DK1931316T4 - Farmaceutiske sammensætninger med kontrolleret frigivelse til brug for syrelabile lægemidler - Google Patents
Farmaceutiske sammensætninger med kontrolleret frigivelse til brug for syrelabile lægemidler Download PDFInfo
- Publication number
- DK1931316T4 DK1931316T4 DK06778240.9T DK06778240T DK1931316T4 DK 1931316 T4 DK1931316 T4 DK 1931316T4 DK 06778240 T DK06778240 T DK 06778240T DK 1931316 T4 DK1931316 T4 DK 1931316T4
- Authority
- DK
- Denmark
- Prior art keywords
- pancreatin
- oral dosage
- dosage form
- release pharmaceutical
- micropellets
- 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
- A61K9/2813—Inorganic compounds
-
- 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
- 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
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Emergency Medicine (AREA)
- Endocrinology (AREA)
- Hematology (AREA)
- Nutrition Science (AREA)
- Obesity (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (14)
1. Farmaceutisk sammensætning med kontrolleret afgivelse omfattende en oral doseringsform af pancreatin og en enterisk coating, hvor den enteriske coating omfatter: a) mindst et filmdannende middel, der er valgt fra gruppen bestående af cel-luloseacetatphthalat, hydroxypropylmethylcellulosacetatsuccinat, hydroxypro-pylmethylcellulosephthalat, methacrylsyre-ethylmethacrylatecopolymer og blandinger af disse filmdannede midler; b) et plastificeringsmiddel, der er en blanding af cetylalkohol og triethylcitrat, der tilsammen er til stede i en mængde, der er større end 3 vægt-% i forhold til det filmdannende middel, og hvor vægt/vægt-forholdet mellem cetylalkohol og triethylcitrat er fra 0,05:1 til 1:1; og c) eventuelt mindst et anti-klæbemiddel.
2. Farmaceutisk sammensætning med kontrolleret frigivelse ifølge krav 1, omfattende et anti-klæbemiddel, der er til stede i en mængde på fra 1,5 til 3 vægt-% i forhold til det filmdannende middel.
3. Farmaceutisk sammensætning med kontrolleret frigivelse ifølge krav 2, hvor anti-klæbemidlet er dimethicon.
4. Farmaceutisk sammensætning med kontrolleret frigivelse ifølge krav 1, hvor plastificeringsmidlet består af cetylalkohol og triethylcitrat, der tilsammen er til stede i en mængde på 4 vægt-% til 20 vægt-% i forhold til det filmdannende middel.
5. Farmaceutisk sammensætning med kontrolleret frigivelse ifølge krav 1, hvor det filmdannende middel er hydroxypropylmethylcellulosephthalat.
6. Farmaceutisk sammensætning med kontrolleret frigivelse ifølge krav 1, hvor den orale doseringsform er valgt fra gruppen, der består af granuler, granulater, mikrotabletter, mikropellets, mikrosfærer, pellets, piller, pulvere og tabletter.
7. Farmaceutisk sammensætning med kontrolleret frigivelse ifølge krav 1 eller krav 6, hvor den orale doseringsform er mikropellets eller mikrosfærer.
8. Farmaceutisk sammensætning med kontrolleret frigivelse ifølge krav 1, hvor den enteriske coating er mellem 20 vægt-% og 30 vægt-% af den samlede sammensætning af den farmaceutiske sammensætning med kontrolleret afgivelse.
9. Fremgangsmåde til fremstilling af en farmaceutisk sammensætning med kontrolleret afgivelse, hvilken fremgangsmåde omfatter trinnene a. tilvejebringelse af en oral doseringsform af pancreatin; b. tilvejebringelse af en enterisk-coating-opløsning, omfattende i. mindst et filmdannende middel, der er valgt fra gruppen bestående af celluloseacetatphthalat, hydroxypropylmethylcellulosacetatsuccinat, hydroxy-propylmethylcellulosephthalat, methacrylsyre-ethylmethacrylatecopolymer og blandinger af disse filmdannede midler; ii. et plastificeringsmiddel, der er en blanding af cetylalkohol og triethyl-citrat, der tilsammen er til stede i en mængde, der er større end 3 vægt-% i forhold til det filmdannende middel, og hvor vægt/vægt-forholdet mellem cetylalkohol og triethylcitrat er fra 0,05:1 til 1:1; og iii. eventuelt mindst et anti-klæbemiddel; og iv. et eller flere enzymvenlige organiske opløsningsmidler valgt fra gruppen bestående af acetone, 2-butanol, tert-butanol, chloroform, dichlor-methan, ethanol, methanol, 1-propanol, 2-propanol og blandinger af opløsningsmidlerne; c. coating af den orale doseringsform med enterisk-coating-opløsningen, hvor produkttemperaturen af den orale doseringsform under coatingen holdes på en temperatur på mellem 32 °C og 55 °C; og d. tørring af den coatede orale doseringsform.
