SI2328539T1 - Gladek obložilni sestavek, ki ima visoko vsebnost trdnih snovi, za tableto - Google Patents
Gladek obložilni sestavek, ki ima visoko vsebnost trdnih snovi, za tableto Download PDFInfo
- Publication number
- SI2328539T1 SI2328539T1 SI200931853T SI200931853T SI2328539T1 SI 2328539 T1 SI2328539 T1 SI 2328539T1 SI 200931853 T SI200931853 T SI 200931853T SI 200931853 T SI200931853 T SI 200931853T SI 2328539 T1 SI2328539 T1 SI 2328539T1
- Authority
- SI
- Slovenia
- Prior art keywords
- coating
- composition
- vinyl
- solid
- pyrrolidone
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Paints Or Removers (AREA)
Claims (8)
- Gladek obložilni sestavek, ki ima visoko vsebnost trdnih snovi, za tableto Patentni zahtevki1. Obložilni sestavek v obliki suhega, prosto tekočega prahu in ki obsega učinkovite količine: (i) 25 % do 55 % vodotopnega celuloznega etra; (ii) 0,5 % do 60 % kopolimera poli(N-vinil-2-pirolidon-ko-vinilacetata) (PVP/VA); (iii) 0,1 % do 45 % film-tvorečega sredstva na osnovi D-glukoze, izbranega izmed maltodekstrina in polidekstroze; (iv) in 6 % do 22 % mehčala; kjer navedeni kopolimer PVP/VA vsebuje od 55 % V-vinil-2-pirolidona : 45 % vinilacetata do 99 % A-vinil-2-pirolidona : 1% vinilacetata.
- 2. Sestavek po zahtevku 1, kjer je navedeni vodotopni celulozni eter izbran iz skupine, ki jo sestavljajo karboksimetilceluloza natrij (CMC Na), hidroksietil celuloza (HEC), hidroksipropil celuloza (HPC), hidroksipropil metil celuloza (HPMC) in metil celuloza (MC).
- 3. Sestavek po zahtevku 1, kjer je navedeno mehčalo izbrano iz 'skupine, ki jo sestavljajo citrati, trigliceridi s srednjo verigo, ftalati, glikoli, stearati in triacetin.
- 4. Postopek oblaganja trdnih snovi, ki obsega stopnje (a) pripravo obložilne suspenzije, ki obsega katerega koli od sestavkov po zahtevkih od 1 do 3, (b) tvorbo plasti na navedeni trdni snovi z nanašanjem navedene obložilne suspenzije, in (c) sušenje navedene plasti na navedeni trdni snovi.
- 5. Postopek po zahtevku 4, kjer ima obložilna suspenzija celokupno vsebnost trdnih snovi v vodi 20 % (m/m) ali več.
- 6. Postopek po zahtevku 5, kjer je celokupna vsebnost trdnih snovi 25 % (m/m) ali več.
- 7. Postopek po zahtevku 4, kje je navedena trdna snov poljedelska, prehranska ali farmacevtska trdna snov.
