol
C07K 16/32 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des produits de traduction des oncogènes
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
C07K 16/22 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des facteurs de croissance
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
There is provided inter alia a storage stable liquid composition concentrate comprising bendamustine or a pharmaceutically acceptable salt thereof and a liquid solvent in which said bendamustine or a pharmaceutically acceptable salt thereof is dissolved; wherein said composition comprises: (i) a mixture of two or more different polyethylene glycol (PEG) polymers, wherein each polyethylene glycol has an average molecular weight in the range 150-650 Da; and (ii) 5-20 % (v/v) of water.
There is provided, inter alia, an aqueous liquid pharmaceutical formulation comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (ill) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25° C.; for use in the treatment of a human subject suffering from diabetes mellitus by administration by subcutaneous injection or subcutaneous infusion at or close to a meal-time wherein the administration of 0.3 U/kg of the formulation leads to one or more specified pharmacokinetic and/or pharmacodynamic parameters.
An aqueous solution composition of pH in the range 4.0-8.5 comprising: an antibody construct comprising an Fc domain; optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.5 and which pKa is within 2 pH units of the pH of the composition; optionally one or more neutral amino acids; and an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration of 0-5 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
C07K 14/705 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire
C07K 14/71 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des facteurs de croissanceRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des régulateurs de croissance
C07K 14/715 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des cytokinesRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des lymphokinesRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des interférons
23.
AQUEOUS SOLUTION COMPOSITIONS FOR INCREASING STABILITY OF ENGINEERED DIMERIC PROTEINS
The present application relates to aqueous solution compositions of engineered dimeric proteins comprising monomers that comprise at least one human serpin polypeptide operably linked to a human immunoglobulin Fc polypeptide or a polypeptide that is derived from an immunoglobulin Fc polypeptide, at low buffer concentrations and low ionic strength and containing a neutral amino acid. The aqueous solution compositions increase the stability of the an Fc domain in aqueous solution compositions, and in particular increase the stability of an engineered dimeric protein.
There is provided inter alia an aqueous solution composition of pH in the range of about 4.0 to about 8.5 comprising: - an engineered protein construct comprising an Fc domain; - optionally one or more buffers being substances having at least one ionisable group with a pKa in the range of about 3.0 to about 9.5 and which pKa is within 2 pH units of the pH of the composition; - optionally one or more neutral amino acids; and - an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration in the range of about 0 mM to about 10 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
25.
AQUEOUS SOLUTION COMPOSITIONS FOR INCREASING STABILITY OF ENGINEERED DIMERIC PROTEINS
The present application relates to aqueous solution compositions of engineered dimeric proteins comprising monomers that comprise at least one human serpin polypeptide operably linked to a human immunoglobulin Fc polypeptide or a polypeptide that is derived from an immunoglobulin Fc polypeptide, at low buffer concentrations and low ionic strength and containing a neutral amino acid. The aqueous solution compositions increase the stability of the an Fc domain in aqueous solution compositions, and in particular increase the stability of an engineered dimeric protein.
A61K 38/57 - Inhibiteurs de protéases provenant d'animauxInhibiteurs de protéases provenant d'humains
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
aa in the range of about 3.0 to about 9.5 and which pKa is within 2 pH units of the pH of the composition; - optionally one or more neutral amino acids; and - an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration in the range of about 0 mM to about 10 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
27.
AQUEOUS SOLUTION COMPOSITIONS FOR INCREASING STABILITY OF ENGINEERED DIMERIC PROTEINS
The present application relates to aqueous solution compositions of engineered dimeric proteins comprising monomers that comprise at least one human serpin polypeptide operably linked to a human immunoglobulin Fc polypeptide or a polypeptide that is derived from an immunoglobulin Fc polypeptide, at low buffer concentrations and low ionic strength and containing a neutral amino acid. The aqueous solution compositions increase the stability of the an Fc domain in aqueous solution compositions, and in particular increase the stability of an engineered dimeric protein.
There is provided, inter alia, an aqueous solution formulation comprising: (i) an Fc fusion protein; and (ii) sulfate ions at a concentration of 5-200 mM to stabilise the Fc fusion protein; which formulation is free of amino acids selected from arginine, lysine and proline, and salts thereof, and which formulation is free of magnesium ions.