10. Fremgangsmåde ifølge krav 9, hvor det filmdannende middel er hydro-xypropylmethylcellulosephthalat.
11. Fremgangsmåde ifølge krav 9, hvor den orale doseringsform er valgt fra gruppen, der består af granuler, granulater, mikrotabletter, mikropellets, mi-krosfærer, pellets, piller, pulvere og tabletter.
12. Fremgangsmåde ifølge krav 9, hvor den orale doseringsform af pancre-atin er mikropellets eller mikrosfærer.
13. Enterisk coatet oral doseringsform af pancreatin, der kan tilvejebringes ved hjælp af en fremgangsmåde ifølge krav 9.
14. Anvendelse af en enterisk coatet oral doseringsform af pancreatin som defineret i krav 13, til fremstilling af et medikament til behandling af fordøjelsesforstyrrelser, exokrin pancreasinsufficiens, pancreatitis, cyktisk fibrose, diabetes type I og/eller diabetes type II.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US70869205P | 2005-08-15 | 2005-08-15 | |
| EP05107472 | 2005-08-15 | ||
| PCT/EP2006/065311 WO2007020259A2 (en) | 2005-08-15 | 2006-08-15 | Controlled release pharmaceutical compositions for acid labile drugs |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DK1931316T3 DK1931316T3 (da) | 2010-05-17 |
| DK1931316T4 true DK1931316T4 (da) | 2017-05-15 |
Family
ID=35253818
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK06778240.9T DK1931316T4 (da) | 2005-08-15 | 2006-08-15 | Farmaceutiske sammensætninger med kontrolleret frigivelse til brug for syrelabile lægemidler |
Country Status (17)
| Country | Link |
|---|---|
| EP (1) | EP1931316B2 (da) |
| JP (1) | JP5452918B2 (da) |
| CN (1) | CN101242811B (da) |
| AT (1) | ATE457719T2 (da) |
| AU (1) | AU2006281414B2 (da) |
| BR (1) | BRPI0614545B8 (da) |
| CA (1) | CA2619475C (da) |
| DK (1) | DK1931316T4 (da) |
| ES (1) | ES2341284T5 (da) |
| MX (1) | MX2008001558A (da) |
| NZ (1) | NZ565960A (da) |
| PL (1) | PL1931316T5 (da) |
| PT (1) | PT1931316E (da) |
| RU (1) | RU2440101C2 (da) |
| SI (2) | SI1931316T2 (da) |
| UA (1) | UA92030C2 (da) |
| WO (1) | WO2007020259A2 (da) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1319655B1 (it) | 2000-11-15 | 2003-10-23 | Eurand Int | Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione. |
| EP1913138B1 (en) | 2005-07-29 | 2016-08-24 | Abbott Laboratories GmbH | Processes for the manufacture of pancreatin powder with low virus content |
| US11266607B2 (en) | 2005-08-15 | 2022-03-08 | AbbVie Pharmaceuticals GmbH | Process for the manufacture and use of pancreatin micropellet cores |
| US9198871B2 (en) | 2005-08-15 | 2015-12-01 | Abbott Products Gmbh | Delayed release pancreatin compositions |
| US8497258B2 (en) | 2005-11-12 | 2013-07-30 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
| US10072256B2 (en) | 2006-05-22 | 2018-09-11 | Abbott Products Gmbh | Process for separating and determining the viral load in a pancreatin sample |
| SG186648A1 (en) | 2007-02-20 | 2013-01-30 | Aptalis Pharma Ltd | Stable digestive enzyme compositions |
| EP2044932A1 (en) * | 2007-10-04 | 2009-04-08 | Laboratorios del Dr. Esteve S.A. | Mechanical protective layer for solid dosage forms |
