DK2965750T3 - Misoprostol dispersible tablet - Google Patents
Misoprostol dispersible tablet Download PDFInfo
- Publication number
- DK2965750T3 DK2965750T3 DK14176821.8T DK14176821T DK2965750T3 DK 2965750 T3 DK2965750 T3 DK 2965750T3 DK 14176821 T DK14176821 T DK 14176821T DK 2965750 T3 DK2965750 T3 DK 2965750T3
- Authority
- DK
- Denmark
- Prior art keywords
- pharmaceutical composition
- seconds
- composition according
- misoprostol
- preferably less
- Prior art date
Links
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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
- A61K31/5575—Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
-
- 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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/20—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
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61P15/04—Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Reproductive Health (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Pregnancy & Childbirth (AREA)
- Gynecology & Obstetrics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (17)
1. En farmaceutisk sammensætning omfattende misoprostol eller et farmaceutisk acceptabelt salt deraf, til anvendelse i en behandling omfattende cervixmodning eller induktion af fødsel, med et indhold på 0,5 - 50 pg misoprostol eller en ækvivalent mængde af farmaceutisk acceptabelt salt deraf, hvor den farmaceutiske sammensætning er egnet til en administrationsform valgt imellem sublingual og oral administration, og hvor sammensætningen tillader dispersion af en eller flere af omtalte farmaceutiske sammensætninger i 100 ml vand ved 25°C indenfor 3 minutter under omrøring, hvorved der tilvejebringes en dispersion; hvilken dispersion er i stand til at passere igennem en si med en nominel maskeåbning på 710 pm.
2. Den farmaceutiske sammensætning ifølge krav 1, hvor den farmaceutiske sammensætning er egnet til sublingual administration.
3. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, omfattende en disintegrant omfattende tværbundet polyvinylpyrrolidon (PVP).
4. Den farmaceutiske sammensætning ifølge krav 3, hvor disintegranten omfatter crospovidon.
5. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, omfattende mindst to disintegranter.
6. Den farmaceutiske sammensætning ifølge krav 5, hvor mindst én af de mindst to disintegranter er en tværbundet carboxymethylcellulose.
7. Den farmaceutiske sammensætning ifølge krav 6, hvor mindst én af de mindst to disintegranter er croscarmellosenatrium.
8. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 5 - 7, hvori de mindst to disintegranter anvender forskellige disintegrationsmekanismer.
9. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 5 - 8, hvor de mindst to disintegranter anvender disintegrationsmekanismer omfattende svulmen, porøsitet og kapillærvirkning, og deformering.
10. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, omfattende en disintegrant, der er stivelse, fortrinsvis majsstivelse.
11. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, hvor den farmaceutiske sammensætning omfatter en mængde disintegrant på 1-50%, fortrinsvis 2-30%, mere foretrukket 3-25%, fortrinsvis 5-20%, mere foretrukket 6-15%, fortrinsvis 8-12%, mere foretrukket 10% af totalmassen.
12. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, hvor den farmaceutiske sammensætning omfatter en mængde crospovidone på 1-50%, fortrinsvis 2-30%, mere foretrukket 3-25%, fortrinsvis 5-20%, mere foretrukket 6-15%, fortrinsvis 8-12%, mere foretrukket 10% af totalmassen.
13. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, hvor den farmaceutiske sammensætning omfatter en mængde stivelse på 1-50%, fortrinsvis 2-30%, mere foretrukket 3-25%, fortrinsvis 5-20%, mere foretrukket 6-15%, fortrinsvis 8-12%, mere foretrukket 10% af totalmassen.
14. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, der har et indhold af misoprostol eller et farmaceutisk acceptabelt salt deraf, valgt imellem 1 - 50, 2,5 - 50, 5 - 50,10 - 50, 20 - 30 og 25
15. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, der har en disintegrationstid på mindre end 10 minutter, fortrinsvis mindre end 5 minutter, mere foretrukket mindre end 3 minutter, fortrinsvis mindre end 2 minutter, mere foretrukket mindre end 1 minut, fortrinsvis mindre end 45 sekunder, mere foretrukket mindre end 30 sekunder, fortrinsvis mindre end 25 sekunder.
16. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, der har en disintegrationstid på mindre end 20 sekunder, fortrinsvis mindre end 15 sekunder, mere foretrukket mindre end 10 sekunder, fortrinsvis mindre end 9 sekunder, mere foretrukket mindre end 8 sekunder, fortrinsvis mindre end 7 sekunder, mere foretrukket mindre end 6 sekunder.
