The present invention relates to an improved method for separating and detecting of free or residual polyethylene glycol (PEG) in pegylated protein mixture. In particular, the method improves sensitivity, effective separation, and robustness of the quantification of free or residual PEG and related substance present in pegylated protein mixture which obtained as drug substance or drug product.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
B01D 15/32 - Chromatographie en phase liée, p. ex. avec une phase normale liée, une phase inverse ou une interaction hydrophobe
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
B01D 15/42 - Adsorption sélective, p. ex. chromatographie caractérisée par le mode de développement, p. ex. par déplacement ou par élution
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak and main peak (fusion protein). The method provides improved sharpness and resolution of pre-peak impurity. The method provides pre-peak area not less than 1.0 and resolution more than 1.3 in SE-HPLC. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak and main peak of the protein mixture.
C07K 1/16 - ExtractionSéparationPurification par chromatographie
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
B01D 15/42 - Adsorption sélective, p. ex. chromatographie caractérisée par le mode de développement, p. ex. par déplacement ou par élution
B01J 20/28 - Compositions absorbantes ou adsorbantes solides ou compositions facilitant la filtrationAbsorbants ou adsorbants pour la chromatographieProcédés pour leur préparation, régénération ou réactivation caractérisées par leur forme ou leurs propriétés physiques
B01J 20/283 - Absorbants ou adsorbants poreux à base de silice
C07K 14/705 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire
3.
AN IMPROVED METHOD FOR SEPARATION AND QUANTIFICATION OF PANCREATIC ENZYMES BY USING CE-SDS
The present disclosure relates to a method for improving separation and quantification profile of pancreatic protein mixture comprising at least one enzyme amylase, protease, and lipase, trypsin, chymotrypsin, elastase and kallikrein glandular and variant thereof through capillary electrophoresis Sodium dodecyl sulfate (CE-SDS). Furthermore, the invention provides a stable pancreatic protein sample comprising substantially free of digested protein which makes the pancreatic sample more suitable for analytical characterization.
G01N 33/573 - Tests immunologiquesTests faisant intervenir la formation de liaisons biospécifiquesMatériaux à cet effet pour enzymes ou isoenzymes
C07K 1/36 - ExtractionSéparationPurification par une combinaison de plusieurs procédés de types différents
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
C12Q 1/34 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir une hydrolase
4.
AN IMPROVED CELL CULTURE PROCESS FOR PRODUCTION OF PROTEIN
The present invention relates to an improved cell culture process for production of proteins with the addition of mitochondria targeted antioxidant to the cell culture. The performance of the cell production is enhanced in aspects of higher viable cell density, protein titer, and reduced oxidation.
The present invention provides an improved assay method for determining the potency of recombinant proteins by culturing tire immune cells such as antigen presenting cell and/or T cell in culture media comprising FBS less than 10%. Furthermore, the invention provides a method to eliminate or reduce tire false estimation of potency of target recombinant protein. The assay method determines the potency of recombinant protein by evaluating the expression of inflammatory protein. More specifically the present invention describes the IL-2 inhibition assays for determination of potency of CTLA4 IgGl .
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
C07K 16/42 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre des immunoglobulines (anticorps anti-idiotypiques)
6.
AN IMPROVED METHOD FOR SEPARATION OF LOW MOLECULAR WEIGHT PROTEINS
The present invention provides the method for the separation of at least more than two Low molecular weight (LMWs) impurities present in the protein mixture comprising fusion protein CTL4-IgGl by using Capillary Electrophoresis-Sodium dodecyl sulfate (CE-SDS) wherein the loading amount of protein mixture is more than 270 pg. The invention further provides a ratio of protein to sodium dodecyl sulfate is 2.7:1 or higher.
G01N 27/26 - Recherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en recherchant des variables électrochimiquesRecherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en utilisant l'électrolyse ou l'électrophorèse
7.
A PROCESS FOR SEPARATION AND QUANTIFICATION OF NON-IONIC SURFACTANT
The present invention relates to a separation and quantification method of a non-ionic surfactant in a composition comprising polypeptide and non-ionic surfactant by using a zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC).
