ES2721849T3 - Forma oral sólida dotada de un doble perfil de liberación que comprende multipartículas - Google Patents
Forma oral sólida dotada de un doble perfil de liberación que comprende multipartículas Download PDFInfo
- Publication number
- ES2721849T3 ES2721849T3 ES09745961T ES09745961T ES2721849T3 ES 2721849 T3 ES2721849 T3 ES 2721849T3 ES 09745961 T ES09745961 T ES 09745961T ES 09745961 T ES09745961 T ES 09745961T ES 2721849 T3 ES2721849 T3 ES 2721849T3
- Authority
- ES
- Spain
- Prior art keywords
- hours
- release
- active principle
- cellulose acetate
- microparticles
- Prior art date
- Legal status (The legal status 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 status listed.)
- Active
Links
- 239000007787 solid Substances 0.000 title 1
- 239000011859 microparticle Substances 0.000 abstract 5
- 229920000642 polymer Polymers 0.000 abstract 4
- 239000004480 active ingredient Substances 0.000 abstract 3
- 229920002301 cellulose acetate Polymers 0.000 abstract 3
- 229920001577 copolymer Polymers 0.000 abstract 3
- 238000005063 solubilization Methods 0.000 abstract 3
- 230000007928 solubilization Effects 0.000 abstract 3
- 239000011248 coating agent Substances 0.000 abstract 2
- 238000000576 coating method Methods 0.000 abstract 2
- 230000001143 conditioned effect Effects 0.000 abstract 2
- 239000000463 material Substances 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 abstract 2
- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 abstract 1
- 229920000623 Cellulose acetate phthalate Polymers 0.000 abstract 1
- 239000001856 Ethyl cellulose Substances 0.000 abstract 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 abstract 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 abstract 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 abstract 1
- 229920002845 Poly(methacrylic acid) Polymers 0.000 abstract 1
- 229920001800 Shellac Polymers 0.000 abstract 1
- IYKJEILNJZQJPU-UHFFFAOYSA-N acetic acid;butanedioic acid Chemical compound CC(O)=O.OC(=O)CCC(O)=O IYKJEILNJZQJPU-UHFFFAOYSA-N 0.000 abstract 1
- 229920006217 cellulose acetate butyrate Polymers 0.000 abstract 1
- 229940081734 cellulose acetate phthalate Drugs 0.000 abstract 1
- 239000011247 coating layer Substances 0.000 abstract 1
- 230000003111 delayed effect Effects 0.000 abstract 1
- 238000007922 dissolution test Methods 0.000 abstract 1
- 150000002148 esters Chemical class 0.000 abstract 1
- 229920001249 ethyl cellulose Polymers 0.000 abstract 1
- 235000019325 ethyl cellulose Nutrition 0.000 abstract 1
- 239000012530 fluid Substances 0.000 abstract 1
- 230000002496 gastric effect Effects 0.000 abstract 1
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 abstract 1
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 abstract 1
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 abstract 1
- 238000000338 in vitro Methods 0.000 abstract 1
- 239000010410 layer Substances 0.000 abstract 1
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 abstract 1
- 229940100467 polyvinyl acetate phthalate Drugs 0.000 abstract 1
- 229910000160 potassium phosphate Inorganic materials 0.000 abstract 1
- 235000011009 potassium phosphates Nutrition 0.000 abstract 1
- 230000002035 prolonged effect Effects 0.000 abstract 1
- 239000004208 shellac Substances 0.000 abstract 1
- 229940113147 shellac Drugs 0.000 abstract 1
- 235000013874 shellac Nutrition 0.000 abstract 1