17. Den farmaceutiske sammensætning ifølge et hvilket som helst af de foregående krav, som tillader dispersion af en eller flere af omtalte farmaceutiske sammensætninger i 100 ml vand ved 25°C indenfor 2 minutter, fortrinsvis indenfor 1 minut, under omrøring, hvorved der tilvejebringes en dispersion; hvilken dispersion er i stand til at passere igennem en si med en nominel maskeåbning på 710 μηι.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP14176821.8A EP2965750B1 (en) | 2014-07-11 | 2014-07-11 | Misoprostol dispersible tablet |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2965750T3 true DK2965750T3 (da) | 2017-10-16 |
Family
ID=51167770
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK14176821.8T DK2965750T3 (da) | 2014-07-11 | 2014-07-11 | Misoprostol dispersible tablet |
Country Status (12)
Country | Link |
---|---|
EP (2) | EP3238715A1 (da) |
CY (1) | CY1119193T1 (da) |
DK (1) | DK2965750T3 (da) |
ES (1) | ES2645481T3 (da) |
HR (1) | HRP20171220T1 (da) |
HU (1) | HUE033619T2 (da) |
LT (1) | LT2965750T (da) |
MA (1) | MA39549B1 (da) |
PL (1) | PL2965750T3 (da) |
PT (1) | PT2965750T (da) |
RS (1) | RS56468B1 (da) |
SI (1) | SI2965750T1 (da) |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2006125450A1 (en) | 2005-05-26 | 2006-11-30 | Atef Mohammed Mostafa Darwish | Rectal and vaginal suppositories containing misoprostol |
WO2006133048A2 (en) | 2005-06-03 | 2006-12-14 | Duramed Pharmaceuticals, Inc. | Pharmaceutical compositions comprising prostanoid-receptor agonists and methods of making and using the same |
US7799530B2 (en) | 2005-09-23 | 2010-09-21 | Celera Corporation | Genetic polymorphisms associated with cardiovascular disorders and drug response, methods of detection and uses thereof |
WO2007035954A2 (en) | 2005-09-23 | 2007-03-29 | Duramed Pharmaceuticals, Inc. | Vaginal tablets comprising misoprostol and methods of making and using the same |
WO2009154810A2 (en) * | 2008-02-25 | 2009-12-23 | Dr. Reddy's Laboratories Ltd. | Delivery systems for multiple active agents |
CN102697746B (zh) * | 2012-06-11 | 2014-03-19 | 广州朗圣药业有限公司 | 一种快速融变的米索前列醇阴道用组合物及其制备方法和应用 |
MX2015001007A (es) | 2012-07-26 | 2015-04-09 | Ferring Bv | Composicion de misoprostol. |
CN102872024B (zh) * | 2012-09-28 | 2015-06-17 | 天津市聚星康华医药科技有限公司 | 口腔内使用的米索前列醇药物组合物 |
CN103340837B (zh) * | 2013-07-08 | 2018-04-27 | 天津市聚星康华医药科技有限公司 | 一种米索前列醇阴道泡腾片及其制备方法 |
-
2014
- 2014-07-11 LT LTEP14176821.8T patent/LT2965750T/lt unknown
- 2014-07-11 PT PT141768218T patent/PT2965750T/pt unknown
- 2014-07-11 SI SI201430402T patent/SI2965750T1/sl unknown
- 2014-07-11 ES ES14176821.8T patent/ES2645481T3/es active Active
- 2014-07-11 PL PL14176821T patent/PL2965750T3/pl unknown
- 2014-07-11 RS RS20170828A patent/RS56468B1/sr unknown
- 2014-07-11 DK DK14176821.8T patent/DK2965750T3/da active
- 2014-07-11 EP EP17176202.4A patent/EP3238715A1/en not_active Withdrawn
- 2014-07-11 HU HUE14176821A patent/HUE033619T2/en unknown
- 2014-07-11 EP EP14176821.8A patent/EP2965750B1/en active Active
-
2015
- 2015-07-10 MA MA39549A patent/MA39549B1/fr unknown
-
2017
- 2017-08-08 CY CY20171100848T patent/CY1119193T1/el unknown
- 2017-08-09 HR HRP20171220TT patent/HRP20171220T1/hr unknown
Also Published As
Publication number | Publication date |
---|---|
EP2965750B1 (en) | 2017-08-02 |
MA39549B1 (fr) | 2019-04-30 |
LT2965750T (lt) | 2017-09-25 |
HRP20171220T1 (hr) | 2017-11-03 |
SI2965750T1 (sl) | 2017-11-30 |
PT2965750T (pt) | 2017-10-03 |
EP2965750A1 (en) | 2016-01-13 |
EP3238715A1 (en) | 2017-11-01 |
MA39549A1 (fr) | 2017-12-29 |
HUE033619T2 (en) | 2017-12-28 |
CY1119193T1 (el) | 2018-02-14 |
ES2645481T3 (es) | 2017-12-05 |
PL2965750T3 (pl) | 2018-01-31 |
RS56468B1 (sr) | 2018-01-31 |
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