B01D 15/36 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction ionique, p. ex. échange d'ions, paire d'ions, suppression d'ions ou exclusion d'ions
G01N 30/30 - Contrôle des paramètres physiques du fluide vecteur de la température
A process for purification of antibody or fusion protein by affinity chromatography wherein the elution is performed with high salt concentration which reduce turbidity in protein mixture during neutralization steps. The present invention provides an improved process of purifying antibodies through affinity chromatography using high salt-based elution.
B01D 15/38 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction spécifique non couverte par un ou plusieurs des groupes , p. ex. chromatographie d'affinité, chromatographie d'échange par ligand ou chromatographie chirale
B01D 15/42 - Adsorption sélective, p. ex. chromatographie caractérisée par le mode de développement, p. ex. par déplacement ou par élution
C07K 16/06 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux provenant de sérum
C07K 16/42 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre des immunoglobulines (anticorps anti-idiotypiques)
9.
CELL CULTURE METHOD TO INCREASE CELL BIOMASS, PRODUCTIVITY AND PROTEIN TITER
The method disclosed in the current invention is used to increase cell biomass, productivity and protein titer in cell culture medium by using at least more than one fermenter. The method specifically discloses cell culture conditions used in fermenter. More specifically, the method discloses the use of primary and secondary fermenter wherein the primary fermenter comprises different cell culture conditions compared to secondary fermenter.
C12N 5/00 - Cellules non différenciées humaines, animales ou végétales, p. ex. lignées cellulairesTissusLeur culture ou conservationMilieux de culture à cet effet
C07K 16/00 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux
C07K 16/22 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des facteurs de croissance
C12P 21/02 - Préparation de peptides ou de protéines comportant une séquence connue de plusieurs amino-acides, p. ex. glutathion
The present invention relates to a stable liquid composition comprising Ocrelizumab antibody. More specifically, the present invention further provides stable liquid composition does not comprise a hyaluronidase enzyme.
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 47/18 - 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
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
G01N 33/53 - Tests immunologiquesTests faisant intervenir la formation de liaisons biospécifiquesMatériaux à cet effet
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
The present invention relates to a method of analysis for estimation of relative potency of antibody of interest using beta-hexosaminidase degranulation in human cell line. The present invention relates to characterization of functional assay of anti-lgE antibody with beta-hexosaminidase. Every area of the biomedical science is in need of a system to assay chemical and biochemical reactions and determine the presence and quantity of a particular analyte. Numerous methodologies have been developed over the years to meet the demands of these fields. In general, limitations exist in the areas of specificity and sensitivity of most assay system.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
13.
AN IMPROVED CELL CULTURE PROCESS FOR PRODUCTION OF PROTEIN
An improved cell culture process for production of protein The present invention relates to an improved cell culture process for production of proteins with the addition of mitochondria targeted antioxidant to the cell culture. The performance of the cell production is enhanced in aspects of higher viable cell density, protein titer, and reduced oxidation.
Title: A Method for separating and detecting of free or residual polyethylene glycol in Pegylated proteins. The present invention relates to an improved method for separating and detecting of free or residual polyethylene glycol (PEG) in pegylated protein mixture. In particular, the method improves sensitivity, effective separation, and robustness of the quantification of free or residual PEG and related substance present in pegylated protein mixture which obtained as drug substance or drug product.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
16.
AN IMPROVED PROCESS FOR THE SEPARATION AND ANALYSIS OF PANCREATIC ENZYMES
Title: An improved process for the separation and analysis of pancreatic enzymes. The present invention relates to reversed phase ultrahigh-performance liquid chromatography (RP- UHPLC) process by using C18 column at a suitable more than one gradient of mobile phase useful for the separation and characterisation of pancreatic protein mixture comprising at least one enzyme lipase, amylase, protease and variant thereof. The present invention further provides qualitative and quantitative analysis of separated Pancreatic protein mixture suitable for pharmaceutical use.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
The present invention relates to a process of improving the production of anti-IgE antibody specifically Omalizumab with improved titer and reduced galactosylation and/or reduced acidic variant expressed in mammalian cell culture in suitable culture condition for an example using fed batch mode by maintaining specific temperature 36.5° C ± 0.5 throughout the duration of cells culture.
