RS56858B1 - Postupak proizvodnje farmaceutske kompozicije u obliku tableta sa produženim-oslobađanjem koje sadrže pirfenidon i njihova upotreba u regresiji hronične renalne insuficijencije, kapsularne kontrakture grudi i hepatičke fibroze kod ljudi - Google Patents
Postupak proizvodnje farmaceutske kompozicije u obliku tableta sa produženim-oslobađanjem koje sadrže pirfenidon i njihova upotreba u regresiji hronične renalne insuficijencije, kapsularne kontrakture grudi i hepatičke fibroze kod ljudiInfo
- Publication number
- RS56858B1 RS56858B1 RS20180168A RSP20180168A RS56858B1 RS 56858 B1 RS56858 B1 RS 56858B1 RS 20180168 A RS20180168 A RS 20180168A RS P20180168 A RSP20180168 A RS P20180168A RS 56858 B1 RS56858 B1 RS 56858B1
- Authority
- RS
- Serbia
- Prior art keywords
- regression
- humans
- extended
- manufacturing
- pharmaceutical composition
- Prior art date
Links
- 206010019668 Hepatic fibrosis Diseases 0.000 title 1
- 206010062575 Muscle contracture Diseases 0.000 title 1
- 210000000481 breast Anatomy 0.000 title 1
- 208000020832 chronic kidney disease Diseases 0.000 title 1
- 208000006111 contracture Diseases 0.000 title 1
- 238000013265 extended release Methods 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- ISWRGOKTTBVCFA-UHFFFAOYSA-N pirfenidone Chemical compound C1=C(C)C=CC(=O)N1C1=CC=CC=C1 ISWRGOKTTBVCFA-UHFFFAOYSA-N 0.000 title 1
- 229960003073 pirfenidone Drugs 0.000 title 1
Classifications
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- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/717—Celluloses
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
MX2011007675A MX2011007675A (es) | 2011-07-19 | 2011-07-19 | Procedimiento para la fabricacion de una composicion farmaceutica en forma de tabletas de liberacion prolongada conteniendo pirfenidona y su aplicacion en la regresion de la insuficiencia renal cronica, contractura capsular mamaria y fibrosis hepatica humanas. |
EP15161929.3A EP2907506B1 (en) | 2011-07-19 | 2012-07-13 | Method for manufacturing a pharmaceutical composition in the form of extended-release tablets containing pirfenidone and use thereof in the regression of chronic renal insufficiency, breast capsular contracture and hepatic fibrosis in humans |
Publications (1)
Publication Number | Publication Date |
---|---|
RS56858B1 true RS56858B1 (sr) | 2018-04-30 |
Family
ID=46940567
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
RS20180168A RS56858B1 (sr) | 2011-07-19 | 2012-07-13 | Postupak proizvodnje farmaceutske kompozicije u obliku tableta sa produženim-oslobađanjem koje sadrže pirfenidon i njihova upotreba u regresiji hronične renalne insuficijencije, kapsularne kontrakture grudi i hepatičke fibroze kod ljudi |
Country Status (34)
Country | Link |
---|---|
US (6) | US9408836B2 (sr) |
EP (2) | EP2735306A1 (sr) |
JP (1) | JP6034380B2 (sr) |
KR (2) | KR20160074016A (sr) |
CN (2) | CN103957892A (sr) |
AR (1) | AR087205A1 (sr) |
AU (1) | AU2012284627B2 (sr) |
BR (1) | BR112014001297B1 (sr) |
CA (1) | CA2842654C (sr) |
CL (1) | CL2014000131A1 (sr) |
CO (1) | CO6970587A2 (sr) |
CR (1) | CR20140019A (sr) |
CY (2) | CY2200005T2 (sr) |
DE (1) | DE15161929T1 (sr) |
DK (1) | DK2907506T3 (sr) |
DO (1) | DOP2014000010A (sr) |
EC (1) | ECSP14013160A (sr) |
ES (1) | ES2550227T3 (sr) |
HK (1) | HK1208172A1 (sr) |
HR (1) | HRP20180183T1 (sr) |
HU (1) | HUE036511T2 (sr) |
LT (1) | LT2907506T (sr) |
MX (1) | MX2011007675A (sr) |
NO (1) | NO2907506T3 (sr) |
PE (1) | PE20141684A1 (sr) |
PL (1) | PL2907506T3 (sr) |
PT (1) | PT2907506T (sr) |
RS (1) | RS56858B1 (sr) |
RU (1) | RU2682177C2 (sr) |
SI (1) | SI2907506T1 (sr) |
UA (1) | UA114181C2 (sr) |
UY (1) | UY34190A (sr) |
WO (1) | WO2013012307A1 (sr) |
ZA (1) | ZA201400386B (sr) |
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MX2007009796A (es) | 2007-08-14 | 2009-02-25 | Cell Therapy And Technology S | Gel conteniendo pirfenidona. |
