FI112916B - Förfarande för framställning av filmdragerad oralt doserbar sammansättning med förlängd frigöring - Google Patents
Förfarande för framställning av filmdragerad oralt doserbar sammansättning med förlängd frigöring Download PDFInfo
- Publication number
- FI112916B FI112916B FI951901A FI951901A FI112916B FI 112916 B FI112916 B FI 112916B FI 951901 A FI951901 A FI 951901A FI 951901 A FI951901 A FI 951901A FI 112916 B FI112916 B FI 112916B
- Authority
- FI
- Finland
- Prior art keywords
- coating
- tablet
- matrix
- usp
- polyethylene glycol
- 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
- A61K9/2072—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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/16—Otologicals
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- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Cosmetics (AREA)
Claims (12)
1. Förfarande för tillverkning av en filmdragerad oralt administrerbar sammansätt-ning med förlängd frigöring, kännetecknat därav, att det innefattar följande steg: 5 (a) följande ingredienser blandas för att bilda granulater och erhällna granulater blandas för att bilda en blandning och den erhällna blandningen pressas för att bilda en matriskärna:
10 Matriskärnans ingredienser ma/kärna Pseudoefedrinsulfat 120 - 360 Hydroxipropylmetylcellulosa 220B (100 000 cps) 160 - 480 Etylcellulosa 40 -120 Tväbasisk kalciumfosfatdihydrat 56 -164
15 Povidon 20 - 60 Kiseldioxid 6-12 och Magnesiumstearat 2 - 6 Matriskärnans viktomräde: 400 -1200 mg och 20 (b) följande ingredienser dispergeras i renat vatten, och uppvärms eventuellt vid behov, för att upplösa eller fördela ingredienserna för att bilda en drageringslös-ning/-dispersion, och därefter tillsätts matriskärnan frän steg (a) i en lämplig anord-ning och drageringslösningen/-dispersionen utbreds för att bilda en filmdragerad 25 oralt administrerbar sammansättning med förlängd frigöring: Draaerinaarnas ingredienser ma/tablett Loratadin 5-15 Hydroxipropylmetylcellulosa 2910 6 cps 17-50
30 Polyetylenglykol 400 0,25 - 5,0 Polyetylenglykol 3350 3,4 - 10,2 Drageringens approximativa viktomräde: 26 - 80 mg . ’ Sammansättningens approximativa (matriskärna : ' · · och dragering) viktomräde: 426 -1280 mg. 112916
2. Förfarande enligt patentkravet 1, kännetecknat därav, att det i förfarandet an-vänds följande ingredienser: Matriskärnans inaredienser ma/kärna
3. Förfarande enligt patentkravet 1 eller 2, kännetecknat därav, att matris-kärnorna drageras med en underdrageringslösning.
4. Förfarande enligt patentkrav 1, 2 eller 3, kännetecknat därav, att matris- 30 kärnorna drageras med en aktiv drageringsdispersion.
5. Förfarande enligt patentkrav 1, 2, 3 eller 4, kännetecknat därav, att matriskär-norna drageras med en poleringsdrageringslösning. 16 112916
5 Pseudoefedrinsulfat USP 240 Hydroxipropylmetylcellulosa 2208 USP 100 000 cps 320 Etylcellulosa NF tyyppi 7 80 Tväbasisk kalciumfosfat USP dihydrat 108 Povidon USP 40
10 Kiseldioxid NF 8 och Magnesiumstearat NF 4 Matriskärnans approximativa vikt: 800 mg och Draqerinaarnas inaredienser ma/tablett Loratadin, mikroniserad 10 Hydroxipropylmetylcellulosa 2910 USP 6 cps 33 Polyetylenglykol 400 N F 0,67
20 Polyetylenglykol 3350 NF 6,75 Färgämnesdispersion (fast ämne) 6,25 Drageringens approximativa vikt: 57 mg Sammansättningens approximativa (matriskärna och dragering) vikt: 857 mg. 25
6. Förfarande enligt nägot av föregäende patentkrav, kännetecknat därav, att det används 240 mg pseudoefedrinsulfat per varje matriskärna och 10 mg loratadin per varje tabletts dragering. 5
7. Förfarande enligt nägot av föregäende patentkrav, kännetecknat därav, att det används 3,4 - 10,15 mg polyetylenglykol 3350 per varje tabletts dragering. 10