C12P 21/00 - Préparation de peptides ou de protéines
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
C12N 5/00 - Cellules non différenciées humaines, animales ou végétales, p. ex. lignées cellulairesTissusLeur culture ou conservationMilieux de culture à cet effet
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
18.
A PROCESS FOR SEPARATION AND QUANTIFICATION OF NON-IONIC SURFACTANT
The present invention relates to a separation and quantification method of a non-ionic surfactant in a composition comprising polypeptide and non-ionic surfactant by using a zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC).
B01D 15/36 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction ionique, p. ex. échange d'ions, paire d'ions, suppression d'ions ou exclusion d'ions
G01N 30/30 - Contrôle des paramètres physiques du fluide vecteur de la température
19.
AN IMPROVED METHOD FOR SEPARATION OF LOW MOLECULAR WEIGHT PROTEINS
The present invention provides the method for the separation of at least more than two Low molecular weight (LMWs) impurities present in the protein mixture comprising fusion protein CTL4-IgG1 by using Capillary Electrophoresis-Sodium dodecyl sulfate (CE-SDS) wherein the loading amount of protein mixture is more than 270 µg. The invention further provides a ratio of protein to sodium dodecyl sulfate is 2.7:1 or higher.
G01N 27/26 - Recherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en recherchant des variables électrochimiquesRecherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en utilisant l'électrolyse ou l'électrophorèse
The present invention provides an improved assay method for determining the potency of recombinant proteins by culturing the immune cells such as antigen presenting cell and/or T cell in culture media comprising FBS less than 10%. Furthermore, the invention provides a method to eliminate or reduce the false estimation of potency of target recombinant protein. The assay method determines the potency of recombinant protein by evaluating the expression of inflammatory protein. More specifically the present invention describes the IL-2 inhibition assays for determination of potency of CTLA4 IgG1.
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 compounds or pharmaceutically acceptable salts thereof, useful for the treatment of cancer. The present disclosure also relates to pharmaceutical composition of the novel compound and method of treating benign or malignant disease of the breast or reproductive tract, prostate cancer, or endometrial cancer using the same.
A61K 31/58 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes contenant des hétérocycles, p. ex. danazol, stanozolol, pancuronium ou digitogénine
22.
MULTICISTRON EXPRESSION VECTOR FOR COVID-19 VACCINE
The present invention provides an expression vector comprises gene of interest encode more than one structural protein to enhance immune responses against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and its variants. Further, the present invention the expression vector comprises spike protein of SARS-CoV-2 and one or more structural protein selected from membrane protein, envelope protein and nucleocapsid protein of SARS-CoV-2. The expression vector expressed mRNA capable to encode more than one structural protein to provide immune response against SARS-CoV-2 virus.
The present invention provides an expression vector comprises gene of interest encode more than one structural protein to enhance immune responses against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and its variants. Furthermore, the expression vector to produce mRNA expresses more than one structural protein to generate immune response against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and its variants.
The invention relates to an injectable composition comprising compound I, pharmaceutically acceptable salts or solvates thereof; and at least one pharmaceutically acceptable excipient, wherein the injectable composition provides sustained release of compound I and thereby maintains blood plasma fulvestrant concentration. Also, the present invention used for method of treatment of breast cancer comprising compound of formula I, pharmaceutically acceptable salts or solvates thereof; and at least one pharmaceutically acceptable excipient.
A61K 31/565 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes non substitués en position 17 bêta par un atome de carbone, p. ex. œstrane, œstradiol
The invention is directed to room temperature stable injectable formulations of carfilzomib or its pharmaceutically acceptable derivatives thereof in the form of ready to dilute solution and concentrates with no hemolytic potential. Further the invention is directed to a method for treating patients with relapsed or refractory multiple myeloma by administering such composition.