| EP3354276B1 (en) | 2007-11-13 | 2020-01-01 | Meritage Pharma, Inc. | Compositions for the treatment of gastrointestinal inflammation |
| US10087493B2 (en) | 2008-03-07 | 2018-10-02 | Aptalis Pharma Canada Ulc | Method for detecting infectious parvovirus in pharmaceutical preparations |
| CA2765033C (en) | 2009-06-12 | 2020-07-14 | Meritage Pharma, Inc. | Methods for treating gastrointestinal disorders |
| CN102946872A (zh) * | 2010-05-03 | 2013-02-27 | 阿普塔利斯制药有限公司 | 包含含有胰酶的消化酶混合物的微丸组合物 |
| UA111726C2 (uk) | 2010-10-01 | 2016-06-10 | Апталіс Фарма Лімітед | Препарат панкреліпази низької сили з кишковорозчинним покриттям |
| EP2741766B1 (en) * | 2011-08-08 | 2015-10-07 | Aptalis Pharma Limited | Method for dissolution testing of solid compositions containing digestive enzymes |
| US10993996B2 (en) | 2013-08-09 | 2021-05-04 | Allergan Pharmaceuticals International Limited | Digestive enzyme composition suitable for enteral administration |
| CA2947998A1 (en) | 2014-06-19 | 2015-12-23 | Aptalis Pharma Ltd. | Methods for removing viral contaminants from pancreatic extracts |
| CN107073084B (zh) | 2014-11-05 | 2022-03-25 | 雅培制药股份有限公司 | 用于生产具有改善的安全特性的具有脂肪酶活性的组合物和适用于药物用途的组合物的方法 |
| CN104906565B (zh) * | 2015-05-13 | 2018-06-19 | 西南大学 | 一种胰酶肠溶微丸及其制备方法 |
| CN105902513B (zh) * | 2016-05-11 | 2018-10-16 | 广州市义和化工有限公司 | 一种肠溶型金霉素微丸预混剂及其制备方法 |
| CN108553439B (zh) * | 2018-04-20 | 2020-10-16 | 广州白云山医药集团股份有限公司白云山制药总厂 | 一种含s-羧甲基-l-半胱氨酸的肠溶片剂 |
| RU2706003C1 (ru) | 2019-09-09 | 2019-11-13 | Акционерное общество "АВВА РУС" | Микрогранулы, содержащие панкреатин |
| KR102432084B1 (ko) * | 2021-11-16 | 2022-08-12 | 알리코제약(주) | S-오메프라졸을 함유하는 안정성이 개선되고 소형화된 정제 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2923279C2 (de) | 1979-06-08 | 1987-07-09 | Kali-Chemie Pharma Gmbh, 3000 Hannover | Verfahren zur Herstellung von Pankreatin-Pellets und diese enthaltende Arzneimittel |
| JPS5855125B2 (ja) * | 1980-03-10 | 1983-12-08 | 信越化学工業株式会社 | 固形薬剤用腸溶性コ−テイング剤組成物 |
| JPS57171428A (en) | 1981-04-13 | 1982-10-22 | Sankyo Co Ltd | Preparation of coated solid preparation |
| GB2189698A (en) * | 1986-04-30 | 1987-11-04 | Haessle Ab | Coated omeprazole tablets |
| US5225202A (en) | 1991-09-30 | 1993-07-06 | E. R. Squibb & Sons, Inc. | Enteric coated pharmaceutical compositions |
| DE4227385A1 (de) | 1992-08-19 | 1994-02-24 | Kali Chemie Pharma Gmbh | Pankreatinmikropellets |
| JP2917799B2 (ja) | 1994-03-11 | 1999-07-12 | 田辺製薬株式会社 | 消化管内適所放出型製剤 |
| JP3355593B2 (ja) | 1994-08-19 | 2002-12-09 | 信越化学工業株式会社 | 固形腸溶製剤の製造方法 |
| JP3435464B2 (ja) * | 1995-01-23 | 2003-08-11 | 信越化学工業株式会社 | 徐放性製剤コーティング用水分散液 |
| SE512835C2 (sv) * | 1996-01-08 | 2000-05-22 | Astrazeneca Ab | Doseringsform innehållande en mångfald enheter alla inneslutande syralabil H+K+ATPas-hämmare |
| JP3611456B2 (ja) * | 1997-09-30 | 2005-01-19 | 日研化学株式会社 | テオフィリン徐放性錠剤 |
| KR19990072826A (ko) * | 1998-02-26 | 1999-09-27 | 우재영 | 판크레아틴장용코팅과립의제조방법 |
