HRP20201315T1 - Pripravak koji sadrži hidrokortizon - Google Patents

Pripravak koji sadrži hidrokortizon Download PDF

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Publication number
HRP20201315T1
HRP20201315T1 HRP20201315TT HRP20201315T HRP20201315T1 HR P20201315 T1 HRP20201315 T1 HR P20201315T1 HR P20201315T T HRP20201315T T HR P20201315TT HR P20201315 T HRP20201315 T HR P20201315T HR P20201315 T1 HRP20201315 T1 HR P20201315T1
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HR
Croatia
Prior art keywords
preparation
amount
hydroxypropylmethylcellulose
hydrocortisone
sealing layer
Prior art date
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HRP20201315TT
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English (en)
Inventor
Hiep Huatan
Richard Ross
Martin Whitaker
Norbert Poellinger
Annette Grave
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Diurnal Limited
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Publication of HRP20201315T1 publication Critical patent/HRP20201315T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • A61K31/573Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5015Organic compounds, e.g. fats, sugars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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 with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/38Drugs for disorders of the endocrine system of the suprarenal hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/38Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/44Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (14)

1. Farmaceutski pripravak prilagođen za oralnu primjenu, naznačen time što sadrži: i) nosač, koji se uglavnom sastoji od čestica mikrokristalne celuloze u količini od 80-81% tež./tež. pripravka, gdje su navedene čestice promjera 350-500 µm; ii) sloj lijeka, koji se uglavnom sastoji od djelotvorne količine hidrokortizona u količini od 0,64-0,66% tež./tež. pripravka i hidroksipropilmetilceluloze u količini od 0,64-0,66% tež./tež. pripravka koji sadrži nosač; iii) brtveni sloj, koji se uglavnom sastoji od hidroksipropilmetilceluloze u količini od 14-16% tež./tež. pripravka i magnezijevog stearata u količini od 1,0-2,0% tež./tež. pripravka koji sadrži navedeni sloj lijeka; i iv) sloj za prikrivanje okusa, koji se uglavnom sastoji od hidroksipropilmetilceluloze u količini od 0,14-0,16% tež./tež. pripravka, etilceluloze u količini od 0,58-0,62% tež./tež. pripravka i magnezijevog stearata u količini od 0,20-0,25% tež./tež. pripravka koji sadrži navedeni brtveni sloj.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što se navedena djelotvorna količina hidrokortizona kreće između otprilike 0,25 mg i 30 mg hidrokortizona po jedinici doze.
3. Pripravak u skladu s patentnim zahtjevom 2, naznačen time što je navedena djelotvorna količina hidrokortizona otprilike 0,25 mg, 0,50 mg, 1,00 mg, 2,00 mg, 5,00 mg, 10,00 mg, 20,00 mg ili 30,00 mg hidrokortizona po jedinici doze.
4. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što navedeni nosač sadrži čestice mikrokristalne celuloze, gdje se promjer navedenih čestica bira iz skupine koju čine: 350 µm, 375 µm, 400 µm, 425 µm, 450 µm, 475 µm i 500 µm.
5. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što brtveni sloj čini 15% tež./tež. ili 16% tež./tež. pripravka.
6. Pripravak u skladu s patentnim zahtjevom 5, naznačen time što brtveni sloj čini otprilike 15% tež./tež. pripravka.
7. Pripravak u skladu s patentnim zahtjevom 5, naznačen time što navedeni brtveni sloj sadrži otprilike 15% tež./tež. hidroksipropilmetilceluloze i otprilike 1,5% tež./tež. magnezijevog stearata u pripravku.
8. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što sadrži: i) nosač, koji se uglavnom sastoji od čestica mikrokristalne celuloze u količini od 80% tež./tež. pripravka, gdje su navedene čestice promjera od 350-500 µm; ii) sloj lijeka, koji se uglavnom sastoji od hidrokortizona u količini od 0,64% tež./tež. pripravka i hidroksipropilmetilceluloze u količini od 0,64% tež./tež. pripravka koji sadrži navedeni nosač; iii) brtveni sloj, koji se uglavnom sastoji od hidroksipropilmetilceluloze u količini od 14% tež./tež. pripravka i magnezijevog stearata u količini od 1,0% tež./tež. pripravka koji sadrži navedeni sloj lijeka; i iv) sloj za prikrivanje okusa, koji se uglavnom sastoji od hidroksipropilmetilceluloze u količini od 0,14% tež./tež. pripravka, etilceluloze u količini od 0,58% tež./tež. pripravka i magnezijevog stearata u količini od 0,20% tež./tež. pripravka koji sadrži navedeni brtveni sloj.
9. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što navedeni pripravak sadrži: i) nosač, koji se sastoji od čestica mikrokristalne celuloze u količini od 81% tež./tež. pripravka; ii) sloj lijeka, koji se sastoji od hidrokortizona u količini od 0,66% tež./tež. pripravka i hidroksipropilmetilceluloze u količini od 0,66% tež./tež. pripravka koji sadrži navedeni nosač; iii) brtveni sloj, koji se sastoji od hidroksipropilmetilceluloze u količini od 15% tež./tež. pripravka i magnezijevog stearata u količini od 1,5% tež./tež. pripravka koji sadrži navedeni sloj lijeka; i iv) sloj za prikrivanje okusa, koji se sastoji od hidroksipropilmetilceluloze u količini od 0,15% tež./tež. pripravka, etilceluloze u količini od 0,61% tež./tež. pripravka i magnezijevog stearata u količini od 0,23% tež./tež. pripravka koji sadrži navedeni brtveni sloj.
10. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što je namijenjen upotrebi u liječenju insuficijencije nadbubrežne žlijezde kod subjekta.
11. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 10, naznačen time što je insuficijencija nadbubrežne žlijezde uzrokovana stanjem kojeg se bira iz skupine koju čine: primarno ili sekundarno ili tercijarno zatajenje nadbubrežne žlijezde, prirođena hiperplazija nadbubrežne žlijezde, prirođena hiperplazija nadbubrežne žlijezde s kasnim početkom, zatajenje policističnih jajnika, aldosteronizam kojeg se može liječiti glukokortikoidima (GRA).
12. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 11, naznačen time što je insuficijencija nadbubrežne žlijezde uzrokovana prirođenom hiperplazijom nadbubrežne žlijezde.
13. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 10 do 12, naznačen time što je subjekt pedijatrijski pacijent.
14. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što je namijenjen upotrebi u kontrola insuficijencije nadbubrežne žlijezde kod pedijatrijskog subjekta koja se sastoji u primjeni djelotvorne količine pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 9 na subjektu kojem je potrebno liječenje insuficijencije nadbubrežne žlijezde najmanje jednom dnevno.
HRP20201315TT 2013-05-17 2020-08-24 Pripravak koji sadrži hidrokortizon HRP20201315T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1308933.9A GB201308933D0 (en) 2013-05-17 2013-05-17 Paediatric composition
EP14727028.4A EP2978414B1 (en) 2013-05-17 2014-05-12 Composition comprising hydrocortisone
PCT/GB2014/051442 WO2014184525A1 (en) 2013-05-17 2014-05-12 Composition comprising hydrocortisone

