Pharmaceutical aerosol formulations containing pre-micronized albuterol sulfate, high amount of green propellant trans-1,3,3,3-tetrafluoropropene (HFO-1234ze(E)), and a surfactant (polysorbate 80 (polyoxyethylene (20) sorbitan monooleate), polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate), polyethylene glycol 1000, span 85 (sorbitan trioleate), polyvinylpyrrolidone K25, or their combination) in a pressurized metered dose inhaler are described. The formulations do not use any co-solvent, i.e., they are co-solvent-free (e.g., free of ethanol, glycerol, propylene glycol, and a combination thereof). The formulations provide highly efficient delivery, through metered dose inhaler (MDI), of pre-micronized albuterol particles into the patients' respiratory tracts and have the advantages of high efficacy, improved safety, and a low global warming potential (GWP) for environmental impact.
A61K 31/137 - Arylalkylamines, p. ex. amphétamine, épinéphrine, salbutamol, éphédrine
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 47/06 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite
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 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
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
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Nasal spray preparations; nasal sprays for medical purposes;
nasal spray preparations for use in treating Type 1
anaphylaxis reactions; pharmaceutical formulations for use
in treating Type 1 anaphylaxis reactions. Printed matter, namely, brochures, leaflets, and manuals in
the field of pharmaceuticals, pharmaceutical research, and
healthcare. Providing medical information via a website; providing
information relating to diagnostic, prophylactic, and
therapeutic properties of pharmaceuticals.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
(1) Nasal spray preparations; nasal sprays for medical purposes; nasal spray preparations for use in treating Type 1 anaphylaxis reactions; pharmaceutical formulations for use in treating Type 1 anaphylaxis reactions.
(2) Printed matter, namely, brochures, leaflets, and manuals in the field of pharmaceuticals, pharmaceutical research, and healthcare. (1) Providing medical information via a website; providing information relating to diagnostic, prophylactic, and therapeutic properties of pharmaceuticals.
7.
Intranasal (IN) Delivery Device for Delivering a Medication Solution
An IN delivery gas-phase impermeable device for delivery between 0.2 mL and 1.0 mL of a medication solution is disclosed. The device includes an injector barrel including a plurality of slit openings disposed circumferentially along the injector barrel, a center guide positioned lengthwise within the injector barrel, a cannula in fluid communication with the medication solution fixed in position by the center guide, and a vial configured to couple with the injector barrel. The vial includes a pliable rubber stopper with multiple seal rings, each seal ring having a geometry configured to form a gas-phase impermeable seal with an internal surface of the vial. The cannula bisects the pliable rubber stopper. The device includes a base configured to reversibly engage with one or more of the slit openings of the injector barrel during actuation of the device, which may involve compression of the base toward the injector barrel.
An IN delivery gas-phase impermeable device for delivery between 0.2 mL and 1.0 mL of a medication solution is disclosed. The device includes an injector barrel including a plurality of slit openings disposed circumferentially along the injector barrel, a center guide positioned lengthwise within the injector barrel, a cannula in fluid communication with the medication solution fixed in position by the center guide, and a vial configured to couple with the injector barrel. The vial includes a pliable rubber stopper with multiple seal rings, each seal ring having a geometry configured to form a gas-phase impermeable seal with an internal surface of the vial. The cannula bisects the pliable rubber stopper. The device includes a base configured to reversibly engage with one or more of the slit openings of the injector barrel during actuation of the device, which may involve compression of the base toward the injector barrel.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Nasal spray preparations; nasal sprays for medical purposes; nasal spray preparations for use in treating Type 1 anaphylaxis reactions; pharmaceutical formulations for use in treating Type 1 anaphylaxis reactions Printed matter, namely, brochures, leaflets, and manuals in the field of pharmaceuticals, pharmaceutical research, and healthcare Providing a website featuring medical information; providing information relating to diagnostic, prophylactic, and therapeutic properties of pharmaceuticals
10.
