HRP20161628T1 - Želučanootporni farmaceutski oblik s produljenim oslobađanjem - Google Patents
Želučanootporni farmaceutski oblik s produljenim oslobađanjem Download PDFInfo
- Publication number
- HRP20161628T1 HRP20161628T1 HRP20161628TT HRP20161628T HRP20161628T1 HR P20161628 T1 HRP20161628 T1 HR P20161628T1 HR P20161628T T HRP20161628T T HR P20161628TT HR P20161628 T HRP20161628 T HR P20161628T HR P20161628 T1 HRP20161628 T1 HR P20161628T1
- Authority
- HR
- Croatia
- Prior art keywords
- polymer
- swelling
- pharmaceutical form
- cyclodextrin
- form according
- Prior art date
Links
- 230000003111 delayed effect Effects 0.000 title 1
- 229920000642 polymer Polymers 0.000 claims 19
- 230000008961 swelling Effects 0.000 claims 9
- 229920000858 Cyclodextrin Polymers 0.000 claims 4
- 239000001913 cellulose Substances 0.000 claims 3
- 229920002678 cellulose Polymers 0.000 claims 3
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims 2
- 239000001116 FEMA 4028 Substances 0.000 claims 2
- 239000004480 active ingredient Substances 0.000 claims 2
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 2
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims 2
- 229960004853 betadex Drugs 0.000 claims 2
- 229920001477 hydrophilic polymer Polymers 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 239000011159 matrix material Substances 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000000661 sodium alginate Substances 0.000 claims 2
- 235000010413 sodium alginate Nutrition 0.000 claims 2
- 229940005550 sodium alginate Drugs 0.000 claims 2
- 210000002784 stomach Anatomy 0.000 claims 2
- YZOUYRAONFXZSI-SBHWVFSVSA-N (1S,3R,5R,6R,8R,10R,11R,13R,15R,16R,18R,20R,21R,23R,25R,26R,28R,30R,31S,33R,35R,36R,37S,38R,39S,40R,41S,42R,43S,44R,45S,46R,47S,48R,49S)-5,10,15,20,25,30,35-heptakis(hydroxymethyl)-37,39,40,41,42,43,44,45,46,47,48,49-dodecamethoxy-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,38-diol Chemical compound O([C@@H]([C@H]([C@@H]1OC)OC)O[C@H]2[C@@H](O)[C@@H]([C@@H](O[C@@H]3[C@@H](CO)O[C@@H]([C@H]([C@@H]3O)OC)O[C@@H]3[C@@H](CO)O[C@@H]([C@H]([C@@H]3OC)OC)O[C@@H]3[C@@H](CO)O[C@@H]([C@H]([C@@H]3OC)OC)O[C@@H]3[C@@H](CO)O[C@@H]([C@H]([C@@H]3OC)OC)O3)O[C@@H]2CO)OC)[C@H](CO)[C@H]1O[C@@H]1[C@@H](OC)[C@H](OC)[C@H]3[C@@H](CO)O1 YZOUYRAONFXZSI-SBHWVFSVSA-N 0.000 claims 1
- FEBUJFMRSBAMES-UHFFFAOYSA-N 2-[(2-{[3,5-dihydroxy-2-(hydroxymethyl)-6-phosphanyloxan-4-yl]oxy}-3,5-dihydroxy-6-({[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}methyl)oxan-4-yl)oxy]-3,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl phosphinite Chemical compound OC1C(O)C(O)C(CO)OC1OCC1C(O)C(OC2C(C(OP)C(O)C(CO)O2)O)C(O)C(OC2C(C(CO)OC(P)C2O)O)O1 FEBUJFMRSBAMES-UHFFFAOYSA-N 0.000 claims 1
- 229920001450 Alpha-Cyclodextrin Polymers 0.000 claims 1
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 1
- 229920002305 Schizophyllan Polymers 0.000 claims 1
- HFHDHCJBZVLPGP-RWMJIURBSA-N alpha-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO HFHDHCJBZVLPGP-RWMJIURBSA-N 0.000 claims 1
- 229940043377 alpha-cyclodextrin Drugs 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 claims 1
- 229940080345 gamma-cyclodextrin Drugs 0.000 claims 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 claims 1
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 claims 1
- 125000005395 methacrylic acid group Chemical group 0.000 claims 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical class O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (10)
1. Čvrsti želučanootporni farmaceutski oblik koji sadrži želučanootpomu matricu koja se sastoji od smjese tri hidrofilna polimera, pri čemu je prvi polimer bubreći pH-nezavisni polimer, drugi polimer je bubreći polimer nerastvorljiv na pH nižem od 4.0 i rastvorljiv na pH višem od 4.0, i treći polimer je oligomer koji može napraviti rastvorljivi kompleks s aktivnim sastojkom.
2. Farmaceutski oblik prema zahtjevu 1, pri čemu je bubreći pH-nezavisni polimer izabran između derivata celuloze, skleroglukana i polietilenoksida.
3. Farmaceutski oblik prema zahtjevu 2, pri čemu je bubreći pH-nezavisni polimer derivat celuloze izabran između hidroksipropilmetilceluloze, hidroksipropilceluloze i hidroksietilceluloze.
