HRP20230174T1 - Farmaceutska formulacija namijenjena liječenju upalnih stanja zadnjeg crijeva - Google Patents
Farmaceutska formulacija namijenjena liječenju upalnih stanja zadnjeg crijeva Download PDFInfo
- Publication number
- HRP20230174T1 HRP20230174T1 HRP20230174TT HRP20230174T HRP20230174T1 HR P20230174 T1 HRP20230174 T1 HR P20230174T1 HR P20230174T T HRP20230174T T HR P20230174TT HR P20230174 T HRP20230174 T HR P20230174T HR P20230174 T1 HRP20230174 T1 HR P20230174T1
- Authority
- HR
- Croatia
- Prior art keywords
- formulation according
- budesonide
- pharmaceutical formulation
- intended
- weight
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 7
- 210000000664 rectum Anatomy 0.000 title claims 2
- 230000002757 inflammatory effect Effects 0.000 title 1
- 239000000203 mixture Substances 0.000 claims 13
- 238000009472 formulation Methods 0.000 claims 12
- 239000000829 suppository Substances 0.000 claims 7
- 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 6
- 229960004436 budesonide Drugs 0.000 claims 6
- 239000002245 particle Substances 0.000 claims 3
- QAQJMLQRFWZOBN-LAUBAEHRSA-N L-ascorbyl-6-palmitate Chemical group CCCCCCCCCCCCCCCC(=O)OC[C@H](O)[C@H]1OC(=O)C(O)=C1O QAQJMLQRFWZOBN-LAUBAEHRSA-N 0.000 claims 2
- 239000011786 L-ascorbyl-6-palmitate Substances 0.000 claims 2
- 239000003963 antioxidant agent Substances 0.000 claims 2
- 230000003078 antioxidant effect Effects 0.000 claims 2
- 235000010385 ascorbyl palmitate Nutrition 0.000 claims 2
- 239000003925 fat Substances 0.000 claims 2
- 230000008018 melting Effects 0.000 claims 2
- 238000002844 melting Methods 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 230000008023 solidification Effects 0.000 claims 2
- 238000007711 solidification Methods 0.000 claims 2
- 206010036774 Proctitis Diseases 0.000 claims 1
- 206010036783 Proctitis ulcerative Diseases 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 1
- 238000002050 diffraction method Methods 0.000 claims 1
- 239000007789 gas Substances 0.000 claims 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- KBOPZPXVLCULAV-UHFFFAOYSA-N mesalamine Chemical compound NC1=CC=C(O)C(C(O)=O)=C1 KBOPZPXVLCULAV-UHFFFAOYSA-N 0.000 claims 1
- 229960004963 mesalazine Drugs 0.000 claims 1
- 239000001301 oxygen Substances 0.000 claims 1
- 229910052760 oxygen Inorganic materials 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 235000002316 solid fats Nutrition 0.000 claims 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 claims 1
- 150000004670 unsaturated fatty acids Chemical class 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
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/606—Salicylic acid; Derivatives thereof having amino groups
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (15)
1. Farmaceutska formulacija namijenjena rektalnoj primjeni koja sadrži budezonid, ili njegovu farmaceutski podnošljivu sol, i najmanje 80%, težinski, čvrste masti ili smjese različitih čvrstih masti na osnovi ukupne težine formulacije kao i najmanje jedan antioksidans podnošljiv, naznačena time što je antioksidans askorbil-palmitat.
2. Formulacija u skladu s patentnim zahtjevom 1, naznačena time što ima mali razmak između točke taljenja i točke stvrdnjavanja, gdje je točka taljenja između 33,5 °C i 35,5 °C, a točka stvrdnjavanja je između 32,5 °C i 34,5 °C.
3. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 ili 2, naznačena time što čvrsta mast ima visoki sadržaj triglicerida, odnosno od ≥ 80%, težinski, broj hidroksila od 1 do 15, te sadrži manje od 1%, težinski, nezasićenih masnih kiselina.
4. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što je supozitorij namijenjen analnoj primjeni.
5. Formulacija u skladu s patentnim zahtjevom 4, naznačena time što sadrži od 1,8 do 4,2 mg budezonida po supozitoriju.
6. Formulacija u skladu s patentnim zahtjevom 5, naznačena time što sadrži od 1,8 do 2,2 mg budezonida po supozitoriju.
7. Formulacija u skladu s patentnim zahtjevom 5, naznačena time što je težina po supozitoriju između 3,8 i 4,2 mg budezonida.
8. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je težina po supozitoriju između 0,8 i 1,2 g.
9. Formulacija u skladu s patentnim zahtjevom 1, naznačena time što je askorbil-palmitat prisutan u koncentraciji od 50 ppm do 200 ppm.
10. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačena time što je budezonid prisutan u mikroniziranom obliku, gdje je 100% čestica manje od 10 µm po čestici, gdje se raspodjelu veličine čestica budezonida određuje laserskom difrakcijskom analizom.
11. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačena time što se farmaceutsku formulaciju stabilnu pri skladištenju pripravlja bez prisutnosti kisika.
12. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačena time što je farmaceutska formulacija pakirana u obliku supozitorija u lijevanom filmu nepropusnom za plinove.
13. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačena time što je namijenjena upotrebi u liječenju upalnih bolesti rektuma.
14. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačena time što je namijenjena upotrebi u liječenju akutnog ulceroznog proktitisa.
15. Farmaceutska formulacija, naznačena time što je namijenjena upotrebi u skladu s bilo kojim od patentnih zahtjeva 13 ili 14 u kombinaciji sa supozitorijima s mesalazinom.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15175806.7A EP3115037B1 (de) | 2015-07-08 | 2015-07-08 | Pharmazeutische formulierung zur behandlung von entzündlichen veränderungen des enddarms |
| PCT/EP2016/064907 WO2017005524A1 (de) | 2015-07-08 | 2016-06-28 | Pharmazeutische formulierung zur behandlung von entzündlichen veränderungen des enddarms |
| EP16732617.2A EP3319586B1 (de) | 2015-07-08 | 2016-06-28 | Pharmazeutische formulierung zur behandlung von entzündlichen veränderungen des enddarms |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230174T1 true HRP20230174T1 (hr) | 2023-04-14 |
Family
ID=53540667
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230174TT HRP20230174T1 (hr) | 2015-07-08 | 2016-06-28 | Farmaceutska formulacija namijenjena liječenju upalnih stanja zadnjeg crijeva |
Country Status (23)
| Country | Link |
|---|---|
| US (3) | US10905699B2 (hr) |
| EP (2) | EP3115037B1 (hr) |
| JP (1) | JP6857644B2 (hr) |
| CN (1) | CN107847435B (hr) |
| AU (1) | AU2016290343B2 (hr) |
| CA (1) | CA2986081C (hr) |
| DK (1) | DK3319586T3 (hr) |
| EA (1) | EA033153B1 (hr) |
| ES (2) | ES2688119T3 (hr) |
| FI (1) | FI3319586T3 (hr) |
| HR (1) | HRP20230174T1 (hr) |
| HU (1) | HUE061585T2 (hr) |
| IL (1) | IL255247B (hr) |
| LT (1) | LT3319586T (hr) |
| MA (1) | MA42367B1 (hr) |
| MD (1) | MD3319586T2 (hr) |
| PL (1) | PL3319586T3 (hr) |
| PT (2) | PT3115037T (hr) |
| RS (1) | RS64020B1 (hr) |
| SI (1) | SI3319586T1 (hr) |
| UA (1) | UA120075C2 (hr) |
| WO (1) | WO2017005524A1 (hr) |
| ZA (1) | ZA201707777B (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022226778A1 (zh) * | 2021-04-27 | 2022-11-03 | 广州共禾医药科技有限公司 | 经直肠施用的奥司他韦或其药学上可接受的盐的药物组合物、及其制备方法和用途 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB701831A (en) * | 1950-10-19 | 1954-01-06 | Rudolf Von Wuelfing | Process for the production of suppositories containing medicaments |
| US3208907A (en) * | 1961-11-13 | 1965-09-28 | Lab Toraude | Stabilized salicylate compositions |
| DE3709861A1 (de) * | 1987-03-25 | 1988-10-06 | Henkel Kgaa | Emulgierende suppositoriengrundmassen und daraus hergestellte zaepfchen |
| JP2927830B2 (ja) * | 1989-09-01 | 1999-07-28 | 東京田辺製薬株式会社 | ダナゾール坐剤 |