TARGETED DELIVERY OF EFFECTIVE THERAPEUTIC MEDICATIONS TO THE RESPIRATORY TRACT
A method for delivering a medication for treatment of a pulmonary disease depending on location(s) of infection lesion(s) within a respiratory tract of a patient is disclosed. The method includes administering metered doses of the medication to the patient having the pulmonary disease by a metered dose inhaler (MDI) actuator having a function of controlling drug particle delivery characteristics. The medication is effective for treating the pulmonary disease. A therapeutically effective amount of medication for treating the pulmonary disease is administered by various metered doses of the medication. The medication includes an active pharmaceutical ingredient (API) associated with treatment of a pulmonary disease. The medication includes a propellant, a co-solvent, and a surfactant. The API is dissolved in the propellant at a pre-determined ratio, with or without a co-solvent. The medication is administered via metered-dose inhalation.
The present disclosure introduces pharmaceutical formulations having epinephrine as the active pharmaceutical ingredient (API), and a bile acid, or salt thereof (e.g., sodium taurocholate (STC)) as an absorption enhancer, for intranasal (IN) delivery. The bile acid, or the salt thereof, enhances absorption of epinephrine by IN delivery. Also disclosed are methods of administering epinephrine to a patient by IN delivery using the disclosed epinephrine formulations for various treatments or indications.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Pharmaceutical and medical preparations; chemical substances for medical and pharmaceutical use; injectable pharmaceuticals; pharmaceutical preparations sold in prefilled injectors; pharmaceutical preparations for inhalers; inhaled pharmaceutical preparations; pharmaceutical preparations in powdered form; nasal sprays; prescription and over-the-counter medicines, for use in connection with humans, namely, pharmaceutical preparations for treating metabolic conditions, cardiovascular conditions, respiratory conditions, allergic reactions, fertility conditions, anesthetic agents, and opioid overdose. Printed publications; printed reports, guides, manuals, studies, textbooks, journals, books, magazines, articles and newsletters; printed matter, namely, brochures, leaflets, and manuals in the field of pharmaceuticals, pharmaceutical research, and healthcare. Medical, medicinal and pharmaceutical consultancy; medical and pharmaceutical advisory services; providing information in the fields of medicine and pharmaceutics; medical and pharmaceutical analysis services; medical diagnostic services [testing and analysis]; medical testing services; providing a website featuring medical information; Providing information relating to diagnostic, prophylactic, and therapeutic properties of pharmaceutical.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
Produits et services
Pharmaceutical and medical preparations; chemical substances for medical and pharmaceutical use; injectable pharmaceuticals; pharmaceutical preparations sold in prefilled injectors; pharmaceutical preparations for inhalers; inhaled pharmaceutical preparations; pharmaceutical preparations in powdered form; nasal sprays; prescription and over-the-counter medicines, for use in connection with humans, namely, pharmaceutical preparations for treating metabolic conditions, cardiovascular conditions, respiratory conditions, allergic reactions, fertility conditions, anesthetic agents, and opioid overdose. Printed publications; printed reports, guides, manuals, studies, textbooks, journals, books, magazines, articles and newsletters; printed matter, namely, brochures, leaflets, and manuals in the field of pharmaceuticals, pharmaceutical research, and healthcare.
