DK2916823T3 - Co-mikroniseringsprodukt omfattende en selektiv progesteronreceptormodulator - Google Patents
Co-mikroniseringsprodukt omfattende en selektiv progesteronreceptormodulator Download PDFInfo
- Publication number
- DK2916823T3 DK2916823T3 DK13801640.7T DK13801640T DK2916823T3 DK 2916823 T3 DK2916823 T3 DK 2916823T3 DK 13801640 T DK13801640 T DK 13801640T DK 2916823 T3 DK2916823 T3 DK 2916823T3
- Authority
- DK
- Denmark
- Prior art keywords
- active ingredient
- pharmaceutical composition
- micronization
- micronization product
- composition according
- Prior art date
Links
Classifications
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- 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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/32—Antioestrogens
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Diabetes (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Bidet-Like Cleaning Device And Other Flush Toilet Accessories (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (15)
1. Co-mikroniseringsprodukt omfattende: - en aktiv ingrediens valgt fra gruppen bestående af selektive progesteronreceptormodulatorer, metabolitter deraf og blandinger deraf, og - en polymer excipiens valgt fra gruppen bestående af polymerer baseret på N-vinyl-2-pyrrolidon og blandinger deraf.
2. Co-mikroniseringsprodukt ifølge krav 1, kendetegnet ved at den aktive ingrediens er valgt fra gruppen bestående af 17a-acetoxy-ll^-(4-N-methylaminophenyl)-19-norpregna-4,9-dien-3,20-dion, 17a-acetoxy-ll^-(4-aminophenyl)-19-norpregna-4,9-dien-3,20-dion, ulipristalacetat og blandinger deraf.
3. Co-mikroniseringsprodukt ifølge et hvilket som helst af kravene 1 og 2, kendetegnet ved at vægtforholdet "den aktive ingrediens/den polymere excipiens" er i området fra 0,1 til 10, fortrinsvis fra 0,5 til 4.
4. Co-mikroniseringsprodukt ifølge et hvilket som helst af kravene 1 til 3, kendetegnet ved at: den aktive ingrediens er ulipristalacetat og den polymere excipiens er valgt fra gruppen bestående af ikke-tværbundet polyvinylpyrrolidon, en tværbundet polyvinylpyrrolidon og blandinger deraf.
5. Co-mikroniseringsprodukt ifølge et hvilket som helst af kravene 1 til 4, kendetegnet ved at det også omfatter et overfladeaktivt middel i fast form, fortrinsvis natriumdodecylsulfat.
6. Co-mikroniseringsprodukt ifølge et hvilket som helst af kravene 1 til 5, med: - en d50 på mindre end 20 pm, fortrinsvis mindre end 15 pm, og/eller - en d90 på mindre end 50 pm, fortrinsvis mindre end 40 pm.
7. Fremgangsmåde til fremstilling af et co-mikroniseringsprodukt som defineret i et hvilket som helst af kravene 1 til 6, omfattende trinnene bestående af: a) at tilvejebringe en aktiv ingrediens som defineret i et hvilket som helst af kravene 1 eller 2; b) at blande den aktive ingrediens fra trin a) med en polymer excipiens som defineret i krav 1 og, eventuelt, med et overfladeaktivt middel i fast form, fortrinsvis natriumdodecylsulfat; og c) at co-mikronisere blandingen opnået i trin b).
8. Farmaceutisk sammensætning omfattende et co-mikroniseringsprodukt som defineret i et af kravene 1 til 6 og en farmaceutisk acceptabel excipiens.
9. Farmaceutisk sammensætning ifølge krav 8, kendetegnet ved at den farmaceutisk acceptable excipiens er valgt fra gruppen bestående af et fortyndingsmiddel, et bindemiddel, et flydemiddel, et smøremiddel, et sprængemiddel og blandinger deraf.
10. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 8 og 9, omfattende fra: - 0,5% til 80% co-mikroniseringsprodukt, - 15% til 95% fortyndingsmiddel, og - 0% til 5% smøremiddel idet procenterne er udtrykt efter vægt i forhold til sammensætningens samlede vægt.
11. Farmaceutisk sammensætning ifølge et af kravene 8 til 10, kendetegnet ved at den omfatter fra 1 mg til 100 mg, fortrinsvis fra 1 mg til 40 mg, aktiv ingrediens pr. dosisenhed.
12. Farmaceutisk sammensætning ifølge et af kravene 8 til 11, kendetegnet ved at det er egnet til oral indgivelse.
13. Farmaceutisk sammensætning ifølge et af kravene 8 til 12, kendetegnet ved at den er i form af et pulver, et granulat, en filmovertrukket eller ikke-overtrukket tablet eller en kapsel.
