ECSP14013160A - Procedimiento para la fabricación de una composición farmacéutica en forma de tabletas de liberación prolongada conteniendo pirfenidona y su aplicación en la regresión de la insuficiencia renal crónica, contractura capsular mamaria y fibrosis hepatica hu - Google Patents
Procedimiento para la fabricación de una composición farmacéutica en forma de tabletas de liberación prolongada conteniendo pirfenidona y su aplicación en la regresión de la insuficiencia renal crónica, contractura capsular mamaria y fibrosis hepatica huInfo
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- ECSP14013160A ECSP14013160A ECSP14013160A ECSP14013160A EC SP14013160 A ECSP14013160 A EC SP14013160A EC SP14013160 A ECSP14013160 A EC SP14013160A EC SP14013160 A ECSP14013160 A EC SP14013160A
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- Ecuador
- Prior art keywords
- regression
- manufacture
- pharmaceutical composition
- renal failure
- chronic renal
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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
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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
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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
- A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
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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
- A61K31/70—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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Rheumatology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Urology & Nephrology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Pulmonology (AREA)
- Gastroenterology & Hepatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Materials For Medical Uses (AREA)
Abstract
La presente invención se relaciona con un procedimiento para la fabricación de una composición farmacéutica en forma de tabletas de liberación prolongada que comprende desde 600 miligramos hasta 2400 miligramos de Pirfenidona (PFD), de manera tal que el fármaco que lo contiene esté biodisponible durante un periodo de tiempo prolongado de 12 horas a partir de su administración. De esta manera se optimiza la acción anti-fibrótica y anti-inflamatoria del medicamento Pirfenidona. Además, la presente invención ofrece ventajas y una mejor eficacia terapéutica sobre otras formas farmacéuticas de Pirfenidona para su administración oral y su aplicación terapéutica en la regresión de la insuficiencia renal crónica secundaria a glomeruloesclerosis primaria; presenta una mejor actividad en la disminución y/o regresión de los efectos nocivos en la contractura capsular mamaria observados después la implantación quirúrgica de implantes mamarios en humanos y ejerce una importante acción anti-TNF- y anti-TGF- 1 para el tratamiento de fibrosis hepática.
Applications Claiming Priority (1)
| 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. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP14013160A true ECSP14013160A (es) | 2014-02-28 |
Family
ID=46940567
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECSP14013160 ECSP14013160A (es) | 2011-07-19 | 2014-01-21 | Procedimiento para la fabricación de una composición farmacéutica en forma de tabletas de liberación prolongada conteniendo pirfenidona y su aplicación en la regresión de la insuficiencia renal crónica, contractura capsular mamaria y fibrosis hepatica hu |
Country Status (35)
| Country | Link |
|---|---|
| US (7) | US9408836B2 (es) |
| EP (2) | EP2735306A1 (es) |
| JP (1) | JP6034380B2 (es) |
| KR (2) | KR101632332B1 (es) |
| CN (2) | CN112386579A (es) |
| AR (1) | AR087205A1 (es) |
| AU (1) | AU2012284627B2 (es) |
| BR (1) | BR112014001297B1 (es) |
| CA (1) | CA2842654C (es) |
| CL (1) | CL2014000131A1 (es) |
| CO (1) | CO6970587A2 (es) |
| CR (1) | CR20140019A (es) |
| CY (2) | CY2200005T2 (es) |
| DE (1) | DE15161929T1 (es) |
| DK (1) | DK2907506T3 (es) |
| DO (1) | DOP2014000010A (es) |
| EC (1) | ECSP14013160A (es) |
| ES (1) | ES2550227T3 (es) |
| HR (1) | HRP20180183T1 (es) |
| HU (1) | HUE036511T2 (es) |
| LT (1) | LT2907506T (es) |
| MX (1) | MX2011007675A (es) |
| NO (1) | NO2907506T3 (es) |
| PE (1) | PE20141684A1 (es) |
| PL (1) | PL2907506T3 (es) |
| PT (1) | PT2907506T (es) |
| PY (1) | PY1233418A (es) |
| RS (1) | RS56858B1 (es) |
| RU (1) | RU2682177C2 (es) |
| SI (1) | SI2907506T1 (es) |
| SM (1) | SMT201800081T1 (es) |
| UA (1) | UA114181C2 (es) |
| UY (1) | UY34190A (es) |
| WO (1) | WO2013012307A1 (es) |
| ZA (1) | ZA201400386B (es) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN105050708A (zh) | 2012-11-14 | 2015-11-11 | 格雷斯公司 | 含有生物活性材料与无序无机氧化物的组合物 |
| US10233195B2 (en) | 2014-04-02 | 2019-03-19 | 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). |
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| 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 |
| CN112004527B (zh) | 2018-04-23 | 2024-09-24 | 盈擘生技股份有限公司 | 用于治疗肺部疾病的可吸入脂质体缓释组合物 |
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| KR102199415B1 (ko) * | 2019-02-18 | 2021-01-06 | 충북대학교 산학협력단 | 중합체 및 채널링제를 포함하는 피르페니돈 또는 이의 약학적으로 허용가능한 염의 지연 방출용 정제 |
| IL297296A (en) * | 2020-04-14 | 2022-12-01 | Excalibur Pharmaceuticals Inc | Pirfenidone for the treatment of the corona virus |
| KR102584268B1 (ko) * | 2020-04-22 | 2023-10-05 | 영진약품 주식회사 | 안전성과 안정성이 개선된 피르페니돈을 포함하는 장용성 제제 및 이의 제조방법 |
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