ZA200106739B - Corticosteroid formulation. - Google Patents

Corticosteroid formulation. Download PDF

Info

Publication number: ZA200106739B
Authority: ZA; South Africa
Prior art keywords: prednisolone; formulation; corticosteroid; dose; patients
Prior art date: 1999-03-15

Application number

ZA200106739A

Other languages

English (en)

Inventor

Hazel Judith Bardsley

Original Assignee

Arakis 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.)

1999-03-15

Filing date

2001-08-15

Publication date

2002-08-15

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=10849634&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ZA200106739(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2001-08-15 Application filed by Arakis Ltd filed Critical Arakis Ltd

2002-08-15 Publication of ZA200106739B publication Critical patent/ZA200106739B/en

Links

238000009472 formulation Methods 0.000 title claims description 30
239000000203 mixture Substances 0.000 title claims description 30
239000003246 corticosteroid Substances 0.000 title claims description 20
229960005205 prednisolone Drugs 0.000 claims description 35
OIGNJSKKLXVSLS-VWUMJDOOSA-N prednisolone Chemical compound O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 OIGNJSKKLXVSLS-VWUMJDOOSA-N 0.000 claims description 35
238000011282 treatment Methods 0.000 claims description 13
239000003862 glucocorticoid Substances 0.000 claims description 11
206010039073 rheumatoid arthritis Diseases 0.000 claims description 11
238000013270 controlled release Methods 0.000 claims description 6
229960004618 prednisone Drugs 0.000 claims description 5
XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 claims description 5
VHRSUDSXCMQTMA-PJHHCJLFSA-N 6alpha-methylprednisolone Chemical compound C([C@@]12C)=CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2[C@@H](O)C[C@]2(C)[C@@](O)(C(=O)CO)CC[C@H]21 VHRSUDSXCMQTMA-PJHHCJLFSA-N 0.000 claims description 3
VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims description 3
229960004436 budesonide Drugs 0.000 claims description 3
229960001145 deflazacort Drugs 0.000 claims description 3
FBHSPRKOSMHSIF-GRMWVWQJSA-N deflazacort Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(C)=N[C@@]3(C(=O)COC(=O)C)[C@@]1(C)C[C@@H]2O FBHSPRKOSMHSIF-GRMWVWQJSA-N 0.000 claims description 3
229960004584 methylprednisolone Drugs 0.000 claims description 3
238000004519 manufacturing process Methods 0.000 claims 1
229940079593 drug Drugs 0.000 description 13
239000003814 drug Substances 0.000 description 13
239000004480 active ingredient Substances 0.000 description 8
230000000694 effects Effects 0.000 description 7
108010074051 C-Reactive Protein Proteins 0.000 description 5
102100032752 C-reactive protein Human genes 0.000 description 5
108090001005 Interleukin-6 Proteins 0.000 description 5
208000024891 symptom Diseases 0.000 description 5
WCDDVEOXEIYWFB-VXORFPGASA-N (2s,3s,4r,5r,6r)-3-[(2s,3r,5s,6r)-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5,6-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@@H]1C[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O)[C@H](O)[C@H]1O WCDDVEOXEIYWFB-VXORFPGASA-N 0.000 description 4
229940014041 hyaluronate Drugs 0.000 description 4
239000008280 blood Substances 0.000 description 3
210000004369 blood Anatomy 0.000 description 3
239000011248 coating agent Substances 0.000 description 3
238000000576 coating method Methods 0.000 description 3
208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
210000001503 joint Anatomy 0.000 description 3
MJHYBJOMJPGNMM-KGWLDMEJSA-N [2-[(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] 4-(nitrooxymethyl)benzoate Chemical compound O=C([C@@]1(O)CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)[C@@H](O)C[C@@]21C)COC(=O)C1=CC=C(CO[N+]([O-])=O)C=C1 MJHYBJOMJPGNMM-KGWLDMEJSA-N 0.000 description 2