14. Co-mikroniseringsprodukt ifølge et hvilket som helst af kravene 1 til 6 eller en farmaceutisk sammensætning ifølge et af kravene 8 til 13, til anvendelse som præventionsmiddel.
15. Co-mikroniseringsprodukt ifølge et hvilket som helst af kravene 1 til 6 eller en farmaceutisk sammensætning ifølge et af kravene 8 til 13, til anvendelse til behandling eller forebyggelse af en gynækologisk lidelse, fortrinsvis påvirkende livmoderen.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1260605A FR2997628B1 (fr) | 2012-11-08 | 2012-11-08 | Produit de co-micronisation comprenant un modulateur selectif des recepteurs a la progesterone |
| PCT/FR2013/052671 WO2014072647A1 (fr) | 2012-11-08 | 2013-11-07 | Produit de co-micronisation comprenant un modulateur selectif du recepteur a la progesterone |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2916823T3 true DK2916823T3 (da) | 2017-05-15 |
Family
ID=47714259
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13801640.7T DK2916823T3 (da) | 2012-11-08 | 2013-11-07 | Co-mikroniseringsprodukt omfattende en selektiv progesteronreceptormodulator |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US20150258118A1 (da) |
| EP (1) | EP2916823B1 (da) |
| JP (1) | JP2015536969A (da) |
| CN (1) | CN105073098B (da) |
| CR (1) | CR20150298A (da) |
| CY (1) | CY1118884T1 (da) |
| DK (1) | DK2916823T3 (da) |
| EA (1) | EA029643B1 (da) |
| EC (1) | ECSP15022505A (da) |
| ES (1) | ES2625012T3 (da) |
| FR (1) | FR2997628B1 (da) |
| GE (1) | GEP201706648B (da) |
| HR (1) | HRP20170686T1 (da) |
| LT (1) | LT2916823T (da) |
| MD (1) | MD4546C1 (da) |
| PL (1) | PL2916823T3 (da) |
| PT (1) | PT2916823T (da) |
| RS (1) | RS55956B1 (da) |
| SI (1) | SI2916823T1 (da) |
| UA (1) | UA115573C2 (da) |
| WO (1) | WO2014072647A1 (da) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265533A (zh) * | 2016-10-10 | 2017-01-04 | 朱隆娅 | 一种阿德呋啉颗粒剂及其制备方法 |
| FR3060389B1 (fr) * | 2016-12-20 | 2019-05-31 | Laboratoire Hra-Pharma | Comprime enrobe comprenant de l'ulipristal acetate ou un de ses metabolites |
| EP3895691A1 (en) | 2020-04-15 | 2021-10-20 | LTS Lohmann Therapie-Systeme AG | Ulipristal acetate otf |
| WO2023033900A1 (en) | 2021-09-06 | 2023-03-09 | Slayback Pharma Llc | Pharmaceutical compositions of mifepristone |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4954490A (en) * | 1988-06-23 | 1990-09-04 | Research Triangle Institute | 11 β-substituted progesterone analogs |
| US5759577A (en) * | 1995-01-17 | 1998-06-02 | American Home Products Corporation | Controlled release of steroids from sugar coatings |
| JP2004099442A (ja) * | 2002-09-04 | 2004-04-02 | Nisshin Pharma Inc | 難溶性薬物含有製剤およびその製造方法 |
| ES2212912B1 (es) | 2003-01-22 | 2005-10-01 | Crystal Pharma, S.A. | Procedimiento para la obtencion de 17alfa-acetoxi-11beta-(4-n,n-dimetilaminofenil)-19-norpregna-4,9-dien-3,20-diona. |
| AU2005265357B2 (en) | 2004-07-09 | 2011-04-07 | Laboratoire Hra Pharma | Sustained release compositions containing progesterone receptor modulators |
| MY150763A (en) * | 2006-10-24 | 2014-02-28 | Repros Therapeutics Inc | Compositions and methods for suppressing endometrial proliferation |
| CA2672888A1 (en) * | 2006-12-28 | 2008-07-10 | Repros Therapeutics Inc. | Methods and formulations for improved bioavailability of antiprogestins |
