HRP20171149T1 - Oralni farmaceutski pripravak koji sadrži tvar za prikrivanje ukusa n-acetilcisteina - Google Patents
Oralni farmaceutski pripravak koji sadrži tvar za prikrivanje ukusa n-acetilcisteina Download PDFInfo
- Publication number
- HRP20171149T1 HRP20171149T1 HRP20171149TT HRP20171149T HRP20171149T1 HR P20171149 T1 HRP20171149 T1 HR P20171149T1 HR P20171149T T HRP20171149T T HR P20171149TT HR P20171149 T HRP20171149 T HR P20171149T HR P20171149 T1 HRP20171149 T1 HR P20171149T1
- Authority
- HR
- Croatia
- Prior art keywords
- particle
- coating
- polysorbate
- acetylcysteine
- core
- Prior art date
Links
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 title claims 4
- 229960004308 acetylcysteine Drugs 0.000 title claims 4
- 239000008203 oral pharmaceutical composition Substances 0.000 title 1
- 239000002245 particle Substances 0.000 claims 10
- 239000011248 coating agent Substances 0.000 claims 6
- 238000000576 coating method Methods 0.000 claims 6
- 239000008187 granular material Substances 0.000 claims 4
- 229920000136 polysorbate Polymers 0.000 claims 4
- 229950008882 polysorbate Drugs 0.000 claims 4
- 238000000034 method Methods 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 150000003626 triacylglycerols Chemical class 0.000 claims 2
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims 2
- PVNIQBQSYATKKL-UHFFFAOYSA-N tripalmitin Chemical compound CCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCC PVNIQBQSYATKKL-UHFFFAOYSA-N 0.000 claims 2
- DCXXMTOCNZCJGO-UHFFFAOYSA-N tristearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCC DCXXMTOCNZCJGO-UHFFFAOYSA-N 0.000 claims 2
- 229920002642 Polysorbate 65 Polymers 0.000 claims 1
- 239000008199 coating composition Substances 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 239000007771 core particle Substances 0.000 claims 1
- 239000007919 dispersible tablet Substances 0.000 claims 1
- 239000007938 effervescent tablet Substances 0.000 claims 1
- 239000012530 fluid Substances 0.000 claims 1
- 239000006191 orally-disintegrating tablet Substances 0.000 claims 1
- 235000010988 polyoxyethylene sorbitan tristearate Nutrition 0.000 claims 1
- 239000001816 polyoxyethylene sorbitan tristearate Substances 0.000 claims 1
- 229940099511 polysorbate 65 Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000003826 tablet Substances 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
- A61K9/48—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
- 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
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
-
- 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
- A61K9/5089—Processes
-
- 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
- A61K9/51—Nanocapsules; Nanoparticles
-
- 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
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5107—Excipients; Inactive ingredients
- A61K9/5123—Organic compounds, e.g. fats, sugars
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Biomedical Technology (AREA)
- Nanotechnology (AREA)
- Optics & Photonics (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (11)
1. Obložena čestica koja sadrži jezgru i prevlaku, pri čemu jezgra sadrži N-acetilcistein, i gdje prevlaka sadrži triglicerid odabran između gliceril tripalmitata i gliceril tristearata i površinski aktivnu tvar, pri čemu je površinski aktivna tvar polisorbat.
2. Čestica prema zahtjevu 1, naznačena time, da je polisorbat polisorbat 65.
3. Čestica prema bilo kojem prethodnom zahtjevu, naznačena time, da prevlaka sadrži 70 do 90 tež.% triglicerida i 10 do 30 tež.% polisorbata.
4. Čestica prema zahtjevu 3, naznačena time, da se prevlaka suštinski sastoji od triglicerida i polisorbata.
5. Čestica prema bilo kojem prethodnom zahtjevu, naznačena time, da težina ovojnice iznosi od 20 do 70 tež.% u odnosu na ukupnu težinu obložene čestice.
6. Čestica prema bilo kojem prethodnom zahtjevu, naznačena time da se jezgra suštinski sastoji od N-acetilcisteina.
7. Farmaceutski pripravak, naznačen time, da sadrži česticu iz bilo kojeg od zahtjeva 1 do 6.
8. Farmaceutski pripravak prema patentnom zahtjevu 7, naznačen time da je formuliran kao granule, kao što su disperzibilne granule, šumeće granule, granule izravno na usta ili kao tablete, kao što su disperzibilne tablete, šumeće tablete ili tablete za oralno dezintegriranje.
9. Postupak za pripravu čestice iz bilo kojeg od zahtjeva 1 do 6, naznačen time, da obuhvaća korake:
a) snabdjevanje česticom jezgre koja sadrži N-acetilcistein,
(b) snabdjevanje pripravkom za premazivanje koji sadrži rastaljeni triglicerid i površinski aktivno sredstvo, i
(d) prevlačenje jezgre čestice sa smjesom za prevlačenje.
10. Postupak prema zahtjevu 9, naznačen time, da se temperatura produkta održava između oko 20 i 50 ° C tijekom izvođenja koraka (c).
