HRP20210969T1 - Farmaceutski sastav koji sadrži darunavir i metoda za njegovu pripremu - Google Patents
Farmaceutski sastav koji sadrži darunavir i metoda za njegovu pripremu Download PDFInfo
- Publication number
- HRP20210969T1 HRP20210969T1 HRP20210969TT HRP20210969T HRP20210969T1 HR P20210969 T1 HRP20210969 T1 HR P20210969T1 HR P20210969T T HRP20210969T T HR P20210969TT HR P20210969 T HRP20210969 T HR P20210969T HR P20210969 T1 HRP20210969 T1 HR P20210969T1
- Authority
- HR
- Croatia
- Prior art keywords
- spray
- mixture
- dried
- weight
- immediate
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 5
- CJBJHOAVZSMMDJ-HEXNFIEUSA-N darunavir Chemical compound C([C@@H]([C@H](O)CN(CC(C)C)S(=O)(=O)C=1C=CC(N)=CC=1)NC(=O)O[C@@H]1[C@@H]2CCO[C@@H]2OC1)C1=CC=CC=C1 CJBJHOAVZSMMDJ-HEXNFIEUSA-N 0.000 title claims 4
- 229960005107 darunavir Drugs 0.000 title claims 4
- 238000002360 preparation method Methods 0.000 title claims 2
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 claims 10
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 6
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 5
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 5
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 5
- 239000008101 lactose Substances 0.000 claims 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims 5
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 4
- 229940069328 povidone Drugs 0.000 claims 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 239000011363 dried mixture Substances 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 238000002156 mixing Methods 0.000 claims 3
- QGVQOXWNOSEKGM-UHFFFAOYSA-N 2-hydroxyacetic acid;prop-1-ene Chemical compound CC=C.OCC(O)=O QGVQOXWNOSEKGM-UHFFFAOYSA-N 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical group O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 239000007888 film coating Substances 0.000 claims 1
- 238000009501 film coating Methods 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Virology (AREA)
- Biophysics (AREA)
- AIDS & HIV (AREA)
- Tropical Medicine & Parasitology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (9)
1. Tableta darunavir propilen glikolata s trenutnim oslobađanjem koja sadrži učinkovitu količinu smjese laktoze, mikrokristalne celuloze i povidona sušene raspršivanjem u količini od 1% do 5% masenog udjela sastava.
2. Tableta s trenutnim oslobađanjem prema zahtjevu 1, naznačena time što se smjesa sušena raspršivanjem sastoji od 75% masenog udjela laktoze i 25% masenog udjela mikrokristalne celuloze.
3. Tableta s trenutnim oslobađanjem prema zahtjevu 1, naznačena time što je smjesa sušena raspršivanjem količina od 10% do 20% masenog udjela ukupne mase sastava.
4. Tableta s trenutnim oslobađanjem prema zahtjevu 1, naznačena time što nadalje sadrži sredstvo za dezintegraciju u količini od 5% do 15% masenog udjela ukupne mase sastava.
5. Tableta s trenutnim oslobađanjem prema zahtjevima 3 i 4, naznačena time što nadalje sadrži klizno sredstvo i mazivo.
6. Tableta s trenutnim oslobađanjem prema zahtjevu 5, naznačena time što je sredstvo za dezintegraciju Crospovidone, a sredstvo za klizanje je koloidni silicij dioksid i mazivo je magnezijev stearat.
7. Postupak za pripravu tablete s trenutnim oslobađanjem s Darunavir propilen glikolatom kao aktivnim sastojkom i učinkovitom količinom smjese laktoze i mikrokristalne celuloze i povidona sušene raspršivanjem u količini od 1% do 5% masenog udjela ukupne mase sastava, pri čemu navedeni postupak obuhvaća korake:
- miješanja Darunavir propilen glikolata sa smjesom laktoze i mikrokristalne celuloze sušene raspršivanjem, sredstvom za klizanje i sredstvom za dezintegraciju;
- otapanja povidona u vodi;
- miješenja otopinom povidona smjese prvog stupnja i zatim sušenje na 40°C;
- dodavanja maziva i miješanja tijekom 3 minute;
- kompresije granula u tablete i po želji nanošenje filmskog premaza.
8. Postupak prema zahtjevu 7, naznačen time što se smjesa sušena raspršivanjem sastoji od 75% masenog udjela laktoze i 25% masenog udjela mikrokristalne celuloze.
