HRP20211759T1 - Topikalna kompozicija koja sadrži kalcipotriol i betametazon dipropionat - Google Patents
Topikalna kompozicija koja sadrži kalcipotriol i betametazon dipropionat Download PDFInfo
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- HRP20211759T1 HRP20211759T1 HRP20211759TT HRP20211759T HRP20211759T1 HR P20211759 T1 HRP20211759 T1 HR P20211759T1 HR P20211759T T HRP20211759T T HR P20211759TT HR P20211759 T HRP20211759 T HR P20211759T HR P20211759 T1 HRP20211759 T1 HR P20211759T1
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- 239000000203 mixture Substances 0.000 title claims 24
- LWQQLNNNIPYSNX-UROSTWAQSA-N calcipotriol Chemical compound C1([C@H](O)/C=C/[C@@H](C)[C@@H]2[C@]3(CCCC(/[C@@H]3CC2)=C\C=C\2C([C@@H](O)C[C@H](O)C/2)=C)C)CC1 LWQQLNNNIPYSNX-UROSTWAQSA-N 0.000 title claims 6
- 229960002882 calcipotriol Drugs 0.000 title claims 6
- 229960001102 betamethasone dipropionate Drugs 0.000 title claims 5
- CIWBQSYVNNPZIQ-XYWKZLDCSA-N betamethasone dipropionate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O CIWBQSYVNNPZIQ-XYWKZLDCSA-N 0.000 title claims 5
- 230000000699 topical effect Effects 0.000 title claims 3
- 239000012071 phase Substances 0.000 claims 18
- 239000003921 oil Substances 0.000 claims 13
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims 12
- 239000006185 dispersion Substances 0.000 claims 10
- 239000004255 Butylated hydroxyanisole Substances 0.000 claims 6
- 229940087168 alpha tocopherol Drugs 0.000 claims 6
- 235000019282 butylated hydroxyanisole Nutrition 0.000 claims 6
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims 6
- 229940043253 butylated hydroxyanisole Drugs 0.000 claims 6
- 229960000984 tocofersolan Drugs 0.000 claims 6
- 239000002076 α-tocopherol Substances 0.000 claims 6
- 235000004835 α-tocopherol Nutrition 0.000 claims 6
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 239000002480 mineral oil Substances 0.000 claims 3
- 235000010446 mineral oil Nutrition 0.000 claims 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 2
- 239000008346 aqueous phase Substances 0.000 claims 2
- 229940057917 medium chain triglycerides Drugs 0.000 claims 2
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims 2
- 150000003626 triacylglycerols Chemical class 0.000 claims 2
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 229960002537 betamethasone Drugs 0.000 claims 1
- UREBDLICKHMUKA-DVTGEIKXSA-N betamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-DVTGEIKXSA-N 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
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
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
-
- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- 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
- A61K31/075—Ethers or acetals
- A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
- 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
- A61K31/573—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 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Dispersion Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (14)
1. Kompozicija za topikalnu primjenu koja sadrži disperziju poliafrona, pri čemu disperzija poliafrona sadrži kontinuiranu vodenu fazu i najmanje jednu diskontinuiranu uljanu fazu,
pri čemu disperzija poliafrona sadrži kalcipotriol, betametazon dipropionat, alfa-tokoferol i butilirani hidroksianizol, i
pri čemu kompozicija ima pH 7.75 ± 0.5.
2. Kompozicija prema zahtjevu 1, naznačena time što kompozicija ima pH 7.75 ± 0.25.
3. Kompozicija prema zahtjevu 1, naznačena time što kompozicija, prema težini kompozicije, sadrži:
od 0.001 do 0.01 tež.% kalcipotriola; i/ili
od 0.02 do 0.1 tež.% betametazona; i/ili
od 0.001 do 0.005 tež.% alfa-tokoferola; i/ili
od 0.05 do 0.5 tež.% butiliranog hidroksianizola.
4. Kompozicija prema bilo kojem od prethodnih zahtjeva, naznačena time, što:
kalcipotriol se pretežno nalazi u najmanje jednoj od navedenih diskontinuiranih uljanih faza; i/ili
betametazon dipropionat se pretežno nalazi u najmanje jednoj od navedenih diskontinuiranih uljanih faza; i/ili
alfa-tokoferol se pretežno nalazi u najmanje jednoj od navedenih diskontinuiranih uljanih faza; i/ili
butilirani hidroksianizol je pretežno u najmanje jednoj od navedenih diskontinuiranih uljanih faza.
5. Kompozicija prema bilo kojem od prethodnih zahtjeva, naznačena time što najmanje jedna od navedenih diskontinuiranih uljanih faza sadrži trigliceride srednjeg lanca i izopropil miristat, pri čemu su izopropil miristat i trigliceridi srednjeg lanca prisutni u težinskom odnosu od 3: 1 do 12: 1.
6. Kompozicija prema bilo kojem od prethodnih zahtjeva, naznačena time što disperzija poliafrona dalje sadrži diskontinuiranu fazu koja sadrži ulje koje nije otopina, poželjno gdje je ulje koje nije otopina mineralno ulje.
