Produits et services

Pharmaceutical and Medicinal Preparations

Produits et services

Pharmaceutical and Medicinal Preparations

Produits et services

Pharmaceutical and Medicinal Preparations

Produits et services

Pharmaceutical and Medicinal Preparations

Produits et services

Pharmaceutical and Medicinal Preparations

Produits et services

Pharmaceutical and Medicinal Preparations

Abrégé

The present application relates to a method of orally administering once daily tablet of minocycline to a subject in need thereof, wherein said tablet is substantially free of lactose. The present application also relates to processes for preparing said once daily tablet of minocycline that provides reduced stock keeping units with improved inventory by supplying multiple doses of minocycline in single tablet.

Classes IPC  ?

• A61K 31/65 - Tétracyclines 
• A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
• A61K 9/20 - Pilules, pastilles ou comprimés
• A61K 9/28 - Dragées; Pilules ou comprimés avec revêtements

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Abrégé

The current invention discloses a method for obtaining a purified antibody composition. The method discloses the use of various chromatography steps in a particular order to obtain a purified composition of a therapeutic monoclonal antibody starting from a composition comprising the monoclonal antibody and one or more process and product related impurities. Further, the method also discloses the use of additional purification steps such as depth filtration, diafiltration, ultrafiltration and tangential flow filtration for obtaining the said purified antibody composition.

Classes IPC  ?

• C07K 1/18 - Chromatographie d'échange d'ions
• C07K 1/22 - Chromatographie d'affinité ou techniques analogues basées sur des procédés d'absorption sélective
• 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

Abrégé

The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1) or programmed death receptor Ligand 1 (PD-L1), and method for preparing the same. The disclosed formulations are free of sugar or sugar alcohol and stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Classes IPC  ?

• 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 47/02 - Composés inorganiques
• A61K 47/18 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides 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 oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine

Abrégé

The present invention relates to a cell culture process for producing a monoclonal antibody composition, the process comprising culturing the mammalian cells at a pH range of about 6.6 to about 7.5, performing a temperature shift from a first culture temperature to a second culture temperature, supplementation of galactose in the cell culture, thereby obtaining an antibody composition comprising galactosylated glycoform and/or G0F glycoform. Further, the cell culture process disclosed in the present invention obtains an antibody composition comprising galactosylated glycoform wherein the percentage of galactosylated glycoform decreases with the decrease in the difference between the first temperature and the second temperature.

Classes IPC  ?

• 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

Abrégé

The method disclosed in the current invention is used to purify an antibody from high molecular weight aggregates. The method discloses the use of anion exchange chromatography for the reduction of high molecular weight aggregates from the antibody composition, in particular, by contacting the antibody composition with the anion exchange resin at a specific pH and conductivity. The disclosed method eliminates the need for further chromatographic steps for the reduction of HMW aggregates.

Classes IPC  ?

• C07K 16/28 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
• A61K 39/395 - Anticorps; Immunoglobulines; Immunsérum, p.ex. sérum antilymphocitaire
• C07K 1/18 - Chromatographie d'échange d'ions

Abrégé

The present application provides an amorphous solid dispersion of Fruquintinib with one or more pharmaceutically acceptable carriers and processes for the preparation thereof. The present application specifically provides an amorphous solid dispersion of Fruquintinib with a pharmaceutically acceptable carrier, selected from a group of co-povidone, HPMC, HPMC-AS, Eudragit, HPC and mixtures thereof.

Classes IPC  ?

• A61K 31/517 - Pyrimidines; Pyrimidines hydrogénées, p.ex. triméthoprime condensées en ortho ou en péri avec des systèmes carbocycliques, p.ex. quinazoline, périmidine
• A61P 35/00 - Agents anticancéreux
• A61K 31/343 - Composés hétérocycliques ayant l'oxygène comme seul hétéro-atome d'un cycle, p.ex. fungichromine ayant des cycles à cinq chaînons avec un oxygène comme seul hétéro-atome d'un cycle, p.ex. isosorbide condensés avec un carbocycle, p.ex. coumarane, bufaralol, béfunolol, clobenfurol, amiodarone
• A61K 9/10 - Dispersions; Emulsions
• A61K 47/38 - Cellulose; Ses dérivés
• 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 o
• A61K 47/61 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif l’ingrédient non actif étant chimiquement lié à l’ingrédient actif, p.ex. conjugués polymère-médicament l’ingrédient non actif étant un agent de modification l’agent de modification étant un composé organique macromoléculaire, p.ex. une molécule oligomérique, polymérique ou dendrimérique le composé organique macromoléculaire étant un polysaccharide ou l’un de ses dérivés
• A61K 47/58 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif l’ingrédient non actif étant chimiquement lié à l’ingrédient actif, p.ex. conjugués polymère-médicament l’ingrédient non actif étant un agent de modification l’agent de modification étant un composé organique macromoléculaire, p.ex. une molécule oligomérique, polymérique ou dendrimérique obtenu par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p.ex. poly[méth]acrylate, polyacrylamide, polystyrène, polyvinylpyrrolidone, alcool polyvinylique ou résine d’acide sulfonique de polystyrène
• A61K 47/50 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif l’ingrédient non actif étant chimiquement lié à l’ingrédient actif, p.ex. conjugués polymère-médicament

Abrégé

The present application relates to novel crystalline forms of Danuglipron and processes for preparation thereof. Specifically, the present application relates to crystalline anhydrate and crystalline hydrate forms of Danuglipron. The present application further relates to crystalline Forms of Danuglipron selected from a group of DN1, DN2, DN3 and mixture thereof. The crystalline form of Danuglipron is used for the preparation of medicament for treating and preventing a disease, such as Type 2 Diabetes Mellitus, pre-diabetes, obesity, NASH, cardiovascular diseases etc., for which an agonist of GLP-1 receptor is indicated.

Classes IPC  ?

• A61K 31/435 - 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
• A61K 31/4439 - Pyridines non condensées; Leurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p.ex. oméprazole
• A61K 31/4427 - Pyridines non condensées; Leurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques
• A61K 31/444 - Pyridines non condensées; Leurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à six chaînons avec l'azote comme hétéro-atome du cycle, p.ex. amrinone

Abrégé

The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1)/programmed death receptor Ligand 1 (PD-L1), and method for preparing the same. The disclosed formulations stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Classes IPC  ?