9. Postupak prema zahtjevu 7, naznačen time što je smjesa sušena raspršivanjem u količini od 10% do 20% masenog udjela ukupne mase sastava.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GR20150100526A GR1008965B (el) | 2015-12-02 | 2015-12-02 | Φαρμακευτικο σκευασμα που περιλαμβανει δαρουναβιρη και μεθοδος παρασκευης αυτου |
| PCT/EP2016/025158 WO2017092874A1 (en) | 2015-12-02 | 2016-11-30 | Pharmaceutical composition comprising darunavir and method for the preparation thereof |
| EP16808570.2A EP3383402B1 (en) | 2015-12-02 | 2016-11-30 | Pharmaceutical composition comprising darunavir and method for the preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210969T1 true HRP20210969T1 (hr) | 2021-09-17 |
Family
ID=57517848
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210969TT HRP20210969T1 (hr) | 2015-12-02 | 2021-06-18 | Farmaceutski sastav koji sadrži darunavir i metoda za njegovu pripremu |
Country Status (13)
| Country | Link |
|---|---|
| EP (1) | EP3383402B1 (hr) |
| CY (1) | CY1124253T1 (hr) |
| DK (1) | DK3383402T3 (hr) |
| ES (1) | ES2875405T3 (hr) |
| GR (1) | GR1008965B (hr) |
| HR (1) | HRP20210969T1 (hr) |
| HU (1) | HUE054502T2 (hr) |
| LT (1) | LT3383402T (hr) |
| PL (1) | PL3383402T3 (hr) |
| PT (1) | PT3383402T (hr) |
| RS (1) | RS61955B1 (hr) |
| SI (1) | SI3383402T1 (hr) |
| WO (1) | WO2017092874A1 (hr) |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI1632232T1 (sl) * | 2004-09-02 | 2011-09-30 | Janssen Pharmaceutica Nv | Sol 4((4((4-(2-cianoetenil)-2,6-dimetilfenil)amino)-2-pirimidinil)amino) benzonitrila |
| GB201118182D0 (en) * | 2011-10-21 | 2011-12-07 | Jagotec Ag | Improvements in or relating to organic compounds |
| US9643976B2 (en) * | 2012-01-18 | 2017-05-09 | Aurobindo Pharma Ltd. | Solvates of darunavir |
-
2015
- 2015-12-02 GR GR20150100526A patent/GR1008965B/el active IP Right Grant
-
2016
- 2016-11-30 SI SI201631226T patent/SI3383402T1/sl unknown
- 2016-11-30 PL PL16808570T patent/PL3383402T3/pl unknown
- 2016-11-30 DK DK16808570.2T patent/DK3383402T3/da active
- 2016-11-30 LT LTEP16808570.2T patent/LT3383402T/lt unknown
- 2016-11-30 HU HUE16808570A patent/HUE054502T2/hu unknown
- 2016-11-30 WO PCT/EP2016/025158 patent/WO2017092874A1/en active Application Filing
- 2016-11-30 RS RS20210721A patent/RS61955B1/sr unknown
- 2016-11-30 PT PT168085702T patent/PT3383402T/pt unknown
- 2016-11-30 ES ES16808570T patent/ES2875405T3/es active Active
- 2016-11-30 EP EP16808570.2A patent/EP3383402B1/en active Active
-
2021
- 2021-06-18 HR HRP20210969TT patent/HRP20210969T1/hr unknown
- 2021-06-23 CY CY20211100557T patent/CY1124253T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| GR1008965B (el) | 2017-02-28 |
| DK3383402T3 (da) | 2021-06-28 |
| LT3383402T (lt) | 2021-06-25 |
| ES2875405T3 (es) | 2021-11-10 |
| PT3383402T (pt) | 2021-06-04 |
| WO2017092874A1 (en) | 2017-06-08 |
| HUE054502T2 (hu) | 2021-09-28 |
| CY1124253T1 (el) | 2022-07-22 |
| EP3383402B1 (en) | 2021-03-24 |
| PL3383402T3 (pl) | 2021-10-18 |
| SI3383402T1 (sl) | 2021-08-31 |
| EP3383402A1 (en) | 2018-10-10 |
| RS61955B1 (sr) | 2021-07-30 |
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