A61P 19/02 - Médicaments pour le traitement des troubles du squelette des troubles articulaires, p. ex. arthrites, arthroses
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
The invention provides inter alia an aqueous solution composition of pH in the range 4.0-6.0 comprising: —terlipressin or a salt thereof; —optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 7.0 and which pKa is within 1 pH unit of the pH of the composition; —optionally an amino acid; and—optionally a tonicity modifier wherein the buffers are present in the composition at a total concentration of 0-5 mM.
A61K 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
A61K 47/22 - Composés hétérocycliques, p. ex. acide ascorbique, tocophérol ou pyrrolidones
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
There is provided inter alia an aqueous solution composition of pH in the range 5.0 to 8.0 comprising: —daptomycin or an analogue thereof, or a salt thereof; —a divalent metal cation; and —optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.0 and which pKa is within 2 pH units of the pH of the composition; wherein the buffers are present at a total concentration of 0-5 mM.
The invention provides inter alia an aqueous solution composition of pH in the range 6.0 to 8.0 comprising: —daptomycin or an analogue thereof, or a salt thereof; —a divalent metal cation; and —one or more salts which are not divalent metal cation salts or amino acid salts or buffer salts at a total concentration of 300 mM or more.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
42 - Services scientifiques, technologiques et industriels, recherche et conception
Produits et services
Medical preparations; medicinal products; pharmaceuticals;
biopharmaceuticals. Medical and pharmacological research services; consultancy
in the field of pharmaceutical research and development;
development of pharmaceutical preparations and medicines;
pharmaceutical product evaluation & development; research
and development of vaccines and medicines.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
42 - Services scientifiques, technologiques et industriels, recherche et conception
Produits et services
Medical preparations; medicinal products; pharmaceuticals;
biopharmaceuticals. Medical and pharmacological research services; consultancy
in the field of pharmaceutical research and development;
development of pharmaceutical preparations and medicines;
pharmaceutical product evaluation & development; research
and development of vaccines and medicines.
inter aliainter alia, an aqueous liquid pharmaceutical formulation comprising (i) a fast acting insulin analogue; (ii) ionic zinc; and (ill) citrate, said formulation being substantially free of a zinc binding species having a logK with respect to zinc ion binding of greater than 12.3 at 25 °C; for use in the treatment of a human subject suffering from diabetes mellitus by administration by subcutaneous injection or subcutaneous infusion at or close to a meal-time wherein the administration of 0.3 U/kg of the formulation leads to one or more specified pharmacokinetic and/or pharmacodynamic parameters.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
42 - Services scientifiques, technologiques et industriels, recherche et conception
Produits et services
Medical preparations, namely, diagnostic preparations for medical purposes, preparations for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, metabolic, immune-oncology, oncology, anti-infective, neuroscience, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmology, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders, rare diseases, autoimmune, inflammatory, immunology, pain, infectious diseases, renal, reproductive health and childbirth, blood disorders, vaccines, haematological related diseases and disorders; Medicinal products, namely, pharmaceutical products for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, metabolic, immune-oncology, oncology, anti-infective, neuroscience, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmology, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders, rare diseases, autoimmune, inflammatory, immunology, pain, infectious diseases, renal, reproductive health and childbirth, blood disorders, vaccines, haematological related diseases and disorders; Pharmaceuticals, namely, preparations and substances for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, metabolic, immune-oncology, oncology, anti-infective, neuroscience, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmology, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders, rare diseases, autoimmune, inflammatory, immunology, pain, infectious diseases, renal, reproductive health and childbirth, blood disorders, vaccines, haematological related diseases and disorders; Biopharmaceuticals, namely, preparations and substances for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, metabolic, immune-oncology, oncology, anti-infectives, neuroscience, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmology, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders, rare diseases, autoimmune, inflammatory, immunology, pain, infectious diseases, renal, reproductive health and childbirth, blood disorders, vaccines, haematological related diseases and disorders Medical and pharmacological research services; consultancy in the field of pharmaceutical research and development; development of pharmaceutical preparations and medicines; pharmaceutical product evaluation and development; research and development of vaccines and medicines
42 - Services scientifiques, technologiques et industriels, recherche et conception
Produits et services
Medical and pharmacological research services; consultancy in the field of pharmaceutical research and development; development of pharmaceutical preparations and medicines; pharmaceutical product evaluation and development; research and development of vaccines and medicines
37.