• 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 9/08 - Solutions
• A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
• A61K 47/12 - Acides carboxyliques; Leurs sels ou anhydrides
• A61K 47/18 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides 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 oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine

Abrégé

The present invention discloses a stable buffer free formulation of anti-PD1/anti-PD-L1 antibody, comprising an anti-PD1 or an anti-PD-L1 antibody, water, mannitol and surfactant, and stabilized at a pH of about 5.0-about 6.0. The disclosed antibody formulation is a liquid formulation and can be lyophilized. Further, the said formulation is also suitable for different mode of administration such as subcutaneous/intravenous, for therapeutic use.

Classes IPC  ?

• A61K 39/395 - Anticorps; Immunoglobulines; Immunsérum, p.ex. sérum antilymphocitaire
• A61K 9/08 - Solutions
• A61K 47/26 - Hydrates de carbone, p.ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
• 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

Abrégé

The present invention discloses a method for precise identification and absolute quantitation of a wide array of analytes present in a sample at nanomolar to millimolar concentration ranges, by mass spectrometry in a single run. Specifically, present method can, in a single run, simultaneously identify and quantify upto 70 cell culture media components including amino acids, amino acid derivatives vitamins, organic acids and sugars or cellular metabolites using liquid chromatography mass spectrometry (LC-MS) coupled with triple quad detector (QqQ) using multiple reaction monitoring (MRM), present at the said concentration range, with substantial accuracy. The method is capable of distinguishing analytes with same or similar molecular mass, is also suitable across production scales and cell culture process types (eg. fed batch or continuous culture) and has immense industrial utility in guiding the cell culture feeding strategy by profiling analytes intermittently during the fermentation process.

Classes IPC  ?

• G01N 30/02 - Chromatographie sur colonne
• G01N 30/72 - Spectromètres de masse
• G01N 30/88 - Systèmes intégrés d'analyse, spécialement adaptés à cet effet, non couverts par un seul des groupes
• G01N 33/68 - Analyse chimique de matériau biologique, p.ex. de sang ou d'urine; Test par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligands; Test immunologique faisant intervenir des protéines, peptides ou amino-acides

Abrégé

The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1)/programmed death receptor Ligand 1 (PD-L1), and method for preparing the same. The disclosed formulations are free of chelators and stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Classes IPC  ?

• 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 9/08 - Solutions
• A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
• A61K 47/12 - Acides carboxyliques; Leurs sels ou anhydrides
• A61K 47/18 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides 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 oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine

Abrégé

The present invention relates to immediate release pharmaceutical composition comprising amorphous solid dispersions of the protein kinase inhibitor, nilotinib or a pharmaceutically acceptable salt thereof, and pharmaceutical compositions comprising the same. More particularly, the present invention relates to improved pharmaceutical compositions of nilotinib, or a pharmaceutically acceptable salt thereof, that can be administered without regard to food 5 consumption and that can be administered at a significantly lower dose as compared to a commercially available immediate-release nilotinib formulation, while providing a comparable therapeutic effect. A method of preparation of the said compositions is also dislcosed.

Classes IPC  ?

• A61K 31/506 - Pyrimidines; Pyrimidines hydrogénées, p.ex. triméthoprime non condensées et contenant d'autres hétérocycles
• C07D 401/14 - Composés hétérocycliques contenant plusieurs hétérocycles comportant des atomes d'azote comme uniques hétéro-atomes du cycle, au moins un cycle étant un cycle à six chaînons avec un unique atome d'azote contenant au moins trois hétérocycles
• A61P 35/02 - Agents anticancéreux spécifiques pour le traitement de la leucémie

Abrégé

The present application relates to a oral composition comprising nutrients to address the nutrition deficiency in human subjects. Particularly the application relates to oral compositions comprising prebiotics and micronutrients. More particularly, the application relates to oral compositions comprising prebiotics, beta-glucan and micronutrients and the process of preparation for the same. The present application further relates to a nutritional composition in the form of gummies and process for preparation thereof.

Classes IPC  ?

• A61K 31/00 - Préparations médicinales contenant des ingrédients actifs organiques 
• A61K 31/702 - Oligosaccharides, c. à. d. ayant trois à cinq radicaux saccharide liés les uns aux autres par des liaisons glycosidiques
• A61K 31/716 - Glucanes
• A61K 33/00 - Préparations médicinales contenant des ingrédients actifs inorganiques

Abrégé

The present invention relates to a mammalian cell culture process to modulate a pharmaceutical composition of a monoclonal antibody composition comprising galactosylated glycoform of the antibody, the process comprising 5 culturing the mammalian cells within a pH range of about 6.7 to about 7.4, performing a temperature shift from a first culture temperature to a second culture temperature, supplementing the cell culture with manganese or galactose, thereby obtaining an antibody composition comprising increased percentage of galactosylated glycoforms. Further, the cell culture process 10 disclosed in the present invention comprises culturing mammalian cells within a pH range of about 6.7 to about 7.4, performing a temperature shift from a first culture temperature to a second culture temperature, supplementing the cell culture with manganese or galactose, thereby obtaining a biosimilar monoclonal antibody composition comprising galactosylated glycoforms of the 15 biosimilar monoclonal antibody at a target/predetermined range as of that of the reference product.

Classes IPC  ?

• C12P 21/08 - Anticorps monoclonaux
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux
• C12N 5/16 - Cellules animales

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes; Pharmaceutical preparations; dietary supplements for human use; Pharmaceutical products.

Abrégé

SS)-2,2,2-trifluoro-l-methyl- ethyl]hydrazine or its salts.

Classes IPC  ?