The invention is directed to room temperature stable injectable formulations of carfilzomib or its pharmaceutically acceptable derivatives thereof in the form of ready to dilute solution and concentrates with no hemolytic potential. Further the invention is directed to a method for treating patients with relapsed or refractory multiple myeloma by administering such composition.
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak and main peak (fusion protein). The method provides improved sharpness and resolution of pre-peak impurity. The method provides pre-peak area not less than 1.0 and resolution more than 1.3 in SE-HPLC. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak and main peak of the protein mixture.
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
B01D 15/38 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction spécifique non couverte par un ou plusieurs des groupes , p. ex. chromatographie d'affinité, chromatographie d'échange par ligand ou chromatographie chirale
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
28.
SEPARATION OF PRE-PEAK AND POST-PEAK IN FUSION PROTEIN SAMPLE BY USING SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak, post-peak and main peak of CTLA4-IgG1 fusion protein, where pre-peak resolution is more than 1.3. The invention further provides effective separation and resolution of post peak impurity present in CTLA4 IgG1 protein. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak, post-peak and main peak of the protein mixture.
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
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
29.
SEPARATION OF PRE-PEAK IN FUSION PROTEIN SAMPLE BY USING SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak and main peak (fusion protein). The method provides improved sharpness and resolution of pre-peak impurity. The method provides pre-peak area not less than 1.0 and resolution more than 1.3 in SE-HPLC. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak and main peak of the protein mixture.
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
B01D 15/38 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction spécifique non couverte par un ou plusieurs des groupes , p. ex. chromatographie d'affinité, chromatographie d'échange par ligand ou chromatographie chirale
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
30.
SEPARATION OF PRE-PEAK AND POST-PEAK IN FUSION PROTEIN SAMPLE BY USING SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak, post-peak and main peak of CTLA4-IgG1 fusion protein, where pre-peak resolution is more than 1.3. The invention further provides effective separation and resolution of post peak impurity present in CTLA4 IgG1 protein. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak, post-peak and main peak of the protein mixture.
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
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
The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention providescytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.
The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention providescytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.
The present invention relates to purification process of pharmacologically active cytotoxic T lymphocyte-associated 4-immunoglobulin (CTLA4-lg) fusion protein by using three column chromatography steps that provides purified form of the fusion protein, substantially free of misfolded species, charge variants and aggregates. A method for purifying a fusion protein from a protein mixture comprising a fusion protein and high molecular weight (HMW) impurity.
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
B01D 15/36 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction ionique, p. ex. échange d'ions, paire d'ions, suppression d'ions ou exclusion d'ions
B01D 15/38 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction spécifique non couverte par un ou plusieurs des groupes , p. ex. chromatographie d'affinité, chromatographie d'échange par ligand ou chromatographie chirale
C07K 1/16 - ExtractionSéparationPurification par chromatographie
The present invention relates to purification process of pharmacologically active cytotoxic T lymphocyte-associated 4-immunoglobulin (CTLA4-lg) fusion protein by using three column chromatography steps that provides purified form of the fusion protein, substantially free of misfolded species, charge variants and aggregates. A method for purifying a fusion protein from a protein mixture comprising a fusion protein and high molecular weight (HMW) impurity.
C07K 16/06 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux provenant de sérum
B01D 15/36 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction ionique, p. ex. échange d'ions, paire d'ions, suppression d'ions ou exclusion d'ions
B01D 15/38 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction spécifique non couverte par un ou plusieurs des groupes , p. ex. chromatographie d'affinité, chromatographie d'échange par ligand ou chromatographie chirale
The present invention relates to an improved method of quantification and/or estimation of purity of antibody or fusion protein from a protein mixture containing impurity by providing long term sample stability. The invention provides a stable protein solution comprising antibody having reduce formation of Fab and Fc related impurities.