MEDICAL INFUSION PUMP SYSTEM FOR THE DELIVERY OF AN INSULIN COMPOUND
There is provided inter alia medical infusion pump system comprising a pump and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said pump to a mammal wherein the composition comprises (i) an insulin compound at a concentration of 400 U/mL or more, (ii) ionic zinc and (iii) a non-ionic surfactant and wherein the said pump delivers the composition in pulses wherein the volume of the pulse is 0.5 μL or less.
A61M 5/168 - Moyens pour commander l'écoulement des agents vers le corps ou pour doser les agents à introduire dans le corps, p. ex. compteurs de goutte-à-goutte
A61M 5/142 - Perfusion sous pression, p. ex. utilisant des pompes
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 31/192 - Acides carboxyliques, p. ex. acide valproïque ayant des groupes aromatiques, p. ex. sulindac, acides 2-aryl-propioniques, acide éthacrynique
38.
MEDICAL INFUSION PUMP SYSTEM FOR THE DELIVERY OF AN INSULIN COMPOUND
There is provided inter alia medical infusion pump system comprising a pump and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said pump to a mammal wherein the composition comprises (i) an insulin C compound, (ii) ionic zinc and (iii) an alkyl glycoside as a non-ionic surfactant.
An aqueous solution composition of pH in the range 4.0-8.5 comprising: an antibody construct comprising an Fc domain; optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.5 and which pKa is within 2 pH units of the pH of the composition; optionally one or more neutral amino acids; and an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration of 0-5 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.
An aqueous solution composition of pH in the range 4.0-8.5 comprising: an antibody construct comprising an Fc domain; optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.5 and which pKa is within 2 pH units of the pH of the composition; optionally one or more neutral amino acids; and an uncharged tonicity modifier; wherein the buffers are present in the composition at a total concentration of 0-5 mM; and wherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.
There is provided inter alia an injection pen system comprising an injector mechanism and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said injector mechanism to a mammal wherein the composition comprises (i) an insulin compound, (ii) ionic zinc and (iii) an alkyl glycoside as a non-ionic surfactant.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
inter alia inter alia, an aqueous solution formulation comprising: (i) an Fc fusion protein;and (ii) sulfate ions at a concentration of 5-200 mM to stabilise the Fcfusion protein; which formulation is free of amino acids selected from arginine, lysineand proline, and salts thereof,and which formulationis free of magnesium ions.
C07K 14/715 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des cytokinesRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des lymphokinesRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des interférons
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61P 19/02 - Médicaments pour le traitement des troubles du squelette des troubles articulaires, p. ex. arthrites, arthroses
The invention provides inter alia an aqueous solution composition of pH in the range 4.0-6.0 comprising: - terlipressin or a salt thereof; - optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 7.0 and which pKa is within 1 pH unit of the pH of the composition; - optionally an amino acid; and - optionally a tonicity modifier wherein the buffers are present in the composition at a total concentration of 0-5 mM.
inter aliainter alia an aqueous solution composition of pH in the range 6.0 to 8.0 comprising: -daptomycin or an analogue thereof, or a salt thereof; -a divalent metal cation; and -one or more salts which are not divalent metal cation salts or amino acid salts or buffer salts at a total concentration of 300 mM or more.
There is provided inter alia an aqueous solution composition of pH in the range 5.0 to 8.0 comprising: - daptomycin or an analogue thereof, or a salt thereof; - a divalent metal cation; and - optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.0 and which pKa is within 2 pH units of the pH of the composition; wherein the buffers are present at a total concentration of 0-5 mM.
