HRP20150158T1 - Äśvrsti farmaceutski dozirani oblici koji sadrže tadalafil i postupci njihove pripreme - Google Patents
Äśvrsti farmaceutski dozirani oblici koji sadrže tadalafil i postupci njihove pripreme Download PDFInfo
- Publication number
- HRP20150158T1 HRP20150158T1 HRP20150158TT HRP20150158T HRP20150158T1 HR P20150158 T1 HRP20150158 T1 HR P20150158T1 HR P20150158T T HRP20150158T T HR P20150158TT HR P20150158 T HRP20150158 T HR P20150158T HR P20150158 T1 HRP20150158 T1 HR P20150158T1
- Authority
- HR
- Croatia
- Prior art keywords
- tadalafil
- preparation
- methods
- dosage forms
- pharmaceutical dosage
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 5
- IEHKWSGCTWLXFU-IIBYNOLFSA-N tadalafil Chemical compound C1=C2OCOC2=CC([C@@H]2C3=C([C]4C=CC=CC4=N3)C[C@H]3N2C(=O)CN(C3=O)C)=C1 IEHKWSGCTWLXFU-IIBYNOLFSA-N 0.000 title claims 3
- 229960000835 tadalafil Drugs 0.000 title claims 3
- 238000002360 preparation method Methods 0.000 title claims 2
- 239000002552 dosage form Substances 0.000 title 1
- 239000007787 solid Substances 0.000 title 1
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 5
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 3
- 239000003960 organic solvent Substances 0.000 claims 3
- 239000012530 fluid Substances 0.000 claims 2
- 238000005469 granulation Methods 0.000 claims 2
- 230000003179 granulation Effects 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 229920003176 water-insoluble polymer Polymers 0.000 claims 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 239000000126 substance 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
- A61K9/14—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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (4)
1. Postupak proizvodnje farmaceutskog oblika, obuhvaća korake
a. priprema otopine tadalafila u organskom otapalu,
b. prijenos tadalafila na u vodi netopljivi polimer pomiješan s razrjeđivačem pomoću granulacije taljenjem u fluidnom sloju, gdje je etilceluloza taj u vodi netopljivi polimer,
c. miješanje granulata s jednom ili više dodatnih pomoćnih tvari.
2. Postupak prema zahtjevu 1 naznačen time što that the organic solvent is selected from the group of methanol, ethanol, isopropanol, acetone and a mixture thereof.
3. Postupak prema bilo kojem od zahtjeva 1 i 2 naznačen time što je organsko otapalo smjesa acetona i izopropanola.
4. Postupak prema bilo kojem od zahtjeva 1 do 3 naznačen time što se granulacija u fluidnom sloju provodi na temperaturi od 50-250°C.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP2010460052 | 2010-12-23 | ||
| PCT/EP2011/006544 WO2012095151A1 (en) | 2010-12-23 | 2011-12-23 | Solid pharmaceutical dosage forms comprising tadalafil and methods of preparation thereof |
| EP11813321.4A EP2654723B1 (en) | 2010-12-23 | 2011-12-23 | Solid pharmaceutical dosage forms comprising tadalafil and methods of preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20150158T1 true HRP20150158T1 (hr) | 2015-04-24 |
Family
ID=45653340
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150158TT HRP20150158T1 (hr) | 2010-12-23 | 2015-02-09 | Äśvrsti farmaceutski dozirani oblici koji sadrže tadalafil i postupci njihove pripreme |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP2654723B1 (hr) |
| HR (1) | HRP20150158T1 (hr) |
| PL (1) | PL2654723T3 (hr) |
| SI (1) | SI2654723T1 (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IN2013MU01177A (hr) * | 2013-03-28 | 2015-04-17 | Astron Res Ltd | |
| CN113577079B (zh) * | 2021-07-28 | 2022-08-23 | 山东裕欣药业有限公司 | 一种磷酸二酯酶抑制剂的制备方法及组合物 |
| CN113855639B (zh) * | 2021-11-04 | 2023-03-24 | 昆明源瑞制药有限公司 | 一种他达拉非片剂及其制备方法 |
-
2011
- 2011-12-23 SI SI201130398T patent/SI2654723T1/sl unknown
- 2011-12-23 PL PL11813321T patent/PL2654723T3/pl unknown
- 2011-12-23 EP EP11813321.4A patent/EP2654723B1/en not_active Not-in-force
-
2015
- 2015-02-09 HR HRP20150158TT patent/HRP20150158T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP2654723A1 (en) | 2013-10-30 |
| SI2654723T1 (sl) | 2015-04-30 |
| PL2654723T3 (pl) | 2015-05-29 |
| EP2654723B1 (en) | 2014-12-31 |
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