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Medical, medicinal and pharmaceutical consultancy; medical and pharmaceutical advisory services; providing information in the fields of medicine and pharmaceutics; medical and pharmaceutical analysis services; medical diagnostic services [testing and analysis]; medical testing services; providing a website featuring medical information; Providing information relating to diagnostic, prophylactic, and therapeutic properties of pharmaceuticals.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Pharmaceutical and medical preparations; chemical substances for medical and pharmaceutical use; injectable pharmaceuticals; pharmaceutical preparations sold in prefilled injectors; pharmaceutical preparations for inhalers; inhaled pharmaceutical preparations; pharmaceutical preparations in powdered form; nasal sprays; prescription and over-the-counter medicines, for use in connection with humans, namely, pharmaceutical preparations for treating metabolic conditions, cardiovascular conditions, respiratory conditions, allergic reactions, fertility conditions, anesthetic agents, and opioid overdose. Printed publications; printed reports, guides, manuals, studies, textbooks, journals, books, magazines, articles and newsletters; printed matter, namely, brochures, leaflets, and manuals in the field of pharmaceuticals, pharmaceutical research, and healthcare. Medical, medicinal and pharmaceutical consultancy; medical and pharmaceutical advisory services; providing information in the fields of medicine and pharmaceutics; medical and pharmaceutical analysis services; medical diagnostic services [testing and analysis]; medical testing services; providing a website featuring medical information; Providing information relating to diagnostic, prophylactic, and therapeutic properties of pharmaceuticals.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Prescription and over-the-counter medicines, for use in connection with humans, namely, pharmaceutical preparations for treating metabolic conditions, cardiovascular conditions, allergic reactions, fertility conditions, anesthetic agents, and opioid overdose Printed matter, namely, brochures, leaflets, and manuals in the field of pharmaceuticals, pharmaceutical research, and healthcare Providing a website featuring medical information; Providing information relating to diagnostic, prophylactic, and therapeutic properties of pharmaceuticals
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Prescription and over-the-counter medicines, for use in connection with humans, namely, pharmaceutical preparations for treating metabolic conditions, cardiovascular conditions, allergic reactions, fertility conditions, anesthetic agents, and opioid overdose Printed matter, namely, brochures, leaflets, and manuals in the field of pharmaceuticals, pharmaceutical research, and healthcare Providing a website featuring medical information; Providing information relating to diagnostic, prophylactic, and therapeutic properties of pharmaceuticals
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
Produits et services
Prescription and over-the-counter medicines, for use in connection with humans, namely, pharmaceutical preparations for treating metabolic conditions, cardiovascular conditions, allergic reactions, fertility conditions, anesthetic agents, and opioid overdose Printed matter, namely, brochures, leaflets, and manuals in the field of pharmaceuticals, pharmaceutical research, and healthcare
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Providing a website featuring medical information; Providing information relating to diagnostic, prophylactic, and therapeutic properties of pharmaceuticals
20.
Nasal powder formulation for treatment of hypoglycemia
The present invention provides a powder formulation containing glucagon or a glucagon analog for nasal administration, useful in the treatment of hypoglycemia, and in particular the treatment of severe hypoglycemia. The present invention also provides a method of making this powder formulation, and to devices and methods for using the powder formulation.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
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 generally pertains to a medical device and more particularly, a metered-dose inhaler (“MDI”) actuator capable of a targeted delivery of fine API particles having particle diameters of about 1.1 μm or less to a portion of a patient's lungs where alveoli are located.
B65D 83/30 - Buses, leurs moyens de support ou leurs accessoires spécialement adaptés à cet effet pour guider le flux du contenu distribué p. ex. entonnoirs ou hottes
B65D 83/14 - Récipients pour distribuer des contenus liquides ou semi-liquides par pression interne de gaz, c.-à-d. réceptacles aérosols contenant un propulseur
B65D 83/36 - Récipients pour distribuer des contenus liquides ou semi-liquides par pression interne de gaz, c.-à-d. réceptacles aérosols contenant un propulseur permettant le fonctionnement dans toutes les positions
22.
Safe Use of Bile Acids and Their Salts as Enhancers for Nasal Delivery of Pharmaceuticals
The present disclosure introduces safe and effective pharmaceutical formulations for intranasal delivery. Specifically, the present disclosure introduces the safe clinical use of bile acids or salts thereof as an enhancer to exhibit improved bioavailability and tissue tolerance. In several embodiments, pharmaceutical formulations including bile acids or salts thereof are provided. In several embodiments, the formulations are suitable and/or configured for the intranasal (IN) delivery, methods of manufacturing such formulations, and methods of treating patients using such formulations. The pharmaceutical formulations comprising bile acids, salts of bile acids, and/or combinations thereof. In several embodiments, bile acids, salts of bile acids, and/or combinations thereof are configured for use as absorption enhancers.
The present disclosure introduces intranasal (IN) pharmaceutical formulations having naloxone or an opioid antagonist as the active agent, and an absorption enhancer, such as a bile acid, or a salt thereof, for IN delivery. The bile acid, or salt thereof, enhances absorption of naloxone or an opioid antagonist into the bloodstream of a human subject.