The present invention provides an aqueous solution comprising an antibody protein at a concentration of at least about 10 mg/mL and an oligomer of ethyleneimine, wherein the number of repeating units of ethyleneimine (n) in the oligomer is in the range of n=2-12.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
The present invention relates inter alia to an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a nicotinic compound (iv) a non-ionic surfactant; and (v) a salt selected from the salts formed between Group 1 metals and a mono or divalent anion. It also provides related methods, uses and pharmaceutical compositions.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
The present invention relates inter alia to an aqueous liquid pharmaceutical formulation comprising: (i) an insulin compound; (ii) ionic zinc; (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-10 at 25° C.; (iv) a zinc binding species selected from species having a log K with respect to zinc ion binding of more than 12.3 at 25° C. at a concentration of less than about 0.3 mM; and (v) a non-ionic surfactant. It also provides related methods, uses and pharmaceutical compositions.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
There is provided, inter alia, an aqueous solution comprising (i) an antibody protein; and (ii) a antibody protein stabilizing mixture of arginine, methionine, and a C3 polyol.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
C07K 1/02 - Procédés généraux de préparation de peptides en solution
C07K 16/22 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des facteurs de croissance
C07K 16/06 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux provenant de sérum
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, EDTA, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
53.
MEDICAL INFUSION PUMP SYSTEM FOR THE DELIVERY OF AN INSULIN COMPOUND
There is provided inter aliaa medical infusion pump system comprising a pump and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said pump to a mammal wherein the composition comprises (i) an insulin compound at a concentration of 400 U/mLor more, (ii) ionic zinc and (iii) a non-ionic surfactant and wherein the said pump delivers the composition in pulses wherein the volume of the pulse is 0.5 µLor less.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
54.
MEDICAL INFUSION PUMP SYSTEM FOR THE DELIVERY OF AN INSULIN COMPOUND
inter aliainter alia medical infusion pump system comprising a pump and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said pump to a mammal wherein the composition comprises (i) an insulin compound, (ii) ionic zinc and (iii) an alkyl glycoside as a non-ionic surfactant.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
There is provided inter aliaa medical infusion pump system comprising a pump and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said pump to a mammal wherein the composition comprises (i) an insulin compound at a concentration of 400 U/mLor more, (ii) ionic zinc and (iii) a non-ionic surfactant and wherein the said pump delivers the composition in pulses wherein the volume of the pulse is 0.5 µLor less.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
inter aliainter alia an injection pen system comprising an injector mechanism and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said injector mechanism to a mammal wherein the composition comprises (i) an insulin compound, (ii) ionic zinc and (iii) an alkyl glycoside as a non-ionic surfactant.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
There is provided inter alia an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant which is an alkyl glycoside; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a log K with respect to zinc ion binding of more than 12.3 at 25° C.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
A61M 5/142 - Perfusion sous pression, p. ex. utilisant des pompes
A61M 5/315 - PistonsTiges de pistonGuidage, blocage, ou limitation des mouvements de la tigeAccessoires disposés sur la tige pour faciliter le dosage
A61M 5/32 - AiguillesParties constitutives des aiguilles relatives au raccordement de celles-ci à la seringue ou au manchonAccessoires pour introduire l'aiguille dans le corps ou l'y maintenirDispositifs pour la protection des aiguilles
There is provided inter alia an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound at a concentration of 500-1000 U/ml, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a logK with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a logK with respect to zinc ion binding of more than 12.3 at 25° C.
A61K 31/194 - Acides carboxyliques, p. ex. acide valproïque ayant plusieurs groupes carboxyle, p. ex. acides succinique, maléique ou phtalique
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
A61M 5/315 - PistonsTiges de pistonGuidage, blocage, ou limitation des mouvements de la tigeAccessoires disposés sur la tige pour faciliter le dosage
A61M 5/142 - Perfusion sous pression, p. ex. utilisant des pompes
A61M 5/32 - AiguillesParties constitutives des aiguilles relatives au raccordement de celles-ci à la seringue ou au manchonAccessoires pour introduire l'aiguille dans le corps ou l'y maintenirDispositifs pour la protection des aiguilles
There is provided, inter alia, an aqueous solution composition of pH in the range 4.0-7.5 comprising: a peptide therapeutic agent; optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 8.5 and which pKa is within 2 pH units of the pH of the composition; and a stabilizer; wherein the peptide therapeutic agent does not contain ionisable groups with pKa in the range 3.0 to 8.5, and wherein the buffers are present in the composition at a total concentration of 0-5 mM.
The present invention relates inter alia to an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a nicotinic compound (iv) a non-ionic surfactant; and (v) a salt selected from the salts formed between Group 1 metals and a mono or divalent anion. It also provides related methods, uses and pharmaceutical compositions.