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US96547092 | 1992-10-23 | ||
| US07/965,470 US5314697A (en) | 1992-10-23 | 1992-10-23 | Stable extended release oral dosage composition comprising loratadine and pseudoephedrine |
| PCT/US1993/009873 WO1994009761A1 (en) | 1992-10-23 | 1993-10-21 | Stable extended release oral dosage composition |
| US9309873 | 1993-10-21 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| FI951901A0 FI951901A0 (sv) | 1995-04-21 |
| FI951901A FI951901A (sv) | 1995-04-21 |
| FI112916B true FI112916B (sv) | 2004-02-13 |
Family
ID=25510010
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FI951901A FI112916B (sv) | 1992-10-23 | 1995-04-21 | Förfarande för framställning av filmdragerad oralt doserbar sammansättning med förlängd frigöring |
Country Status (28)
| Country | Link |
|---|---|
| US (1) | US5314697A (sv) |
| EP (1) | EP0665744B1 (sv) |
| JP (1) | JP3580815B2 (sv) |
| KR (1) | KR100283709B1 (sv) |
| CN (1) | CN1038474C (sv) |
| AT (1) | ATE161420T1 (sv) |
| AU (1) | AU676229B2 (sv) |
| CA (1) | CA2147606C (sv) |
| CZ (1) | CZ287687B6 (sv) |
| DE (1) | DE69316023T2 (sv) |
| DK (1) | DK0665744T3 (sv) |
| EE (1) | EE03106B1 (sv) |
| ES (1) | ES2110633T3 (sv) |
| FI (1) | FI112916B (sv) |
| GR (1) | GR3026198T3 (sv) |
| HK (1) | HK1004327A1 (sv) |
| HU (1) | HU220629B1 (sv) |
| IL (1) | IL107354A (sv) |
| MY (1) | MY109090A (sv) |
| NO (1) | NO308771B1 (sv) |
| NZ (1) | NZ257447A (sv) |
| PH (1) | PH29940A (sv) |
| PL (1) | PL172862B1 (sv) |
| SG (1) | SG42947A1 (sv) |
| SK (1) | SK281090B6 (sv) |
| TW (1) | TW251239B (sv) |
| WO (1) | WO1994009761A1 (sv) |
| ZA (1) | ZA937830B (sv) |
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| AU7966694A (en) * | 1993-07-21 | 1996-05-02 | University Of Kentucky Research Foundation, The | A multicompartment hard capsule with control release properties |
| US6818229B1 (en) | 1993-09-20 | 2004-11-16 | Kos Pharmaceuticals, Inc. | Intermediate release nicotinic acid compositions for treating hyperlipidemia |
| US6080428A (en) | 1993-09-20 | 2000-06-27 | Bova; David J. | Nicotinic acid compositions for treating hyperlipidemia and related methods therefor |
| US6676967B1 (en) * | 1993-09-20 | 2004-01-13 | Kos Pharmaceuticals, Inc. | Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia |
| US6746691B2 (en) | 1993-09-20 | 2004-06-08 | Kos Pharmaceuticals, Inc. | Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics |
| US6129930A (en) | 1993-09-20 | 2000-10-10 | Bova; David J. | Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night |
| US7211582B1 (en) | 1994-12-30 | 2007-05-01 | Sepracor Inc. | Methods for treating urticaria using descarboethoxyloratadine |
| US7214683B1 (en) | 1994-12-30 | 2007-05-08 | Sepracor Inc. | Compositions of descarboethoxyloratadine |
| MX9706449A (es) | 1995-02-28 | 1997-11-29 | Hoechst Marion Roussel Inc | Composicion farmaceutica para compuestos de piperidinalcanol. |
| US5807579A (en) * | 1995-11-16 | 1998-09-15 | F.H. Faulding & Co. Limited | Pseudoephedrine combination pharmaceutical compositions |
| EP0811374A1 (en) | 1996-05-29 | 1997-12-10 | Pfizer Inc. | Combination dosage form comprising cetirizine and pseudoephedrine |
| CZ150999A3 (cs) * | 1996-10-31 | 1999-10-13 | Schering Corporation | Farmaceutický prostředek pro léčbu astmatu obsahující loratadin a dekongestant |
| PE71699A1 (es) * | 1997-02-07 | 1999-08-03 | Sepracor Inc | Composicion farmaceutica de descarboetoxiloratadina sin lactosa, no higroscopica y anhidra |
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| US6051585A (en) * | 1998-12-07 | 2000-04-18 | Weinstein; Robert E. | Single-dose antihistamine/decongestant formulations for treating rhinitis |