• C07D 231/38 - Atomes d'azote
• C07D 231/14 - Composés hétérocycliques contenant des cycles diazole-1, 2 ou diazole-1, 2 hydrogéné non condensés avec d'autres cycles comportant deux ou trois liaisons doubles entre chaînons cycliques ou entre chaînons cycliques et chaînons non cycliques avec des hétéro-atomes ou avec des atomes de carbone comportant trois liaisons à des hétéro-atomes, avec au plus une liaison à un halogène, p.ex. radicaux ester ou nitrile, liés directement aux atomes de carbone du cycle
• A61K 31/415 - 1,2-Diazoles
• A61P 35/00 - Agents anticancéreux

Produits et services

Non-medicated cosmetics and toiletry preparations; Non-medicated dentifrices; Perfumery, essential oils; toothpaste; mouthwashes; Cosmetics; cosmetic creams; cosmetic preparations for skin care; herbal extracts for cosmetic purposes; lotions for cosmetic purposes; oils for cosmetic purposes; gels for cosmetic purposes, creams for cosmetic purposes, spray, shampoo, soaps and lotions for non-medical purposes; Non-medicated cosmetics preparations and substances containing cannabis. Pharmaceutical preparations for medical purposes, Medicines, Pharmaceutical and medicinal preparations for use in the treatment of allergies, analgesics, diabetes, asthma, osteoporosis and pain, nausea and vertigo; antibiotics; anti-hypertensives; diarrhea medication, anti-bacterial preparations, cardio-vascular preparations, dermatological preparations, and other pharmaceutical preparations for the treatment of diseases and medical conditions; nutritional supplements; haemostatics and sleep inducers, sanitary preparations and substances; food for babies; medical plasters and dressings; disinfectants; food supplements and dietary food supplements; medicated Gels, creams, spray, pain patch and lotions for medical purposes; food supplements; nutritional supplements containing CBD, Cannabis for medical purposes; marijuana for medical purposes; medicine; Medicinal preparations and substances containing cannabis and CBD; medicated skin care preparations; antiseptic body care preparations; herbal extracts for medical purposes; plant extracts for pharmaceutical purposes; medicinal oils; medicinal roots; medicinal tea; dietary supplements for human beings; lotions for pharmaceutical purposes; medicinal infusions; pharmaceutical preparations for skin care; pharmaceutical creams; body gels and nasal spray for pharmaceutical use; medicated gel to reduce inflammation and muscoskeletal pain; anti pain patch for swelling and pain relief of muscles and joints, etc. Surgical instruments and apparatus; Medical apparatus and instruments; Dental apparatus and instruments; Orthopedic fixation devices; Scanners for medical diagnosis; Scanners for medical use; Artificial limbs; Eyes (Artificial -); Artificial teeth; Orthopedic implants; Orthopaedic supports; Orthopedic footwear; Orthopedic joint implants; Orthopaedic braces; Orthopedic belts; Suture materials; Devices for measuring blood sugar; Blood pressure measuring apparatus; Elastic bandages; Supportive Bandages. Medical assistance services; Pharmaceutical advice; Dentistry; Healthcare specialty services namely providing advanced medical, diagnostic or surgical services for human beings; Medical services involving the use of healthcare devices with associated software support, Telemedicine services based on app usage for health management; Providing health and medical information via a website; Providing medical and health information for use in the acquisition, storage, organizing, tracking, sharing, reporting and analysis of medical and physiological data via a website; providing medical data and information of patients via a website; medical consultations provided via online chat.

Produits et services

Cosmetics; hair lotions; soaps; shampoo; perfumery; essential oils; dentifrices; Deodorant for personal use. Pharmaceutical preparations for medical purposes, Medicines, Pharmaceutical and medicinal preparations for use in the treatment of allergies, analgesics, diabetes, asthma, osteoporosis and pain, nausea and vertigo; antibiotics; anti-hypertensives; diarrhea medication, anti-bacterial preparations, cardio-vascular preparations, dermatological preparations, and other pharmaceutical preparations for the treatment of diseases and medical conditions; nutritional supplements; haemostatics and sleep inducers, sanitary preparartions and substances; food for babies; medical plasters and dressings; disinfectants; food supplements and dietary food supplements. Surgical instruments and apparatus; Medical apparatus and instruments; Dental apparatus and instruments; Orthopedic fixation devices; Scanners for medical diagnosis; Scanners for medical use; Artificial limbs; Eyes (Artificial -); Artificial teeth; Orthopedic implants; Orthopaedic supports; Orthopedic footwear; Orthopedic joint implants; Orthopaedic braces; Orthopedic belts; Suture materials; Devices for measuring blood sugar; Blood pressure measuring apparatus. Medical assistance services; Pharmaceutical advice; Dentistry; Healthcare specialty services namely providing advanced medical, diagnostic or surgical services for human beings.

Abrégé

The method disclosed in the current invention is used to purify an antibody from process and product related impurities. The method discloses the use of cation exchange chromatography for the reduction of impurities such as high molecular weight aggregates, protein-A leachates and host cell proteins from an antibody composition. The disclosed method leads to a significant reduction of HMW aggregates and other process related impurities without compromising on the recovery of the protein.

Classes IPC  ?

• C07K 1/18 - Chromatographie d'échange d'ions
• 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

Abrégé

The present invention relates to an improved hair care shampoo composition which provides enhanced hair conditioning performance, anchorage, stimulation of hair growth, control of hair fall. The composition of present invention comprises Procapil, redensyl, one or more amino acid based conditioning agents, (iii) one or more foaming agents which is useful in the treatment of hair loss and improves hair anchorage. The compositions of the present invention are free of sulphate and parabens and also discloses the methods of preparing such compositions and use of such compositions in controlling the hair fall and improving the anchorage of the hair to scalp with good conditioning effect and promotes hair growth.

Classes IPC  ?

• A61K 8/30 - Cosmétiques ou préparations similaires pour la toilette caractérisés par la composition contenant des composés organiques
• A61Q 5/12 - Préparations contenant des agents de conditionnement des cheveux
• A61Q 5/02 - Préparations pour le lavage des cheveux

Abrégé

The present invention discloses a stable formulation of an α4β7 antibody, wherein the formulation comprises α4β7 antibody, amino acid, a mono carboxylic acid or dicarboxylic acid or dicarboxylic acid, and surfactant. The disclosed antibody formulations are liquid high concentration formulations that are also suitable for different mode of administration (subcutaneous/intravenous). The disclosed formulations exhibit stability under various accelerated stress conditions.

Classes IPC  ?

• 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 47/12 - Acides carboxyliques; Leurs sels ou anhydrides
• A61K 47/18 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides ayant jusqu’à cinq acides aminés
• A61K 47/22 - Composés hétérocycliques, p.ex. acide ascorbique, tocophérol ou pyrrolidones
• A61K 47/26 - Hydrates de carbone, p.ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine

Abrégé

The present application relates to a process for the preparation Niraparib of formula (II) or its pharmaceutically acceptable salts thereof. The present application also related to novel intermediates of Niraparib. Further, the present application also related to the application of such novel intermediates in the preparation of Niraparib of formula (II) and its tosylate salt of formula (I).

