BR112014011745A2 - composição farmacêutica, e, processo para a fabricação de uma composição farmacêutica de hidrocortisona - Google Patents

composição farmacêutica, e, processo para a fabricação de uma composição farmacêutica de hidrocortisona

Info

Publication number
BR112014011745A2
BR112014011745A2 BR112014011745A BR112014011745A BR112014011745A2 BR 112014011745 A2 BR112014011745 A2 BR 112014011745A2 BR 112014011745 A BR112014011745 A BR 112014011745A BR 112014011745 A BR112014011745 A BR 112014011745A BR 112014011745 A2 BR112014011745 A2 BR 112014011745A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
manufacture
hydrocortisone
hydrocortisone pharmaceutical
composition
Prior art date
Application number
BR112014011745A
Other languages
English (en)
Other versions
BR112014011745B1 (pt
Inventor
Huatan Hiep
Whitaker Martin
Ross Richard
Original Assignee
Diurnal Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Diurnal Ltd filed Critical Diurnal Ltd
Publication of BR112014011745A2 publication Critical patent/BR112014011745A2/pt
Publication of BR112014011745B1 publication Critical patent/BR112014011745B1/pt

Links

Classifications

    • 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
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52Adding ingredients
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • 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
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • A61K9/5089Processes
    • 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
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Mycology (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Saccharide Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)
BR112014011745-4A 2011-11-19 2012-11-19 Composição farmacêutica de hidrocortisona BR112014011745B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1119985.8 2011-11-19
GBGB1119985.8A GB201119985D0 (en) 2011-11-19 2011-11-19 Treatment of adrenal insufficiency
PCT/GB2012/052864 WO2013072707A1 (en) 2011-11-19 2012-11-19 Treatment of adrenal insufficiency

Publications (2)

Publication Number Publication Date
BR112014011745A2 true BR112014011745A2 (pt) 2017-05-30
BR112014011745B1 BR112014011745B1 (pt) 2022-04-05

Family

ID=45475414

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014011745-4A BR112014011745B1 (pt) 2011-11-19 2012-11-19 Composição farmacêutica de hidrocortisona

Country Status (22)

Country Link
US (2) US9675559B2 (pt)
EP (1) EP2780003B1 (pt)
JP (2) JP6228125B2 (pt)
KR (1) KR101995999B1 (pt)
AU (1) AU2012338583B2 (pt)
BR (1) BR112014011745B1 (pt)
CA (1) CA2854717C (pt)
CY (1) CY1123130T1 (pt)
DK (1) DK2780003T3 (pt)
ES (1) ES2782503T3 (pt)
GB (2) GB201119985D0 (pt)
HK (1) HK1194005A1 (pt)
HR (1) HRP20200452T1 (pt)
HU (1) HUE048445T2 (pt)
IL (1) IL232065A (pt)
LT (1) LT2780003T (pt)
PL (1) PL2780003T3 (pt)
PT (1) PT2780003T (pt)
RS (1) RS60132B1 (pt)
SI (1) SI2780003T1 (pt)
WO (1) WO2013072707A1 (pt)
ZA (1) ZA201403462B (pt)

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
WO2019221483A1 (ko) 2018-05-14 2019-11-21 주식회사 엘지화학 화합물 및 이를 포함하는 유기 발광 소자

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69101291T2 (de) * 1990-08-30 1994-07-07 Senju Pharma Co Zusammensetzung zur kontrollierten Abgabe von Medikamenten.
WO1997025980A1 (en) 1996-01-16 1997-07-24 Advanced Polymer Systems, Inc. Topical delivery of drugs to the lower gastrointestinal tract
DE69721559T2 (de) * 1997-01-06 2003-11-27 Pfizer Geschmacksmaskierte pharmazeutische dosisform mit schneller freisetzung
WO2005102287A2 (en) 2004-04-22 2005-11-03 Duocort Ab Pharmaceutical compositions for acute glucocorticoid therapy
SE0401031D0 (sv) * 2004-04-22 2004-04-22 Duocort Ab A new glucocorticoid replacement therapy
RU2382637C2 (ru) 2004-04-30 2010-02-27 Астеллас Фарма Инк. Фармацевтическая композиция для перорального введения в форме частиц с рассчитанным временем высвобождения и быстро распадающиеся таблетки, содержащие указанную композицию
US20070281007A1 (en) 2004-08-27 2007-12-06 Jacob Jules S Mucoadhesive Oral Formulations of High Permeability, High Solubility Drugs
WO2008126076A2 (en) 2007-04-11 2008-10-23 Perrigo Israel Pharmaceuticals Ltd. Low-dose mometasone formulations
US8298585B2 (en) * 2007-06-06 2012-10-30 Asahi Kasei Chemicals Corporation Cellulose-based fine core particle and process for producing the same
GB0817120D0 (en) 2008-09-19 2008-10-29 Diurnal Ltd Treatment of adrenal insufficiency
NZ595428A (en) 2009-04-07 2013-04-26 Duocourt Pharma Ab Improved glucocorticoid therapy
WO2011032916A1 (de) * 2009-09-17 2011-03-24 Basf Se Mit wirkstoffhaltigen überzügen beschichtete pellets
MX337429B (es) 2010-05-20 2016-03-04 Duocort Pharma Ab Posologia y administracion de composiciones basadas en glucocortticoides.
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

Also Published As

Publication number Publication date
LT2780003T (lt) 2020-04-27
GB201119985D0 (en) 2012-01-04
BR112014011745B1 (pt) 2022-04-05
US9717740B1 (en) 2017-08-01
HRP20200452T1 (hr) 2020-10-16
CY1123130T1 (el) 2021-10-29
AU2012338583B2 (en) 2017-01-19
RS60132B1 (sr) 2020-05-29
IL232065A (en) 2016-04-21
GB2509663B (en) 2015-01-07
EP2780003B1 (en) 2020-02-19
ES2782503T3 (es) 2020-09-15
US9675559B2 (en) 2017-06-13
JP2014533679A (ja) 2014-12-15
AU2012338583A1 (en) 2014-05-01
IL232065A0 (en) 2014-05-28
DK2780003T3 (da) 2020-03-30
KR101995999B1 (ko) 2019-07-03
GB2509663A (en) 2014-07-09
KR20140108638A (ko) 2014-09-12
ZA201403462B (en) 2016-05-25
SI2780003T1 (sl) 2020-07-31
HUE048445T2 (hu) 2020-08-28
WO2013072707A1 (en) 2013-05-23
CA2854717A1 (en) 2013-05-23
PL2780003T3 (pl) 2020-06-29
EP2780003A1 (en) 2014-09-24
JP6228125B2 (ja) 2017-11-08
US20170202856A1 (en) 2017-07-20
PT2780003T (pt) 2020-04-08
HK1194005A1 (en) 2014-10-10
CA2854717C (en) 2020-12-08
JP2017200942A (ja) 2017-11-09
US20140287052A1 (en) 2014-09-25
GB201407380D0 (en) 2014-06-11

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B25G Requested change of headquarter approved

Owner name: DIURNAL LIMITED (GB)

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06T Formal requirements before examination [chapter 6.20 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/11/2012, OBSERVADAS AS CONDICOES LEGAIS.