- 8. Uporaba sestavka, kot je definiran v katerem koli od zahtevkov od 1 do 3, v oblaganju poljedelske, prehranske ali farmacevtske trdne snovi.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10003608P | 2008-09-25 | 2008-09-25 | |
| PCT/US2009/058177 WO2010036777A1 (en) | 2008-09-25 | 2009-09-24 | Smooth, high solids tablet coating composition |
| EP09816838.8A EP2328539B1 (en) | 2008-09-25 | 2009-09-24 | Smooth, high solids tablet coating composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2328539T1 true SI2328539T1 (sl) | 2018-08-31 |
Family
ID=42060080
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200931853T SI2328539T1 (sl) | 2008-09-25 | 2009-09-24 | Gladek obložilni sestavek, ki ima visoko vsebnost trdnih snovi, za tableto |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US8883176B2 (sl) |
| EP (1) | EP2328539B1 (sl) |
| JP (1) | JP5946641B2 (sl) |
| CN (1) | CN102164576B (sl) |
| BR (1) | BRPI0919249B1 (sl) |
| CA (1) | CA2736899C (sl) |
| DK (1) | DK2328539T3 (sl) |
| ES (1) | ES2674271T3 (sl) |
| HU (1) | HUE038709T2 (sl) |
| MX (1) | MX2011002790A (sl) |
| PL (1) | PL2328539T3 (sl) |
| SI (1) | SI2328539T1 (sl) |
| TR (1) | TR201809389T4 (sl) |
| WO (1) | WO2010036777A1 (sl) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20140072716A (ko) * | 2012-12-05 | 2014-06-13 | 삼성정밀화학 주식회사 | 헤이즈가 개선된 필름 |
| CA2933202C (en) | 2014-01-21 | 2022-05-31 | Jason Teckoe | Immediate release film coatings containing medium chain glycerides and substrates coated therewith |
| CN105168166A (zh) * | 2015-09-08 | 2015-12-23 | 深圳信立泰药业股份有限公司 | 用于治疗心血管疾病固体制剂的包衣技术 |
| ES2901598T3 (es) * | 2016-03-31 | 2022-03-23 | Intercept Pharmaceuticals Inc | Comprimido recubierto con película que tiene una alta estabilidad química del ingrediente activo |
| WO2020073034A1 (en) * | 2018-10-05 | 2020-04-09 | Isp Investments Llc | Smooth high solids film coating composition comprising water soluble cellulose ether, process for preparing the same |
| TWI692499B (zh) | 2019-07-19 | 2020-05-01 | 怡定興科技股份有限公司 | 用於微針貼片之針底組成物及包含其之微針貼片 |
Family Cites Families (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4576604A (en) | 1983-03-04 | 1986-03-18 | Alza Corporation | Osmotic system with instant drug availability |
| GB8414221D0 (en) | 1984-06-04 | 1984-07-11 | Sterwin Ag | Unit dosage form |
| US4802924A (en) * | 1986-06-19 | 1989-02-07 | Colorcon, Inc. | Coatings based on polydextrose for aqueous film coating of pharmaceutical food and confectionary products |
| US6468561B1 (en) * | 1986-06-19 | 2002-10-22 | Bpsi Holdings, Inc. | Aqueous film coating with improved properties |
| WO1991015548A1 (en) | 1990-04-04 | 1991-10-17 | Berwind Pharmaceutical Services, Inc. | Aqueous maltodextrin and cellulosic polymer film coatings |
| US5407686A (en) | 1991-11-27 | 1995-04-18 | Sidmak Laboratories, Inc. | Sustained release composition for oral administration of active ingredient |
| US5286493A (en) | 1992-01-27 | 1994-02-15 | Euroceltique, S.A. | Stabilized controlled release formulations having acrylic polymer coating |
| US5273760A (en) | 1991-12-24 | 1993-12-28 | Euroceltigue, S.A. | Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer |
| JP3703481B2 (ja) | 1992-01-17 | 2005-10-05 | バーウィンド・ファーマスーティカル・サーヴィスィーズ・インコーポレーテッド | セルロース重合体およびラクトースに基づくフィルム被覆および被覆組成物 |