Disclosed herein are pharmaceutical formulations including epinephrine that have increased epinephrine retention over long-term storage, e.g., 30-months. In one aspect, a formulation includes: one or more of 0.1 mg/mL of epinephrine or a pharmaceutically acceptable salt thereof provided without any overage, a tonicity regulating agent including 8.2 mg/mL of sodium chloride, a pH adjusting agent including a mixture of 1.5 mg/mL sodium citrate dihydrate, 3.3 mg/mL of citric acid monohydrate, and, optionally, an as-needed amount of sodium hydroxide to maintain the pH level of the formulation within a range of 3.6 to 4.0, 0.075 mg/mL of sodium metabisulfite, and 4 μg/mL of ethylene diamine tetra-acetate disodium. The formulation has an API recovery of 94.5% or more after at least 30 months of storage at long-term storage conditions defined as 25° C.±2° C. at 1 atmosphere. In addition, in another aspect, a formulation includes 1 mg/mL of epinephrine and other ingredients.
Disclosed herein are pharmaceutical formulations including epinephrine that have increased epinephrine retention over long-term storage, e.g., 30-months. In one aspect, a formulation includes: one or more of 0.1 mg/mL of epinephrine or a pharmaceutically acceptable salt thereof provided without any overage, a tonicity regulating agent including 8.2 mg/mL of sodium chloride, a pH adjusting agent including a mixture of 1.5 mg/mL sodium citrate dihydrate, 3.3 mg/mL of citric acid monohydrate, and, optionally, an as-needed amount of sodium hydroxide to maintain the pH level of the formulation within a range of 3.6 to 4.0, 0.075 mg/mL of sodium metabisulfite, and 4 μg/mL of ethylene diamine tetra-acetate disodium. The formulation has an API recovery of 94.5% or more after at least 30 months of storage at long-term storage conditions defined as 25° C.±2° C. at 1 atmosphere. In addition, in another aspect, a formulation includes 1 mg/mL of epinephrine and other ingredients.
The present disclosure introduces methods for characterizing iron core carbohydrate colloid drug products, such as iron sucrose drug products. Disclosed methods enable the characterization of the iron core size of the iron core nanoparticles in iron carbohydrates as they exist in the formulation in solution, such as e.g. iron sucrose drug products, and more particularly, the average particle diameter size and size distribution(s) of the iron core nanoparticles. The disclosed methods apply small-angle X-ray scattering (SAXS) in parallel beam transmission geometry, with a sample mounted inside a capillary and centered in the X-ray beam, to iron carbohydrates, such as iron sucrose, in solution without the need to modify the sample, such as to remove unbound carbohydrates, dilute, or dry the sample, to accurately characterize the average iron core particle diameter size of the iron core nanoparticles. An example application of the disclosed method is to perform SAXS measurements under identical instrument settings on two samples of the same type of iron core nanoparticle colloid drug product for the purpose of comparing their iron core structures. Such comparisons are typically performed during the iron core carbohydrate colloid drug development process, and can include comparisons of samples that have been manipulated.