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HRP20201315T1 true HRP20201315T1 (hr) 2020-11-27

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HRP20201315TT HRP20201315T1 (hr) 2013-05-17 2020-08-24 Pripravak koji sadrži hidrokortizon

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US (1) US9649280B2 (hr)
EP (1) EP2978414B1 (hr)
JP (1) JP6371379B2 (hr)
KR (1) KR102219919B1 (hr)
CN (1) CN105120848B (hr)
AU (1) AU2014267041B2 (hr)
BR (1) BR112015028025B1 (hr)
CA (1) CA2909060C (hr)
CY (1) CY1123284T1 (hr)
DK (1) DK2978414T3 (hr)
ES (1) ES2813382T3 (hr)
GB (2) GB201308933D0 (hr)
HK (1) HK1214131A1 (hr)
HR (1) HRP20201315T1 (hr)
HU (1) HUE050917T2 (hr)
IL (1) IL242275B (hr)
LT (1) LT2978414T (hr)
MX (1) MX2015015759A (hr)
PL (1) PL2978414T3 (hr)
PT (1) PT2978414T (hr)
RS (1) RS60734B1 (hr)
RU (1) RU2664678C2 (hr)
SI (1) SI2978414T1 (hr)
WO (1) WO2014184525A1 (hr)
ZA (1) ZA201507210B (hr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201119985D0 (en) 2011-11-19 2012-01-04 Diurnal Ltd Treatment of adrenal insufficiency
GB201308933D0 (en) 2013-05-17 2013-07-03 Diurnal Ltd Paediatric composition
US20190180872A1 (en) * 2017-12-12 2019-06-13 International Business Machines Corporation Second Opinion Decision Support Using Patient Electronic Medical Records

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Also Published As

Publication number Publication date
PL2978414T3 (pl) 2020-11-16
LT2978414T (lt) 2020-09-25
KR102219919B1 (ko) 2021-02-25
JP6371379B2 (ja) 2018-08-08
RS60734B1 (sr) 2020-09-30
US9649280B2 (en) 2017-05-16
GB2527233B (en) 2017-07-05
DK2978414T3 (da) 2020-08-24
HK1214131A1 (zh) 2016-07-22
ES2813382T3 (es) 2021-03-23
CY1123284T1 (el) 2021-12-31
IL242275B (en) 2018-08-30
RU2015150303A (ru) 2017-06-22
BR112015028025A8 (pt) 2019-12-31
GB201516973D0 (en) 2015-11-11
BR112015028025A2 (pt) 2017-07-25
BR112015028025B1 (pt) 2022-11-29
HUE050917T2 (hu) 2021-01-28
CN105120848A (zh) 2015-12-02
AU2014267041A1 (en) 2015-10-15
KR20160011205A (ko) 2016-01-29
MX2015015759A (es) 2016-03-15
CA2909060A1 (en) 2014-11-20
RU2015150303A3 (hr) 2018-03-26
PT2978414T (pt) 2020-08-27
JP2016518439A (ja) 2016-06-23
NZ712756A (en) 2020-12-18
WO2014184525A1 (en) 2014-11-20
EP2978414A1 (en) 2016-02-03
US20160081942A1 (en) 2016-03-24
GB2527233A (en) 2015-12-16
SI2978414T1 (sl) 2020-10-30
GB201308933D0 (en) 2013-07-03
CA2909060C (en) 2020-03-10
EP2978414B1 (en) 2020-07-22
CN105120848B (zh) 2019-06-04
RU2664678C2 (ru) 2018-08-21
ZA201507210B (en) 2017-07-26
AU2014267041B2 (en) 2018-11-22

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