HRP20221162T1 - Pelete s višeslojnom strukturom, namijenjene odgođenom otpuštanju aktivne tvari u distalnom debelom crijevu - Google Patents
Pelete s višeslojnom strukturom, namijenjene odgođenom otpuštanju aktivne tvari u distalnom debelom crijevu Download PDFInfo
- Publication number
- HRP20221162T1 HRP20221162T1 HRP20221162TT HRP20221162T HRP20221162T1 HR P20221162 T1 HRP20221162 T1 HR P20221162T1 HR P20221162T T HRP20221162T T HR P20221162TT HR P20221162 T HRP20221162 T HR P20221162T HR P20221162 T1 HRP20221162 T1 HR P20221162T1
- Authority
- HR
- Croatia
- Prior art keywords
- pellet
- active substance
- budesonide
- layer
- pellets
- Prior art date
Links
- 239000008188 pellet Substances 0.000 title claims 21
- 230000003111 delayed effect Effects 0.000 title claims 2
- 210000004921 distal colon Anatomy 0.000 title claims 2
- 239000003814 drug Substances 0.000 title 1
- 229940079593 drug Drugs 0.000 title 1
- 239000013543 active substance Substances 0.000 claims 10
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims 7
- 229960004436 budesonide Drugs 0.000 claims 7
- 230000008961 swelling Effects 0.000 claims 4
- 239000002775 capsule Substances 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 239000011248 coating agent Substances 0.000 claims 3
- 238000000576 coating method Methods 0.000 claims 3
- 239000012530 fluid Substances 0.000 claims 3
- 230000000968 intestinal effect Effects 0.000 claims 3
- 239000002245 particle Substances 0.000 claims 3
- 229920002845 Poly(methacrylic acid) Polymers 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 2
- 229920001577 copolymer Polymers 0.000 claims 2
- 238000001727 in vivo Methods 0.000 claims 2
- 239000000463 material Substances 0.000 claims 2
- 210000002784 stomach Anatomy 0.000 claims 2
- 229920002125 Sokalan® Polymers 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 235000011389 fruit/vegetable juice Nutrition 0.000 claims 1
- 210000004051 gastric juice Anatomy 0.000 claims 1
- 239000007903 gelatin capsule Substances 0.000 claims 1
- 229920001519 homopolymer Polymers 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 229920003229 poly(methyl methacrylate) Polymers 0.000 claims 1
- 239000004584 polyacrylic acid Substances 0.000 claims 1
- 229920000193 polymethacrylate Polymers 0.000 claims 1
- 239000004926 polymethyl methacrylate Substances 0.000 claims 1
- 230000000979 retarding effect Effects 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000000080 wetting agent 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
- A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/009—Sachets, pouches characterised by the material or function of the envelope
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
-
- 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
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (15)
1. Peleta s višeslojnom ovojnicom, namijenjena odgođenom otpuštanju aktivne tvari, osobito u distalnom debelom crijevu, gdje navedena peleta sadrži sljedeće komponente:
a) polaznu peletu, koja se sastoji samo od inertnog materijala, gdje polazna peleta u sebi ne sadrži farmaceutski djelotvornu aktivnu tvar,
b) sloj aktivne tvari, kojeg se primijenjuje izravno na polaznu peletu a) i uz aktivnu tvar sadrži pomoćna sredstva koja tvore film,
c) bubreći sloj, kojeg se primijenjuje izravno na sloj aktivne tvari b) i sadrži bubreći materijali koji bubre u kontaktu s crijevnom tekućinom,
d) sloj za usporavanje, koji se ne otapa u kontaktu s crijevnom tekućinom, no postaje propustan za tekućine i izravno ga se primijenjuje na c),
e) najvanjskiju oblogu, koja se ne otapa kod vrijednosti pH < 5,5, no dobro se otapa kod vrijednosti pH iznad 6,0 i izravno je se primijenjuje na d);
naznačena time što je aktivna tvar budezonid, ili njegova farmaceutski prihvatljiva sol.
2. Peleta u skladu s patentnim zahtjevom 1, naznačena time što polazna peleta (a) ima srednji promjer od 0,2 do 2,0 mm, gdje je najmanje 90% čestica unutar danog raspona veličina, te gdje polazne pelete imaju kuglasti oblik jednoličnog vanjskog izgleda.
3. Peleta u skladu s patentnim zahtjevom 2, naznačena time što najmanje 95% čestica ima raspodjelu veličina u rasponu između 0,2 i 2,0 mm.
4. Peleta u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačena time što sloj aktivne tvari (b) uz aktivnu tvar budezonid sadrži punilo, vezivo, te sredstvo za vlaženje, kao i sredstvo za otpuštanje.
5. Peleta u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačena time što je aktivna tvar mikronizirani budezonid, u kojem je 100% pojedinačnih čestica manje od 10 µm, a najmanje 95% je manje od 5 µm.
6. Peleta u skladu s bilo kojim od patentnih zahtjeva 1-5, naznačena time što bubreći sloj (c) kao sredstvo za bubrenje sadrži homopolimer poliakrilne kiseline tipa A, vezivo, te sredstvo za otpuštanje.
