HRP20100269T4 - Farmaceutski spojevi za kontrolirano otpuštanje kiselinsko-labilnog lijeka - Google Patents
Farmaceutski spojevi za kontrolirano otpuštanje kiselinsko-labilnog lijeka Download PDFInfo
- Publication number
- HRP20100269T4 HRP20100269T4 HRP20100269TT HRP20100269T HRP20100269T4 HR P20100269 T4 HRP20100269 T4 HR P20100269T4 HR P20100269T T HRP20100269T T HR P20100269TT HR P20100269 T HRP20100269 T HR P20100269T HR P20100269 T4 HRP20100269 T4 HR P20100269T4
- Authority
- HR
- Croatia
- Prior art keywords
- controlled release
- film
- pharmaceutical compound
- weight
- protective layer
- Prior art date
Links
- 238000013270 controlled release Methods 0.000 title claims 11
- 239000003814 drug Substances 0.000 title claims 3
- 229940079593 drug Drugs 0.000 title claims 2
- 239000002253 acid Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000003795 chemical substances by application Substances 0.000 claims 13
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims 10
- 150000001875 compounds Chemical class 0.000 claims 9
- 230000002496 gastric effect Effects 0.000 claims 7
- 239000000203 mixture Substances 0.000 claims 7
- 239000006186 oral dosage form Substances 0.000 claims 7
- 239000011241 protective layer Substances 0.000 claims 7
- 238000000034 method Methods 0.000 claims 6
- 108010019160 Pancreatin Proteins 0.000 claims 5
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims 5
- 229960000541 cetyl alcohol Drugs 0.000 claims 5
- 229940055695 pancreatin Drugs 0.000 claims 5
- 239000001069 triethyl citrate Substances 0.000 claims 5
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims 5
- 235000013769 triethyl citrate Nutrition 0.000 claims 5
- 239000008187 granular material Substances 0.000 claims 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 4
- 239000004005 microsphere Substances 0.000 claims 4
- 239000003826 tablet Substances 0.000 claims 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 3
- BTANRVKWQNVYAZ-UHFFFAOYSA-N butan-2-ol Chemical compound CCC(C)O BTANRVKWQNVYAZ-UHFFFAOYSA-N 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 239000011325 microbead Substances 0.000 claims 3
- 239000004014 plasticizer Substances 0.000 claims 3
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 claims 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 2
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims 2
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims 2
- DKGAVHZHDRPRBM-UHFFFAOYSA-N Tert-Butanol Chemical compound CC(C)(C)O DKGAVHZHDRPRBM-UHFFFAOYSA-N 0.000 claims 2
- IYKJEILNJZQJPU-UHFFFAOYSA-N acetic acid;butanedioic acid Chemical compound CC(O)=O.OC(=O)CCC(O)=O IYKJEILNJZQJPU-UHFFFAOYSA-N 0.000 claims 2
- 239000000853 adhesive Substances 0.000 claims 2
- 230000000181 anti-adherent effect Effects 0.000 claims 2
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims 2
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- 229920001577 copolymer Polymers 0.000 claims 2
- 206010012601 diabetes mellitus Diseases 0.000 claims 2
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 claims 2
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 claims 2
- 239000010410 layer Substances 0.000 claims 2
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims 2
- 239000006187 pill Substances 0.000 claims 2
- 239000000843 powder Substances 0.000 claims 2
- 201000003883 Cystic fibrosis Diseases 0.000 claims 1
- 206010033645 Pancreatitis Diseases 0.000 claims 1
- 230000001079 digestive effect Effects 0.000 claims 1
- 229940008099 dimethicone Drugs 0.000 claims 1
- 239000004205 dimethyl polysiloxane Substances 0.000 claims 1
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- SUPCQIBBMFXVTL-UHFFFAOYSA-N ethyl 2-methylprop-2-enoate Chemical group CCOC(=O)C(C)=C SUPCQIBBMFXVTL-UHFFFAOYSA-N 0.000 claims 1