G01N 23/201 - Recherche ou analyse des matériaux par l'utilisation de rayonnement [ondes ou particules], p. ex. rayons X ou neutrons, non couvertes par les groupes , ou en utilisant la diffraction de la radiation par les matériaux, p. ex. pour rechercher la structure cristallineRecherche ou analyse des matériaux par l'utilisation de rayonnement [ondes ou particules], p. ex. rayons X ou neutrons, non couvertes par les groupes , ou en utilisant la diffusion de la radiation par les matériaux, p. ex. pour rechercher les matériaux non cristallinsRecherche ou analyse des matériaux par l'utilisation de rayonnement [ondes ou particules], p. ex. rayons X ou neutrons, non couvertes par les groupes , ou en utilisant la réflexion de la radiation par les matériaux en mesurant la diffusion sous un petit angle, p. ex. la diffusion des rayons X sous un petit angle [SAXS]
G01N 15/02 - Recherche de la dimension ou de la distribution des dimensions des particules
G01N 23/207 - Diffractométrie, p. ex. en utilisant une sonde en position centrale et un ou plusieurs détecteurs déplaçables en positions circonférentielles
Disclosed herein are pharmaceutical formulations including epinephrine that have increased epinephrine retention over long-term storage, e.g., 30-months. In one aspect, a formulation includes: one or more of 0.1 mg/mL of epinephrine or a pharmaceutically acceptable salt thereof provided without any overage, a tonicity regulating agent including 8.2 mg/mL of sodium chloride, a pH adjusting agent including a mixture of 1.5 mg/mL sodium citrate dihydrate, 3.3 mg/mL of citric acid monohydrate, and, optionally, an as-needed amount of sodium hydroxide to maintain the pH level of the formulation within a range of 3.6 to 4.0, 0.075 mg/mL of sodium metabisulfite, and 4 μg/mL of ethylene diamine tetra-acetate disodium. The formulation has an API recovery of 94.5% or more after at least 30 months of storage at long-term storage conditions defined as 25° C.±2° C. at 1 atmosphere. In addition, in another aspect, a formulation includes 1 mg/mL of epinephrine and other ingredients.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations, namely, opioid antagonists and narcotic antagonists administered only by nasal spray; pharmaceutical and drug preparations for use in treatment of opiate, opioid or narcotic overdose administered only by nasal spray; Intranasal drug delivery devices, injector devices for nasal delivery, or devices for nasal delivery, all pre-filled with pharmaceuticals, namely, opioid antagonists and narcotic antagonists and pharmaceutical and drug preparations for use in treatment of opiate, opioid or narcotic overdose
The present invention provides an improved method for preparing a powder formulation containing a peptide. The present invention further provides an improved method for preparing a powder formulation containing glucagon or a glucagon analog, wherein said powder formulation is suitable for nasal administration.
The present disclosure introduces epinephrine pharmaceutical formulations having a low epinephrine concentration and a low amount of impurities during its shelf-life, including up to 15 months, 18 months, 21 months, or more. Additionally, the disclosed epinephrine formulations have a very low concentration of antioxidant, a very low concentration of metal-chelate, and suitable pH that causes less irritation to patients. In several embodiments, the epinephrine concentration is about 0.1 mg/mL.
A61M 5/20 - Seringues automatiques, p. ex. avec tige de piston actionnée automatiquement, avec injection automatique de l'aiguille, à remplissage automatique
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
The present disclosure introduces intranasal (IN) pharmaceutical formulations having naloxone or an opioid antagonist as the active agent, and an absorption enhancer, such as a bile acid, or a salt thereof, for IN delivery. The bile acid, or salt thereof, enhances absorption of naloxone or an opioid antagonist into the bloodstream of a human subject.
A61K 31/4468 - Pipéridines non condensées, p. ex. pipérocaïne ayant un atome d'azote lié directement en position 4, p. ex. clébopride, fentanyl
A61K 31/451 - Pipéridines non condensées, p. ex. pipérocaïne ayant un carbocycle lié directement à l'hétérocycle, p. ex. glutéthimide, mépéridine, lopéramide, phencyclidine, piminodine
33.
EPINEPHRINE PHARMACEUTICAL FORMULATIONS FOR INTRANASAL DELIVERY
The present disclosure introduces pharmaceutical formulations having epinephrine as the active pharmaceutical ingredient (API), and a bile acid, or salt thereof (e.g., sodium taurocholate (STC)) as an absorption enhancer, for intranasal (IN) delivery. The bile acid, or the salt thereof, enhances absorption of epinephrine by IN delivery. Also disclosed are methods of administering epinephrine to a patient by IN delivery using the disclosed epinephrine formulations for various treatments or indications.
The present disclosure provides NMR relaxation methods for characterizing iron carbohydrate drug products. The methods measure 13C and 1H nuclei relaxation parameters such as T1 and PWHH include performing 2D T1 NMR, 1D 13C NMR and 12255 and an 1H NMR method to monitor the Fe(III)/Fe(II) reduction process.