The present invention relates to an improved method of quantification and/or estimation of purity of antibody or fusion protein from a protein mixture containing impurity by providing long term sample stability. The invention provides a stable protein solution comprising antibody having reduce formation of Fab and Fc related impurities.
C07K 1/16 - ExtractionSéparationPurification par chromatographie
C07K 16/00 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux
C12P 21/06 - Préparation de peptides ou de protéines préparés par hydrolyse d'une liaison peptidique, p. ex. hydrolysats
C12Q 1/37 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir une hydrolase faisant intervenir une peptidase ou une protéinase
G01N 1/28 - Préparation d'échantillons pour l'analyse
The invention provided herein a pharmaceutical process used for an extraction of proteins from pancreatic sample and estimation of the extracted proteins. Moreover, the invention provides a use of suitable is selected from citrate-phosphate buffer and bicarbonate buffer capable to extract proteins from pancreatic sample. The invention further provides an analytical method to perform estimation of extracted proteins. This process provides an improved extraction method to quantify protein present in the pancreatic sample.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
40.
AN EXTRACTION PROCESS OF PANCRELIPASE AND EVALUATION THREOF
The invention provided herein a pharmaceutical process used for an extraction of proteins from pancreatic sample and estimation of the extracted proteins. Moreover, the invention provides a use of suitable is selected from citrate-phosphate buffer and bicarbonate buffer capable to extract proteins from pancreatic sample. The invention further provides an analytical method to perform estimation of extracted proteins. This process provides an improved extraction method to quantify protein present in the pancreatic sample.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
The present invention provides an improved method for analysis of pancreatic protein mixture comprises at least more than one biological active protein selected from amylase, protease and lipase, wherein the analysis and quantification of pancreatic protein mixtures is performed with Size Exclusion High Performance Liquid Chromatography (SE-HPLC). Also, the present invention provides the process for the separation, analysis and quantification of low molecular weight and high molecular weight enzymes present in pancreatic protein mixture.
G01N 33/48 - Matériau biologique, p. ex. sang, urineHémocytomètres
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
42.
METHOD FOR SIZE BASED EVALUATION OF PANCREATIC PROTEIN MIXTURE
The present invention provides an improved method for analysis of pancreatic protein mixture comprises at least more than one biological active protein selected from amylase, protease and lipase, wherein the analysis and quantification of pancreatic protein mixtures is performed with Size Exclusion High Performance Liquid Chromatography (SE-HPLC). Also, the present invention provides the process for the separation, analysis and quantification of low molecular weight and high molecular weight enzymes present in pancreatic protein mixture.
G01N 33/48 - Matériau biologique, p. ex. sang, urineHémocytomètres
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
The present invention relates to novel liquid formulations comprising pharmacologically active fusion protein. The present invention discloses the use of histidine buffer in combination with other excipients to stabilize the fusion protein by lowering the product related impurities. In another aspects invention provides a formulation of fusion protein with low viscosity.
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 47/26 - 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 14/71 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des facteurs de croissanceRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des régulateurs de croissance
The present invention relates to novel liquid formulations comprising pharmacologically active fusion protein. The present invention discloses the use of histidine buffer in combination with other excipients to stabilize the fusion protein by lowering the product related impurities. In another aspects invention provides a formulation of fusion protein with low viscosity.
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 47/26 - 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 14/71 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des facteurs de croissanceRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des régulateurs de croissance
The present invention relates to compounds of formula I and therapeutic use of the same. The present invention also discloses pharmaceutical composition of compounds of formula I and method of treatment using the same.
The present invention provides a method for reducing the protein aggregation by adjusting the pH below 6.0 of liquid formulation comprising the antibody or fusion protein. The present invention also provides methods for storing the pre-formulation for longer period without using any sugar or additives which can be utilized for preparation of liquid or lyophilized formulation.
A61K 9/19 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p. ex. poudres lyophilisées
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/14 - Esters d’acides carboxyliques, p. ex. acides gras monoglycérides, triglycérides à chaine moyenne, parabènes ou esters d’acide gras de PEG
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 16/00 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux
50.