206010003246 arthritis Diseases 0.000 description 2
230000008901 benefit Effects 0.000 description 2
229960001334 corticosteroids Drugs 0.000 description 2
230000003111 delayed effect Effects 0.000 description 2
201000010099 disease Diseases 0.000 description 2
238000011156 evaluation Methods 0.000 description 2
239000011159 matrix material Substances 0.000 description 2
238000000034 method Methods 0.000 description 2
239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 2
229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 2
230000003204 osmotic effect Effects 0.000 description 2
239000012466 permeate Substances 0.000 description 2
229920000642 polymer Polymers 0.000 description 2
229940037128 systemic glucocorticoids Drugs 0.000 description 2
230000002618 waking effect Effects 0.000 description 2
206010065687 Bone loss Diseases 0.000 description 1
108090000695 Cytokines Proteins 0.000 description 1
102000004127 Cytokines Human genes 0.000 description 1
206010012438 Dermatitis atopic Diseases 0.000 description 1
208000022559 Inflammatory bowel disease Diseases 0.000 description 1
206010023232 Joint swelling Diseases 0.000 description 1
241000219061 Rheum Species 0.000 description 1
208000025747 Rheumatic disease Diseases 0.000 description 1
238000010521 absorption reaction Methods 0.000 description 1
239000011149 active material Substances 0.000 description 1
239000013543 active substance Substances 0.000 description 1
230000001154 acute effect Effects 0.000 description 1
239000003708 ampul Substances 0.000 description 1
125000000129 anionic group Chemical group 0.000 description 1
208000006673 asthma Diseases 0.000 description 1
201000008937 atopic dermatitis Diseases 0.000 description 1
239000002775 capsule Substances 0.000 description 1
125000002091 cationic group Chemical group 0.000 description 1
238000013461 design Methods 0.000 description 1
208000035475 disorder Diseases 0.000 description 1
238000001647 drug administration Methods 0.000 description 1
238000001727 in vivo Methods 0.000 description 1
208000027866 inflammatory disease Diseases 0.000 description 1
230000002757 inflammatory effect Effects 0.000 description 1
238000011221 initial treatment Methods 0.000 description 1
238000002347 injection Methods 0.000 description 1
239000007924 injection Substances 0.000 description 1
238000005342 ion exchange Methods 0.000 description 1
150000002500 ions Chemical class 0.000 description 1
238000012423 maintenance Methods 0.000 description 1
239000011859 microparticle Substances 0.000 description 1
239000000902 placebo Substances 0.000 description 1
229940068196 placebo Drugs 0.000 description 1
230000036470 plasma concentration Effects 0.000 description 1
229940002612 prodrug Drugs 0.000 description 1
239000000651 prodrug Substances 0.000 description 1
108090000623 proteins and genes Proteins 0.000 description 1
102000004169 proteins and genes Human genes 0.000 description 1
229920005989 resin Polymers 0.000 description 1
239000011347 resin Substances 0.000 description 1
230000004044 response Effects 0.000 description 1
238000012552 review Methods 0.000 description 1
230000000405 serological effect Effects 0.000 description 1
210000002966 serum Anatomy 0.000 description 1
210000000813 small intestine Anatomy 0.000 description 1
239000000725 suspension Substances 0.000 description 1
238000013268 sustained release Methods 0.000 description 1
239000012730 sustained-release form Substances 0.000 description 1
239000003826 tablet Substances 0.000 description 1
238000012360 testing method Methods 0.000 description 1
231100001274 therapeutic index Toxicity 0.000 description 1
238000002560 therapeutic procedure Methods 0.000 description 1
238000011179 visual inspection Methods 0.000 description 1