| JP2008169135A (ja) * | 2007-01-11 | 2008-07-24 | Takada Seiyaku Kk | グリメピリド組成物の製造方法 |
| US8299050B2 (en) * | 2008-01-29 | 2012-10-30 | Laboratoire Hra-Pharma | Method for treating uterine fibroids |
| TWI539953B (zh) * | 2008-04-28 | 2016-07-01 | 瑞波若斯治療學公司 | 用於治療乳癌之組成物和方法 |
| US8512745B2 (en) * | 2008-12-08 | 2013-08-20 | Laboratoire Hra Pharma | Ulipristal acetate tablets |
| ME02548B (me) | 2009-04-14 | 2017-02-20 | Hra Pharma Lab | Postupak za kontracepciju po potrebi |
| US9044758B2 (en) * | 2009-11-13 | 2015-06-02 | Moriroku Chemicals Company, Ltd. | Method for producing fine powder and the fine powder produced by the same |
| FR2988610B1 (fr) * | 2012-03-30 | 2014-10-31 | Effik | Progestatif co-micronise avec un polymere portant le groupe pyrrolidone, composition et utilisations |
| CN102871977A (zh) * | 2012-10-19 | 2013-01-16 | 北京紫竹药业有限公司 | 醋酸优力司特分散片及其制备方法 |
-
2012
- 2012-11-08 FR FR1260605A patent/FR2997628B1/fr not_active Expired - Fee Related
-
2013
- 2013-07-11 UA UAA201505667A patent/UA115573C2/uk unknown
- 2013-11-07 US US14/441,054 patent/US20150258118A1/en not_active Abandoned
- 2013-11-07 SI SI201330642T patent/SI2916823T1/sl unknown
- 2013-11-07 PL PL13801640T patent/PL2916823T3/pl unknown
- 2013-11-07 PT PT138016407T patent/PT2916823T/pt unknown
- 2013-11-07 CN CN201380069081.4A patent/CN105073098B/zh not_active Expired - Fee Related
- 2013-11-07 DK DK13801640.7T patent/DK2916823T3/da active
- 2013-11-07 LT LTEP13801640.7T patent/LT2916823T/lt unknown
- 2013-11-07 EP EP13801640.7A patent/EP2916823B1/fr active Active
- 2013-11-07 RS RS20170457A patent/RS55956B1/sr unknown
- 2013-11-07 JP JP2015541215A patent/JP2015536969A/ja active Pending
- 2013-11-07 ES ES13801640.7T patent/ES2625012T3/es active Active
- 2013-11-07 WO PCT/FR2013/052671 patent/WO2014072647A1/fr active Application Filing
- 2013-11-07 GE GEAP201313848A patent/GEP201706648B/en unknown
- 2013-11-07 MD MDA20150054A patent/MD4546C1/ro not_active IP Right Cessation
- 2013-11-07 EA EA201500514A patent/EA029643B1/ru not_active IP Right Cessation
-
2015
- 2015-06-05 CR CR20150298A patent/CR20150298A/es unknown
- 2015-06-05 EC ECIEPI201522505A patent/ECSP15022505A/es unknown
-
2017
- 2017-05-08 HR HRP20170686TT patent/HRP20170686T1/hr unknown
- 2017-05-10 CY CY20171100500T patent/CY1118884T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| GEP201706648B (en) | 2017-03-27 |
| RS55956B1 (sr) | 2017-09-29 |
| US20150258118A1 (en) | 2015-09-17 |
| JP2015536969A (ja) | 2015-12-24 |
| ES2625012T3 (es) | 2017-07-18 |
| EP2916823A1 (fr) | 2015-09-16 |
| MD4546C1 (ro) | 2019-03-31 |
| UA115573C2 (uk) | 2017-11-27 |
| ECSP15022505A (es) | 2016-01-29 |
| SI2916823T1 (sl) | 2017-08-31 |
| FR2997628B1 (fr) | 2015-01-16 |
| CY1118884T1 (el) | 2018-01-10 |
| WO2014072647A1 (fr) | 2014-05-15 |
| PT2916823T (pt) | 2017-05-22 |
| MD20150054A2 (ro) | 2015-10-31 |
| EA201500514A1 (ru) | 2015-09-30 |
| FR2997628A1 (fr) | 2014-05-09 |
| PL2916823T3 (pl) | 2017-08-31 |
| MD4546B9 (ro) | 2018-08-31 |
| LT2916823T (lt) | 2017-07-25 |
| MD4546B1 (ro) | 2018-01-31 |
| CR20150298A (es) | 2015-08-14 |
| EP2916823B1 (fr) | 2017-02-15 |
| HRP20170686T1 (hr) | 2017-09-08 |
| EA029643B1 (ru) | 2018-04-30 |
| CN105073098B (zh) | 2019-02-19 |
| CN105073098A (zh) | 2015-11-18 |
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