HRP20170686T1 - Produkt komikronizacije koji sadrži selektivni modulator receptora progesterona - Google Patents
Produkt komikronizacije koji sadrži selektivni modulator receptora progesterona Download PDFInfo
- Publication number
- HRP20170686T1 HRP20170686T1 HRP20170686TT HRP20170686T HRP20170686T1 HR P20170686 T1 HRP20170686 T1 HR P20170686T1 HR P20170686T T HRP20170686T T HR P20170686TT HR P20170686 T HRP20170686 T HR P20170686T HR P20170686 T1 HRP20170686 T1 HR P20170686T1
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- HR
- Croatia
- Prior art keywords
- product
- pharmaceutical composition
- cochronization
- active ingredient
- mixtures
- Prior art date
Links
- 102000003998 progesterone receptors Human genes 0.000 title 1
- 108090000468 progesterone receptors Proteins 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 8
- 239000004480 active ingredient Substances 0.000 claims 7
- 239000000203 mixture Substances 0.000 claims 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims 6
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- 229960000499 ulipristal acetate Drugs 0.000 claims 2
- OOLLAFOLCSJHRE-ZHAKMVSLSA-N ulipristal acetate Chemical compound C1=CC(N(C)C)=CC=C1[C@@H]1C2=C3CCC(=O)C=C3CC[C@H]2[C@H](CC[C@]2(OC(C)=O)C(C)=O)[C@]2(C)C1 OOLLAFOLCSJHRE-ZHAKMVSLSA-N 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000003433 contraceptive agent Substances 0.000 claims 1
- 230000002254 contraceptive effect Effects 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 239000010408 film Substances 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 239000002207 metabolite Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 239000002379 progesterone receptor modulator Substances 0.000 claims 1
- 210000004291 uterus Anatomy 0.000 claims 1
Classifications
-
- 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. Produkt komikronizacije sadrži:
- aktivni sastojak odabran iz grupe koja se sastoji od selektivnih modulatora receptora progesterona, njihovih metabolita i njihovih smjesa, i
- polimerni ekscipijens odabranog iz grupe koja se sastoji od polimera na bazi N-vinil-2-pirolidona i njihovih smjesa.
2. Produkt komikronizacije u skladu s patentnim zahtjevom 1, naznačen time što je aktivni sastojak odabran iz grupe koja se sastoji od 17α-acetoksi-11β-(4-N-metilaminofenil)-19-norpregna-4,9-dien-3,20-diona, 17α-acetoksi-11β-(4-aminofenil)-19-norpregna-4,9-dien-3,20-diona, ulipristal acetata i njihovih smjesa.
3. Produkt komikronizacije u skladu s bilo kojim od patentnih zahtjeva 1 i 2, naznačen time što je omjer masa “aktivni sastojak/polimerni ekscipijens” u rasponu od 0.1 do 10, poželjno od 0.5 do 4.
4. Produkt komikronizacije u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što je:
◾ aktivni sastojak ulipristal acetat i
◾ polimerni ekscipijens odabran iz grupe koja se sastoji od neumreženog polivinilpirolidona, umreženog polivinilpirolidona i njihovih smjesa.
5. Produkt komikronizacije u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što također sadrži kruti surfaktant, poželjno natrijev dodecil sulfat.
6. Produkt komikronizacije u skladu s bilo kojim od patentnih zahtjeva 1 do 5, ima:
- d50 manji od 20 µm, poželjno manji od 15 µm, i/ili
- d90 manji od 50 µm, poželjno manji od 40 µm.
7. Metoda za pripravu produkta komikronizacije prema bilo kojem od patentnih zahtjeva 1 do 6, obuhvaća korake koji se sastoje od:
a) opskrbe aktivnim sastojkom definiranim u bilo kojem od patentnih zahtjeva 1 ili 2;
b) miješanja aktivnog sastojka iz koraka a) s polimernim ekscipijensom definiranim u patentnom zahtjevu 1 i, opcionalno, s krutim surfaktantom, poželjno natrijevim dodecil sulfatom; i
c) komikronizacije smjese dobivene u koraku b).