| US5998478A (en) | 1997-01-15 | 1999-12-07 | Platt; Chris E. | Timed release tablet comprising naproxen and pseudoephedrine |
| US6432448B1 (en) * | 1999-02-08 | 2002-08-13 | Fmc Corporation | Edible coating composition |
| US6274162B1 (en) * | 2000-01-14 | 2001-08-14 | Bpsi Holdings, Inc. | Elegant film coating system |
| US6620426B2 (en) | 2001-06-05 | 2003-09-16 | Isp Investments Inc. | Tablet coating composition |
| US6723348B2 (en) | 2001-11-16 | 2004-04-20 | Ethypharm | Orodispersible tablets containing fexofenadine |
| US20040001884A1 (en) * | 2002-06-21 | 2004-01-01 | Isp Investments Inc. | Pharmaceutical tablet coating composition |
| US20040052844A1 (en) * | 2002-09-16 | 2004-03-18 | Fang-Hsiung Hsiao | Time-controlled, sustained release, pharmaceutical composition containing water-soluble resins |
| EP1708684A2 (en) * | 2003-09-26 | 2006-10-11 | Alza Corporation | Drug coating providing high drug loading and methods for providing the same |
| JP2007517038A (ja) * | 2003-12-30 | 2007-06-28 | ドクター レディズ ラボラトリーズ リミテッド | 薬学的組成物 |
| BRPI0509971A (pt) * | 2004-04-15 | 2007-10-02 | Reddys Lab Inc Dr | uma forma de dosagem farmacêutica, comprimido e método de preparação |
| CN1275651C (zh) * | 2004-09-27 | 2006-09-20 | 梧州嘉进科纳包衣材料有限公司 | 含纳米材料的药用包衣粉 |
| EP1909762A2 (en) * | 2005-07-28 | 2008-04-16 | Isp Investments Inc. | Amorphous efavirenz and the production thereof |
| CN100563638C (zh) * | 2006-10-24 | 2009-12-02 | 北京红林制药有限公司 | 硝苯地平控释片及其制备方法 |
-
2009
- 2009-09-24 MX MX2011002790A patent/MX2011002790A/es active IP Right Grant
- 2009-09-24 SI SI200931853T patent/SI2328539T1/sl unknown
- 2009-09-24 US US13/062,807 patent/US8883176B2/en active Active
- 2009-09-24 WO PCT/US2009/058177 patent/WO2010036777A1/en active Application Filing
- 2009-09-24 HU HUE09816838A patent/HUE038709T2/hu unknown
- 2009-09-24 JP JP2011529216A patent/JP5946641B2/ja active Active
- 2009-09-24 CN CN2009801378804A patent/CN102164576B/zh active Active
- 2009-09-24 ES ES09816838.8T patent/ES2674271T3/es active Active
- 2009-09-24 PL PL09816838T patent/PL2328539T3/pl unknown
- 2009-09-24 CA CA2736899A patent/CA2736899C/en active Active
- 2009-09-24 DK DK09816838.8T patent/DK2328539T3/en active
- 2009-09-24 EP EP09816838.8A patent/EP2328539B1/en active Active
- 2009-09-24 TR TR2018/09389T patent/TR201809389T4/tr unknown
- 2009-09-24 BR BRPI0919249-2A patent/BRPI0919249B1/pt active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| TR201809389T4 (tr) | 2018-07-23 |
| CN102164576B (zh) | 2013-08-28 |
| DK2328539T3 (en) | 2018-06-18 |
| EP2328539B1 (en) | 2018-04-18 |
| HUE038709T2 (hu) | 2018-11-28 |
| ES2674271T8 (es) | 2018-08-24 |
| JP2012503667A (ja) | 2012-02-09 |
| BRPI0919249A2 (pt) | 2017-05-30 |
| JP5946641B2 (ja) | 2016-07-06 |
| EP2328539A1 (en) | 2011-06-08 |
| WO2010036777A1 (en) | 2010-04-01 |
| CN102164576A (zh) | 2011-08-24 |
| MX2011002790A (es) | 2011-04-05 |
| PL2328539T3 (pl) | 2018-09-28 |
| US20110189245A1 (en) | 2011-08-04 |
| CA2736899A1 (en) | 2010-04-01 |
| US8883176B2 (en) | 2014-11-11 |
| ES2674271T3 (es) | 2018-06-28 |
| EP2328539A4 (en) | 2013-11-27 |
| CA2736899C (en) | 2016-08-30 |
| BRPI0919249B1 (pt) | 2017-12-19 |
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