| UA69413C2 (uk) | 1998-05-22 | 2004-09-15 | Брістол-Майерс Сквібб Компані | Фармацевтична композиція, яка містить серцевину та ентеросолюбільну оболонку, фармацевтична композиція у вигляді сфероїдальних гранул, спосіб одержання сфероїдальних гранул та спосіб одержання фармацевтичної композиції |
| SK284677B6 (sk) | 1999-03-17 | 2005-09-08 | Solvay Pharmaceuticals Gmbh | Farmaceutický prípravok na liečbu diabetu a spôsob jeho prípravy |
| US20020146451A1 (en) | 2000-07-15 | 2002-10-10 | Sharma Virender K. | Method for the administration of acid-labile drugs |
| IT1319655B1 (it) * | 2000-11-15 | 2003-10-23 | Eurand Int | Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione. |
| US20040213847A1 (en) | 2003-04-23 | 2004-10-28 | Matharu Amol Singh | Delayed release pharmaceutical compositions containing proton pump inhibitors |
-
2006
- 2006-08-15 SI SI200630639A patent/SI1931316T2/sl unknown
- 2006-08-15 PL PL06778240T patent/PL1931316T5/pl unknown
- 2006-08-15 DK DK06778240.9T patent/DK1931316T4/da active
- 2006-08-15 MX MX2008001558A patent/MX2008001558A/es active IP Right Grant
- 2006-08-15 EP EP06778240.9A patent/EP1931316B2/en active Active
- 2006-08-15 UA UAA200803186A patent/UA92030C2/ru unknown
- 2006-08-15 ES ES06778240.9T patent/ES2341284T5/es active Active
- 2006-08-15 RU RU2008109652/15A patent/RU2440101C2/ru active
- 2006-08-15 WO PCT/EP2006/065311 patent/WO2007020259A2/en active Application Filing
- 2006-08-15 SI SI200630639T patent/SI1931316T1/sl unknown
- 2006-08-15 AU AU2006281414A patent/AU2006281414B2/en active Active
- 2006-08-15 CN CN200680029688.XA patent/CN101242811B/zh active Active
- 2006-08-15 JP JP2008526492A patent/JP5452918B2/ja active Active
- 2006-08-15 AT AT06778240T patent/ATE457719T2/de active
- 2006-08-15 CA CA2619475A patent/CA2619475C/en active Active
- 2006-08-15 NZ NZ565960A patent/NZ565960A/en unknown
- 2006-08-15 PT PT06778240T patent/PT1931316E/pt unknown
- 2006-08-15 BR BRPI0614545A patent/BRPI0614545B8/pt active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| PL1931316T3 (pl) | 2010-07-30 |
| CN101242811B (zh) | 2015-06-17 |
| SI1931316T2 (sl) | 2017-05-31 |
| ES2341284T3 (es) | 2010-06-17 |
| SI1931316T1 (sl) | 2010-06-30 |
| CN101242811A (zh) | 2008-08-13 |
| AU2006281414B2 (en) | 2011-09-01 |
| PT1931316E (pt) | 2010-03-29 |
| EP1931316B1 (en) | 2010-02-17 |
| CA2619475C (en) | 2015-09-29 |
| JP2009504709A (ja) | 2009-02-05 |
| NZ565960A (en) | 2012-03-30 |
| EP1931316A2 (en) | 2008-06-18 |
| MX2008001558A (es) | 2008-02-15 |
| UA92030C2 (ru) | 2010-09-27 |
| DK1931316T3 (da) | 2010-05-17 |
| EP1931316B2 (en) | 2017-02-22 |
| RU2008109652A (ru) | 2009-09-27 |
| WO2007020259A3 (en) | 2007-05-10 |
| BRPI0614545A2 (pt) | 2011-04-05 |
| ATE457719T2 (de) | 2010-03-15 |
| RU2440101C2 (ru) | 2012-01-20 |
| WO2007020259A2 (en) | 2007-02-22 |
| ES2341284T5 (es) | 2017-09-05 |
| JP5452918B2 (ja) | 2014-03-26 |
| AU2006281414A1 (en) | 2007-02-22 |
| BRPI0614545B8 (pt) | 2021-05-25 |
| CA2619475A1 (en) | 2007-02-22 |
| BRPI0614545B1 (pt) | 2020-03-31 |
| PL1931316T5 (pl) | 2017-10-31 |
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