- 239000002356 single layer Substances 0.000 abstract 1
- UIERETOOQGIECD-ONEGZZNKSA-N tiglic acid Chemical compound C\C=C(/C)C(O)=O UIERETOOQGIECD-ONEGZZNKSA-N 0.000 abstract 1
- 238000000870 ultraviolet spectroscopy Methods 0.000 abstract 1
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
- A61K9/20—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
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
Comprimido, destinado a la administración por vía oral de al menos un principio activo y apto para garantizar un doble mecanismo de liberación de dicho principio activo, condicionándose el primero por el tiempo y condicionándose el segundo por el pH, en el que dicho principio activo está presente en forma de un sistema microparticular cuyas micropartículas poseen un núcleo formado en todo o parte de dicho principio activo y revestidos con al menos una capa que condiciona dicho perfil de liberación de dicho principio activo y formada de un material compuesto de al menos: - del 30 al 50% en peso con respecto al peso total de dicho revestimiento de al menos un polímero A insoluble en los fluidos gastrointestinales, seleccionado entre la etilcelulosa, el acetato butirato de celulosa, el acetato de celulosa, los copolímeros de amonio (met)acrilato de tipo "A" o de tipo "B", los ésteres de ácidos poli(met)acrílicos, y sus mezclas; - del 30 al 60% en peso con respecto al peso total de dicho revestimiento de al menos un polímero B que posee un valor de pH de solubilización comprendido en el intervalo de pH de 5 a 7, seleccionado entre: - el o los copolímeros de ácido metacrílico y de metacrilato de metilo, - el o los copolímeros de ácido metacrílico y de acrilato de etilo, - los derivados celulósicos tales como el acetato ftalato de celulosa, el acetato succinato de celulosa, el acetato trimelilato de celulosa, el ftalato de hidroxipropilmetilcelulosa, el acetato succinato de hidroxipropilmetilcelulosa, - la goma laca, - el polivinilo de acetato ftalato, y - sus mezclas, y estando dicha capa de revestimiento de las micropartículas compuesta de una única capa formada de dicho material; estando dichas micropartículas dispersadas dentro del comprimido, estando dichas micropartículas aptas para liberar dicho principio activo según un perfil de liberación modificada en tres fases caracterizado por: - al contacto de un medio cuyo pH está a un valor inferior al del pH de solubilización del polímero B, un perfil de liberación retrasada y prolongada con un tiempo de latencia dado y comprendido entre 0,5 y 12 horas, en particular entre 0,5 y 8 horas, incluso entre 1 y 5 horas y según un tiempo de semi liberación t1/2 comprendido entre 0,75 y 24 horas, especialmente entre 0,75 y 12 horas, incluso entre 0,75 y 8 horas, en particular entre 1 y 5 horas, tiempo al final del cual se libera la mitad del principio activo contenido; - al contacto de un medio cuyo pH está a un valor superior al del pH de solubilización del polímero B, una liberación del principio activo sin tiempo de latencia y con un t1/2 comprendido entre 0,1 y 2 horas; pudiendo la cinética de liberación del principio activo determinarse por unos ensayos de disolución in vitro, efectuados en un aparato de palas USP tipo II con una velocidad de rotación de las palas de 75 rpm, por espectrometría UV, por un lado, en un medio 0,1 N HCl y, por otro lado, en un medio fosfato de potasio 0,05 M a pH 6,8.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US7125008P | 2008-04-18 | 2008-04-18 | |
