AR116033A1 - Composiciones farmacéuticas semisólidas de base oleosa conteniendo pirfenidona para su aplicación en la reparación tisular - Google Patents

Composiciones farmacéuticas semisólidas de base oleosa conteniendo pirfenidona para su aplicación en la reparación tisular

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Publication number
AR116033A1
AR116033A1 ARP190102459A ARP190102459A AR116033A1 AR 116033 A1 AR116033 A1 AR 116033A1 AR P190102459 A ARP190102459 A AR P190102459A AR P190102459 A ARP190102459 A AR P190102459A AR 116033 A1 AR116033 A1 AR 116033A1
Authority
AR
Argentina
Prior art keywords
pirfenidone
solid pharmaceutical
semi
cremophor
pharmaceutical composition
Prior art date
Application number
ARP190102459A
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English (en)
Original Assignee
Cell Therapy And Tech S A De C V
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cell Therapy And Tech S A De C V filed Critical Cell Therapy And Tech S A De C V
Publication of AR116033A1 publication Critical patent/AR116033A1/es

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    • 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
    • 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
    • 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
    • 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
    • A61K47/06—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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/342—Alcohols having more than seven atoms in an unbroken chain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4906—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom
    • A61K8/4926—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom having six membered rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4973—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Birds (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)

Abstract

La presente describe composiciones farmacéuticas semisólidas conteniendo Pirfenidona, que ofrece ventajas sobre otras formas farmacéuticas de administración cutánea conocidas en el estado de la técnica, gracias a sus características de permeabilidad y absorción, que es útil en el tratamiento para la restauración de los tejidos que han sufrido pérdida o degradación de matriz extracelular dando como resultado la formación de arrugas o adelgazamiento de la piel. Reivindicación 1: Composición farmacéutica semisólida de pirfenidona caracterizada porque comprende 2% al 12% de pirfenidona, de 20% a 60% de un disolvente humectante, de 5% a 10% de uno o una combinación de emulsificantes, del 2% al 8% de un agente de consistencia y emoliencia, del 0.5% al 3% de uno o varios agentes emolientes, del 0.1% al 2% de un agente conservador, del 0.05% al 0.2% de un agente reológico o viscosante, del 0.05% al 0.2% de un neutralizante, del 0.05% al 2% de un conservador y del 0.0005% al 0.003% de un agente estabilizante y opcionalmente un antiséptico / conservador del 0.008% a 0.8%. Reivindicación 3: Composición farmacéutica semisólida de pirfenidona en forma de crema de conformidad con la reivindicación 2, caracterizada porque la base el humectante es Propilenglicol, los emulsificantes son Span 60, Cremophor A-6, Cremophor A-25 y Tween 60; los agentes de consistencia y emoliencia son Alcohol cetílico y Alcohol estearílico; el emoliente es Dimeticona, los conservantes son Metilparabeno sódico y Propilparabeno sódico, agente reológico o viscosante es Carbómero; neutralizante Trietanolamina; y el estabilizante es Ácido cítrico anhidro. Reivindicación 8: La composición farmacéutica semisólida de pirfenidona de conformidad con la reivindicación 1, caracterizada porque la base el humectante es Propilenglicol, los emulsificantes son Span 60, Cremophor A-6, Cremophor A-25 y Tween 60; los agentes de consistencia y emoliencia son Alcohol cetílico y Alcohol estearílico; el conservador también antiséptico es Óxido Dialil Disulfuro Modificado (ODDM) y la base de consistencia es Petrolato blanco sólido; en donde la composición farmacéutica semisólida está en forma de pomada. Reivindicación 10: Proceso de fabricación de una composición farmacéutica semisólida de Pirfenidona en forma de pomada de conformidad con la reivindicación 8, caracterizado porque comprende las siguientes etapas: A) Fase Oleosa: colocar en un reactor, agitar y calentar a (75ºC - 80ºC), hasta fusión completa; Span 60, Alcohol Cetílico, Alcohol Estearílico, Cremophor A-6, Cremophor A-25 y Petrolato blanco sólido. Identifíquese Fase Oleosa; B) Solución “A”: coloque en un marmita Propilenglicol y calentar a (75ºC - 80ºC y agitar a 131 rpm ± 10%) y agitar. Agregar poco a poco la Pirfenidona con agitación constante y manteniendo el calentamiento a (75ºC - 80ºC) hasta completa disolución. Mantener en agitación y calentamiento 20 minutos, agregar poco a poco ODDM 2%, agitar 10 min.; agregar Tween 60 y agitar 10 min.; C) Mezcla de Fases: agregar al reactor con la Fase Oleosa todo el contenido de la Fase Acuosa, con agitación constante a 71 rpm durante 20 min. Disminuir la temperatura a 30 - 35ºC.
ARP190102459A 2018-08-31 2019-08-29 Composiciones farmacéuticas semisólidas de base oleosa conteniendo pirfenidona para su aplicación en la reparación tisular AR116033A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
MX2018010528A MX368750B (es) 2018-08-31 2018-08-31 Composiciones farmaceuticas semisolidas de base oleosa conteniendo pirfenidona para su aplicacion en la reparacion tisular.