8. Farmaceutski sastav sadrži produkt komikronizacije kako je definiran u nekom od patentnih zahtjeva 1 do 6 i farmaceutski prihvatljivi ekscipijens.
9. Farmaceutski sastav u skladu s patentnim zahtjevom 8, naznačen time što je farmaceutski prihvatljivi ekscipijens odabran iz grupe koja se sastoji od diluenta, agensa za vezanje, protočnog agensa, lubrikanta, dezintegranta i njihovih smjesa.
10. Farmaceutski sastav u skladu s patentnim zahtjevima 8 i 9, sastoji se od:
- 0.5% do 80% produkta komikronizacije,
- 15% do 95% diluenta, i
- 0% do 5% lubrikanta,
postoci su izraženi prema masi u odnosu na ukupnu masu sastava.
11. Farmaceutski sastav u skladu s jednim od patentnih zahtjeva 8 do 10, naznačen time što sadrži od 1 mg do 100 mg, poželjno od 1 mg do 40 mg aktivnog sastojka po jedinici doziranja.
12. Farmaceutski sastav u skladu s jednim od patentnih zahtjeva 8 do 11, naznačen time što je pogodan za oralnu primjenu.
13. Farmaceutski sastav u skladu s jednim od patentnih zahtjeva 8 do 12, naznačen time što je u obliku praha, granula, filmom obloženih ili neobloženih tableta, ili kapsula.
14. Produkt komikronizacije u skladu s bilo kojim od patentnih zahtjeva 1 do 6 ili farmaceutski sastav u skladu s jednim od patentnih zahtjeva 8 do 13, za uporabu kao kontraceptiv.
15. Produkt komikronizacije u skladu s bilo kojim od patentnih zahtjeva 1 do 6 ili farmaceutski sastav u skladu s jednim od patentnih zahtjeva 8 do 13, za uporabu u liječenju ili prevenciji ginekološkog poremećaja, posebno onog koji zahvaća maternicu.
Applications Claiming Priority (3)
| 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 |
| EP13801640.7A EP2916823B1 (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 |
|---|---|
| HRP20170686T1 true HRP20170686T1 (hr) | 2017-09-08 |
Family
ID=47714259
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20170686TT HRP20170686T1 (hr) | 2012-11-08 | 2017-05-08 | Produkt komikronizacije koji sadrži selektivni modulator receptora progesterona |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US20150258118A1 (hr) |
| EP (1) | EP2916823B1 (hr) |
| JP (1) | JP2015536969A (hr) |
| CN (1) | CN105073098B (hr) |
| CR (1) | CR20150298A (hr) |
| CY (1) | CY1118884T1 (hr) |
| DK (1) | DK2916823T3 (hr) |
| EA (1) | EA029643B1 (hr) |
| EC (1) | ECSP15022505A (hr) |
| ES (1) | ES2625012T3 (hr) |
| FR (1) | FR2997628B1 (hr) |
| GE (1) | GEP201706648B (hr) |
| HR (1) | HRP20170686T1 (hr) |
| LT (1) | LT2916823T (hr) |
| MD (1) | MD4546C1 (hr) |
| PL (1) | PL2916823T3 (hr) |
| PT (1) | PT2916823T (hr) |
| RS (1) | RS55956B1 (hr) |
| SI (1) | SI2916823T1 (hr) |
| UA (1) | UA115573C2 (hr) |
| WO (1) | WO2014072647A1 (hr) |
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 |
| US11878025B2 (en) | 2021-09-06 | 2024-01-23 | 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. |
