BR112019004892A2 - composição farmacêutica de liberação prolongada de clozapina sob a forma de multiparticulados, e processo para a preparação de uma composição farmacêutica de liberação prolongada de clozapina - Google Patents
composição farmacêutica de liberação prolongada de clozapina sob a forma de multiparticulados, e processo para a preparação de uma composição farmacêutica de liberação prolongada de clozapinaInfo
- Publication number
- BR112019004892A2 BR112019004892A2 BR112019004892A BR112019004892A BR112019004892A2 BR 112019004892 A2 BR112019004892 A2 BR 112019004892A2 BR 112019004892 A BR112019004892 A BR 112019004892A BR 112019004892 A BR112019004892 A BR 112019004892A BR 112019004892 A2 BR112019004892 A2 BR 112019004892A2
- Authority
- BR
- Brazil
- Prior art keywords
- clozapine
- pharmaceutical composition
- release pharmaceutical
- extended release
- preparation
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
- A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5089—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5192—Processes
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Physics & Mathematics (AREA)
- Biomedical Technology (AREA)
- Nanotechnology (AREA)
- Optics & Photonics (AREA)
- Inorganic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
Abstract
a presente invenção se relaciona com uma composição farmacêutica de liberação prolongada de clozapina. a presente invenção fornece uma composição farmacêutica de liberação prolongada compreendendo clozapina, um revestimento vedante, um revestimento ácido e um revestimento de liberação prolongada. a invenção é particularmente adequada para dispensar uma vez por dia uma formulação farmacêutica oral sólida que libera uma quantidade terapeuticamente eficaz de clozapina durante um período de tempo prolongado.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IN201621031726 | 2016-09-17 | ||
PCT/IB2017/055615 WO2018051292A1 (en) | 2016-09-17 | 2017-09-16 | Extended release pharmaceutical composition of clozapine |
Publications (1)
Publication Number | Publication Date |
---|---|
BR112019004892A2 true BR112019004892A2 (pt) | 2019-06-11 |
Family
ID=61619971
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112019004892A BR112019004892A2 (pt) | 2016-09-17 | 2017-09-16 | composição farmacêutica de liberação prolongada de clozapina sob a forma de multiparticulados, e processo para a preparação de uma composição farmacêutica de liberação prolongada de clozapina |
Country Status (9)
Country | Link |
---|---|
US (2) | US11504336B2 (pt) |
EP (1) | EP3512521B1 (pt) |
AU (1) | AU2017328245B2 (pt) |
BR (1) | BR112019004892A2 (pt) |
CA (1) | CA3036316A1 (pt) |
ES (1) | ES2960331T3 (pt) |
MX (2) | MX2019003010A (pt) |
WO (1) | WO2018051292A1 (pt) |
ZA (1) | ZA201902379B (pt) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11504336B2 (en) * | 2016-09-17 | 2022-11-22 | Intas Pharmaceuticals Ltd. | Extended release pharmaceutical composition of clozapine |
CN109030684B (zh) * | 2018-10-29 | 2021-06-15 | 湖南洞庭药业股份有限公司 | 氯氮平片剂药物组合物和制法 |
US11648207B1 (en) * | 2021-12-15 | 2023-05-16 | Intas Pharmaceuticals Ltd. | Extended release pharmaceutical composition of Clozapine |
US11918590B2 (en) * | 2021-12-15 | 2024-03-05 | Intas Pharmaceuticals Ltd. | Stable extended release pharmaceutical composition of clozapine |
CN115745897B (zh) * | 2022-11-09 | 2024-03-22 | 武汉科技大学 | 一种氯氮平重结晶方法 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3539573A (en) | 1967-03-22 | 1970-11-10 | Jean Schmutz | 11-basic substituted dibenzodiazepines and dibenzothiazepines |
EP2266542A3 (en) | 1998-10-01 | 2013-07-31 | Elan Pharma International Limited | Controlled release nanoparticulate compositions |
ITMI20042232A1 (it) | 2004-11-19 | 2005-02-19 | Unihart Corp | Composizione farmaceutica contenente clozapina |
FR2891459B1 (fr) | 2005-09-30 | 2007-12-28 | Flamel Technologies Sa | Microparticules a liberation modifiee d'au moins un principe actif et forme galenique orale en comprenant |
WO2007056424A2 (en) | 2005-11-07 | 2007-05-18 | Penwest Pharmaceuticals, Co. | Controlled-release emulsion compositions |
US20080026062A1 (en) | 2006-07-31 | 2008-01-31 | Isaac Farr | Pharmaceutical compositions including nano-sized active agent |
US20080026040A1 (en) | 2006-07-31 | 2008-01-31 | Isaac Farr | Active agent-releasing dosage forms |
EP2416764A4 (en) * | 2009-04-09 | 2013-09-04 | Alkermes Pharma Ireland Ltd | COMPOSITION FOR ACTIVE COMPOSITION |
US11504336B2 (en) * | 2016-09-17 | 2022-11-22 | Intas Pharmaceuticals Ltd. | Extended release pharmaceutical composition of clozapine |
US11648207B1 (en) * | 2021-12-15 | 2023-05-16 | Intas Pharmaceuticals Ltd. | Extended release pharmaceutical composition of Clozapine |
-
2017
- 2017-09-16 US US16/334,115 patent/US11504336B2/en active Active
- 2017-09-16 AU AU2017328245A patent/AU2017328245B2/en active Active
- 2017-09-16 EP EP17850399.1A patent/EP3512521B1/en active Active
- 2017-09-16 ES ES17850399T patent/ES2960331T3/es active Active
- 2017-09-16 CA CA3036316A patent/CA3036316A1/en active Pending
- 2017-09-16 BR BR112019004892A patent/BR112019004892A2/pt unknown
- 2017-09-16 WO PCT/IB2017/055615 patent/WO2018051292A1/en unknown
- 2017-09-16 MX MX2019003010A patent/MX2019003010A/es unknown
-
2019
- 2019-03-14 MX MX2022006518A patent/MX2022006518A/es unknown
- 2019-04-15 ZA ZA2019/02379A patent/ZA201902379B/en unknown
-
2022
- 2022-10-17 US US17/967,244 patent/US11833253B1/en active Active
Also Published As
Publication number | Publication date |
---|---|
EP3512521A1 (en) | 2019-07-24 |
MX2019003010A (es) | 2019-11-28 |
ES2960331T3 (es) | 2024-03-04 |
MX2022006518A (es) | 2022-08-04 |
EP3512521B1 (en) | 2023-08-02 |
US20200054573A1 (en) | 2020-02-20 |
ZA201902379B (en) | 2020-08-26 |
CA3036316A1 (en) | 2018-03-22 |
US11833253B1 (en) | 2023-12-05 |
EP3512521A4 (en) | 2020-04-15 |
AU2017328245B2 (en) | 2023-07-06 |
WO2018051292A1 (en) | 2018-03-22 |
AU2017328245A1 (en) | 2019-03-28 |
US11504336B2 (en) | 2022-11-22 |
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Legal Events
Date | Code | Title | Description |
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B350 | Update of information on the portal [chapter 15.35 patent gazette] | ||
B06W | Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette] |