AN IMPROVED PROCESS OF STORING AND PREPARING THE PROTEIN
The present invention provides a method for reducing the protein aggregation by adjusting the pH below 6.0 of liquid formulation comprising the antibody or fusion protein. The present invention also provides methods for storing the pre-formulation for longer period without using any sugar or additives which can be utilized for preparation of liquid or lyophilized formulation.
A61K 9/19 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p. ex. poudres lyophilisées
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
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
A process for purification of antibody or fusion protein through anion exchange chromatography to produce an antibody or fusion protein which is substantially free of at least one of the product-related impurities.
A process for purification of antibody or fusion protein by affinity chromatography wherein the elution is performed with high salt concentration which reduce turbidity in protein mixture during neutralization steps. The present invention provides an improved process of purifying antibodies through affinity chromatography using high salt-based elution.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
B01D 12/00 - Déplacement d'un liquide au moyen d'un autre liquide, p. ex. en retirant le liquide de solides humides, ou de dispersions de liquides, ou de solides se trouvant dans des liquides
B01D 15/08 - Adsorption sélective, p. ex. chromatographie
B01D 15/10 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement
The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.
The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.
A process for purification of antibody or fusion protein through anion exchange chromatography to produce an antibody or fusion protein which is substantially free of at least one of the product-related impurities.
A process for purification of antibody or fusion protein by affinity chromatography wherein the elution is performed with high salt concentration which reduce turbidity in protein mixture during neutralization steps. The present invention provides an improved process of purifying antibodies through affinity chromatography using high salt-based elution.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
B01D 12/00 - Déplacement d'un liquide au moyen d'un autre liquide, p. ex. en retirant le liquide de solides humides, ou de dispersions de liquides, ou de solides se trouvant dans des liquides
B01D 15/08 - Adsorption sélective, p. ex. chromatographie
B01D 15/10 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement
57.
STABLE READY TO DILUTE FORMULATIONS OF CARFILZOMIB
The invention provides room temperature stable ready to dilute injectable formulation comprising carfilzomib or it pharmaceutically acceptable derivatives. The invention further provides methods for treating patients with multiple myeloma by administering room temperature stable ready to dilute injectable formulations comprising carfilzomib or its pharmaceutically acceptable derivatives.
The invention provides room temperature stable ready to dilute injectable formulation comprising carfilzomib or it pharmaceutically acceptable derivatives. The invention further provides methods for treating patients with multiple myeloma by administering room temperature stable ready to dilute injectable formulations comprising carfilzomib or its pharmaceutically acceptable derivatives.
The present invention relates to Fulvestrant prodrugs and process for the preparation thereof. The present disclosure also relates to pharmaceutical composition of Fulvestrant prodrugs and method of treatment using the same.
A61K 31/565 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes non substitués en position 17 bêta par un atome de carbone, p. ex. œstrane, œstradiol
C07J 51/00 - Stéroïdes normaux à squelette du cyclopenta[a]hydrophénanthrène non modifié non prévus dans les groupes
The present disclosure describes pharmaceutically stable high concentration liquid formulations of antibody. Such formulations comprise, in addition to the antibody, at least one anti-aggregating agent selected from arginine or lysine, buffer and poloxamer 188. In addition, the present disclosure provides high concentrated antibody formulation having high monomer, low aggregates and desirable viscosity.
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 47/24 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant des atomes autres que des atomes de carbone, d'hydrogène, d'oxygène, d'halogènes, d'azote ou de soufre, p. ex. cyclométhicone ou phospholipides
The present invention relates to compounds useful as bradykinin receptor antagonist, pharmaceutical composition comprising such compounds, and therapeutic use of the same. The present invention further relates to the combination of compounds useful for the therapeutic use. The present invention relates to the pharmaceutical composition comprising the compound and combination of compounds useful for treatment of urinary bladder pain, the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
A61K 31/4439 - Pyridines non condenséesLeurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p. ex. oméprazole
C07D 413/04 - Composés hétérocycliques contenant plusieurs hétérocycles, au moins un cycle comportant des atomes d'azote et d'oxygène comme uniques hétéro-atomes du cycle contenant deux hétérocycles liés par une liaison directe de chaînon cyclique à chaînon cyclique
63.
