HRP20201284T1 - Stabilizirana modificirana formulacija za otpuštanje vitamina d i metoda primjene iste - Google Patents
Stabilizirana modificirana formulacija za otpuštanje vitamina d i metoda primjene iste Download PDFInfo
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- HRP20201284T1 HRP20201284T1 HRP20201284TT HRP20201284T HRP20201284T1 HR P20201284 T1 HRP20201284 T1 HR P20201284T1 HR P20201284T T HRP20201284T T HR P20201284TT HR P20201284 T HRP20201284 T HR P20201284T HR P20201284 T1 HRP20201284 T1 HR P20201284T1
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- Croatia
- Prior art keywords
- preparation
- disease
- hydroxyvitamin
- dosage
- vitamin
- Prior art date
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- 238000000034 method Methods 0.000 title claims 10
- 229940046008 vitamin d Drugs 0.000 title claims 6
- 238000009472 formulation Methods 0.000 title claims 2
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 7
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims 6
- JWUBBDSIWDLEOM-UHFFFAOYSA-N 25-Hydroxycholecalciferol Natural products C1CCC2(C)C(C(CCCC(C)(C)O)C)CCC2C1=CC=C1CC(O)CCC1=C JWUBBDSIWDLEOM-UHFFFAOYSA-N 0.000 claims 6
- JWUBBDSIWDLEOM-DCHLRESJSA-N 25-Hydroxyvitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=C/C=C1\C[C@@H](O)CCC1=C JWUBBDSIWDLEOM-DCHLRESJSA-N 0.000 claims 6
- JWUBBDSIWDLEOM-NQZHSCJISA-N 25-hydroxy-3 epi cholecalciferol Chemical compound C1([C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=CC=C1C[C@H](O)CCC1=C JWUBBDSIWDLEOM-NQZHSCJISA-N 0.000 claims 6
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- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims 5
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- KJKIIUAXZGLUND-ICCVIKJNSA-N 25-hydroxyvitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](\C=C\[C@H](C)C(C)(C)O)C)=C\C=C1\C[C@@H](O)CCC1=C KJKIIUAXZGLUND-ICCVIKJNSA-N 0.000 claims 4
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Classifications
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Claims (20)
1. Pripravak kontroliranog oslobađanja spoja vitamina D za oralnu primjenu, koji se sastoji bilo od 25-hidroksivitamina D2 ili 25-hidroksivitamina D3 ili oboje, a čija formula sadrži matricu koja vezuje u oslobađanju i kontrolirano oslobađa spoj vitamin D, a koja sadrži eter celuloze pri čemu je eter celuloze prisutan u količini od najmanje 5 % pripravka, na temelju ukupne težine pripravka bez dodatnih premaza ili ovojnica (wt%).
2. Stabilizirani pripravak za kontrolirano oslobađanje spoja vitamina D za oralnu primjenu, koji se sastoji od mješavine:
25-hidroksivitamina D2 ili 25-hidroksivitamina D3 ili oboje;
voštane matrice; i
stabilizatora, koji sadrži eter celuloze pri čemu je eter celuloze prisutan u količini od najmanje 5 % pripravka, na temelju ukupne težine pripravka bez dodatnih premaza ili ovojnica (wt%).
3. Pripravak iz bilo kojeg od gore navedenih patentnih zahtjeva, koji se sastoji od mješavine:
25-hidroksivitamina D2 ili 25-hidroksivitamina D3 ili oboje;
voštane matrice; i
djelotvorne količine stabilizatora, koji sadrži eter celuloze za održavanje razlike od manje od 30 % između količine spoja vitamina D koji se oslobađa u danom trenutku nakon četiri sata tijekom in vitro testiranja otapanja dva mjeseca u uvjetima skladištenja na 25 °C i 60 % relativne vlažnosti i količine spoja koji se oslobađa u istom trenutku otapanja tijekom in vitro otapanja prije izlaganja pripravka uvjetima skladištenja.
4. Pripravak iz bilo kojeg od gore navedenih patentnih zahtjeva, koji se sastoji od:
voštane matrice s aktivnom tvari koja se sastoji bilo od 25-hidroksivitamina D2 ili 25-hidroksivitamina D3 ili oboje; i
etera celuloze kao stabilizatora;
pri čemu pripravak oslobađa količinu 25-hidroksivitamina D tijekom in vitro otapanja nakon dva mjeseca skladištenja na 25 °C i 60 % relativne vlažnosti koja se razlikuje u bilo kojem danom trenutku otapanja u usporedbi s količinom oslobođenom u
istom trenutku otapanja tijekom in vitro otapanja prije izlaganja pripravka uvjetima skladištenja za 30 % ili manje bez celuloze kao stabilizatora.