| IT1243379B (it) | 1990-07-27 | 1994-06-10 | Giuliani Spa | Composizione farmaceutica adatta alla somministrazione rettale di principi attivi che esplicano un'azione di medicazione a livello del colon prevalentemente di tipo topico |
| DE29717252U1 (de) * | 1997-09-26 | 1998-02-19 | Dr. Falk Pharma GmbH, 79108 Freiburg | Arzneimittelkit aus einem Budesonid-haltigen und einem Ursodesoxycholsäure-haltigen Arzneimittel zur Behandlung von cholestatischen Lebererkrankungen |
| DE19849737A1 (de) * | 1998-10-28 | 2000-05-04 | Falk Pharma Gmbh | Kombinationsmittel zur Behandlung entzündlicher Darmerkrankungen |
| US20020085978A1 (en) * | 2000-11-10 | 2002-07-04 | Mina Buenafe | Degradation-resistant glucocorticosteroid formulations |
| CU23203A1 (es) * | 2002-12-27 | 2007-05-18 | Ct Ingenieria Genetica Biotech | Formulaciones que contienen agentes de accion trombolitica para su administracion por via rectal |
| WO2008156671A2 (en) * | 2007-06-13 | 2008-12-24 | Jay Pravda | Materials and methods for treatment and diagnosis of disorders associated with oxidative stress |
| JP5223307B2 (ja) * | 2006-11-17 | 2013-06-26 | 大正製薬株式会社 | 坐剤 |
| JP2012509892A (ja) * | 2008-11-26 | 2012-04-26 | サティオゲン ファーマシューティカルズ，インク． | サティオゲン類を含有する組成物及び使用の方法 |
| WO2012022796A2 (de) * | 2010-08-20 | 2012-02-23 | Boehringer Ingelheim International Gmbh | Neue kombinationen |
| CN102525883B (zh) * | 2010-12-09 | 2013-05-08 | 丽珠集团丽珠制药厂 | 一种伏立康唑栓剂及其制备方法和用途 |
| WO2015073846A1 (en) | 2013-11-15 | 2015-05-21 | Salix Pharmaceuticals, Inc. | Method of treating ulcerative colitis |
-
2015
- 2015-07-08 PT PT15175806T patent/PT3115037T/pt unknown
- 2015-07-08 EP EP15175806.7A patent/EP3115037B1/de active Active
- 2015-07-08 ES ES15175806.7T patent/ES2688119T3/es active Active
-
2016
- 2016-06-28 FI FIEP16732617.2T patent/FI3319586T3/fi active
- 2016-06-28 CA CA2986081A patent/CA2986081C/en active Active
- 2016-06-28 WO PCT/EP2016/064907 patent/WO2017005524A1/de active Application Filing
- 2016-06-28 PT PT167326172T patent/PT3319586T/pt unknown
- 2016-06-28 LT LTEPPCT/EP2016/064907T patent/LT3319586T/lt unknown
- 2016-06-28 UA UAA201800685A patent/UA120075C2/uk unknown
- 2016-06-28 RS RS20230170A patent/RS64020B1/sr unknown
- 2016-06-28 EP EP16732617.2A patent/EP3319586B1/de active Active
- 2016-06-28 HU HUE16732617A patent/HUE061585T2/hu unknown
- 2016-06-28 AU AU2016290343A patent/AU2016290343B2/en active Active
- 2016-06-28 US US15/742,710 patent/US10905699B2/en active Active
- 2016-06-28 DK DK16732617.2T patent/DK3319586T3/da active
- 2016-06-28 MA MA42367A patent/MA42367B1/fr unknown
- 2016-06-28 MD MDE20180489T patent/MD3319586T2/ro unknown
- 2016-06-28 SI SI201631664T patent/SI3319586T1/sl unknown
- 2016-06-28 ES ES16732617T patent/ES2938358T3/es active Active
- 2016-06-28 EA EA201792685A patent/EA033153B1/ru unknown
- 2016-06-28 HR HRP20230174TT patent/HRP20230174T1/hr unknown
- 2016-06-28 CN CN201680039904.2A patent/CN107847435B/zh active Active
- 2016-06-28 PL PL16732617.2T patent/PL3319586T3/pl unknown
- 2016-06-28 JP JP2018500330A patent/JP6857644B2/ja active Active
-
2017
- 2017-10-24 IL IL255247A patent/IL255247B/en active IP Right Grant
- 2017-11-16 ZA ZA2017/07777A patent/ZA201707777B/en unknown
-
2020
- 2020-11-10 US US17/094,233 patent/US11738032B2/en active Active
-
2023
- 2023-07-12 US US18/221,164 patent/US20230364113A1/en active Pending
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