4. Farmaceutski oblik prema zahtjevu 3, pri čemu je bubreći pH-nezavisni polimer hidroksipropilmetilceluloza.
5. Farmaceutski oblik prema zahtjevu 1 pri čemu je drugi bubreći polimer izabran između metakrilnih polimera rastvorljivih na baznom pH, celuloza acetoftalata, hidroksipropilmetilceluloza ftalata i natrij alginata.
6. Farmaceutski oblik prema zahtjevu 1, pri čemu je drugi bubreći polimer natrij alginat.
7. Farmaceutski oblik prema zahtjevu 1 pri čemu je oligomer derivat ciklodekstrina izabran između α-ciklodekstrina, β-ciklodekstrina, γ-ciklodekstrina, metil-β-ciklodekstrina i hidroksipropil-β-ciklodekstrina.
8. Farmaceutski oblik prema zahtjevu 7, pri čemu je oligomer β-ciklodekstrin.
9. Farmaceutski oblik prema zahtjevu 1, pri čemu je težinski odnos prvi polimendrugi polimertreći polimer od 1:1:1 do 3:2:1.
10. Primjena smjese tri hidrofilna polimera, pri čemu je prvi polimer bubreći pH-nezavisni polimer, drugi polimer je bubreći polimer nerastvorljiv na pH nižem od 4.0 i rastvorljiv na pH višem od 4.0, i treći polimer je oligomer koji može napravi rastvorljivi kompleks s aktivnim sastojkom za dobivanje želučanootporne matrice farmaceutskih oblika bez želučanootporne obloge u vidu filma.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT001264A ITMI20121264A1 (it) | 2012-07-19 | 2012-07-19 | Forma farmaceutica gastro-resistente a rilascio ritardato |
| PCT/EP2013/065169 WO2014013008A1 (en) | 2012-07-19 | 2013-07-18 | Gastro-resistant delayed release pharmaceutical form |
| EP13739677.6A EP2874611B1 (en) | 2012-07-19 | 2013-07-18 | Gastro-resistant delayed release pharmaceutical form |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161628T1 true HRP20161628T1 (hr) | 2017-01-13 |
Family
ID=46939787
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161628TT HRP20161628T1 (hr) | 2012-07-19 | 2016-12-05 | Želučanootporni farmaceutski oblik s produljenim oslobađanjem |
Country Status (12)
| Country | Link |
|---|---|
| EP (1) | EP2874611B1 (hr) |
| DK (1) | DK2874611T3 (hr) |
| ES (1) | ES2606352T3 (hr) |
| HR (1) | HRP20161628T1 (hr) |
| HU (1) | HUE032412T2 (hr) |
| IT (1) | ITMI20121264A1 (hr) |
| LT (1) | LT2874611T (hr) |
| PL (1) | PL2874611T3 (hr) |
| PT (1) | PT2874611T (hr) |
| RS (1) | RS55373B1 (hr) |
| SI (1) | SI2874611T1 (hr) |
| WO (1) | WO2014013008A1 (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT201700048797A1 (it) * | 2017-05-05 | 2018-11-05 | Neilos S R L | Sistema di rilascio controllato di ingredienti attivi a base di materiali polimerici e suo impiego in campo nutraceutico. |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW224049B (hr) * | 1991-12-31 | 1994-05-21 | Sunkyong Ind Ltd | |
| FI20085369A0 (fi) * | 2008-04-25 | 2008-04-25 | Kuopion Yliopisto | Gastroresistentti siklosporiiniformulaatio |
-
2012
- 2012-07-19 IT IT001264A patent/ITMI20121264A1/it unknown
-
2013
- 2013-07-18 HU HUE13739677A patent/HUE032412T2/en unknown
- 2013-07-18 WO PCT/EP2013/065169 patent/WO2014013008A1/en active Application Filing
- 2013-07-18 PL PL13739677T patent/PL2874611T3/pl unknown
- 2013-07-18 RS RS20161067A patent/RS55373B1/sr unknown
- 2013-07-18 SI SI201330417A patent/SI2874611T1/sl unknown
- 2013-07-18 DK DK13739677.6T patent/DK2874611T3/da active
- 2013-07-18 LT LTEP13739677.6T patent/LT2874611T/lt unknown
- 2013-07-18 ES ES13739677.6T patent/ES2606352T3/es active Active
- 2013-07-18 PT PT137396776T patent/PT2874611T/pt unknown
- 2013-07-18 EP EP13739677.6A patent/EP2874611B1/en active Active
-
2016
- 2016-12-05 HR HRP20161628TT patent/HRP20161628T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| RS55373B1 (sr) | 2017-03-31 |
| PL2874611T3 (pl) | 2017-07-31 |
| HUE032412T2 (en) | 2017-09-28 |
| ES2606352T3 (es) | 2017-03-23 |
| ITMI20121264A1 (it) | 2014-01-20 |
| EP2874611A1 (en) | 2015-05-27 |
| LT2874611T (lt) | 2016-12-12 |
| EP2874611B1 (en) | 2016-09-14 |
| DK2874611T3 (da) | 2017-01-02 |
| WO2014013008A1 (en) | 2014-01-23 |
| SI2874611T1 (sl) | 2017-04-26 |
| PT2874611T (pt) | 2016-12-20 |
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