5. Pripravak prema bilo kojem od gore navedenih patentnih zahtjeva, pri čemu se eter celuloze sastoji od:
a) etera celuloze odabranog iz skupine koja se sastoji od metilceluloze, hidroksipropil-metilceluloze, hidroksietil-metilceluloze, hidroksietil-celuloze i hidroksipropil-celuloze; ili
b) hidroksipropil-metilceluloze.
6. Pripravak prema bilo kojem od gore navedenih patentnih zahtjeva, pri čemu se matrica sastoji od voštane matrice koja sadrži tvar za kontrolirano oslobađanje, emulzifikator i pojačivač apsorpcije.
7. Pripravak prema patentnom zahtjevu 6., pri čemu:
a) tvar za kontrolirano oslobađanje sadrži parafin; i/ili
b) HLB vrijednost emulzifikatora manja je od 7, pri čemu emulzifikator može sadržavati glicerol-monostearat; i/ili
c) pojačivač apsorpcije ima HLB vrijednost u rasponu od 13 do oko 18, pri čemu pojačivač apsorpcije može biti mješavina lauroil-makrogolglicerida i lauoril-polioksiglicerida.
8. Pripravak prema bilo kojem od patentnih zahtjeva 6. – 7., koji dodatno sadrži:
a) uljnu podlogu; ili
b) mineralno ulje.
9. Pripravak prema patentnom zahtjevu 8., pri čemu se pripravak sastoji od oko 20 wt% parafina, oko 20 wt% do oko 25 wt% glicerol-monostearata, oko 10 wt% mješavine lauoril-makrogolglicerida i lauroil-polioksiglicerida, oko 30 wt% do oko 35 wt% mineralnog ulja i oko 10 wt% do oko 15 wt% hidroksipropil-metilceluloze.
10. Pripravak prema bilo kojem od patentnih zahtjeva 6. – 9., pri čemu se pripravak sastoji od:
a) glicerol-monostearata; i/ili
b) jednog ili više poliglikoliziranih glicerida.
11. Doziranje produženog oslobađanja u obliku oralne kapsule, tablete, vrećice ili dražeje, koja sadrži pripravak prema bilo kojem od gore navedenih patentnih zahtjeva.
12. Pripravak ili stabilizirano doziranje produženog oslobađanja prema bilo kojem od patentnih zahtjeva 1. – 11. za primjenu metodom liječenja koja se sastoji od:
a) nadomještanja vitamina D u bolesnika; ili
b) liječenja ili sprječavanja bolesti odgovora na vitamin D u bolesnika.
13. Pripravak ili doziranje za primjenu u metodi liječenja prema patentnom zahtjevu 12., pri čemu je bolest jedna od idućih: rak (npr. dojke, pluća, kože, melanom, crijeva, debelog crijeva, rektuma, prostate i kosti), autoimuna bolest, npr. dijabetes tipa I, multipla skleroza, reumatoidni artritis, polimiozitis, dermatomiozitis, sklerodermija, fibroza, Gravesova bolest, Hashimotova bolest, akutno ili kronično odbacivanje transplantiranog organa, akutna ili kronična reakcija transplantata protiv primatelja, upalna bolest crijeva, Crohnova bolest, sistemski eritemski lupus, Sjögrenov sindrom, ekcem i psorijaza, dermatitis, uključujući atopijski dermatitis, kontaktni dermatitis, alergijski dermatitis i/ili kronični dermatitis, upalne bolesti, npr. astma, kronična opstruktivna bolest pluća, policistična bolest bubrega, sindrom policističnih jajnika, pankreatitis, nefritis, hepatitis, i/ili infekcija, hipertenzija, kardiovaskularne bolesti, npr. subjekti s aterosklerozom, arteriosklerozom, bolešću koronarne arterije, cerebrovaskularnom bolešću, perifernom vaskularnom bolešću, miokardijalnim infarktom, miokardijalnom ishemijom, cerebralnom ishemijom, moždanim udarom, kongestivnim zatajenjem srca, kardiomiopatijom, gojaznost ili drugi poremećaji tjelesne težine, poremećaji lipida (npr. hiperlipidemija, dislipidemija, uključujući povezanu dijabetičku dislipidemiju i mješovitu dislipidemiju hipoalfalipoproteinemiju, hipertrigliceridemiju, hiperkolesterolemiju i nizak HDL (lipoprotein visoke gustoće)), metabolički poremećaji (npr. metabolički sindrom, dijabetes mellitus tipa II, dijabetes mellitus tipa I, hiperinzulinemija, smanjena podnošljivost glukoze, inzulinska rezistencija, dijabetička komplikacija, uključujući neuropatiju, nefropatiju, osteoporozu, retinopatiju, dijabetičko stopalo i katarakte) i/ili tromboza.
