BR112015030268A2 - composição farmacêutica, recipiente, kit, e, método para a preparação de uma composição - Google Patents

composição farmacêutica, recipiente, kit, e, método para a preparação de uma composição

Info

Publication number
BR112015030268A2
BR112015030268A2 BR112015030268A BR112015030268A BR112015030268A2 BR 112015030268 A2 BR112015030268 A2 BR 112015030268A2 BR 112015030268 A BR112015030268 A BR 112015030268A BR 112015030268 A BR112015030268 A BR 112015030268A BR 112015030268 A2 BR112015030268 A2 BR 112015030268A2
Authority
BR
Brazil
Prior art keywords
composition
kit
preparing
container
pharmaceutical composition
Prior art date
Application number
BR112015030268A
Other languages
English (en)
Other versions
BR112015030268B1 (pt
Inventor
Cohen Daniel
Chumakov Ilya
Nabirochkin Serguei
Bertrand Viviane
Original Assignee
Pharnext
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 Pharnext filed Critical Pharnext
Publication of BR112015030268A2 publication Critical patent/BR112015030268A2/pt
Publication of BR112015030268B1 publication Critical patent/BR112015030268B1/pt

Links

Classifications

    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • 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
    • A61K47/26—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
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/08—Solutions
    • 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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • 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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Abstract

resumo composição farmacêutica, recipiente, kit, e, método para a preparação de uma composição a presente invenção se refere a uma solução farmacêutica homogênea, estável, e palatável que compreende baclofeno, sorbitol e naltrexona. 1/1
BR112015030268-8A 2013-06-05 2014-06-05 Composição farmacêutica BR112015030268B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13170583 2013-06-05
EP13170583.2 2013-06-05
PCT/EP2014/061664 WO2014195394A1 (en) 2013-06-05 2014-06-05 Stable oral solutions for combined api

Publications (2)

Publication Number Publication Date
BR112015030268A2 true BR112015030268A2 (pt) 2017-07-25
BR112015030268B1 BR112015030268B1 (pt) 2023-01-31

Family

ID=48569977

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015030268-8A BR112015030268B1 (pt) 2013-06-05 2014-06-05 Composição farmacêutica

Country Status (28)

Country Link
US (2) US10300015B2 (pt)
EP (1) EP3003268B1 (pt)
JP (1) JP6300906B2 (pt)
KR (1) KR102203491B1 (pt)
CN (2) CN105473131A (pt)
AU (1) AU2014276856B2 (pt)
BR (1) BR112015030268B1 (pt)
CA (1) CA2913331C (pt)
CY (1) CY1120758T1 (pt)
DK (1) DK3003268T3 (pt)
EA (1) EA029478B1 (pt)
ES (1) ES2691309T3 (pt)
HK (1) HK1223278A1 (pt)
HR (1) HRP20181607T1 (pt)
HU (1) HUE040023T2 (pt)
IL (1) IL242735B (pt)
LT (1) LT3003268T (pt)
MX (1) MX367210B (pt)
NZ (1) NZ714684A (pt)
PL (1) PL3003268T3 (pt)
PT (1) PT3003268T (pt)
RS (1) RS57906B1 (pt)
SG (1) SG11201509824UA (pt)
SI (1) SI3003268T1 (pt)
TR (1) TR201815059T4 (pt)
UA (1) UA115811C2 (pt)
WO (1) WO2014195394A1 (pt)
ZA (1) ZA201508675B (pt)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2065038A1 (en) 2007-11-30 2009-06-03 Pharnext New therapeutic approaches for treating Charcot-Marie-Tooth disease
EP2263665A1 (en) 2009-06-02 2010-12-22 Pharnext New compositions for treating CMT and related disorders
US9393241B2 (en) 2009-06-02 2016-07-19 Pharnext Compositions for treating CMT and related disorders
WO2014195394A1 (en) 2013-06-05 2014-12-11 Pharnext Stable oral solutions for combined api
JP6619744B2 (ja) 2014-02-11 2019-12-11 ファーネクストＰｈａｒｎｅｘｔ 神経障害の処置のためのバクロフェン、アカンプロセート、及び中鎖トリグリセライドの併用
US10383870B2 (en) 2016-06-10 2019-08-20 Pharnext Early treatment of CMT disease
CN109922801B (zh) 2016-09-09 2023-07-18 库蒂斯制药公司 甲硝唑和巴氯芬的混悬剂和稀释剂
CN106389313A (zh) * 2016-10-08 2017-02-15 安徽省逸欣铭医药科技有限公司 一种巴氯芬口服液组合物
WO2019075127A1 (en) * 2017-10-10 2019-04-18 Vertice Pharma, Llc ORAL MICODRIN HYDROCHLORIDE SOLUTION AND USES THEREOF
US10952981B2 (en) 2019-05-27 2021-03-23 Slayback Pharma Llc Liquid pharmaceutical compositions of baclofen for oral administration
US10792262B1 (en) * 2019-07-29 2020-10-06 Saol International Limited Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
US10610502B1 (en) 2019-08-30 2020-04-07 Metacel Pharmaceuticals, LLC Oral baclofen solutions