7. Kompozicija prema bilo kojem od prethodnih zahtjeva, naznačena time što navedena diskontinuirana uljana faza (faze) sadrži prvu diskontinuiranu fazu, drugu diskontinuiranu fazu i, po izboru, treću diskontinuiranu fazu koja sadrži mineralno ulje,
pri čemu je kalcipotriol pretežno u prvoj diskontinuiranoj fazi,
pri čemu je betametazon dipropionat pretežno u drugoj diskontinuiranoj fazi, i
pri čemu su alfa-tokoferol i butilirani hidroksianizol pretežno u prvoj diskontinuiranoj fazi, ili pretežno u prvoj i drugoj diskontinuiranoj fazi zajedno.
8. Kompozicija prema zahtjevu 7, naznačena time što svaka prva diskontinuirana faza i druga diskontinuirana faza sadrže isto farmaceutski prihvatljivo ulje,
gdje je farmaceutski prihvatljivo ulje mješavina kaprilnih kaprinskih triglicerida (CCT) i izopropil miristata, i
pri čemu su izopropil miristat i kaprilni kaprinski trigliceridi su prisutni u težinskom odnosu od 3: 1 do 12: 1.
9. Kompozicija prema bilo kojem od prethodnih zahtjeva, naznačena time što kontinuirana vodena faza sadrži najmanje 4 tež.% izopropanola po težini kompozicije.
10. Kompozicija prema bilo kojem od prethodnih zahtjeva, naznačena time što je kompozicija kemijski stabilna najmanje 6 mjeseci na 25°C ± 2°C, mjereno pri 60% RH ± 5%; i/ili
pri čemu je kompozicija kemijski stabilna najmanje 12 mjeseci na 5°C ± 3°C, mjereno pri 60% relativne vlažnosti ± 5%.
11. Kompozicija prema bilo kojem od prethodnih zahtjeva za uporabu u postupku liječenja ljudskog ili životinjskog tijela terapijom.
12. Kompozicija prema bilo kojem od zahtjeva 1 do 10 za uporabu u liječenju psorijaze.
13. Postupak proizvodnje kompozicije za topikalnu primjenu prema zahtjevu 1, naznačen time što postupak obuhvaća:
(a) pripremanje prve poliafronske disperzije koja sadrži kalcipotriol, alfa-tokoferol i butilirani hidroksianizol;
(b) pripremanje druge poliafronske disperzije koja sadrži betametazon dipropionat i poželjno dalje sadrži alfa-tokoferol i butilirani hidroksianizol; i
miješanje prve i druge poliafronske disperzije da bi se formirala kompozicija.
14. Postupak prema zahtjevu 13, koji dalje sadrži:
pripremanje treće disperzije poliafrona koja sadrži ulje koje nije otopina, poželjno gdje je ulje koje nije otopina mineralno ulje; i
miješanje treće disperzije poliafrona sa prvom i drugom disperzijom poliafrona da bi se dobila kompozicija.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP18162664.9A EP3542788A1 (en) | 2018-03-19 | 2018-03-19 | Topical composition comprising calcipotriol and betamethasone dipropionate |
EP19709992.2A EP3768241B1 (en) | 2018-03-19 | 2019-03-18 | Topical composition comprising calcipotriol and betamethasone dipropionate |
PCT/EP2019/056735 WO2019179958A1 (en) | 2018-03-19 | 2019-03-18 | Topical composition |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20211759T1 true HRP20211759T1 (hr) | 2022-02-18 |
Family
ID=61691823
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20211759TT HRP20211759T1 (hr) | 2018-03-19 | 2019-03-18 | Topikalna kompozicija koja sadrži kalcipotriol i betametazon dipropionat |
Country Status (23)
Country | Link |
---|---|
US (2) | US11696919B2 (hr) |
EP (3) | EP3542788A1 (hr) |
JP (2) | JP7506603B2 (hr) |
KR (2) | KR20230172042A (hr) |
CN (2) | CN113499343B (hr) |
AU (1) | AU2019239544B2 (hr) |
BR (1) | BR112020019075A2 (hr) |
CA (1) | CA3093999A1 (hr) |
CY (1) | CY1124719T1 (hr) |
DK (1) | DK3768241T3 (hr) |
ES (1) | ES2896931T3 (hr) |
HR (1) | HRP20211759T1 (hr) |
HU (1) | HUE056223T2 (hr) |
IL (1) | IL277213B1 (hr) |
LT (1) | LT3768241T (hr) |
MX (1) | MX2020009764A (hr) |
PH (1) | PH12020551467A1 (hr) |
PL (1) | PL3768241T3 (hr) |
PT (1) | PT3768241T (hr) |
RS (1) | RS62492B1 (hr) |
SG (1) | SG11202008698QA (hr) |
SI (1) | SI3768241T1 (hr) |
WO (1) | WO2019179958A1 (hr) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB201701583D0 (en) | 2017-01-31 | 2017-03-15 | Drug Delivery Solutions Ltd | Topical composition |
CN113092601B (zh) * | 2021-03-02 | 2022-12-20 | 苏州市药品检验检测研究中心 | 一种化妆品中倍他米松17-丙酸酯及倍他米松21-丙酸酯的检测方法 |
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- 2019-03-18 BR BR112020019075-6A patent/BR112020019075A2/pt unknown
- 2019-03-18 SI SI201930129T patent/SI3768241T1/sl unknown
- 2019-03-18 WO PCT/EP2019/056735 patent/WO2019179958A1/en unknown
- 2019-03-18 DK DK19709992.2T patent/DK3768241T3/da active
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- 2019-03-18 CN CN201980019695.9A patent/CN111867563A/zh active Pending
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