Classes IPC  ?

• C07D 231/56 - Benzopyrazoles; Benzopyrazoles hydrogénés
• C07D 211/12 - Composés hétérocycliques contenant des cycles pyridiques hydrogénés, non condensés avec d'autres cycles avec uniquement des atomes d'hydrogène et de carbone liés directement à l'atome d'azote du cycle  ne comportant pas de liaison double entre chaînons cycliques ou entre chaînons cycliques et chaînons non cycliques avec des radicaux hydrocarbonés ou des radicaux hydrocarbonés substitués, liés directement aux atomes de carbone du cycle avec des radicaux ne contenant que des atomes de carbone et d'hydrogène liés aux atomes de carbone du cycle avec uniquement des atomes d'hydrogène liés à l'atome d'azote du cycle

Abrégé

The present application relates to processes for the preparation of tirzepatide. The present application also relates to processes for the preparation of intermediate fragments of tirzepatide and their application in preparation of tirzepatide and pharmaceutically acceptable salts thereof. The present application also relates pharmaceutical compositions containing tirzepatide prepared by the process of the present invention.

Classes IPC  ?

• C07K 14/00 - Peptides ayant plus de 20 amino-acides; Gastrines; Somatostatines; Mélanotropines; Leurs dérivés
• C07K 1/113 - Procédés généraux de préparation de peptides par modification chimique de peptides précurseurs sans changement de la structure primaire

Abrégé

The present invention discloses a cell culture method for producing a CTLA-4 fusion protein composition comprising a target % of monomer species of the fusion protein, wherein the cell culture method comprises addition of cysteine in the cell culture medium. The invention further discloses a cell culture process to produce CTLA-4 fusion protein composition with target % of monomer species involving a dual temperature shift with addition of cysteine. Also, the present invention provides a CTLA-4 fusion protein composition comprised of target % of monomer species and/or homodimer species of the CTLA-4 fusion protein.

Classes IPC  ?

• C07K 14/705 - Récepteurs; Antigènes de surface cellulaire; Déterminants de surface cellulaire

Abrégé

The present invention relates to sustained release composition of Hydroxyzine or a pharmaceutically acceptable salt or a solvate thereof with less sedation. The present invention also relates sustained release compositions of Hydroxyzine hydrochloride comprising core matrix, barrier coating and film coating. The invention also relates to method of preparation of such compositions of Hydroxyzine or pharmaceutically acceptable salts or solvate thereof.

Classes IPC  ?

• A61K 31/495 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p.ex. guanéthidine ou rifamycines ayant des cycles à six chaînons avec deux azote comme seuls hétéro-atomes d'un cycle, p.ex. pipérazine
• A61K 9/22 - Pilules, pastilles ou comprimés du type à libération prolongée ou discontinue

Abrégé

The present invention discloses a buffer free formulation of high concentration α4β7 antibody, comprising α4β7 antibody, water, and surfactant, and stabilized at a pH of 6.0-6.5. The disclosed antibody formulations are liquid formulations and can be lyophilized. Further, the said formulations are also suitable for different mode of administration such as subcutaneous/intravenous, for therapeutic use.

Classes IPC  ?

• 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 47/10 - Alcools; Phénols; Leurs sels, p.ex. glycérol; Polyéthylène glycols [PEG]; Poloxamères; Alkyléthers de PEG/POE

Abrégé

The present invention discloses an optimal lyophilization method to prepare a room-temperature-stable freeze-dried formulation of an anti-α4β7 antibody wherein the lyophilized anti-α4β7 antibody formulation obtained from the said method exhibits stability at room temperature for at least three months and reconstituted anti-α4β7 antibody formulation exhibits stability at room temperature at least for 24 hours.

Classes IPC  ?

• A61K 39/395 - Anticorps; Immunoglobulines; Immunsérum, p.ex. sérum antilymphocitaire
• A61K 9/19 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p.ex. poudres lyophilisées
• A61K 47/18 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides 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 oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
• 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

Abrégé

The present invention discloses a pharmaceutical formulation of antibody that binds to interleukin. The invention also discloses methods of making the same. The formulation composition comprises a weak organic acid and organic base buffer and pharmaceutically acceptable excipients. The said composition stabilizes the antibody by controlling aggregation, degradation, oxidation and formation of charge variants. The disclosed antibody formulations are liquid formulations that are also suitable for lyophilization.

Classes IPC  ?

• C07K 16/24 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
• A61K 47/12 - Acides carboxyliques; Leurs sels ou anhydrides
• A61K 47/18 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides 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 oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine

Abrégé

The present invention discloses a therapeutic composition comprising fusion protein with reduced heterogeneity in the glycosylation profile of the protein and methods thereof. More particularly the invention provides the composition with reduced heterogeneity in the glycosylation profile. By reducing heterogeneity, the resultant preparation is expected to exhibit superior, consistent results in terms of safety, purity and potency. The invention is of particular importance as it can form the part of the critical quality attributes (CQA) that help in ensuring batch-to-batch consistency and predicted shelf-life of complex protein molecules.

Classes IPC  ?

• C07K 14/705 - Récepteurs; Antigènes de surface cellulaire; Déterminants de surface cellulaire

Abrégé

The present invention discloses a method of cell culture for producing a fusion glycoprotein composition comprising a target glycosylation profile. More particularly, the invention provides a process to produce a glycoprotein composition from mammalian cell culture, wherein the composition comprises a target total sialylated and or di- and tri-sialylated N-glycan variant.

Classes IPC  ?

• C12P 21/00 - Préparation de peptides ou de protéines
• C07K 14/705 - Récepteurs; Antigènes de surface cellulaire; Déterminants de surface cellulaire

Abrégé

The present invention discloses a stable pharmaceutical formulation of an α4β7 antibody, wherein the formulation contains buffer, PEG, salt, amino acid and surfactant and wherein the formulation is devoid of sugar and/or sugar alcohols. The disclosed antibody formulations are liquid formulations, and are also suitable to be formulated as a lyophilized powder.

Classes IPC  ?