7. Peleta u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačena time što je sloj za usporavanje (d) kombinacija kopolimera amonijevog metakrilata (tip A) s kopolimerom amonijevog metakrilata (tip B).
8. Peleta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je najvanjskija obloga (e), koja se ne otapa kod vrijednosti pH ispod 6,0 kopolimer poli(met)akrilna kiselina/poli(met)akrilat, s omjerom između poli(met)akrilne kiseline i polimetil-metakrilata od 1:1.
9. Peleta u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačena time što se budezonid uglavnom ne otpušta prilikom otuštanja in vitro u umjetnom želučanom soku s vrijednošću pH od 1,2 u trajanju do 2 sata, dok se nakon 270 minuta otpusti 10 do 30%, nakon 330 minuta otpusti 40 do 70%, te nakon 540 minuta otpusti više od 80% aktivne tvari budezonida u umjetnom crijevnom soku kod pH od 6,5.
10. Peleta u skladu s bilo kojim od patentnih zahtjeva 1-9, naznačena time što se otpusti manje od 30% aktivne tvari unutar četiri sata in vivo u skladu s uvjetima testiranja u farmakokinetičkoj studiji.
11. Peleta u skladu s bilo kojim od patentnih zahtjeva 1-10, naznačena time što maksimalna koncentracija u plazmi u prosjeku najranije se postiže tek nakon 7,0 do 7,5 sati in vivo u skladu s uvjetima testiranja u farmakokinetičkoj studiji.
12. Kapsula koje se brzo otapa u želucu, naznačena time što sadrži više peleta u skladu s patentnim zahtjevima 1-11.
13. Kapsula u skladu s patentnim zahtjevom 12, naznačena time što je želatinska kapsula koja se lako otapa u želucu.
14. Kapsula u skladu s patentnim zahtjevom 13, naznačena time što pelete koje sadrži sadrže 3 mg do 9 mg budezonida.
15. Vrećica, naznačena time što sadrži isto toliko peleta u skladu s patentnim zahtjevima 1 do 12 koliko ta vrećica sadrži između 3 mg i 9 mg budezonida.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP18190638.9A EP3613414A1 (de) | 2018-08-24 | 2018-08-24 | Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon |
| PCT/EP2019/072429 WO2020039017A1 (de) | 2018-08-24 | 2019-08-22 | Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon |
| EP19765417.1A EP3840734B1 (de) | 2018-08-24 | 2019-08-22 | Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20221162T1 true HRP20221162T1 (hr) | 2022-11-25 |
Family
ID=63405023
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20221162TT HRP20221162T1 (hr) | 2018-08-24 | 2019-08-22 | Pelete s višeslojnom strukturom, namijenjene odgođenom otpuštanju aktivne tvari u distalnom debelom crijevu |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US11173121B2 (hr) |
| EP (2) | EP3613414A1 (hr) |
| JP (1) | JP7374992B2 (hr) |
| CN (1) | CN112512513A (hr) |
| AU (1) | AU2019326752A1 (hr) |
| CA (1) | CA3108257A1 (hr) |
| DK (1) | DK3840734T3 (hr) |
| EA (1) | EA202190565A1 (hr) |
| ES (1) | ES2927000T3 (hr) |
| HR (1) | HRP20221162T1 (hr) |
| HU (1) | HUE060169T2 (hr) |
| IL (1) | IL279825B2 (hr) |
| LT (1) | LT3840734T (hr) |
| PL (1) | PL3840734T3 (hr) |
| PT (1) | PT3840734T (hr) |
| RS (1) | RS63628B1 (hr) |
| SI (1) | SI3840734T1 (hr) |
| UA (1) | UA127521C2 (hr) |
| WO (1) | WO2020039017A1 (hr) |
| ZA (1) | ZA202100512B (hr) |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5643602A (en) * | 1989-11-22 | 1997-07-01 | Astra Aktiebolag | Oral composition for the treatment of inflammatory bowel disease |
| SE8903914D0 (sv) | 1989-11-22 | 1989-11-22 | Draco Ab | Oral composition for the treatment of inflammatory bowel diseases |
| DE4332394A1 (de) * | 1993-09-23 | 1995-03-30 | Falk Pharma Gmbh | Budesonid-Pellets mit kontrolliertem Freigabeprofil und Verfahren zu ihrer Herstellung |
| DE4340057A1 (de) * | 1993-11-24 | 1995-06-01 | Falk Pharma Gmbh | Budesonid-Arzneimittel zur Verbesserung der enteralen Flüssigkeitsresorption, insbesondere nach postoperativen Zuständen |