G01N 24/08 - Recherche ou analyse des matériaux par l'utilisation de la résonance magnétique nucléaire, de la résonance paramagnétique électronique ou d'autres effets de spin en utilisant la résonance magnétique nucléaire
G01R 33/44 - Dispositions ou appareils pour la mesure des grandeurs magnétiques faisant intervenir la résonance magnétique utilisant la résonance magnétique nucléaire [RMN]
35.
SAFE USE OF BILE ACIDS AND THEIR SALTS AS ENHANCERS FOR NASAL DELIVERY OF PHARMACEUTICALS
The present disclosure introduces safe and effective pharmaceutical formulations for intranasal delivery. Specifically, the present disclosure introduces the safe clinical use of bile acids or salts thereof as an enhancer to exhibit improved bioavailability and tissue tolerance. In several embodiments, pharmaceutical formulations including bile acids or salts thereof are provided. In several embodiments, the formulations are suitable and/or configured for the intranasal (IN) delivery, methods of manufacturing such formulations, and methods of treating patients using such formulations. The pharmaceutical formulations comprising bile acids, salts of bile acids, and/or combinations thereof. In several embodiments, bile acids, salts of bile acids, and/or combinations thereof are configured for use as absorption enhancers.
A61K 38/18 - Facteurs de croissanceRégulateurs de croissance
C07K 14/50 - Facteur de croissance des fibroblastes [FGF]
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
36.
SMALL ANGLE X-RAY SCATTERING METHODS FOR CHARACTERIZING THE IRON CORE OF IRON CARBOHYDRATE COLLOID DRUG PRODUCTS
The present disclosure introduces methods for characterizing iron core carbohydrate colloid drug products, such as iron sucrose drug products. Disclosed methods enable the characterization of the iron core size of the iron core nanoparticles in iron carbohydrates as they exist in the formulation in solution, such as e.g. iron sucrose drug products, and more particularly, the average particle diameter size and size distribution(s) of the iron core nanoparticles. The disclosed methods apply small-angle X-ray scattering (SAXS) in parallel beam transmission geometry, with a sample mounted inside a capillary and centered in the X- ray beam, to iron carbohydrates, such as iron sucrose, in solution without the need to modify the sample, such as to remove unbound carbohydrates, dilute, or dry the sample, to accurately characterize the average iron core particle diameter size of the iron core nanoparticles. An example application of the disclosed method is to perform SAXS measurements under identical instrument settings on two samples of the same type of iron core nanoparticle colloid drug product for the purpose of comparing their iron core structures. Such comparisons are typically performed during the iron core carbohydrate colloid drug development process, and can include comparisons of samples that have been manipulated.
G01N 23/201 - Recherche ou analyse des matériaux par l'utilisation de rayonnement [ondes ou particules], p. ex. rayons X ou neutrons, non couvertes par les groupes , ou en utilisant la diffraction de la radiation par les matériaux, p. ex. pour rechercher la structure cristallineRecherche ou analyse des matériaux par l'utilisation de rayonnement [ondes ou particules], p. ex. rayons X ou neutrons, non couvertes par les groupes , ou en utilisant la diffusion de la radiation par les matériaux, p. ex. pour rechercher les matériaux non cristallinsRecherche ou analyse des matériaux par l'utilisation de rayonnement [ondes ou particules], p. ex. rayons X ou neutrons, non couvertes par les groupes , ou en utilisant la réflexion de la radiation par les matériaux en mesurant la diffusion sous un petit angle, p. ex. la diffusion des rayons X sous un petit angle [SAXS]
The present disclosure generally pertains to a medical device and more particularly, a metered-dose inhaler ("MDI") actuator capable of a targeted delivery of fine API particles having particle diameters of about 1.1 μm or less to a portion of a patient's lungs where alveoli are located.
41 - Éducation, divertissements, activités sportives et culturelles
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Educational services, namely, online and telephone coaching regarding the treatment of diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction Medical information services in the field of diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction
41 - Éducation, divertissements, activités sportives et culturelles
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Educational services, namely, online and telephone coaching regarding the treatment of diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction Medical information services in the field of diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction
40.