The present invention relates inter alia to an aqueous liquid pharmaceutical formulation comprising: (i) an insulin compound; (ii) ionic zinc; (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a logK with respect to zinc ion binding in the range 4.5-10 at 25 °C; (iv) a zinc binding species selected from species having a logK with respect to zinc ion binding of more than 12.3 at 25 °C at a concentration of less than about 0.3 mM; and (v) a non-ionic surfactant. It also provides related methods, uses and pharmaceutical compositions.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
The present invention relates inter alia to an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound other than insulin glargine, (ii) ionic zinc, (iii) a zinc binding species selected from diethylenetriamine (DETA) and triethylenetetramine (TETA), and (iv) a non-ionic surfactant. It also provides related methods, uses and pharmaceutical compositions.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, EDTA, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, EDTA, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
There is provided, inter alia, an aqueous solution comprising (i) an antibody protein; and (ii) a stabilizing mixture of arginine, methionine and a C3 polyol.
C07K 16/30 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire provenant de cellules de tumeurs
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
There is provided, inter alia, an aqueous solution comprising an antibody protein and a stabilizing mixture of (i) a chelating agent which is a multi-anion; and (ii) a C3 polyol.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
There is provided, inter alia, an aqueous solution composition comprising a GLP-1 receptor agonist as an active ingredient and multivalent anions having a charge of at least minus 2 as stabilising agent, wherein the total concentration of multivalent anions in the composition having a charge of at least minus 2 is at least 15 mM.
There is provided inter aliaan aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of mM or more selected from species having a logK with respect to zinc ion binding in 5 the range 4.5-12.3 at 25 °C, and (iv) a non-ionic surfactant which is an alkyl glycoside; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a logK with respect to zinc ion binding of more than 12.3 at 25 °C.
There is provided inter aliaan aqueous liquid pharmaceutical formulationcomprising (i) an insulincompound at a concentration of 500-1000 U/ml, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a logK with respect to zinc ion binding in the range 4.5-12.3 at 25 °C, and (iv) a non- ionic surfactant; and wherein the formulation is substantially free of EDTA and any other zinc binding species havinga logK with respect to zinc ion binding of more than 12.3at 25 °C.
There is provided inter aliaan aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of mM or more selected from species having a logK with respect to zinc ion binding in 5 the range 4.5-12.3 at 25 °C, and (iv) a non-ionic surfactant which is an alkyl glycoside; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a logK with respect to zinc ion binding of more than 12.3 at 25 °C.
There is provided inter aliaan aqueous liquid pharmaceutical formulationcomprising (i) an insulincompound at a concentration of 500-1000 U/ml, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a logK with respect to zinc ion binding in the range 4.5-12.3 at 25 °C, and (iv) a non- ionic surfactant; and wherein the formulation is substantially free of EDTA and any other zinc binding species havinga logK with respect to zinc ion binding of more than 12.3at 25 °C.
According to the invention there is provided inter alia an aqueous liquid pharmaceutical formulation comprising insulin or an insulin analogue, ionic zinc, a chelating agent and polysorbate 80.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61M 5/00 - Dispositifs pour faire pénétrer des agents dans le corps par introduction sous-cutanée, intravasculaire ou intramusculaireAccessoires à cet effet, p. ex. dispositifs de remplissage ou de nettoyage, appuis-bras
There is provided inter alia an aqueous solution composition comprising insulin glargine as an active ingredient and an amino acid selected from aspartic acid and glutamic acid as a stabilising agent, wherein the amino acid is present at a concentration of 1-50 mM.
A61K 38/00 - Préparations médicinales contenant des peptides
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p. ex. les supports ou les additifs inertesAgents de ciblage ou de modification chimiquement liés à l’ingrédient actif
A61P 3/10 - Médicaments pour le traitement des troubles du métabolisme de l'homéostase du glucose de l'hyperglycémie, p. ex. antidiabétiques
There is provided inter alia an aqueous solution composition comprising insulin glargine as an active ingredient and triethylenetetramine (TETA) as a stabilising agent.