• 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 9/19 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p.ex. poudres lyophilisées
• A61K 47/10 - Alcools; Phénols; Leurs sels, p.ex. glycérol; Polyéthylène glycols [PEG]; Poloxamères; Alkyléthers de PEG/POE
• A61K 47/18 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides 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 oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine

Abrégé

The present application relates to process for preparation of Mavacamten, preparative methods of various crystalline forms of Mavacamten and amorphous form of Mavacamten, its preparative method, and pharmaceutical compositions thereof. The present application also relates to solid dispersions of Mavacamten, their preparative methods and pharmaceutical compositions containing solid dispersions of Mavacamten.

Classes IPC  ?

• A61K 31/513 - Pyrimidines; Pyrimidines hydrogénées, p.ex. triméthoprime ayant des groupes oxo liés directement à l'hétérocycle, p.ex. cytosine
• A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p.ex. carbomères
• A61K 47/38 - Cellulose; Ses dérivés
• C07D 239/10 - Atomes d'oxygène ou de soufre

Abrégé

The present invention provides an improved process for the preparation of Voclosporin, comprising oxidation of cyclosporin A acetate with potassium osmate and N-methyl morpholine N-oxide (NMMO) followed by sodium periodate and further conversion to Voclosporin. The present invention also covers crystallization of crude Voclosporin from acetone and heptane mixture.

Classes IPC  ?

• C07K 7/64 - Peptides cycliques ne comportant que des liaisons peptidiques normales
• A61P 37/00 - Médicaments pour le traitement des troubles immunologiques ou allergiques

Abrégé

The free thiol group present in free cysteines in recombinant therapeutic antibodies are reactive to process components and generates product variants during early stages of biosimilar development. Free thiol group present on the structural motifs, especially in the complementary determining regions (CDR), support maximal antigen binding capability. Product variants associated with these free thiol groups are detrimental for safety and efficacy of these therapeutic antibodies. Methods to identify and characterize various thiol variants an antibody composition is provided and an anti-IL-17A IgG1 composition having these thiol variants are described.

Classes IPC  ?

• G01N 33/68 - Analyse chimique de matériau biologique, p.ex. de sang ou d'urine; Test par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligands; Test immunologique faisant intervenir des protéines, peptides ou amino-acides
• C07K 16/24 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons

Abrégé

The present invention relates to pharmaceutical formulations of anti-CD38 antibodies. In particular, the invention discloses a composition stabilizing the antibodies from its lower to higher concentration. The stable composition thus obtained can be formulated as intravenous and subcutaneous formulations with the desired antibody concentrations enabling therapeutic use. The prepared composition, additionally controls fragmentation of the antibody during storage.

Classes IPC  ?

• C07K 16/28 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
• A61K 39/395 - Anticorps; Immunoglobulines; Immunsérum, p.ex. sérum antilymphocitaire
• A61K 47/12 - Acides carboxyliques; Leurs sels ou anhydrides
• A61K 47/18 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides 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 oligosaccharides; Leurs dérivés, p.ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
• A61K 9/08 - Solutions

Abrégé

Aspects of the present application relates to amorphous solid dispersions of evocalcet with polymer matrix, formic acid salt of evocalcet and process for the preparation of evocalcet.

Classes IPC  ?

• A61K 9/14 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p.ex. poudres
• C07C 211/30 - Composés contenant des groupes amino liés à un squelette carboné ayant des groupes amino liés à des atomes de carbone acycliques d'un squelette carboné non saturé contenant au moins un cycle aromatique à six chaînons le cycle aromatique à six chaînons faisant partie d'un système cyclique condensé formé par deux cycles

Abrégé

The present invention discloses a method for the selective reduction of disulfide bonds in an immunoglobulin composition. More specifically, the method disclosed in the current invention is capable of selectively reducing the inter-chain disulfide bond between the light and heavy chain of an immunoglobulin without the use of commonly used chemicals such as DTT, DTE, and β- mercaptoethanol. The method is advantageous over the existing methods as it eliminates the need of an additional purification step to remove the chemicals used for reduction, i.e., DTT, DTE, etc. before subjecting the immunoglobulin sample for further analyses such as LC-MS..

Classes IPC  ?

• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux
• C07K 1/113 - Procédés généraux de préparation de peptides par modification chimique de peptides précurseurs sans changement de la structure primaire
• A61K 39/395 - Anticorps; Immunoglobulines; Immunsérum, p.ex. sérum antilymphocitaire

Abrégé

The present invention relates to liquid injectable compositions of trilaciclib or pharmaceutical acceptable salts, hydrates, solvates, polymorphs, and mixtures thereof. More particularly, the present invention relates to liquid injectable compositions which are either ready-to-dilute or ready-to-use or reconstituted from lyophilized forms of trilaciclib and further comprise of aqueous solvents or non-aqueous solvents of mixtures thereof.

Classes IPC  ?

• A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier

Abrégé

The present application relates to process for the preparation of Tucatinib. The present application also relates to the process for the preparation of Tucatinib intermediates. The present application also provides a process for the preparation of amorphous tucatinib. The present application also provides tucatinib triflate salt characterized by PXRD peaks.

Classes IPC  ?

• A61K 31/517 - Pyrimidines; Pyrimidines hydrogénées, p.ex. triméthoprime condensées en ortho ou en péri avec des systèmes carbocycliques, p.ex. quinazoline, périmidine
• A61P 35/00 - Agents anticancéreux
• C07D 471/04 - Systèmes condensés en ortho
• C07D 403/12 - Composés hétérocycliques contenant plusieurs hétérocycles, comportant des atomes d'azote comme uniques hétéro-atomes du cycle, non prévus par le groupe contenant deux hétérocycles liés par une chaîne contenant des hétéro-atomes comme chaînons

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes.

Abrégé

The present invention discloses a method for the purification of Fc-fusion proteins from the contaminants. In particular, the disclosed method describes a process for the purification of Fc-fusion proteins using a specific order of chromatographic steps. The specific order of chromatography steps as disclosed results in reducing contaminants such as high-molecular weight aggregates and sialylated isoforms and obtaining a purified Fc-fusion protein composition.

Classes IPC  ?

• C07K 1/36 - Extraction; Séparation; Purification par une combinaison de plusieurs procédés de types différents
• C07K 16/06 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux provenant de sérum

Abrégé

The present invention discloses a high concentration formulation of an α4β7antibody, comprising α4β7antibody, amino acid(s), salt and surfactant, wherein the free amino acid(s) are hydrophobic amino acids and/or basic amino acid (s). The disclosed antibody formulations are liquid formulations that are also suitable for different mode of administration (subcutaneous/intravenous) and exhibits stability under various accelerated conditions.