| FR0852627A FR2930147B1 (fr) | 2008-04-18 | 2008-04-18 | Forme orale solide dotee d'un double profil de liberation |
| PCT/FR2009/050719 WO2009138642A1 (fr) | 2008-04-18 | 2009-04-17 | Forme orale solide dotee d'un double profil de liberation comprenant des multiparticules |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2721849T3 true ES2721849T3 (es) | 2019-08-05 |
Family
ID=40110982
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES09745961T Active ES2721849T3 (es) | 2008-04-18 | 2009-04-17 | Forma oral sólida dotada de un doble perfil de liberación que comprende multipartículas |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20090291137A1 (es) |
| EP (1) | EP2276474B1 (es) |
| JP (1) | JP5687185B2 (es) |
| KR (1) | KR101380507B1 (es) |
| CN (1) | CN102046155A (es) |
| AU (1) | AU2009247921B2 (es) |
| BR (1) | BRPI0910572B1 (es) |
| CA (1) | CA2721232C (es) |
| ES (1) | ES2721849T3 (es) |
| FR (1) | FR2930147B1 (es) |
| IL (1) | IL208572A (es) |
| MX (1) | MX339671B (es) |
| WO (1) | WO2009138642A1 (es) |
| ZA (1) | ZA201007238B (es) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2945947B1 (fr) | 2009-05-29 | 2011-07-29 | Flamel Tech Sa | Compositions pharmaceutiques flottantes a liberation controlee |
| WO2013156163A1 (en) | 2012-04-19 | 2013-10-24 | Glatt Ag | Taste-masked pharmaceutical compositions containing diclofenac |
| WO2016053835A1 (en) * | 2014-09-30 | 2016-04-07 | Dow Global Technologies Llc | Aqueous ethylcellulose dispersions with polymeric additive |
| WO2016114812A1 (en) * | 2015-01-12 | 2016-07-21 | Robert Niichel | Layered sustained-release microbeads and methods of making the same |
| JP6112696B1 (ja) * | 2015-10-05 | 2017-04-12 | 富山化学工業株式会社 | ソリスロマイシンを含む錠剤 |
| 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 |
| FR3089405A1 (fr) | 2018-12-07 | 2020-06-12 | Urgo Recherche Innovation Et Developpement | Dispositif de retenue et système de contention comprenant un article de contention et un tel dispositif de retenue |
| FR3089406B1 (fr) | 2018-12-07 | 2020-11-20 | Urgo Rech Innovation Et Developpement | Dispositif de retenue et système de contention comprenant un article de contention et un tel dispositif de retenue |
| CA3138094A1 (en) | 2019-04-17 | 2020-10-22 | Compass Pathfinder Limited | Methods for treating anxiety disorders, headache disorders, and eating disorders with psilocybin |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IE66933B1 (en) * | 1990-01-15 | 1996-02-07 | Elan Corp Plc | Controlled absorption naproxen formulation for once-daily administration |
| DE69331906T2 (de) * | 1992-08-05 | 2002-12-19 | F.H. Faulding & Co. Ltd., Underdale | Granulierte pharmazeutische zusammensetzung |
| US5260069A (en) * | 1992-11-27 | 1993-11-09 | Anda Sr Pharmaceuticals Inc. | Pulsatile particles drug delivery system |
| US5458888A (en) * | 1994-03-02 | 1995-10-17 | Andrx Pharmaceuticals, Inc. | Controlled release tablet formulation |
| JPH0826977A (ja) * | 1994-07-19 | 1996-01-30 | Tanabe Seiyaku Co Ltd | 溶出制御型経口製剤 |
| TW580397B (en) * | 1997-05-27 | 2004-03-21 | Takeda Chemical Industries Ltd | Solid preparation |
| US8545880B2 (en) * | 1999-02-26 | 2013-10-01 | Andrx Pharmaceuticals, Llc | Controlled release oral dosage form |
| US6627223B2 (en) * | 2000-02-11 | 2003-09-30 | Eurand Pharmaceuticals Ltd. | Timed pulsatile drug delivery systems |