NOVEL FORMULATION OF HIGHLY CONCENTRATED PHARMACOLOGICALLY ACTIVE ANTIBODY
The present disclosure describes pharmaceutically stable high concentration liquid formulations of antibody. Such formulations comprise, in addition to the antibody, at least one anti-aggregating agent selected from arginine or lysine, buffer and poloxamer 188. In addition, the present disclosure provides high concentrated antibody formulation having high monomer, low aggregates and desirable viscosity.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
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 47/24 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant des atomes autres que des atomes de carbone, d'hydrogène, d'oxygène, d'halogènes, d'azote ou de soufre, p. ex. cyclométhicone ou phospholipides
The present disclosure provides a method for analyzing, detecting and separating at least one low molecular weight impurity from a protein mixture using capillary electrophoresis, e.g., capillary electrophoresis - sodium dodecyl sulfate (CE-SDS). The present disclosure further provides methods to improve protein peak separation efficiency and quantification of a protein. Furthermore, the present disclosure provides an improved reduced CE-SDS method for analyzing a protein mixture comprising protein of interest which is pegylated and separates LMW or HMW fragments present in the protein mixture.
C12Q 1/04 - Détermination de la présence ou du type de micro-organismeEmploi de milieux sélectifs pour tester des antibiotiques ou des bactéricidesCompositions à cet effet contenant un indicateur chimique
C12Q 1/70 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir des virus ou des bactériophages
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
The present disclosure provides a method for analyzing, detecting and separating at least one low molecular weight impurity from a protein mixture using capillary electrophoresis, e.g., capillary electrophoresis - sodium dodecyl sulfate (CE-SDS). The present disclosure further provides methods to improve protein peak separation efficiency and quantification of a protein. Furthermore, the present disclosure provides an improved reduced CE-SDS method for analyzing a protein mixture comprising protein of interest which is pegylated and separates LMW or HMW fragments present in the protein mixture.
C12P 21/00 - Préparation de peptides ou de protéines
C12Q 1/70 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir des virus ou des bactériophages
G01N 27/26 - Recherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en recherchant des variables électrochimiquesRecherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en utilisant l'électrolyse ou l'électrophorèse
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
66.
GASTRORETENTIVE DOSAGE FORMS OF LEVODOPA AND CARBIDOPA
maxminmin) compared to marketed CD/LD products. The compositions provide extended release of CD/LD for about 8 to about 14 hours, without losing gastroretentive attributes of the system (GRS attributes), and collapse/squeeze after at least about 80% of the drug (CD/LD) is released from the system. The compositions of the disclosure, when consumed or when in contact with media simulating gastric conditions, float in about 45 minutes or less, swell in about 60 minutes or less to a swollen state that prevents their passage through the pyloric sphincter, and remain in the swollen state, while releasing steady therapeutic concentrations of the drug, for prolonged periods, e.g., about 8-14 hours.
The present disclosure provides programmable osmotic-controlled oral compositions providing delayed extended release of a therapeutically acceptable amount of methylphenidate hydrochloride. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm that matches the circadian rhythm of an individual being treated to optimize therapeutic outcome and minimize side effects.
maxminmaxmax ratio of ≥ 0.4, while maintaining a therapeutically effective concentration for a period of at least about 16 hours. The compositions of the disclosure improve solubility of trihexyphenidyl hydrochloride, at a pH of greater than or equal to 5, to maintain its minimum effective concentration at such pH. In certain embodiments, the compositions of the disclosure comprise an IR drug layer to provide extended release with a minimal lag time, while maintaining a therapeutically effective concentration of trihexyphenidyl hydrochloride for a period of at least about 16 hours.
