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HRP20180068T1 - Formulacije lijeka s produljenim oslobađanjem - Google Patents

Formulacije lijeka s produljenim oslobađanjem Download PDF

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Publication number
HRP20180068T1
HRP20180068T1 HRP20180068TT HRP20180068T HRP20180068T1 HR P20180068 T1 HRP20180068 T1 HR P20180068T1 HR P20180068T T HRP20180068T T HR P20180068TT HR P20180068 T HRP20180068 T HR P20180068T HR P20180068 T1 HRP20180068 T1 HR P20180068T1
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Croatia
Prior art keywords
polymeric material
polycarboxylic acid
release drug
acid polymer
drug formulation
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HRP20180068TT
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English (en)
Inventor
Roberto Carlos Bravo Gonzàles
Thomas Buser
Frédéric Jean-Claude Goutte
Abdul Waseh Basit
Felipe José Oliveira VARUM
Ana Cristina Freire
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Tillotts Pharma Ag
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Application filed by Tillotts Pharma Ag filed Critical Tillotts Pharma Ag
Publication of HRP20180068T1 publication Critical patent/HRP20180068T1/hr

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    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
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    • A61K9/00—Medicinal preparations characterised by special physical form
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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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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    • A61K31/60—Salicylic acid; Derivatives thereof
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    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
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  • Grain Derivatives (AREA)
  • General Preparation And Processing Of Foods (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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Claims (16)