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CA2345642A1 (en) 1998-10-02 2000-04-13 Celtrix Pharmaceuticals, Inc. Methods for the treatment of non-thyroid disorders
WO2002049607A2 (en) * 2000-12-20 2002-06-27 Firmenich Sa Flavoured oral drug delivery system
JP3805646B2 (ja) 2001-05-25 2006-08-02 久光メディカル株式会社 医薬液剤
US20030229111A1 (en) 2002-03-14 2003-12-11 Benjamin Oshlack Naltrexone hydrochloride compositions
FR2842422B1 (fr) 2002-07-16 2006-06-30 Univ Aix Marseille Ii Compositions destinees au traitement des neuropathies peripheriques, preparation et utilisations
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EP2065038A1 (en) 2007-11-30 2009-06-03 Pharnext New therapeutic approaches for treating Charcot-Marie-Tooth disease
EP2135607A1 (en) 2008-06-18 2009-12-23 Pharnext Combination of pilocarpin and methimazol for treating Charcot-MarieTooth disease and related disorders
US9393241B2 (en) 2009-06-02 2016-07-19 Pharnext Compositions for treating CMT and related disorders
EP2263665A1 (en) 2009-06-02 2010-12-22 Pharnext New compositions for treating CMT and related disorders
EP2322163A1 (en) 2009-11-03 2011-05-18 Pharnext New therapeutics approaches for treating alzheimer disease
IT1400067B1 (it) * 2010-05-21 2013-05-17 Molteni & C Spray nasale liquido contenente naltrexone a bassi dosaggi.
EP2727588B1 (en) 2011-03-01 2018-08-29 Pharnext Baclofen and acamprosate based therapy of neurological disorders
WO2014195394A1 (en) 2013-06-05 2014-12-11 Pharnext Stable oral solutions for combined api
US10383870B2 (en) 2016-06-10 2019-08-20 Pharnext Early treatment of CMT disease

Also Published As

Publication number Publication date
AU2014276856A1 (en) 2015-12-17
KR20160048040A (ko) 2016-05-03
CA2913331C (en) 2021-08-24
MX2015016676A (es) 2016-06-23
PT3003268T (pt) 2018-11-08
EA201592227A1 (ru) 2016-04-29
AU2014276856B2 (en) 2018-11-15
CA2913331A1 (en) 2014-12-11
US20190290578A1 (en) 2019-09-26
EP3003268A1 (en) 2016-04-13
CN105473131A (zh) 2016-04-06
CY1120758T1 (el) 2019-12-11
IL242735B (en) 2019-10-31
JP6300906B2 (ja) 2018-03-28
US10849851B2 (en) 2020-12-01
DK3003268T3 (en) 2018-11-05
PL3003268T3 (pl) 2019-01-31
ZA201508675B (en) 2017-07-26
LT3003268T (lt) 2018-12-10
NZ714684A (en) 2020-05-29
CN113209101A (zh) 2021-08-06
SI3003268T1 (sl) 2019-01-31
KR102203491B1 (ko) 2021-01-14
TR201815059T4 (tr) 2018-11-21
ES2691309T3 (es) 2018-11-26
HK1223278A1 (zh) 2017-07-28
MX367210B (es) 2019-08-08
HRP20181607T1 (hr) 2018-12-28
EP3003268B1 (en) 2018-07-25
US10300015B2 (en) 2019-05-28
EA029478B1 (ru) 2018-03-30
US20160113867A1 (en) 2016-04-28
BR112015030268B1 (pt) 2023-01-31
RS57906B1 (sr) 2019-01-31
JP2016521698A (ja) 2016-07-25
WO2014195394A1 (en) 2014-12-11
UA115811C2 (uk) 2017-12-26
HUE040023T2 (hu) 2019-02-28
SG11201509824UA (en) 2015-12-30

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/06/2014, OBSERVADAS AS CONDICOES LEGAIS