| JP5017109B2 (ja) | 2004-07-09 | 2012-09-05 | ザ・ポピュレイション・カウンシル，インコーポレイテッド | プロゲステロン受容体モジュレーターを含有する徐放性組成物 |
| SI2078032T1 (sl) * | 2006-10-24 | 2017-12-29 | Repros Therapeutics Inc. | Sestave in postopki za zaviranje proliferacije endometrija |
| WO2008083192A2 (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 |
| BRPI1014035A2 (pt) | 2009-04-14 | 2016-04-12 | Hra Pharma Lab | método para contracepção. |
| EP2535114A4 (en) * | 2009-11-13 | 2015-11-18 | Moriroku Chemicals Company Ltd | PROCESS FOR PRODUCING FINE POWDER AND FINE POWDER PRODUCED ACCORDING TO THIS METHOD |
| 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 CN CN201380069081.4A patent/CN105073098B/zh not_active Expired - Fee Related
- 2013-11-07 PT PT138016407T patent/PT2916823T/pt unknown
- 2013-11-07 ES ES13801640.7T patent/ES2625012T3/es active Active
- 2013-11-07 SI SI201330642T patent/SI2916823T1/sl unknown
- 2013-11-07 PL PL13801640T patent/PL2916823T3/pl unknown
- 2013-11-07 JP JP2015541215A patent/JP2015536969A/ja active Pending
- 2013-11-07 EP EP13801640.7A patent/EP2916823B1/fr active Active
- 2013-11-07 MD MDA20150054A patent/MD4546C1/ro not_active IP Right Cessation
- 2013-11-07 GE GEAP201313848A patent/GEP201706648B/en unknown
- 2013-11-07 LT LTEP13801640.7T patent/LT2916823T/lt unknown
- 2013-11-07 DK DK13801640.7T patent/DK2916823T3/en active
- 2013-11-07 WO PCT/FR2013/052671 patent/WO2014072647A1/fr active Application Filing
- 2013-11-07 EA EA201500514A patent/EA029643B1/ru not_active IP Right Cessation
- 2013-11-07 RS RS20170457A patent/RS55956B1/sr unknown
- 2013-11-07 US US14/441,054 patent/US20150258118A1/en not_active Abandoned
-
2015
- 2015-06-05 EC ECIEPI201522505A patent/ECSP15022505A/es unknown
- 2015-06-05 CR CR20150298A patent/CR20150298A/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 |
|---|---|
| CN105073098B (zh) | 2019-02-19 |
| RS55956B1 (sr) | 2017-09-29 |
| EP2916823A1 (fr) | 2015-09-16 |
| CN105073098A (zh) | 2015-11-18 |
| EA029643B1 (ru) | 2018-04-30 |
| EP2916823B1 (fr) | 2017-02-15 |
| PT2916823T (pt) | 2017-05-22 |
| MD4546B1 (ro) | 2018-01-31 |
| FR2997628A1 (fr) | 2014-05-09 |
| MD4546B9 (ro) | 2018-08-31 |
| CY1118884T1 (el) | 2018-01-10 |
| PL2916823T3 (pl) | 2017-08-31 |
| UA115573C2 (uk) | 2017-11-27 |
| LT2916823T (lt) | 2017-07-25 |
| US20150258118A1 (en) | 2015-09-17 |
| MD4546C1 (ro) | 2019-03-31 |
| EA201500514A1 (ru) | 2015-09-30 |
| ES2625012T3 (es) | 2017-07-18 |
| JP2015536969A (ja) | 2015-12-24 |
| FR2997628B1 (fr) | 2015-01-16 |
| MD20150054A2 (ro) | 2015-10-31 |
| CR20150298A (es) | 2015-08-14 |
| DK2916823T3 (en) | 2017-05-15 |
| SI2916823T1 (sl) | 2017-08-31 |
| ECSP15022505A (es) | 2016-01-29 |
| WO2014072647A1 (fr) | 2014-05-15 |
| GEP201706648B (en) | 2017-03-27 |
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