MX2011007675A (es) | 2011-07-19 | 2012-07-11 | Cell Therapy And Technology S A De C V | Procedimiento para la fabricacion de una composicion farmaceutica en forma de tabletas de liberacion prolongada conteniendo pirfenidona y su aplicacion en la regresion de la insuficiencia renal cronica, contractura capsular mamaria y fibrosis hepatica humanas. |
MX346763B (es) | 2012-03-28 | 2017-03-31 | Cell Therapy And Tech S A De C V | Composición tópica semisólida conteniendo pirfenidona y dialil óxido de disulfuro modificado (odd-m) para eliminar o prevenir el acné. |
MX356551B (es) | 2012-08-23 | 2018-06-04 | Grupo Medifarma S A De C V Star | Composición antiséptica, antiseborreica y exfoliante para eliminar o prevenir el acné. |
AR092742A1 (es) | 2012-10-02 | 2015-04-29 | Intermune Inc | Piridinonas antifibroticas |
KR102237799B1 (ko) | 2012-11-14 | 2021-04-08 | 더블유.알. 그레이스 앤드 캄파니-콘. | 생물학적 활성 물질 및 비-정렬된 무기 산화물을 함유하는 조성물 |
CA2943363A1 (en) | 2014-04-02 | 2015-10-08 | Intermune, Inc. | Anti-fibrotic pyridinones |
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MX364040B (es) * | 2016-11-11 | 2019-04-11 | Cell Therapy And Tech S A De C V | Uso farmacéutico de una composición que contiene pirfenidona de liberación prolongada (pfd-lp) para la reversión y tratamiento de la esteatohepatitis humana (nafld/nash). |
KR20180100869A (ko) * | 2017-03-02 | 2018-09-12 | 영진약품 주식회사 | 피르페니돈의 입자크기 조절에 따른 타정성이 개선된 약제학적 조성물 및 이의 제조방법 |
CN107080741A (zh) * | 2017-04-28 | 2017-08-22 | 北京工业大学 | 吡非尼酮缓释制剂及制备方法 |
MX366086B (es) | 2017-08-15 | 2019-06-27 | Cell Therapy And Tech S A De C V | Composicion topica semisolida conteniendo un agente antimicrobiano y pirfenidona para el tratamiento de daños cronicos de la piel. |
US10980747B2 (en) * | 2017-11-27 | 2021-04-20 | Shin-Etsu Chemical Co., Ltd. | Composition for solid preparation, solid preparation, and method for producing the same |
EP3511001B1 (en) | 2018-01-12 | 2021-09-22 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Pirfenidone-containing tablet and capsule formulation |
BR112020021412A8 (pt) | 2018-04-23 | 2022-07-05 | Taiwan Liposome Co Ltd | Composição lipossômica, inalável de liberação prolongada para uso no tratamento de doenças pulmonares |
WO2020115774A1 (en) * | 2018-12-06 | 2020-06-11 | Cipla Limited | High drug load extended release formulations |
KR102199415B1 (ko) | 2019-02-18 | 2021-01-06 | 충북대학교 산학협력단 | 중합체 및 채널링제를 포함하는 피르페니돈 또는 이의 약학적으로 허용가능한 염의 지연 방출용 정제 |
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WO2021215856A1 (ko) * | 2020-04-22 | 2021-10-28 | 영진약품 주식회사 | 안전성과 안정성이 개선된 피르페니돈을 포함하는 장용성 제제 및 이의 제조방법 |
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MX346763B (es) | 2012-03-28 | 2017-03-31 | Cell Therapy And Tech S A De C V | Composición tópica semisólida conteniendo pirfenidona y dialil óxido de disulfuro modificado (odd-m) para eliminar o prevenir el acné. |
MX356551B (es) | 2012-08-23 | 2018-06-04 | Grupo Medifarma S A De C V Star | Composición antiséptica, antiseborreica y exfoliante para eliminar o prevenir el acné. |
MX352342B (es) | 2013-07-12 | 2017-11-22 | Moleculas Naturales S A De C V Star | Un procedimiento para fabricar un complejo mejorado de cloruro de bencetonio-dialil oxido de disulfuro modificado, el complejo obtenido y sus usos. |
MX364040B (es) | 2016-11-11 | 2019-04-11 | Cell Therapy And Tech S A De C V | Uso farmacéutico de una composición que contiene pirfenidona de liberación prolongada (pfd-lp) para la reversión y tratamiento de la esteatohepatitis humana (nafld/nash). |
MX366086B (es) | 2017-08-15 | 2019-06-27 | Cell Therapy And Tech S A De C V | Composicion topica semisolida conteniendo un agente antimicrobiano y pirfenidona para el tratamiento de daños cronicos de la piel. |
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