11. Postupak prema zahtjevu 9 ili 10, naznačen time, da se korak (c) provodi u premazivaču s fluidnim slojem ili premazivaču sa zračnim protokom.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13163638 | 2013-04-12 | ||
| EP14716609.4A EP2983650B1 (en) | 2013-04-12 | 2014-04-11 | Oral pharmaceutical composition comprising taste-masked n-acetylcysteine |
| PCT/EP2014/057442 WO2014167124A1 (en) | 2013-04-12 | 2014-04-11 | Oral pharmaceutical composition comprising taste-masked n-acetylcysteine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20171149T1 true HRP20171149T1 (hr) | 2017-10-06 |
Family
ID=48050614
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20171149TT HRP20171149T1 (hr) | 2013-04-12 | 2017-07-27 | Oralni farmaceutski pripravak koji sadrži tvar za prikrivanje ukusa n-acetilcisteina |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US9636307B2 (hr) |
| EP (1) | EP2983650B1 (hr) |
| DK (1) | DK2983650T3 (hr) |
| ES (1) | ES2638789T3 (hr) |
| HR (1) | HRP20171149T1 (hr) |
| HU (1) | HUE033723T2 (hr) |
| LT (1) | LT2983650T (hr) |
| PL (1) | PL2983650T3 (hr) |
| PT (1) | PT2983650T (hr) |
| SI (1) | SI2983650T1 (hr) |
| WO (1) | WO2014167124A1 (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK3157506T3 (da) * | 2014-06-20 | 2020-11-23 | Hermes Arzneimittel Gmbh | Smagsmaskeret oral, farmaceutisk sammensætning |
| RU2667637C1 (ru) * | 2017-06-26 | 2018-09-21 | Гермес Арцнаймиттель ГмбХ | Фармацевтическая композиция для перорального применения, содержащая n-ацетилцистеин с маскированным вкусом |
| BR112021002157A2 (pt) | 2018-10-22 | 2021-05-04 | Ioi Oleo Gmbh | material de revestimento para uso em um método de revestimento hot-melt, combinação de material de revestimento e método de revestimento hot-melt |
| US11590090B2 (en) * | 2019-09-14 | 2023-02-28 | Anzen Pharmaceuticals, LLC | Acetaminophen formulation with protection against toxic effects of overdose |
| US20220370368A1 (en) | 2019-10-31 | 2022-11-24 | Hermes Pharma Gmbh | Oral pharmaceutical composition comprising a melt-agglomerated active ingredient core |
| CN113750052B (zh) * | 2021-10-19 | 2022-11-18 | 桂林华信制药有限公司 | 一种乙酰半胱氨酸颗粒及其制备方法 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE839528T1 (de) | 1996-10-29 | 1998-10-22 | Staroil Ltd | Mundlösliche Zusammensetzungen die N-Acetylcystein und Cyclodextrin enthalten |
| US5891476A (en) | 1997-12-22 | 1999-04-06 | Reo; Joe P. | Tastemasked pharmaceutical system |
| US20030180352A1 (en) * | 1999-11-23 | 2003-09-25 | Patel Mahesh V. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| US20060034937A1 (en) * | 1999-11-23 | 2006-02-16 | Mahesh Patel | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| DE102006059510A1 (de) | 2006-12-14 | 2008-06-19 | Grünenthal GmbH | Beschichtete Pellets |
| ITPD20070049A1 (it) | 2007-02-14 | 2008-08-15 | Sila S R L | Prodotto a base di acido linoleico coniugato e processo per la sua fabbricazione |
| EP2198859A1 (en) | 2008-12-17 | 2010-06-23 | Losan Pharma GmbH | Melt-coated pharmaceutical composition with fast release |
-
2014
- 2014-04-11 DK DK14716609.4T patent/DK2983650T3/en active
- 2014-04-11 EP EP14716609.4A patent/EP2983650B1/en active Active
- 2014-04-11 PT PT147166094T patent/PT2983650T/pt unknown
- 2014-04-11 LT LTEP14716609.4T patent/LT2983650T/lt unknown
- 2014-04-11 US US14/783,794 patent/US9636307B2/en active Active
- 2014-04-11 SI SI201430333T patent/SI2983650T1/sl unknown
- 2014-04-11 ES ES14716609.4T patent/ES2638789T3/es active Active
- 2014-04-11 PL PL14716609T patent/PL2983650T3/pl unknown
- 2014-04-11 HU HUE14716609A patent/HUE033723T2/en unknown
- 2014-04-11 WO PCT/EP2014/057442 patent/WO2014167124A1/en active Application Filing
-
2017
- 2017-07-27 HR HRP20171149TT patent/HRP20171149T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ES2638789T3 (es) | 2017-10-24 |
| PT2983650T (pt) | 2017-09-01 |
| LT2983650T (lt) | 2017-09-11 |
| EP2983650B1 (en) | 2017-06-28 |
| DK2983650T3 (en) | 2017-09-18 |
| US20160067189A1 (en) | 2016-03-10 |
| EP2983650A1 (en) | 2016-02-17 |
| HUE033723T2 (en) | 2018-01-29 |
| PL2983650T3 (pl) | 2017-11-30 |
| SI2983650T1 (sl) | 2017-12-29 |
| WO2014167124A1 (en) | 2014-10-16 |
| US9636307B2 (en) | 2017-05-02 |
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