Publications (1)

Publication Number Publication Date
AR116033A1 true AR116033A1 (es) 2021-03-25

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ID=69513965

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ARP190102459A AR116033A1 (es) 2018-08-31 2019-08-29 Composiciones farmacéuticas semisólidas de base oleosa conteniendo pirfenidona para su aplicación en la reparación tisular

Country Status (17)

Country Link
US (1) US20210401989A1 (es)
EP (1) EP3842030A2 (es)
JP (2) JP7421558B2 (es)
CN (1) CN113056257A (es)
AR (1) AR116033A1 (es)
AU (1) AU2019329007A1 (es)
BR (1) BR112021003877A2 (es)
CA (1) CA3111314A1 (es)
CL (1) CL2021000509A1 (es)
CO (1) CO2021003927A2 (es)
CR (1) CR20210161A (es)
EC (1) ECSP21022187A (es)
IL (1) IL281142A (es)
MX (1) MX368750B (es)
PE (1) PE20212365A1 (es)
UY (1) UY38355A (es)
WO (1) WO2020046102A2 (es)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
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.
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.
WO2024051687A1 (zh) * 2022-09-06 2024-03-14 南京迈诺威医药科技有限公司 一种含有吡非尼酮的局部外用制剂及其用途

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JPH02215719A (ja) 1989-02-15 1990-08-28 Yamauchi Akitomo 線維化病変組織の修復並びに線維化病変の阻止剤
BR9406461A (pt) * 1993-05-07 1996-01-30 Solomon Begelfor Margolin Composições e métodos para a reparação e prevenção de les~es fibróticas
EP1069898B1 (en) * 1998-03-17 2004-05-12 MARGOLIN, Solomon B. Topical antiseptic compositions and methods
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JP6225030B2 (ja) 2011-02-15 2017-11-01 アラーガン、インコーポレイテッドＡｌｌｅｒｇａｎ，Ｉｎｃｏｒｐｏｒａｔｅｄ 酒さの症状を治療するためのオキシメタゾリンの薬学的クリーム組成物
CN102670600A (zh) 2011-03-12 2012-09-19 赵海静 一种抑制瘢痕和促进创口愈合的医药产品,其制备方法和应用
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.
CA2905587A1 (en) 2013-03-15 2014-09-18 Medicis Pharmaceutical Corporation Topical compositions of flunisolide and methods of treatment

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Publication number Publication date
EP3842030A2 (en) 2021-06-30
UY38355A (es) 2020-03-31
CA3111314A1 (en) 2020-03-05
WO2020046102A3 (es) 2020-09-10
US20210401989A1 (en) 2021-12-30
JP2024029232A (ja) 2024-03-05
WO2020046102A2 (es) 2020-03-05
ECSP21022187A (es) 2021-06-30
JP2022508418A (ja) 2022-01-19
CR20210161A (es) 2021-08-19
AU2019329007A1 (en) 2021-04-01
PE20212365A1 (es) 2021-12-21
JP7421558B2 (ja) 2024-01-24
MX368750B (es) 2019-10-15
IL281142A (en) 2021-06-30
CL2021000509A1 (es) 2021-07-19
BR112021003877A2 (pt) 2021-05-18
CO2021003927A2 (es) 2021-07-30
CN113056257A (zh) 2021-06-29

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