A61K 38/00 - Préparations médicinales contenant des peptides
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p. ex. les supports ou les additifs inertesAgents de ciblage ou de modification chimiquement liés à l’ingrédient actif
A61P 3/10 - Médicaments pour le traitement des troubles du métabolisme de l'homéostase du glucose de l'hyperglycémie, p. ex. antidiabétiques
There is provided inter alia an aqueous solution composition having pH between 4 and 7 comprising: (i) glucagon at a concentration of 1 mg/mL or more; (ii) a cationic surfactant selected from benzalkonium salts and benzethonium salts at a concentration of 2.5 mg/mL or less; and (iii) a polyol at a concentration of 0.5 M or more, wherein the polyol is selected from 1,2-propanediol and glycerol; and wherein the ratio of glucagon to cationic surfactant (mg/mL:mg/mL) is 2: 1 or more.
According to the invention there is provided inter alia an aqueous liquid pharmaceutical formulation comprising insulin or an insulin analogue, ionic zinc, a chelating agent and polysorbate 80.
A61M 5/00 - Dispositifs pour faire pénétrer des agents dans le corps par introduction sous-cutanée, intravasculaire ou intramusculaireAccessoires à cet effet, p. ex. dispositifs de remplissage ou de nettoyage, appuis-bras
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
The present invention is based on the surprising discovery that the inclusion of an anionic polymer in the adenovirus formulation enhances long-term stability of the vector composition. An aqueous formulation comprising an adenovirus vector and at least one anionic polymer is provided, together with methods of the preparation of a storage stable adenovirus aqueous formulation.
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 48/00 - Préparations médicinales contenant du matériel génétique qui est introduit dans des cellules du corps vivant pour traiter des maladies génétiquesThérapie génique
The present invention provides an aqueous solution comprising an antibody protein at a concentration of at least about 10 mg/mL and an oligomer of ethyleneimine, wherein the number of repeating units of ethyleneimine (n) in the oligomer is in the range n=2-12.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
The present invention is based on the surprising discovery that the inclusion of an anionic polymer in the adenovirus formulation enhances long-term stability of the vector composition. An aqueous formulation comprising an adenovirus vector and at least one anionic polymer is provided, together with methods of the preparation of a storage stable adenovirus aqueous formulation.
A61K 48/00 - Préparations médicinales contenant du matériel génétique qui est introduit dans des cellules du corps vivant pour traiter des maladies génétiquesThérapie génique
The present invention is based on the surprising discovery that the inclusion of an anionic polymer in the adenovirus formulation enhances long-term stability of the vector composition. An aqueous formulation comprising an adenovirus vector and at least one anionic polymer is provided, together with methods of the preparation of a storage stable adenovirus aqueous formulation.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 47/36 - PolysaccharidesLeurs dérivés, p. ex. gommes, amidon, alginate, dextrine, acide hyaluronique, chitosane, inuline, agar-agar ou pectine
A61K 48/00 - Préparations médicinales contenant du matériel génétique qui est introduit dans des cellules du corps vivant pour traiter des maladies génétiquesThérapie génique
There is provided according to the invention an aqueous composition having pH between 4 and 7 comprising (i) glucagon at a concentration of 0.05% w/v or more and (ii) a cationic surfactant selected from benzalkonium salts and benzethonium salts as solubilizing agent in an amount sufficient to dissolve the glucagon in the composition.
The present invention provides an aqueous solution comprising an antibody protein at a concentration of at least about 10 mg/mL and an oligomer of ethyleneimine, wherein the number of repeating units of ethyleneimine (n) in the oligomer is in the range n = 2-12.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
The present invention provides an aqueous solution comprising an antibody protein at a concentration of at least about 10 mg/mL and an oligomer of ethyleneimine, wherein the number of repeating units of ethyleneimine (n) in the oligomer is in the range n = 2-12.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
C07K 16/24 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
There is provided according to the invention an aqueous composition having pH between (4) and (7) comprising (i) glucagon at a concentration of 0.05 % w/v or more and (ii) a cationic surfactant selected from benzalkonium salts and benzethonium salts as solubilising agent in an amount sufficient to dissolve the glucagon in the composition.
There is provided according to the invention an aqueous composition having pH between (4) and (7) comprising (i) glucagon at a concentration of 0.05 % w/v or more and (ii) a cationic surfactant as solubilising agent in an amount sufficient to dissolve the glucagon in the composition, wherein the overall concentration of charged species, other than those originating from glucagon and the cationic surfactant, in the composition is less than 150 mM.