1. Formulacije lijeka s produljenim oslobađanjem za oralnu primjenu za isporuku lijeka u debelo crijevo pacijenta, pri čemu spomenuta formulacija sadrži jezgro, to jezgro sadrži lijek i prevlaku za jezgru, jezgru koja sadrži lijek i ovojnicu koja sadrži vanjski i unutarnji sloj, pri čemu vanjski sloj sadrži smjesu prvog polimernog materijala koji je osjetljiv na napad bakterija debelog crijeva i drugi polimerni materijal koji ima graničnu vrijednost pH na pH 6,5 ili više, i pri čemu unutarnji sloj sadrži treći polimerni materijal koji je topiv u crijevnoj tekućini, spomenuti treći polimerni materijal je polimer polikarboksilne kiseline koji je bar djelomično neutraliziran, pri čemu bar 10% skupina karboksilne kiseline polimera polikarboksilne kiseline su u obliku aniona karboksilata.
2. Polimer polikarboksilne kiseline koji je bar djelomično neutraliziran, pri čemu bar 90 % skupina karboksilne kiseline polimera polikarboksilne kiseline su u obliku anjona karboksilata.
3. Formulacija lijeka s produljenim oslobađanjem za koju se traži zaštita patentom u patentnom zahtjevu 1 ili patentnom zahtjevu 2, pri čemu je treći polimerni materijal potpuno neutraliziran.
4. Formulacija lijeka s produljenim oslobađanjem za koju se traži zaštita patentom u bilo kojem od patentnih zahtjeva 1 do 3, pri čemu su drugi i treći polimerni materijal na bazi istog polimera polikarboksilne kiseline s trećim polimernim materijalom koji ima viši stupanj neutralizacije od drugog polimernog materijala.
5. Formulacija lijeka s produljenim oslobađanjem za koju se traži zaštita patentom u bilo kojem od prethodnih patentnih zahtjeva, pri čemu je treći polimerni materijal odabran iz polimetakrilata; celuloznog acetat ftalata (CAP); polivinil acetat ftalata (PVAP); hidroksipropil metilceluloza ftalata (HPMCP); hidroksipropil metilceluloznog acetat sukcinata (HPMC-AS); celuloznog acetat trimelitata (CAT); ksantanove gume; alginata; i šelaka.
6. Formulacija lijeka s produljenim oslobađanjem za koju se traži zaštita patentom u bilo kojem od prethodnih patentnih zahtjeva, pri čemu je treći polimerni materijal bar djelomično neutraliziran kopolimera (met)akrilne kiseline i (met)akrilna kiselina C1-4 alkil ester.
7. Formulacija lijeka s produljenim oslobađanjem za koju se traži zaštita patentom bilo kojem od prethodnih patentnih zahtjeva, pri čemu je treći polimerni materijal potpuno neutraliziran kopolimer (met)akrilne kiseline i (met)akrilne kiseline metil estera.
8. Formulacija lijeka s produljenim oslobađanjem za koju se traži zaštita patentom u bilo kojem od prethodnih patentnih zahtjeva, pri čemu unutarnji sloj sadrži puferski agens odabran iz anorganske soli ili farmaceutski prihvatljive karboksilne kiseline koja ima od 1 do 16 atoma ugljika.
9. Formulacija lijeka s produljenim oslobađanjem za koju se traži zaštita patentom u bilo kojem od prethodnih patentnih zahtjeva, pri čemu unutarnji sloj sadrži farmaceutski prihvatljivu osnovu odabranu od anorganske osnove ili fiziološki toleriranog amina.
10. Formulacija lijeka s produljenim oslobađanjem za koju se traži zaštita patentom u bilo kojem od prethodnih patentnih zahtjeva, pri čemu je treći polimerni materijal topiv u vodi neovisno od pH.
11. Postupak proizvodnje formulacije lijeka s produljenim oslobađanjem za oralnu primjenu za isporuku lijeka u debelo crijevo za koju se traži zaštita patentom u patentnom zahtjevu 1, navedeni postupak sadrži: formiranje jezgra koje sadrži lijek; oblaganje jezgre upotrebom unutarnjeg preparata za oblaganje sadrži treći polimerni materijal koji je topiv u crijevnoj tekućini, u sustavu otapala da se formira unutrašnje obložena jezgra; i oblaganje unutarnje obložene jezgre s vanjskim premaznim pripravkom sadrži prvi polimerni materijal koji je osjetljiv na napad bakterija debelog crijeva i drugi polimerni materijal koji ima pH granicu od pH 6,5 ili više u sustavu otapala, da se dobije vanjska obložena jezgra; pri čemu je spomenuti treći polimerni materijal je polimer polikarboksilne kiseline koji je barem djelimično neutraliziran, pri čemu najmanje 10% skupina karboksilne kiseline polimera polikarboksilne kiseline su u obliku aniona karboksilata.
12. Postupak za koji se traži zaštita patenta u patentnom zahtjevu 11, pri čemu je sustav otapala unutarnjeg pripravka za oblaganje vodik.
13. Postupak za koji se traži zaštita patentom u patentom zahtjevu 11 ili patentnom zahtjevu 12, spomenuti postupak sadrži disperziju polimera polikarboksilne kiseline u otapalu, izborno s puferskim sredstvom, i dodavanje baze da se barem delimično neutralizira polimer polikarboksilne kiseline da bi se formirao preparat unutarnje obloge.
14. Postupak za koji se traži zaštita patentom u patentnom zahtjevu 13, pri čemu je dodana količina baze najmanje dovoljna da neutralizira bar 90% skupina karboksilne kiseline u polimeru polikarboksilne kiseline.
15. Postupak za koji se traži zaštita patentom u patentnom zahtjevu 13, ili patentnom zahtjevu 14, pri čemu je dodana količina baze više nego dovoljna da potpuno neutralizira polimer polikarboksilne kiseline.
16. Postupak za koji se traži zaštita patentom u bilo kojem od patentnih zahtjeva 11 do 15, pri čemu je pH unutarnjeg pripravka za oblaganje podešen da bude od pH 7,5 do pH 10.
HRP20180068TT 2012-04-30 2018-01-15 Formulacije lijeka s produljenim oslobađanjem HRP20180068T1 (hr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP12166110.2A EP2659881B1 (en) 2012-04-30 2012-04-30 A delayed release drug formulation

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