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| US6267986B1 (en) | 1999-09-24 | 2001-07-31 | Ranbaxy Laboratories Limited | Process for the preparation of a controlled drug delivery system containing pseudoephedrine and a long acting antihistamine |
| US6114346A (en) * | 1999-10-22 | 2000-09-05 | Schering Corporation | Treating sleep disorders using desloratadine |
| WO2001045668A2 (en) * | 1999-12-20 | 2001-06-28 | Schering Corporation | Stable extended release oral dosage composition comprising pseudoephedrine and desloratadine |
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| CN101015519B (zh) * | 2007-02-27 | 2012-03-21 | 重庆医药工业研究院有限责任公司 | 一种氯雷他定口服复方药物组合物 |
| WO2008105920A1 (en) * | 2007-02-28 | 2008-09-04 | Collegium Pharmaceutical, Inc. | Antihistamine combination |
| US8173637B2 (en) * | 2008-07-24 | 2012-05-08 | Handa Pharmaceuticals, Llc | Stabilized atypical antipsychotic formulation |
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| CN102160859B (zh) * | 2011-02-23 | 2012-11-07 | 海南斯达制药有限公司 | 一种氯雷伪麻复方缓释药物 |
| JP5752578B2 (ja) * | 2011-12-09 | 2015-07-22 | ジェイ−メド ファーマシューティカルズ，インコーポレーティッド | 鼻炎治療のための単一投与抗ヒスタミン薬／鬱血除去薬製剤 |
| CN104983708A (zh) * | 2015-06-24 | 2015-10-21 | 万特制药(海南)有限公司 | 一种地氯雷他定硫酸伪麻黄碱缓释片及其制备方法 |
| CN108576895B (zh) * | 2018-03-06 | 2021-04-30 | 特素生物科技（天津）有限公司 | 缓释营养主食及其制备方法 |
| EP4188339A1 (en) | 2020-07-30 | 2023-06-07 | Faes Farma, S.A. | Decongestant drug delivery system |
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-
1992
- 1992-10-23 US US07/965,470 patent/US5314697A/en not_active Expired - Lifetime
-
1993
- 1993-10-21 WO PCT/US1993/009873 patent/WO1994009761A1/en active IP Right Grant
- 1993-10-21 HU HU9501143A patent/HU220629B1/hu unknown
- 1993-10-21 DE DE69316023T patent/DE69316023T2/de not_active Expired - Lifetime
- 1993-10-21 AT AT93924327T patent/ATE161420T1/de active
- 1993-10-21 AU AU54050/94A patent/AU676229B2/en not_active Expired
- 1993-10-21 CZ CZ19951014A patent/CZ287687B6/cs not_active IP Right Cessation
- 1993-10-21 ZA ZA937830A patent/ZA937830B/xx unknown
- 1993-10-21 EP EP93924327A patent/EP0665744B1/en not_active Expired - Lifetime
- 1993-10-21 MY MYPI93002189A patent/MY109090A/en unknown
- 1993-10-21 JP JP51111094A patent/JP3580815B2/ja not_active Expired - Lifetime
- 1993-10-21 CA CA002147606A patent/CA2147606C/en not_active Expired - Lifetime
- 1993-10-21 DK DK93924327T patent/DK0665744T3/da active
- 1993-10-21 ES ES93924327T patent/ES2110633T3/es not_active Expired - Lifetime
- 1993-10-21 PH PH47120A patent/PH29940A/en unknown
- 1993-10-21 KR KR1019950701529A patent/KR100283709B1/ko not_active IP Right Cessation
- 1993-10-21 PL PL93308491A patent/PL172862B1/pl unknown
- 1993-10-21 SG SG1996001282A patent/SG42947A1/en unknown
- 1993-10-21 NZ NZ257447A patent/NZ257447A/en not_active IP Right Cessation
- 1993-10-21 SK SK522-95A patent/SK281090B6/sk not_active IP Right Cessation
- 1993-10-21 IL IL107354A patent/IL107354A/en not_active IP Right Cessation
- 1993-10-22 TW TW082108823A patent/TW251239B/zh not_active IP Right Cessation
- 1993-10-22 CN CN93118769A patent/CN1038474C/zh not_active Expired - Lifetime
-
1994
- 1994-11-21 EE EE9400250A patent/EE03106B1/xx unknown
-
1995
- 1995-04-21 NO NO19951527A patent/NO308771B1/no not_active IP Right Cessation
- 1995-04-21 FI FI951901A patent/FI112916B/sv not_active IP Right Cessation
-
1998
- 1998-02-23 GR GR980400376T patent/GR3026198T3/el unknown
- 1998-04-23 HK HK98103388A patent/HK1004327A1/xx not_active IP Right Cessation
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PC | Transfer of assignment of patent |
Owner name: MERCK SHARP & DOHME CORP. |
|
| MA | Patent expired |