BR112017025739A2 - composição farmacêutica oral de isotretinoína que tem biodisponibilidade aumentada, processo para preparar a mesma e método de tratamento - Google Patents

composição farmacêutica oral de isotretinoína que tem biodisponibilidade aumentada, processo para preparar a mesma e método de tratamento

Info

Publication number
BR112017025739A2
BR112017025739A2 BR112017025739A BR112017025739A BR112017025739A2 BR 112017025739 A2 BR112017025739 A2 BR 112017025739A2 BR 112017025739 A BR112017025739 A BR 112017025739A BR 112017025739 A BR112017025739 A BR 112017025739A BR 112017025739 A2 BR112017025739 A2 BR 112017025739A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
oral pharmaceutical
preparing
treatment
increased bioavailability
Prior art date
Application number
BR112017025739A
Other languages
English (en)
Inventor
Prabhakar Amrutkar Pankaj
Kochhar Ravi
Deshmukh Subodh
Madan Sumit
Original Assignee
Sun Pharmaceutical Ind Ltd
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 Sun Pharmaceutical Ind Ltd filed Critical Sun Pharmaceutical Ind Ltd
Publication of BR112017025739A2 publication Critical patent/BR112017025739A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/203Retinoic acids ; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/006Pressing and sintering powders, granules or fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074Filling capsules; Related operations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor

Abstract

a presente invenção fornece uma composição farmacêutica oral de isotretinoína que tem biodisponibilidade aumentada, em que a dita composição está na forma de uma dispersão sólida que compreende isotretinoína e uma matriz farmaceuticamente aceitável. a presente invenção refere-se adicionalmente a um processo para preparar a composição farmacêutica oral da presente invenção.
BR112017025739A 2015-05-29 2015-05-29 composição farmacêutica oral de isotretinoína que tem biodisponibilidade aumentada, processo para preparar a mesma e método de tratamento BR112017025739A2 (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2015/054090 WO2016193779A1 (en) 2015-05-29 2015-05-29 Oral pharmaceutical composition of isotretinoin

Publications (1)

Publication Number Publication Date
BR112017025739A2 true BR112017025739A2 (pt) 2018-08-07

Family

ID=57397385

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017025739A BR112017025739A2 (pt) 2015-05-29 2015-05-29 composição farmacêutica oral de isotretinoína que tem biodisponibilidade aumentada, processo para preparar a mesma e método de tratamento

Country Status (9)

Country Link
US (1) US20160346241A1 (pt)
EP (1) EP3302438A4 (pt)
JP (1) JP2018516262A (pt)
AU (1) AU2015397336A1 (pt)
BR (1) BR112017025739A2 (pt)
CA (1) CA2987517A1 (pt)
MX (1) MX2017015322A (pt)
RU (1) RU2017144222A (pt)
WO (1) WO2016193779A1 (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10517846B2 (en) 2016-05-26 2019-12-31 Dr. Reddy's Laboratories Ltd. Pharmaceutical compositions for treating acne
EP3534961A4 (en) 2016-11-02 2020-05-27 Centrexion Therapeutics Corporation STABLE AQUEOUS INJECTABLE CAPSAICIN FORMULATIONS AND MEDICAL USES THEREOF
CN111201015A (zh) 2017-07-20 2020-05-26 中枢疗法公司 使用辣椒素治疗疼痛的方法和组合物
US10716774B1 (en) 2018-01-05 2020-07-21 Yale Pharmaceuticals LLC Pharmaceutical compositions containing isotretinoin with improved dissolution profile and enhanced stability

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4545977A (en) * 1985-01-11 1985-10-08 G. D. Searle & Co. Compositions and methods for treating severe acne with isotretinoin
KR100336090B1 (ko) * 1998-06-27 2002-05-27 윤승원 오일, 지방산 또는 이들의 혼합물을 함유한 난용성 약물의 고형분산제제
US6350786B1 (en) * 1998-09-22 2002-02-26 Hoffmann-La Roche Inc. Stable complexes of poorly soluble compounds in ionic polymers
AU2001289438A1 (en) * 2000-09-22 2002-04-02 Galephar M/F Pharmaceutical semi-solid composition of isotretinoin
JP2005507934A (ja) * 2001-10-30 2005-03-24 ネクター セラピューティックス エイエル,コーポレイション レチノイン酸の水溶性ポリマー結合体
PL2200588T3 (pl) * 2007-09-25 2019-09-30 Solubest Ltd. Kompozycje zawierające lipofilowe związki aktywne i sposób ich wytwarzania
CA2836228A1 (en) * 2012-12-13 2014-03-06 Galephar Pharmaceutical Research, Inc. Pharmaceutical semi-solid composition of isotretinoin
WO2016189481A1 (en) * 2015-05-25 2016-12-01 Sun Pharmaceutical Industries Limited Once daily oral pharmaceutical composition of isotretinoin

Also Published As

Publication number Publication date
US20160346241A1 (en) 2016-12-01
EP3302438A4 (en) 2019-01-09
RU2017144222A (ru) 2019-07-02
CA2987517A1 (en) 2016-12-08
AU2015397336A1 (en) 2017-12-21
WO2016193779A1 (en) 2016-12-08
JP2018516262A (ja) 2018-06-21
MX2017015322A (es) 2018-03-28
RU2017144222A3 (pt) 2019-07-17
EP3302438A1 (en) 2018-04-11

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2594 DE 24-09-2020 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.