Classes IPC  ?

• 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 - Amines; Amides; Urées; Composés d’ammonium quaternaire; Acides aminés; Oligopeptides ayant jusqu’à cinq acides aminés
• A61K 47/02 - Composés inorganiques

Abrégé

The present application relates to a process for the preparation of semaglutide. The present application also relates to a recombinant process for the preparation of semapeptide. The present invention is related to a process for producing semapeptide, the process comprising the steps of, a) culturing a host cell comprising a nucleotide sequence encoding of Formula (II) under suitable conditions for expression, wherein, insoluble tag is a nucleotide sequence of Alanine-Valine; b) recovering semapeptide, wherein semapeptide amino acid sequence is Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Arg-Gly-Arg-Gly.

Classes IPC  ?

• C12P 21/02 - Préparation de peptides ou de protéines comportant une séquence connue de plusieurs amino-acides, p.ex. glutathion
• C12N 15/70 - Vecteurs ou systèmes d'expression spécialement adaptés à E. coli
• C07K 14/605 - Glucagons

Abrégé

The method disclosed in the current invention is used to purify an antibody from process and product related impurities. The method discloses the use of affinity chromatography, cation exchange chromatography and mixed-mode chromatography for the reduction of process and product-related impurities. More specifically, the method discloses the use of cation exchange chromatography for the reduction of impurities such as high molecular weight aggregates and charge variants from an antibody composition.

Classes IPC  ?

• C07K 14/00 - Peptides ayant plus de 20 amino-acides; Gastrines; Somatostatines; Mélanotropines; Leurs dérivés
• C07K 1/00 - Procédés généraux de préparation de peptides

Abrégé

The present application relates to amorphous solid dispersions of Deucravacitinib, process for the preparation of amorphous solid dispersion of Deucravacitinib, process for the preparation crystalline form of Deucravacitinib and process for the preparation of stable premix of amorphous solid dispersion of Deucravacitinib together with at least one pharmaceutically acceptable polymer matrix and syloid.

Classes IPC  ?

• C07D 403/12 - Composés hétérocycliques contenant plusieurs hétérocycles, comportant des atomes d'azote comme uniques hétéro-atomes du cycle, non prévus par le groupe contenant deux hétérocycles liés par une chaîne contenant des hétéro-atomes comme chaînons
• C07D 249/08 - Triazoles-1, 2, 4; Triazoles-1, 2, 4 hydrogénés
• A61K 31/501 - Pyridazines; Pyridazines hydrogénées non condensées et contenant d'autres hétérocycles
• A61P 29/00 - Agents analgésiques, antipyrétiques ou anti-inflammatoires non centraux, p.ex. agents antirhumatismaux; Médicaments anti-inflammatoires non stéroïdiens [AINS]

Abrégé

The present application relates to substantially pure Sitagliptin and its pharmaceutically acceptable salts, and more particularly a process for preparing substantially pure Sitagliptin and its pharmaceutically acceptable salts and pharmaceutical compositions thereof. The present application also describes pharmaceutical compositions comprising sitagliptin or a salt thereof having less than about 100 ppm of compound of formula VII and/or less than about 1 ppm of Nitrosamine impurity of the compound of formula VIII.

Classes IPC  ?

• C07D 487/04 - Systèmes condensés en ortho
• C01B 25/46 - Préparation comportant une extraction solvant-solvant

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Migraine treatment preparations.

Abrégé

The present invention relates to method culturing of mammalian cells expressing recombinant proteins. The cell culture method of the present invention implements the N-1 seed stage and the N stage production phase in the same bioreactor. In particular the cell culture method of the present invention provides for consistency in product quailty and productivity upon scale up of the early stage cell culture methods.

Classes IPC  ?

• C12N 5/00 - Cellules non différenciées humaines, animales ou végétales, p.ex. lignées cellulaires; Tissus; Leur culture ou conservation; Milieux de culture à cet effet
• C12P 21/00 - Préparation de peptides ou de protéines

Abrégé

The present specification relates to pharmaceutical composition comprising duloxetine, or pharmaceutically acceptable salts thereof, and capsaicin. The present specification more particulary relates to topical pharmaceutical composition comprising duloxetine, or pharmaceutically acceptable salts thereof, and capsaicin, for the treatment and/or management of neuropathic pain. Methods of preparing such compositions are also provided.

Classes IPC  ?

• A61K 31/381 - Composés hétérocycliques ayant le soufre comme hétéro-atome d'un cycle ayant des cycles à cinq chaînons
• A61K 31/00 - Préparations médicinales contenant des ingrédients actifs organiques 
• A61K 9/06 - Onguents; Excipients pour ceux-ci
• A61K 9/107 - Emulsions
• C07D 333/20 - Radicaux substitués par des hétéro-atomes, autres que les halogènes, liés par des liaisons simples par des atomes d'azote

Abrégé

The present invention relates to oral solid pharmaceutical dosage forms comprising proton pump inhibitor, as single active drug. The present specification specifically relates to orally disintegrating tablets that readily disintegrates in the mouth, releasing enteric coated drug pellets or units, comprising a proton pump inhibitor, Rabeprazole or a pharmaceutically acceptable salt thereof. The specification also relates to modified release oral dosage forms, which comprise of a core and a combination of a release modifying layers that together achieve beneficial release properties, suitable for once daily administration. The application also relates to processes for preparing the dosage forms as well as their use in the treatment of gastrointestinal diseases.

Classes IPC  ?

• A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
• A61K 9/20 - Pilules, pastilles ou comprimés
• A61P 1/04 - Médicaments pour le traitement des troubles du tractus alimentaire ou de l'appareil digestif des ulcères, des gastrites ou des œsophagites par reflux, p.ex. antiacides, antisécrétoires, protecteurs de la muqueuse
• A61K 9/28 - Dragées; Pilules ou comprimés avec revêtements

Abrégé

The present application relates to a process for preparation of relugolix or its pharmaceutically acceptable salts thereof. The present application also relates to the process for preparation of Relugolix crystalline form R1.

Classes IPC  ?