14. Pripravak ili doziranje za primjenu u metodi liječenja iz patentnog zahtjeva 12., pri čemu je bolest jedna od bolesti (i) doštitne žlijezde: hipoparatiroidizam, pseudohipo-paratiroidizam, sekundarni hiperparatiroidizam; (ii) gušterače: dijabetes; (iii) štitnjače: medularni karcinom; (iv) kože: psorijaza; zacjeljivanje rana; (v) pluća: sarkoidoza i tuberkuloza; (vi) bubrega: kronična bolest bubrega, hipofosfatemični rahitis, vitamin D-rezistentni rahitis; (vii) kosti: liječenje antikonvulzivima, fibrogenesis imperfecta ossium, osteitis fibrosa cystica, osteomalacija, osteoporoza, osteopenija, osteoskleroza, bubrežna osteodistrofija, rahitis; (viii) crijeva: glukokortikoidni antagonizam, idiopatska hiperkalcemija, malapsorpcijski sindrom, steatoreja, tropska sprue; i (ix) autoimune bolesti.
15. Pripravak ili doziranje za primjenu u metodi liječenja iz patentnog zahtjeva 12., pri čemu je bolest:
a) jedna od idućih: rak, dermatološki poremećaji (npr. psorijaza), poremećaji doštitne žlijezde (npr. hiperparatiroidizam i sekundarni hiperparatiroidizam), koštani poremećaji (npr. osteoporoza) i autoimune bolesti; ili
b) sekundarni hiperparatiroidizam.
16. Pripravak ili doziranje za primjenu u metodi liječenja bilo kojeg od patentnih zahtjeva 12. – 15., pri čemu bolesnik:
a) ima kroničnu bubrežnu bolest (KBB); ili
b) ima kroničnu bubrežnu bolest 3. ili 4. stadija; ili
c) ima kroničnu bubrežnu bolest 3. ili 4. stadija i nedostatak vitamina D.
17. Pripravak ili doziranje za primjenu u metodi liječenja bilo kojeg od patentnih zahtjeva 12. – 16., pri čemu je bolesnik:
a) ljudsko biće; ili
b) odraslo ljudsko biće.
18. Pripravak ili doziranje za primjenu u metodi liječenja prema patentnom zahtjevu 17.b), pri čemu se pripravak ili doziranje daje odraslom bolesniku koji boluje od sekundarnog hiperparatiroidizma zbog kronične bubrežne bolesti 3. ili 4. stadija.
19. Pripravak ili doziranje za primjenu u metodi liječenja prema patentnom zahtjevu 18., pri čemu pripravak omogućuje 25-hidroksivitamin D3 u oralnom pripravku s kontroliranim oslobađanjem koji sadrži matricu koja vezuje u oslobađanju i kontrolirano oslobađa 25-hidroksivitamin D3, a matrica sadrži eter celuloze, pri čemu je eter celuloze prisutan u količini od najmanje 5 wt% pripravka.
20. Pripravak ili doziranje za primjenu u metodi liječenja prema patentnom zahtjevu 18. ili 19., pri čemu bolesnik pati od nedostatka vitamina D i ima razine seruma 25-hidroksivitamina D niže od 30 ng/mL.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201361801896P | 2013-03-15 | 2013-03-15 | |
EP14717038.5A EP2968172B8 (en) | 2013-03-15 | 2014-03-14 | Stabilized modified release vitamin d formulation and method of administring same |
PCT/US2014/028132 WO2014143941A1 (en) | 2013-03-15 | 2014-03-14 | Stabilized modified release vitamin d formulation and method of administring same |
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HRP20201284T1 true HRP20201284T1 (hr) | 2020-12-11 |
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HRP20201284TT HRP20201284T1 (hr) | 2013-03-15 | 2020-08-17 | Stabilizirana modificirana formulacija za otpuštanje vitamina d i metoda primjene iste |
HRP20201869TT HRP20201869T1 (hr) | 2013-03-15 | 2020-11-25 | Stabilizirana formulacija vitamina d s modificiranim otpuštanjem i postupak njene primjene |
HRP20211265TT HRP20211265T1 (hr) | 2013-03-15 | 2021-08-05 | Stabilizirana formulacija s prilagođenim oslobađanjem vitamina d i način primjene |
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HRP20201869TT HRP20201869T1 (hr) | 2013-03-15 | 2020-11-25 | Stabilizirana formulacija vitamina d s modificiranim otpuštanjem i postupak njene primjene |
HRP20211265TT HRP20211265T1 (hr) | 2013-03-15 | 2021-08-05 | Stabilizirana formulacija s prilagođenim oslobađanjem vitamina d i način primjene |
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US (6) | US9861644B2 (hr) |
EP (4) | EP2968172B8 (hr) |
JP (4) | JP6492051B2 (hr) |
KR (4) | KR101847947B1 (hr) |
CN (2) | CN111346071A (hr) |
AR (1) | AR095576A1 (hr) |
AU (2) | AU2014228069B2 (hr) |
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