| US6991807B2 (en) * | 2000-02-24 | 2006-01-31 | Advancis Pharmaceutical, Corp. | Antibiotic composition |
| US7223421B2 (en) * | 2000-06-30 | 2007-05-29 | Mcneil-Ppc, Inc. | Teste masked pharmaceutical particles |
| US6500457B1 (en) * | 2000-08-14 | 2002-12-31 | Peirce Management, Llc | Oral pharmaceutical dosage forms for pulsatile delivery of an antiarrhythmic agent |
| EP1258241A1 (en) * | 2001-05-16 | 2002-11-20 | BIOPROGRESS S.p.A. | Method of increasing the bioavailability of nimesulide |
| 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 |
| US7939102B2 (en) * | 2002-06-07 | 2011-05-10 | Torrent Pharmaceuticals Ltd. | Controlled release formulation of lamotrigine |
| US7294347B2 (en) * | 2004-06-21 | 2007-11-13 | Council Of Scientific And Industrial Research | Coating compositions for bitterness inhibition |
| US20060263429A1 (en) * | 2005-05-20 | 2006-11-23 | Hengsheng Feng | Compressible mixture, compressed pharmaceutical compositions, and method of preparation thereof |
| KR20070021806A (ko) * | 2005-08-19 | 2007-02-23 | (주)아모레퍼시픽 | α1-수용체 차단제의 서방형 펠렛제제 및 이의 제조 방법 |
| GB0517205D0 (en) * | 2005-08-22 | 2005-09-28 | Novartis Ag | Organic compounds |
| FR2891459B1 (fr) * | 2005-09-30 | 2007-12-28 | Flamel Technologies Sa | Microparticules a liberation modifiee d'au moins un principe actif et forme galenique orale en comprenant |
| MX370905B (es) * | 2006-08-31 | 2020-01-09 | Adare Pharmaceuticals Inc | Sistema de distribucion de farmacos, que comprenden soluciones solidas de farmacos debilmente basicos. |
-
2008
- 2008-04-18 FR FR0852627A patent/FR2930147B1/fr active Active
-
2009
- 2009-04-17 US US12/425,875 patent/US20090291137A1/en not_active Abandoned
- 2009-04-17 JP JP2011504516A patent/JP5687185B2/ja active Active
- 2009-04-17 CA CA2721232A patent/CA2721232C/fr active Active
- 2009-04-17 KR KR1020107025760A patent/KR101380507B1/ko not_active IP Right Cessation
- 2009-04-17 CN CN2009801202525A patent/CN102046155A/zh active Pending
- 2009-04-17 ES ES09745961T patent/ES2721849T3/es active Active
- 2009-04-17 EP EP09745961.4A patent/EP2276474B1/fr active Active
- 2009-04-17 WO PCT/FR2009/050719 patent/WO2009138642A1/fr active Application Filing
- 2009-04-17 BR BRPI0910572-7A patent/BRPI0910572B1/pt active IP Right Grant
- 2009-04-17 MX MX2010011409A patent/MX339671B/es active IP Right Grant
- 2009-04-17 AU AU2009247921A patent/AU2009247921B2/en active Active
-
2010
- 2010-10-07 IL IL208572A patent/IL208572A/en not_active IP Right Cessation
- 2010-10-11 ZA ZA2010/07238A patent/ZA201007238B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2009247921A1 (en) | 2009-11-19 |
| IL208572A0 (en) | 2010-12-30 |
| EP2276474A1 (fr) | 2011-01-26 |
| JP2011518139A (ja) | 2011-06-23 |
| WO2009138642A1 (fr) | 2009-11-19 |
| CA2721232A1 (fr) | 2009-11-19 |
| MX2010011409A (es) | 2010-12-02 |
| US20090291137A1 (en) | 2009-11-26 |
| AU2009247921B2 (en) | 2013-09-05 |
| CN102046155A (zh) | 2011-05-04 |
| IL208572A (en) | 2016-02-29 |
| KR101380507B1 (ko) | 2014-04-11 |
| FR2930147B1 (fr) | 2013-02-08 |
| KR20110005876A (ko) | 2011-01-19 |
| FR2930147A1 (fr) | 2009-10-23 |
| CA2721232C (fr) | 2016-03-29 |
| BRPI0910572B1 (pt) | 2021-10-13 |
| JP5687185B2 (ja) | 2015-03-18 |
| MX339671B (es) | 2016-06-03 |
| ZA201007238B (en) | 2011-06-29 |
| BRPI0910572A2 (es) | 2017-08-08 |
| EP2276474B1 (fr) | 2019-03-06 |
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