Highly purified recombinant human insulin (RHI) API and methods of producing the same
A21-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclosed are API compositions of highly purified RHI having a purity of 99.0% (w/w) or greater, a Total Impurity of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less.
B01D 15/18 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives aux différents types d'écoulement
B01D 15/32 - Chromatographie en phase liée, p. ex. avec une phase normale liée, une phase inverse ou une interaction hydrophobe
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
C07K 1/06 - Procédés généraux de préparation de peptides utilisant des groupes protecteurs ou des agents d'activation
C07K 1/16 - ExtractionSéparationPurification par chromatographie
Methods are disclosed for producing highly purified recombinant human insulin (RHI) having a purity of 99.0% (w/w) or greater, a Total Impurity (not including the related substance desamido AsnA21-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclosed are API compositions of highly purified RHI having a purity of 99.0% (w/w) or greater, a Total Impurity of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 9/127 - Vecteurs à bicouches synthétiques, p. ex. liposomes ou liposomes comportant du cholestérol en tant qu’unique agent tensioactif non phosphatidylique
A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics: (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 μm, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
(1) Medical information services in the field of diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction
45.
Nasal powder formulation for treatment of hypoglycemia
The present invention provides a powder formulation containing glucagon or a glucagon analog for nasal administration, useful in the treatment of hypoglycemia, and in particular the treatment of severe hypoglycemia. The present invention also provides a method of making this powder formulation, and to devices and methods for using the powder formulation.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
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
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
(1) Medical information services in the field of diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Medical information services; Medical information services in the field of diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction; Pharmaceutical preparations.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction
61.
Nasal powder formulation for treatment of hypoglycemia
The present invention provides a powder formulation containing glucagon or a glucagon analog for nasal administration, useful in the treatment of hypoglycemia, and in particular the treatment of severe hypoglycemia. The present invention also provides a method of making this powder formulation, and to devices and methods for using the powder formulation.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
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
A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics: (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 μm, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.
A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics: (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 μm, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.
A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics: (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 μm, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.
A method of preparing a thioic acid intermediate of fluticasone propionate includes: treating a 17β-[(N,N-dimethyl carbamoyl)thio]carbonyl compound in a solution including an alcohol and an alkali metal hydroxide, an alkaline-earth metal hydroxide, or a mixture thereof to cleave an amide from the 17β-[(N,N-dimethyl carbamoyl)thio]carbonyl compound; treating the solution to separate an aqueous portion; and adding an acid to the aqueous portion to obtain the thioic acid intermediate of fluticasone propionate. A method of preparing fluticasone propionate includes preparing the thioic acid intermediate of fluticasone propionate, and alkylating the thioic acid intermediate of fluticasone propionate to prepare the fluticasone propionate.
A method of resolving a racemic mixture of (±) Huperzine A to (-)-Huperzine A includes: separating the (-)-Huperzine A from the racemic mixture of (±) Huperzine A by chiral high performance liquid chromatography (HPLC), the chiral HPLC being performed utilizing a mobile phase including a solution including an alcohol and one selected from dichloromethane, trichloromethane, and a mixture thereof, and the chiral HPLC being performed utilizing a chiral stationary phase including a polysaccharide derivative.
A61K 31/439 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à six chaînons avec un azote comme seul hétéro-atome d'un cycle le cycle formant une partie d'un système cyclique ponté, p. ex. quinuclidine
A61K 31/4748 - QuinoléinesIsoquinoléines formant une partie de systèmes cycliques pontés
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction.
68.
Micronized insulin and micronized insulin analogues prepared under acidic conditions, and methods of manufacturing the same under acidic conditions
A method of preparing an inhalable insulin suitable for pulmonary delivery includes: dissolving an insulin raw material in an acidic solution to form a dissolved insulin solution; titrating the dissolved insulin solution with a buffer solution to form a suspension comprising micronized insulin particles; and stabilizing the micronized insulin particles.