- 201000007089 exocrine pancreatic insufficiency Diseases 0.000 claims 1
- -1 micro-grains Substances 0.000 claims 1
- 239000003960 organic solvent Substances 0.000 claims 1
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims 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
- A61K9/28—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
- A61K38/00—Medicinal preparations containing peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (14)
1. Farmaceutski spoj za kontrolirano otpuštanje koji se sastoji od oblika za oralnu dozu od pankreatina i želučanog zaštitnog sloja naznačen time što želučani zaštitni sloj sadrži:
a) barem jedan agens koji stvara film iz skupine koju čine celulozni acetat ftalat, hidroksipropil meticelulozni acetat sukcinat, hidroksipropil meticelulozni ftalat, raetakrilik acido-etilni metakrilat-kopolimer, i mješavine navedenih agensa koji stvaraju film (sloj);
b) plastifikator koji je mješavina cetilnog alkohola i trietil citrata, koji su zajednički prisutni u količini većoj od 3% težine u odnosu na agens koji stvara film pri čemu je odnos težine spram težine cetilnog alkohola i trietil citrata od 0.05:1 do 1:1; i
c) po izboru barem jedan protuljepljivi agens.
2. Farmaceutski spoj za kontrolirano otpuštanje temeljem zahtjeva 1, koji se sastoji od protuljepljivog agensa naznačen time da je prisutan u količini od 1.5 do 3% težine u odnosu na agens koji stvara film.
3. 3 Farmaceutski spoj za kontrolirano otpuštanje temeljem zahtjeva 2, naznačen time da je protuljepljivi agens dimetikon.
4. Farmaceutski spoj za kontrolirano otpuštanje temeljem zahtjeva 1, naznačen time da je plastifikator sastavljen od cetilnog alkohola i trietil citrata koji su zajedno prisutni u količini od 4% do 20% težine u odnosu na agens koji stvara film.
5. Farmaceutski spoj za kontrolirano otpuštanje temeljeni zahtjeva 1, naznačen time da je agens koji stvara film hidroksipropil metilcelulozni ftalat.
6. Farmaceutski spoj za kontrolirano otpuštanje temeljem zahtjeva 1 naznačen time da je oblik oralne doze odabran iz skupine koju čine granule, granulati, mikro-tablete, mikrozrna, mikrosfere, zrna, pilule, prašci i tablete.
7. Farmaceutski spoj za kontrolirano otpuštanje temeljem zahtjeva 1 ili zahtjeva 6 naznačen time da je oblik oralne doze mikrozrna ili mikrosfere.
8. Farmaceutski spoj za kontrolirano otpuštanje temeljem zahtjeva 1 naznačen time da je želučani zaštitni sloj između 20% i 30% težine ukupnog sastava farmaceutskog spoja za kontrolirano otpuštanje.
9. Postupak za proizvodnju farmaceutske mješavine sa kontroliranim otpuštanjem, naznačen time da se postupak sastoji od koraka:
a. predviđanje oblika oralne doze pankreatina;
b. predviđanje otopine želučanog zaštitnog sloja koji se sastoji od
i. barem jednog agensa koji stvara film odabranog iz skupine koju čine celulozni acetat ftalat, hidroksipropil meticelulozni acetat sukcinat, hidroksipropil meticelulozni ftalat, metakrilik acido-etilni metakriiat-kopolimer, i mješavine navedenih agensa koji stvaraju film (sloj);
ii. plastiflkator koji je mješavina cetilnog alkohola i trietil citrata, koji su zajednički prisutni u količini većoj od 3% težine u odnosu na agens koji stvara film pri čemu je odnos težine spram težine cetilnog alkohola i trietil citrata od 0.05:1 do 1:1;
iii. po izboru, barem jednog protuljepljivog agensa; i
iv. jednog ili više enzimski-prihvatljivog organskog otapala odabranog iz skupine koju čine aceton, 2-butanol, terc-butanol, kloroform, diklorometan, etanol, metanol, 1-propanol, 2-propanol i mješavina navedenih agensa;
c. presvlačenje oblika oralne doze sa otopinom želučanog zaštitnog sloja pri čemu se proizvodna temperatura oblika oralne doze tijekom stavljanja premaza drži na temperaturi između 32°C i 55°C; i
d. sušenje presvučenog oblika oralne doze.
