BR112012008626A2 - forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo - Google Patents
forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativoInfo
- Publication number
- BR112012008626A2 BR112012008626A2 BR112012008626A BR112012008626A BR112012008626A2 BR 112012008626 A2 BR112012008626 A2 BR 112012008626A2 BR 112012008626 A BR112012008626 A BR 112012008626A BR 112012008626 A BR112012008626 A BR 112012008626A BR 112012008626 A2 BR112012008626 A2 BR 112012008626A2
- Authority
- BR
- Brazil
- Prior art keywords
- active ingredient
- weight
- coating
- dosage form
- oral dosage
- Prior art date
Links
Classifications
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- 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
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different 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
-
- 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
- A61P25/26—Psychostimulants, e.g. nicotine, cocaine
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Emergency Medicine (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
forma farmacêutica oral sólida com liberação modifica de pelo menos um ingrediente ativo a presente invenção refere-se a um forma farmacêutica oral sólida, com liberação modificada de pelo menos um ingrediente ativo, contendo pelo menos micropartículas contendo o dito ingrediente ativo e pelo menos um agente viscosificante em uma forma isolada a partir das ditas micropartículas do ingrediente ativo, caracterizada pelo de que as ditas micropartículas possuem um diâmetro médio na faixa de 100 a 600pm, e são formadas por um núcleo contendo pelo menos o dito ingrediente ativo e são revestidas com pelo menos uma camada de revestimento, - sendo o dito núcleo formado por uma partícula de suporte revestida por uma camada compreendendo pelo menos o dito ingrediente ativo, - sendo a dita camada de revestimento formada por um material composto de pelo menos 25 a 70% em peso em relação ao peso total do dito revestimento, de pelo menos um polímero a, que é insolúvel em água, 30 a 75% em peso em relação ao peso total do dito revestimento, de pelo menos um polímero b insolúvel em água abaixo do ph 5 e solúvel em água acima do ph 7, e 0 a 25% em peso ao peso total do dito revestimento, de pelo menos um plastificante, - estando os ditos polímeros a e b em uma proporção de peso polímero (s) b/polímero (s) a compreendida entre 0.25 e 4, e - a dita camada de revestimento representando pelo menos 35% em peso, em relação ao peso total da dita micropartícula.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25231709P | 2009-10-16 | 2009-10-16 | |
| FR0957270A FR2951378B1 (fr) | 2009-10-16 | 2009-10-16 | Forme pharmaceutique orale solide anti-mesusage et dotee d'un profil specifique de liberation modifiee |
| PCT/IB2010/054674 WO2011045769A2 (fr) | 2009-10-16 | 2010-10-15 | Forme pharmaceutique orale solide anti-mésusage et dotée d'un profil spécifique de libération modifiée |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112012008626A2 true BR112012008626A2 (pt) | 2016-04-19 |
Family
ID=42111016
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112012008626A BR112012008626A2 (pt) | 2009-10-16 | 2010-10-15 | forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20110091537A1 (pt) |
| EP (1) | EP2488161B1 (pt) |
| JP (1) | JP5562428B2 (pt) |
| KR (1) | KR101551732B1 (pt) |
| CN (1) | CN102596181A (pt) |
| AU (1) | AU2010308016B2 (pt) |
| BR (1) | BR112012008626A2 (pt) |
| CA (1) | CA2777010C (pt) |
| ES (1) | ES2582453T3 (pt) |
| FR (1) | FR2951378B1 (pt) |
| IL (1) | IL218992B (pt) |
| MX (1) | MX2012004472A (pt) |
| WO (1) | WO2011045769A2 (pt) |
| ZA (1) | ZA201202451B (pt) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102917697B (zh) | 2010-03-24 | 2016-01-20 | 爵士制药有限公司 | 用于高剂量的水溶性和吸湿性药物的控释剂型 |
| MX362838B (es) | 2012-07-12 | 2019-02-19 | SpecGx LLC | Composiciones farmacéuticas de liberación prolongada para disuadir el abuso de opioides que comprenden un plastómero, un elastómero y un plastificante delicuescente. |
| WO2014034929A1 (ja) * | 2012-09-03 | 2014-03-06 | 第一三共株式会社 | ヒドロモルフォン塩酸塩含有の経口用徐放性医薬組成物 |
| FR2999426B1 (fr) * | 2012-12-13 | 2015-01-02 | Flamel Tech Sa | Forme orale multiparticulaire a liberation immediate d'au moins un compose actif, comprenant des particules enrobees resistantes au broyage. |
| CA3042642A1 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| US9492444B2 (en) | 2013-12-17 | 2016-11-15 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US9707184B2 (en) | 2014-07-17 | 2017-07-18 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| AU2015336065A1 (en) | 2014-10-20 | 2017-05-04 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
| US10398662B1 (en) | 2015-02-18 | 2019-09-03 | Jazz Pharma Ireland Limited | GHB formulation and method for its manufacture |