22 from a gas-generating agent(s), and adequate membrane elasticity that provides for rapid expansion of the membrane. The hydrated core, especially the polyethylene oxide in the push layer, and the permeable elastic membrane with an orifice (1) provide extended release of the active pharmaceutical agent, and (2) maintain the dosage form at a size suitable for gastric retention. The self-regulating composition collapses, or breaks into pieces, after releasing at least about 80% of the drug from the composition.
Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release / dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.
The present invention relates to fulvestrant prodrugs of formula II and process for the preparation thereof. The present disclosure also relates to pharmaceutical composition of fulvestrant prodrugs and method of treatment using the same.
A61K 31/565 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes non substitués en position 17 bêta par un atome de carbone, p. ex. œstrane, œstradiol
The present invention is directed to pro-drugs of Eliglustat (formula A) and process for the preparation thereof. The present invention is further directed to pharmaceutical composition thereof and method of treatment using the same.
A61K 31/357 - Composés hétérocycliques ayant l'oxygène comme seul hétéro-atome d'un cycle, p. ex. fungichromine ayant plusieurs atomes d'oxygène dans le même cycle, p. ex. éthers en couronne, guanadrel
C07D 319/18 - Éthylènedioxybenzènes, non substitués sur l'hétérocycle
C07D 413/06 - Composés hétérocycliques contenant plusieurs hétérocycles, au moins un cycle comportant des atomes d'azote et d'oxygène comme uniques hétéro-atomes du cycle contenant deux hétérocycles liés par une chaîne carbonée contenant uniquement des atomes de carbone aliphatiques
76.
STABLE PHARMACEUTICAL COMPOSITIONS OF DIANHYDROGALACTITOL
The present invention relates to a stable pharmaceutical preparation containing dianhydrogalactitol or its pharmaceutically acceptable salts for the treatment of various types of cancer. For purpose of the present invention, the formulation is preferably a ready to use or ready to dilute injection formulation for parenteral administration. The formulation of the present invention provides a better patient compliance as compared to the currently available lyophilized formulation.
A61K 31/336 - Composés hétérocycliques ayant l'oxygène comme seul hétéro-atome d'un cycle, p. ex. fungichromine ayant des cycles à trois chaînons, p. ex. oxirane, fumagilline
A61K 31/4188 - 1,3-Diazoles condensés avec des systèmes hétérocycliques, p. ex. biotine, sorbinil
A61K 45/06 - Mélanges d'ingrédients actifs sans caractérisation chimique, p. ex. composés antiphlogistiques et pour le cœur
The present invention relates to anti-progestational agents of compounds of general formula (I) and process for the preparation thereof. The present invention further relates to pharmaceutical composition thereof and method of treatment using the same.
A61K 31/56 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes
A61K 31/57 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes substitués en position 17 bêta par une chaîne à deux atomes de carbone, p. ex. prégnane ou progestérone
The presently disclosed subject matter provides a solid immediate release pharmaceutical particulate dosage form containing one population of particulates, and/or a solid immediate release pharmaceutical multi-particulate dosage form containing at least two different populations of particulates. In certain embodiments, the immediate release pharmaceutical dosage forms contain at least three different populations of multi-particulates. Each population of particulates is designed for a specific function to accomplish the desired combination of abuse deterrence and overdose protection.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
42 - Services scientifiques, technologiques et industriels, recherche et conception
Produits et services
Pharmaceutical research and development services for providing abuse deterrent and/or overdose protection formulations for immediate release or modified release of an active ingredient from a pharmaceutical formulation
87.
ENHANCED ABUSE-DETERRENT FORMULATIONS OF OXYCODONE
The present technology relates to an extended-release solid oral pharmaceutical composition, comprising a cured blend of a melt-extruded first component and a second component, wherein the melt-extruded first component comprises a therapeutically effective amount of an opioid or a pharmaceutically acceptable salt thereof, at least one PEO polymer, and a stabilizing agent; and the second component comprises at least one PEO polymer and an oxidative stabilizing agent. The extended-release pharmaceutical compositions of the present technology provide crush-resistant and abuse-deterrent formulations featuring enhanced heat stability, resistance to drug segregation, and resistance to alcohol-induced dose dumping.