• C07D 495/04 - Systèmes condensés en ortho
• A61P 15/08 - Médicaments pour le traitement des troubles génitaux ou sexuels; Contraceptifs pour les troubles gonadiques ou pour augmenter la fertilité, p.ex. inducteurs d'ovulation ou de spermatogénèse
• A61P 5/00 - Médicaments pour le traitement des troubles du système endocrinien
• C07D 333/38 - Atomes de carbone comportant trois liaisons à des hétéro-atomes avec au plus une liaison à un halogène, p.ex. radicaux ester ou nitrile

Abrégé

The present invention relates to a pharmaceutical composition comprising combination of herbal powder and standardised solvent extract(s) of the herbal mixture. More particularly, the present invention relates to pharmaceutical composition comprising combination of herbal powder and standardised solvent extract(s) of the herbal mixture useful for the treatment of liver and kidney disorders. The invention also provides the process for the preparation of such compositions.

Classes IPC  ?

• A61K 36/80 - Scrophulariaceae (famille de la scrofulaire)
• A61K 36/47 - Euphorbiaceae (famille de l'euphorbe), p.ex. Ricinus (ricin)
• A61K 36/185 - Magnoliopsida (dicotylédones)

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes.

Produits et services

Pharmaceuticals; Medicinal preparations and substances; Medical preparations; Medicine; Medicines for human purposes.

Abrégé

The present application relates to a method of treating an inflammatory skin condition by administering a pharmaceutical composition comprising a reduced dose of minocycline to a subject in need thereof, wherein said administration provides an effective plasma or interstitial fluid concentration of minocycline for treating the inflammatory skin condition.

Classes IPC  ?

• A61K 31/165 - Amides, p.ex. acides hydroxamiques ayant des cycles aromatiques, p.ex. colchicine, aténolol, progabide
• A61P 17/02 - Médicaments pour le traitement des troubles dermatologiques pour traiter les blessures, les ulcères, les brûlures, les cicatrices, les cheloïdes, ou similaires
• A61P 17/06 - Antipsoriasiques
• A61P 17/10 - Antiacnéïques
• A61K 31/65 - Tétracyclines 
• A61P 17/04 - Antiprurigineux
• A61P 17/00 - Médicaments pour le traitement des troubles dermatologiques
• A61P 29/00 - Agents analgésiques, antipyrétiques ou anti-inflammatoires non centraux, p.ex. agents antirhumatismaux; Médicaments anti-inflammatoires non stéroïdiens [AINS]
• A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier

Abrégé

The present invention relates to an antibody composition comprising antibody variants resulted due to chemical modifications, which are the critical quality attributes (CQA) of the antibody. The invention also discloses a method to reduce the % of acidic variants in an antibody composition by culturing mammalian cells in cell culture medium having low cystine content. The present invention provides a method to reduce cysteinylated and/or glutathionylated variants in an antibody composition by using a cell culture process comprising culturing mammalian cells producing the said antibody in cell culture medium having low cystine content.

Classes IPC  ?

• C12P 21/00 - Préparation de peptides ou de protéines
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The present invention relates to a cell culture process for producing a pharmaceutical monoclonal antibody composition, the process comprising culturing mammalian cells expressing the monoclonal antibody at a pH range of about 6.7 to about 7.2, performing a temperature shift from a first culture temperature to a second culture temperature, thereby obtaining an antibody composition comprising charge variants. Further, the present invention discloses that the obtained antibody composition comprises of basic charge variants, wherein the percentage of basic charge variants is not less than 16%.

Classes IPC  ?

• C12P 21/00 - Préparation de peptides ou de protéines
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1) or programmed death receptor Ligand 1 (PD-Ll), and method for preparing the same. The disclosed formulations are free of sugar or sugar alcohol and stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Classes IPC  ?

• A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
• A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The present invention discloses a stable buffer free formulation of anti-PD1/anti-PD-L1 antibody, comprising an anti-PD1 or an anti-PD-L1 antibody, water, mannitol and surfactant, and stabilized at a pH of about 5.0 – about 6.0. The disclosed antibody formulation is a liquid formulation and can be lyophilized. Further, the said formulation is also suitable for different mode of administration such as subcutaneous/intravenous, for therapeutic use.

Classes IPC  ?

• A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
• A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The current invention discloses a method for obtaining a purified antibody composition. The method discloses the use of various chromatography steps in a particular order to obtain a purified composition of a therapeutic monoclonal antibody starting from a composition comprising the monoclonal antibody and one or more process and product related impurities. Further, the method also discloses the use of additional purification steps such as depth filtration, diafiltration, ultrafiltration and tangential flow filtration for obtaining the said purified antibody composition.

Classes IPC  ?

• C07K 1/16 - Extraction; Séparation; Purification par chromatographie

Abrégé

The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1)/ programmed death receptor Ligand 1 (PD-Ll), and method for preparing the same. The disclosed formulations stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Classes IPC  ?

• A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
• A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1)/ programmed death receptor Ligand 1 (PD-Ll), and method for preparing the same. The disclosed formulations are free of chelators and stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Classes IPC  ?

• A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
• A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The present invention relates to a cell culture process for producing a monoclonal antibody composition, the process comprising culturing the mammalian cells at a pH range of about 6.6 to about 7.5, performing a temperature shift from a first culture temperature to a second culture temperature, supplementation of galactose in the cell culture, thereby obtaining an antibody composition comprising galactosylated glycoform and/or G0F glycoform. Further, the cell culture process disclosed in the present invention obtains an antibody composition comprising galactosylated glycoform wherein the percentage of galactosylated glycoform decreases with the decrease in the difference between the first temperature and the second temperature.

Classes IPC  ?

• C12P 21/00 - Préparation de peptides ou de protéines
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The method disclosed in the current invention is used to purify an antibody from process and product related impurities. The method discloses the use of cation exchange chromatography for the reduction of impurities such as high molecular weight aggregates, protein-A leachates and host cell proteins from an antibody composition. The disclosed method leads to a significant reduction of HMW aggregates and other process related impurities without compromising on the recovery of the protein.

Classes IPC  ?

• C07K 1/18 - Chromatographie d'échange d'ions

Abrégé

The present specification relates to solid oral pharmaceutical compositions of Itraconazole or a pharmaceutically acceptable salts thereof, said compositions comprises itraconazole in a matrix polymer dispersion. Methods of preparing such formulations are also provided. The specification also relates to use of such formulations methods for treating disorders including, but not limited to, fungal infections are also provided.

Classes IPC  ?