The present invention provides an aqueous solution comprising an antibody protein at a concentration of at least about 10 mg/m L and a stabilizing amount of polyethyleneimine.
The invention relates to the discovery that the addition of aromatic carboxylate ions inhibit protein instability caused by aromatic preservatives. Thus, the invention relates to compositions, preferably aqueous compositions, comprising a protein, an aromatic preservative and aromatic carboxylate ions. The proteins remain stable and suitable for storage at ambient temperatures or lower, even in aqueous form. Preferably, the aqueous composition comprises a protein, a phenolic preservative and benzoate ions, wherein the pH of the composition is at least 1 unit greater than the pKa of benzoic acid. The invention also provides methods of reducing protein degradation by aromatic preservatives in an aqueous formulation of a protein susceptible to such degradation, comprising the step of adding aromatic carboxylate ions to the formulation wherein the formulation is maintained at a pH that is at least 1 unit greater than the pKa of the corresponding aromatic carboxylic acid.
The invention allows substantial improvements in stability of coagulation Factor IX in aqueous compositions. An aqueous composition sealed in a non-glass container comprising Factor IX in a buffer and calcium ions is provided, together with methods of stabilizing an aqueous Factor IX composition comprising storing said composition in a non-glass container for at least 7 days.
The invention relates to the discovery that the addition of aromatic carboxylate ions inhibit protein instability caused by aromatic preservatives. Thus, the invention relates to compositions, preferably aqueous compositions, comprising a protein, an aromatic preservative and aromatic carboxylate ions. The proteins remain stable and suitable for storage at ambient temperatures or lower, even in aqueous form. Preferably, the aqueous composition comprises a protein, a phenolic preservative and benzoate ions, wherein the pH of the composition is at least 1 unit greater than the pKa of benzoic acid. The invention also provides methods of reducing protein degradation by aromatic preservatives in an aqueous formulation of a protein susceptible to such degradation, comprising the step of adding aromatic carboxylate ions to the formulation wherein the formulation is maintained at a pH that is at least 1 unit greater than the pKa of the corresponding aromatic carboxylic acid.
An aqueous composition which comprises a protein or other biological molecule and also (i) optionally comprises one or more metal ions at a concentration of 0.01 to 20 mM; (ii) comprises excipients which are weak ligands; and (iii) is substantially free of excipients which are medium-strength ligands, and is substantially free of excipients which are strong ligands in free form.
A composition comprises a biological molecule that is susceptible to aggregation, dimerization or hydrolysis, wherein the ionic strength is less than 40 mM.
There is provided inter alia a cell culture medium for recombinant Factor VIII production characterized in that the culture medium contains calcium ions and a strong ligand such as EDTA.
C12N 5/00 - Cellules non différenciées humaines, animales ou végétales, p. ex. lignées cellulairesTissusLeur culture ou conservationMilieux de culture à cet effet
The invention relates inter alia to a composition which is storage-stable at 25°C for a minimum of 18 weeks comprising a therapeutically effective amount of Factor VIII and an aqueous medium having a Factor VIII potency after 18 weeks of storage at 25° C of at least 90% of the Factor VIII potency of a Control Composition.
A dry composition for use in therapy or diagnosis, obtainable by drying an aqueous composition comprising a protein and one or more displacement buffers, such as TRIS, lactate, lysine and histidine wherein the pH of the aqueous composition is such that the protein is stable, wherein the or each displacement buffer has a pKa that is at least 1 unit greater or less than the pH of the aqueous composition, and wherein the aqueous composition is substantially free of a conventional buffer having a pKa that is within one pH unit of the pH of the aqueous composition.
An aqueous composition comprising a therapeutic protein further characterized in that (i) the pH of the composition is adjusted to be between about 5.9 and 6.3, preferably about 6.1; (ii) the composition comprises at least one displaced buffer having a pKa within 1 to 3 pH units of the pH of the composition such as lactate and TRIS; (iv) the osmolarity of the composition is between 150 - 500 mOsm/L.
An aqueous composition which comprises a protein or other biological molecule and also (i) optionally comprises one or more metal ions at a concentration of 0.01 to 20 mM; (ii) comprises excipients which which are weak ligands; and (iii) is substantially free of excipients which are medium-strength ligands or strong ligands.