| US20180185352A1 (en) * | 2015-06-09 | 2018-07-05 | KVK-Tech, Inc. | Abuse deterrent pharmaceutical compositions |
| US11602513B1 (en) | 2016-07-22 | 2023-03-14 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| UY37341A (es) | 2016-07-22 | 2017-11-30 | Flamel Ireland Ltd | Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada |
| US11602512B1 (en) | 2016-07-22 | 2023-03-14 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US11504347B1 (en) | 2016-07-22 | 2022-11-22 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US11986451B1 (en) | 2016-07-22 | 2024-05-21 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US20180263936A1 (en) | 2017-03-17 | 2018-09-20 | Jazz Pharmaceuticals Ireland Limited | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
| GB2571696B (en) | 2017-10-09 | 2020-05-27 | Compass Pathways Ltd | Large scale method for the preparation of Psilocybin and formulations of Psilocybin so produced |
| EP3473246A1 (en) | 2017-10-19 | 2019-04-24 | Capsugel Belgium NV | Immediate release abuse deterrent formulations |
| US11400052B2 (en) | 2018-11-19 | 2022-08-02 | Jazz Pharmaceuticals Ireland Limited | Alcohol-resistant drug formulations |
| CN113473980A (zh) | 2019-03-01 | 2021-10-01 | 弗拉梅尔爱尔兰有限公司 | 在进食状态下具有改善的药代动力学的γ-羟基丁酸酯组合物 |
| CN113993523A (zh) | 2019-04-17 | 2022-01-28 | 指南针探路者有限公司 | 用赛洛西宾治疗抑郁症和其他各种病症 |
| US11779557B1 (en) | 2022-02-07 | 2023-10-10 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
| US11583510B1 (en) | 2022-02-07 | 2023-02-21 | Flamel Ireland Limited | Methods of administering gamma hydroxybutyrate formulations after a high-fat meal |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AT374025B (de) * | 1981-03-20 | 1984-03-12 | Hoffelner Volkwin | Vorrichtung zur erzeugung hochfrequenter schall- wellen |
| CA2007181C (en) * | 1989-01-06 | 1998-11-24 | Angelo Mario Morella | Sustained release pharmaceutical composition |
| FR2830447B1 (fr) * | 2001-10-09 | 2004-04-16 | Flamel Tech Sa | Forme galenique orale microparticulaire pour la liberation retardee et controlee de principes actifs pharmaceutiques |
| CA2498798A1 (en) * | 2002-09-20 | 2004-04-01 | Alpharma, Inc. | Sustained-release opioid formulations and methods of use |
| US8652529B2 (en) * | 2005-11-10 | 2014-02-18 | Flamel Technologies | Anti-misuse microparticulate oral pharmaceutical form |
| FR2892937B1 (fr) * | 2005-11-10 | 2013-04-05 | Flamel Tech Sa | Forme pharmaceutique orale microparticulaire anti-mesusage |
| KR101468053B1 (ko) * | 2006-08-31 | 2014-12-02 | 앱탈리스 파마테크, 인코포레이티드 | 약 염기성 약물의 고용체를 포함하는 약물 전달 시스템 |
| DE102007030987A1 (de) * | 2007-07-04 | 2009-01-08 | Robert Bosch Gmbh | Vorrichtung zur Bestimmung einer Geschwindigkeit mit einem Beschleunigungssensor |
| JP5204847B2 (ja) * | 2007-09-21 | 2013-06-05 | エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング | エタノールの影響に対して耐性を有するｐｈ依存性制御放出医薬オピオイド組成物 |
-
2009
- 2009-10-16 FR FR0957270A patent/FR2951378B1/fr active Active
-
2010
- 2010-10-15 AU AU2010308016A patent/AU2010308016B2/en not_active Ceased
- 2010-10-15 EP EP10773994.8A patent/EP2488161B1/fr not_active Not-in-force
- 2010-10-15 CN CN2010800468172A patent/CN102596181A/zh active Pending
- 2010-10-15 JP JP2012533733A patent/JP5562428B2/ja not_active Expired - Fee Related
- 2010-10-15 MX MX2012004472A patent/MX2012004472A/es not_active Application Discontinuation
- 2010-10-15 WO PCT/IB2010/054674 patent/WO2011045769A2/fr active Application Filing
- 2010-10-15 US US12/905,387 patent/US20110091537A1/en not_active Abandoned
- 2010-10-15 ES ES10773994.8T patent/ES2582453T3/es active Active
- 2010-10-15 BR BR112012008626A patent/BR112012008626A2/pt not_active IP Right Cessation
- 2010-10-15 CA CA2777010A patent/CA2777010C/fr not_active Expired - Fee Related
- 2010-10-15 KR KR1020127012578A patent/KR101551732B1/ko not_active IP Right Cessation
-
2012
- 2012-04-02 IL IL218992A patent/IL218992B/en not_active IP Right Cessation
- 2012-04-04 ZA ZA2012/02451A patent/ZA201202451B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JP5562428B2 (ja) | 2014-07-30 |
| FR2951378B1 (fr) | 2012-06-01 |
| MX2012004472A (es) | 2012-05-08 |
| EP2488161B1 (fr) | 2016-04-20 |
| IL218992B (en) | 2018-07-31 |
| JP2013508268A (ja) | 2013-03-07 |
| AU2010308016A1 (en) | 2012-04-26 |
| IL218992A0 (en) | 2012-06-28 |
| CN102596181A (zh) | 2012-07-18 |
| WO2011045769A2 (fr) | 2011-04-21 |
| EP2488161A2 (fr) | 2012-08-22 |
| KR20120110167A (ko) | 2012-10-09 |
| KR101551732B1 (ko) | 2015-09-10 |
| ES2582453T3 (es) | 2016-09-13 |
| US20110091537A1 (en) | 2011-04-21 |
| FR2951378A1 (fr) | 2011-04-22 |
| CA2777010C (fr) | 2017-01-10 |
| WO2011045769A3 (fr) | 2011-06-16 |
| CA2777010A1 (fr) | 2011-04-21 |
| ZA201202451B (en) | 2012-11-28 |
| AU2010308016B2 (en) | 2014-06-05 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE AS 4A, 5A E 6A ANUIDADES. |
|
| 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 2384 DE 13-09-2016 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. |