• A61K 9/48 - Préparations en capsules, p.ex. de gélatine, de chocolat
• A61K 47/38 - Cellulose; Ses dérivés
• A61P 31/10 - Antifongiques

Abrégé

The method disclosed in the current invention is used to purify an antibody from high molecular weight aggregates. The method discloses the use of anion exchange chromatography for the reduction of high molecular weight aggregates from the antibody composition, in particular, by contacting the antibody composition with the anion exchange resin at a specific pH and conductivity. The disclosed method eliminates the need for further chromatographic steps for the reduction of HMW aggregates.

Classes IPC  ?

• A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
• A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The present invention relates to process for the continuous manufacture of Statins or salts thereof. The present invention relates to process for the continuous manufacture of Atorvastatin or a salt thereof. The present invention relates to a continuous manufacturing process for the crystallization of Atorvastatin calcium. The present invention also relates to a continuous manufacturing process for the crystallization of Atorvastatin calcium Form I.

Classes IPC  ?

• C07D 207/34 - Composés hétérocycliques contenant des cycles à cinq chaînons, non condensés avec d'autres cycles, ne comportant qu'un atome d'azote comme unique hétéro-atome du cycle avec uniquement des atomes d'hydrogène ou de carbone liés directement à l'atome d'azote du cycle  comportant deux liaisons doubles entre chaînons cycliques ou entre chaînons cycliques et chaînons non cycliques avec des hétéro-atomes ou avec des atomes de carbone comportant trois liaisons à des hétéro-atomes, avec au plus une liaison à un halogène, p.ex. radicaux ester ou nitrile, liés directement aux atomes de carbone du cycle

Abrégé

Aspects of the present application relate to process for the preparation of Omecamtiv mecarbil and salts thereof. Specific aspects relate to novel urea intermediate, preparative process thereof and its use in the preparation of Omecamtiv mecarbil and salts thereof. The improved process for the preparation of Omecamtiv mecarbil are industrially viable.

Classes IPC  ?

• C07D 213/75 - Radicaux amino ou imino, acylés par un acide carboxylique, par l'acide carbonique ou par leurs analogues du soufre ou de l'azote, p.ex. des carbamates

Abrégé

Aspects of the present application relate to solid forms of Omecamtiv mecarbil dihydrochloride. Specific aspects relate to crystalline forms and amorphous solid dispersions of Omecamtiv mecarbil dihydrochloride. Further specific aspects related to crystalline forms DP1, DP2, DP3, DP4, OMT-D, OMT-L, OMT-O, OMT-F, OMT-FS and amorphous solid dispersions of Omecamtiv mecarbil dihydrochloride and pharmaceutical compositions thereof.

Classes IPC  ?

• C07D 213/75 - Radicaux amino ou imino, acylés par un acide carboxylique, par l'acide carbonique ou par leurs analogues du soufre ou de l'azote, p.ex. des carbamates
• A61K 9/19 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p.ex. poudres lyophilisées
• A61K 9/16 - Agglomérés; Granulés; Microbilles

Abrégé

The present application relates to improved and effective purification processes and also relates to method of increasing the solubility of for GLP-1 analog and its derivatives particularly Liraglutide. The purification process of present application is advantageous not only in terms of providing the highly pure peptide chemically but also in terms of affording peptide drug substance which is having good physical stability even at a large scale during holding or in-use period, while making drug substance compatible for formulation.

Classes IPC  ?

• C07K 1/20 - Chromatographie de partage, de phase inverse ou d'interaction hydrophobe
• C07K 14/605 - Glucagons
• A61K 38/26 - Glucagons
• A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif

Abrégé

Aspects of the present application relates to crystalline Form TLP of Tafamidis. The present application provides a process for the preparation of crystalline Form TLP of Tafamidis, comprising the step of crystallizing from a mixture comprising Tafamidis free acid and L-Proline in suitable solvent(s). The present application further relates to its pharmaceutical composition.

Classes IPC  ?

• A61K 31/423 - Oxazoles condensés avec des carbocycles
• C07D 263/57 - Radicaux aryle ou aryle substitués
• C07D 263/54 - Benzoxazoles; Benzoxazoles hydrogénés
• A61P 25/00 - Médicaments pour le traitement des troubles du système nerveux
• A61P 25/28 - Médicaments pour le traitement des troubles du système nerveux des troubles dégénératifs du système nerveux central, p.ex. agents nootropes, activateurs de la cognition, médicaments pour traiter la maladie d'Alzheimer ou d'autres formes de démence

Abrégé

The present invention discloses a stable formulation of an α4β7antibody, wherein the formulation comprises α4β7antibody, amino acid, a mono carboxylic acid or dicarboxylic acid, and surfactant. The disclosed antibody formulations are liquid high concentration formulations that are also suitable for different mode of administration (subcutaneous/intravenous). The disclosed formulations exhibit stability under various accelerated stress conditions.

Classes IPC  ?

• A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
• A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. les supports ou les additifs inertes; Agents de ciblage ou de modification chimiquement liés à l’ingrédient actif
• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux

Abrégé

The present invention discloses a cell culture method for producing a CTLA-4 fusion protein composition comprising a target % of monomer species of the fusion protein, wherein the cell culture method comprises addition of cysteine in the cell culture medium. The invention further discloses a cell culture process to produce CTLA-4 fusion protein composition with target % of monomer species involving a dual temperature shift with addition of cysteine. Also, the present invention provides a CTLA-4 fusion protein composition comprised of target % of monomer species and/or homodimer species of the CTLA-4 fusion protein.

Classes IPC  ?

• C07K 16/00 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux
• C12N 5/071 - Cellules ou tissus de vertébrés, p.ex. cellules humaines ou tissus humains

Abrégé

Aspect of the present application relates to process for the preparation of crystalline form of Apalutamide and process for the preparation of Apalutamide in the presence of neutralizing agent selected from triethylsilylchloride, trimethylsilyl chloride, zinc chloride, aluminium chloride, iron chloride, sodium chloride, acetic acid, ammonium chloride or mixture thereof followed by treating with acid to obtain Apalutamide.

Classes IPC  ?

• C07D 401/04 - Composés hétérocycliques contenant plusieurs hétérocycles comportant des atomes d'azote comme uniques hétéro-atomes du cycle, au moins un cycle étant un cycle à six chaînons avec un unique atome d'azote contenant deux hétérocycles liés par une liaison directe de chaînon cyclique à chaînon cyclique