A method of preparing an inhalable insulin suitable for pulmonary delivery includes: dissolving an insulin raw material in an acidic solution to form a dissolved insulin solution; titrating the dissolved insulin solution with a buffer solution to form a suspension comprising micronized insulin particles; and stabilizing the micronized insulin particles.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations, namely, glucagon for diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Hypoglycemia and diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction, prevention and treatment medications; glucagon.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Hypoglycemia and diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction, prevention and treatment medications; glucagon.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Hypoglycemia and diabetes related hypoglycemia, including low blood sugar, diabetes insulin shock, and insulin reaction, prevention and treatment medications, namely, glucagon.
74.
Stable epinephrine suspension formulation with high inhalation delivery efficiency
A stable suspension aerosol formulation of epinephrine is suitable for administration through inhalation comprising a therapeutically effective amount of epinephrine, hydrofluorocarbon propellant, co-solvent, surfactant, and antioxidant. The suspension aerosol formulation further comprises [pre-] pre-micronized epinephrine suspended in an alcohol/surfactant solution with hydrofluoroalkane propellant. The suspension formulation provides a highly efficient delivery of drug microparticles into the respirable region of patients' lungs and has the following advantages: lower dosage requirement, minimum alcohol content, with less impurities generated during storage, improved efficacy and safety, and exhibits no ozone depleting potential compared to a formulation containing chlorofluorocarbon.
An oil-in-water propofol emulsion that contains soybean oil and egg lecithin, which provide a source of nutrition for microorganisms. Current products include additives to act as a microbial growth retardation agent, the processes described herein detail several methods for the optimization of the innate microbial retardation capability of propofol. Using this process improves the safety of a propofol emulsion solution by controlling microbial growth without the side effects associated with growth retardation additives.
Pharmaceutical compositions for long-term sustained release of bisphosphonate drugs are provided. In one embodiment, the composition includes an aqueous suspension of a solid which includes a salt of a bisphosphonate drug and a salt of pentavalent phosphorus oxoacid. The compositions can be used to treat a variety of bone diseases, including osteoporosis.
A01N 57/00 - Biocides, produits repoussant ou attirant les animaux nuisibles, ou régulateurs de croissance des végétaux, contenant des composés organiques du phosphore
Pharmaceutical compositions for long-term sustained release of bisphosphonate drugs are provided. In one embodiment, the composition includes an aqueous suspension of a solid which includes a salt of a bisphosphonate drug and a salt of pentavalent phosphorus oxoacid. The compositions can be used to treat a variety of bone diseases, including osteoporosis.
The present invention relates to a pharmaceutical composition comprising a salt of quaternary ammonium of an acid drug in the form of a suspension or an emulsion, suitable for parenteral administration and providing a sustained release of the drug. In one preferred embodiment, the present invention is directed to a long term sustained release composition for parenteral administration, comprising a salt of heparin or low molecular weight heparin in an emulsion with a salt of acylcholine, for the prevention and treatment of venous thrombosis and pulmonary embolism.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparation used as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents
The present invention provides a powder formulation containing glucagon or a glucagon analog for nasal administration, useful in the treatment of hypoglycemia, and in particular the treatment of severe hypoglycemia. The present invention also provides a method of making this powder formulation, and to devices and methods for using the powder formulation.
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
A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics: (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 µm, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.
Pharmaceutical compositions for long-term sustained release of bisphosphonate drugs are provided. In one embodiment, the composition includes an aqueous suspension of a solid which includes a salt of a bisphosphonate drug and a salt of pentavalent phosphorus oxoacid. The compositions can be used to treat a variety of bone diseases, including osteoporosis.
A method of preparing an inhalable insulin suitable for pulmonary delivery includes: dissolving an insulin raw material in an acidic solution to form a dissolved insulin solution; titrating the dissolved insulin solution with a buffer solution to form a suspension comprising micronized insulin particles; and stabilizing the micronized insulin particles.
The present invention provides an improved method for preparing a powder formulation containing a peptide. The present invention further provides an improved method for preparing a powder formulation containing glucagon or a glucagon analog, wherein said powder formulation is suitable for nasal administration.