| ATE251449T1 (de) | 1999-06-14 | 2003-10-15 | Cosmo Spa | Geschmacksmaskierte orale pharmazeutische zusammensetzungen mit kontrollierter abgabe |
| DE50013843D1 (de) | 2000-08-29 | 2007-01-18 | Mepha Ag | Arzneimittel zur behandlung von darmerkrankungen |
| HU231030B1 (hu) | 2001-11-23 | 2019-12-30 | Warner Chilcott Company, Llc | Többszörös bevonattal ellátott gyógyszer dózisforma |
| DE10214002A1 (de) * | 2002-03-27 | 2003-10-09 | Roehm Gmbh | Pharmazeutische Formulierung für den Wirkstoff Budesonid |
| DE10250543A1 (de) * | 2002-10-29 | 2004-05-19 | Röhm GmbH & Co. KG | Mehrschichtige Arzneiform |
| US20060188563A1 (en) * | 2003-03-27 | 2006-08-24 | Hisamitsu Pharmaceutical Co., Inc. | Medicinal oral preparations for colon delivery, medicinal oral preparations for treating colon cancer and medicinal oral preparations for treating colitis |
| ATE476185T1 (de) | 2003-09-15 | 2010-08-15 | Nycomed Gmbh | Verwendung von ciclesonid zur behandlung von entzündlichen darmerkrankungen |
| CN101108171A (zh) * | 2006-07-17 | 2008-01-23 | 复旦大学 | 一种布地奈德肠溶缓释微丸及其制备方法 |
| JPWO2008117814A1 (ja) | 2007-03-26 | 2010-07-15 | 帝國製薬株式会社 | 大腸送達用経口製剤 |
| GB0808537D0 (en) | 2008-05-12 | 2008-06-18 | Archimedes Dev Ltd | Compositions |
| CN103705481B (zh) | 2013-11-15 | 2017-10-20 | 中国药科大学 | 一种萘普生结肠定位释药微丸及其制备方法 |
| WO2017042835A1 (en) * | 2015-09-11 | 2017-03-16 | Sun Pharmaceutical Industries Ltd. | Oral pharmaceutical dosage forms of budesonide |
| EP3257501A1 (en) | 2016-06-14 | 2017-12-20 | Tillotts Pharma AG | Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material, and an enteric core coating |
-
2018
- 2018-08-24 EP EP18190638.9A patent/EP3613414A1/de not_active Withdrawn
-
2019
- 2019-08-22 US US17/263,710 patent/US11173121B2/en active Active
- 2019-08-22 CA CA3108257A patent/CA3108257A1/en active Pending
- 2019-08-22 JP JP2021510044A patent/JP7374992B2/ja active Active
- 2019-08-22 WO PCT/EP2019/072429 patent/WO2020039017A1/de active Search and Examination
- 2019-08-22 UA UAA202101343A patent/UA127521C2/uk unknown
- 2019-08-22 PL PL19765417.1T patent/PL3840734T3/pl unknown
- 2019-08-22 HU HUE19765417A patent/HUE060169T2/hu unknown
- 2019-08-22 AU AU2019326752A patent/AU2019326752A1/en active Pending
- 2019-08-22 PT PT197654171T patent/PT3840734T/pt unknown
- 2019-08-22 LT LTEPPCT/EP2019/072429T patent/LT3840734T/lt unknown
- 2019-08-22 DK DK19765417.1T patent/DK3840734T3/da active
- 2019-08-22 RS RS20220919A patent/RS63628B1/sr unknown
- 2019-08-22 SI SI201930318T patent/SI3840734T1/sl unknown
- 2019-08-22 ES ES19765417T patent/ES2927000T3/es active Active
- 2019-08-22 EA EA202190565A patent/EA202190565A1/ru unknown
- 2019-08-22 HR HRP20221162TT patent/HRP20221162T1/hr unknown
- 2019-08-22 EP EP19765417.1A patent/EP3840734B1/de active Active
- 2019-08-22 CN CN201980049484.XA patent/CN112512513A/zh active Pending
- 2019-08-22 IL IL279825A patent/IL279825B2/en unknown
-
2021
- 2021-01-25 ZA ZA2021/00512A patent/ZA202100512B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ZA202100512B (en) | 2022-02-23 |
| EP3613414A1 (de) | 2020-02-26 |
| DK3840734T3 (da) | 2022-09-26 |
| ES2927000T3 (es) | 2022-10-31 |
| EP3840734B1 (de) | 2022-07-20 |
| UA127521C2 (uk) | 2023-09-20 |
| JP7374992B2 (ja) | 2023-11-07 |
| PL3840734T3 (pl) | 2022-12-19 |
| CA3108257A1 (en) | 2020-02-27 |
| IL279825B2 (en) | 2024-04-01 |
| EA202190565A1 (ru) | 2021-06-01 |
| LT3840734T (lt) | 2022-10-25 |
| AU2019326752A1 (en) | 2021-01-28 |
| US11173121B2 (en) | 2021-11-16 |
| HUE060169T2 (hu) | 2023-02-28 |
| US20210228487A1 (en) | 2021-07-29 |
| SI3840734T1 (sl) | 2022-10-28 |
| CN112512513A (zh) | 2021-03-16 |
| PT3840734T (pt) | 2022-09-19 |
| WO2020039017A1 (de) | 2020-02-27 |
| RS63628B1 (sr) | 2022-10-31 |
| EP3840734A1 (de) | 2021-06-30 |
| IL279825B1 (en) | 2023-12-01 |
| JP2022503581A (ja) | 2022-01-12 |
| IL279825A (en) | 2021-03-01 |
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