10. Postupak temeljem zahtjeva 9 naznačen time da je agens koji stvara film hidroksipropilmetil celulozni ftalat,
11. Postupak temeljen: zahtjeva 9 naznačen time da je oblik oralne doze kiselinsko-labilnog lijeka odabran iz skupine koju čine granule, granulati, mikro-tablete, mikro-zrna, mikro-sfere, zrna, pilule, prašci i tablete.
12. Postupak temeljem zahtjeva 9 naznačen time da su oblik oralne doze pankreatina mikro-zrna ili mikro-sfere.
13. Oblik oralne doze sa želučanim zaštitnim slojem pankreatina, naznačen time da se može dobiti temeljem postupka iz zahtjeva 9.
14. Uporaba oblika oralne doze sa želučanim zaštitnim slojem pankreatina kako je definirano zahtjevom 13 za proizvodnju medikamenta naznačeno time da je za liječenje probavnih poremećaja, egzokrine insufincijencije pankreasa, pankreatitisa, cistične fibroze, dijabetesa tipa I i/ili dijabetesa tipa II.
Applications Claiming Priority (4)
| 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 |
| EP06778240.9A EP1931316B2 (en) | 2005-08-15 | 2006-08-15 | Controlled release pharmaceutical compositions for acid labile drugs |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20100269T1 HRP20100269T1 (hr) | 2010-06-30 |
| HRP20100269T4 true HRP20100269T4 (hr) | 2017-06-30 |
Family
ID=37415587
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20100269TT HRP20100269T4 (hr) | 2005-08-15 | 2010-05-14 | Farmaceutski spojevi za kontrolirano otpuštanje kiselinsko-labilnog lijeka |
Country Status (6)
| Country | Link |
|---|---|
| KR (1) | KR101344546B1 (hr) |
| DE (1) | DE602006012346D1 (hr) |
| HK (1) | HK1121037A1 (hr) |
| HR (1) | HRP20100269T4 (hr) |
| IL (1) | IL189456A (hr) |
| NO (1) | NO342633B1 (hr) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2189698A (en) * | 1986-04-30 | 1987-11-04 | Haessle Ab | Coated omeprazole tablets |
| 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 |
| IT1319655B1 (it) * | 2000-11-15 | 2003-10-23 | Eurand Int | Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione. |
-
2006
- 2006-08-15 DE DE602006012346T patent/DE602006012346D1/de active Active
-
2008
- 2008-02-12 IL IL189456A patent/IL189456A/en active IP Right Grant
- 2008-03-13 KR KR1020087006200A patent/KR101344546B1/ko active IP Right Grant
- 2008-03-14 NO NO20081377A patent/NO342633B1/no unknown
- 2008-11-21 HK HK08112748.2A patent/HK1121037A1/xx unknown
-
2010
- 2010-05-14 HR HRP20100269TT patent/HRP20100269T4/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| KR101344546B1 (ko) | 2013-12-26 |
| NO342633B1 (no) | 2018-06-25 |
| DE602006012346D1 (de) | 2010-04-01 |
| KR20080034515A (ko) | 2008-04-21 |
| NO20081377L (no) | 2008-05-14 |
| HK1121037A1 (en) | 2009-04-17 |
| IL189456A (en) | 2015-11-30 |
| IL189456A0 (en) | 2008-06-05 |
| HRP20100269T1 (hr) | 2010-06-30 |
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