Classifications

- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
- 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
- A61P17/04—Antipruritics
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
- A61P5/44—Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids

Landscapes

Health & Medical Sciences (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)
Bioinformatics & Cheminformatics (AREA)
Engineering & Computer Science (AREA)
Epidemiology (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Chemical Kinetics & Catalysis (AREA)
Organic Chemistry (AREA)
Rheumatology (AREA)
Pulmonology (AREA)
Dermatology (AREA)
Pain & Pain Management (AREA)
Diabetes (AREA)
Immunology (AREA)
Orthopedic Medicine & Surgery (AREA)
Physical Education & Sports Medicine (AREA)
Endocrinology (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Steroid Compounds (AREA)
Medicinal Preparation (AREA)

ZA200106739A 1999-03-15 2001-08-15 Corticosteroid formulation. ZA200106739B (en)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
GBGB9905898.4A GB9905898D0 (en)	1999-03-15	1999-03-15	Controlled-dose formulation

Publications (1)

Publication Number	Publication Date
ZA200106739B true ZA200106739B (en)	2002-08-15

Family

ID=10849634

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
ZA200106739A ZA200106739B (en)	1999-03-15	2001-08-15	Corticosteroid formulation.

Country Status (8)

Country	Link
US (1)	US6488960B1 (fr)
EP (1)	EP1158988A2 (fr)
JP (1)	JP5355833B2 (fr)
AU (1)	AU771088B2 (fr)
CA (1)	CA2361503A1 (fr)
GB (1)	GB9905898D0 (fr)
WO (1)	WO2000054780A2 (fr)
ZA (1)	ZA200106739B (fr)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
GB0023220D0 (en) *	2000-09-21	2000-11-01	Arakis Ltd	Corticosteroid formulation
DE10012555A1 (de) *	2000-03-15	2001-09-20	Merck Patent Gmbh	Glucocorticoide in einer Modified Release-Formulierung
ES2335008T3 (es) *	2003-04-24	2010-03-18	Jagotec Ag	Comprimido con nucleo coloreado.
JP4790597B2 (ja)	2003-04-24	2011-10-12	ヤゴテックアーゲー	規定されたコア幾何学的配置を有する遅延放出錠
CA2579540A1 (fr) *	2004-09-07	2006-03-16	Sosei R&D Ltd.	Traitement de troubles et de douleurs inflammatoires
DE102004043863A1 (de)	2004-09-10	2006-03-16	Nitec Pharma Ag	Tabletten mit orts- und zeitgesteuerter Wirkstofffreisetzung im Gastrointestinum
DK2049123T4 (en) *	2006-08-03	2016-11-28	Horizon Pharma Ag	LATE discharge-glucocorticoid treatment of rheumatoid ILLNESS
US20100016265A1 (en) *	2008-07-16	2010-01-21	Qaiser Yusuf	Anti-inflammatory composition and method for preparation
TWI494108B (zh)	2009-01-26	2015-08-01	Nitec Pharma Ag	糖皮質激素用以製備嚴重夜間氣喘用之於延遲釋放型的藥物之用途
WO2011126910A2 (fr)	2010-03-30	2011-10-13	Algynomics Inc.	Compositions et procédés pour le traitement de troubles somatosensoriels
US8716350B2 (en)	2010-03-30	2014-05-06	Algynomics Inc.	Compositions and methods for the treatment of somatosensory disorders
WO2013177154A1 (fr)	2012-05-21	2013-11-28	The General Hospital Corporation	Appareil, dispositif et procédé pour microscopie par capsule
WO2014201332A1 (fr) *	2013-06-14	2014-12-18	Vertex Pharmaceuticals Incorporated	Combinaisons pharmaceutiques utiles pour traiter la polyarthrite rhumatoïde

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
DE4332394A1 (de) *	1993-09-23	1995-03-30	Falk Pharma Gmbh	Budesonid-Pellets mit kontrolliertem Freigabeprofil und Verfahren zu ihrer Herstellung
US5792476A (en) *	1996-12-19	1998-08-11	Abigo Medical Ab	Sustained release glucocorticoid pharmaceutical composition

1999
- 1999-03-15 GB GBGB9905898.4A patent/GB9905898D0/en not_active Ceased
2000
- 2000-03-14 US US09/936,586 patent/US6488960B1/en not_active Expired - Lifetime
- 2000-03-14 AU AU31790/00A patent/AU771088B2/en not_active Ceased
- 2000-03-14 EP EP00909510A patent/EP1158988A2/fr not_active Withdrawn
- 2000-03-14 WO PCT/GB2000/000924 patent/WO2000054780A2/fr not_active Ceased
- 2000-03-14 CA CA002361503A patent/CA2361503A1/fr not_active Abandoned
- 2000-03-14 JP JP2000604856A patent/JP5355833B2/ja not_active Expired - Fee Related
2001
- 2001-08-15 ZA ZA200106739A patent/ZA200106739B/en unknown

Also Published As

Publication number	Publication date
WO2000054780A3 (fr)	2000-12-28
AU771088B2 (en)	2004-03-11
GB9905898D0 (en)	1999-05-05
WO2000054780A2 (fr)	2000-09-21
CA2361503A1 (fr)	2000-09-21
AU3179000A (en)	2000-10-04
JP2002539167A (ja)	2002-11-19
US6488960B1 (en)	2002-12-03
EP1158988A2 (fr)	2001-12-05
JP5355833B2 (ja)	2013-11-27

Publication	Publication Date	Title
US6677326B2 (en)	2004-01-13	Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration
Gupta et al.	2015	Efficacy and safety of oral budesonide suspension in pediatric patients with eosinophilic esophagitis
JP4976011B2 (ja)	2012-07-18	制御放出モルヒネ製剤
US6488960B1 (en)	2002-12-03	Corticosteroid formulation
US20080193564A1 (en)	2008-08-14	Method for preventing or reducing secondary fractures after hip fracture
Kundhal et al.	2001	Controlled ileal release budesonide in pediatric Crohn disease: efficacy and effect on growth
MX2012013014A (es)	2013-02-27	Regimenes terapeuticos.
KR100425045B1 (ko)	2004-09-01	약물중독의치료를위한멜라토닌함유약학적조성물
HK1218079A1 (zh)	2017-02-03	亞硝酸鹽的藥物製劑及其用途
US6521254B2 (en)	2003-02-18	Single-dose antihistamine/decongestant formulations for treating rhinitis
JP2009545546A5 (fr)	2010-07-15
ZuWallack et al.	1997	The effectiveness of once-daily dosing of inhaled flunisolide in maintaining asthma control
CA2422991A1 (fr)	2002-03-28	Formulation de corticosteroide comprenant moins de 2,5 mg de prednisolone pour administration quotidienne en une seule fois
MXPA01009208A (en)	2002-05-09	Corticosteroid formulation
CA3209781A1 (fr)	2022-09-09	Utilisation de luvadaxistat pour le traitement d'une deficience cognitive
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Wijekoon et al.	2022	Efficacy and safety of once weekly thyroxine versus daily thyroxine as maintenance therapy of hypothyroidism: a randomised controlled clinical trial
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Morice et al.	0	Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough
BRPI1007346A2 (pt)	2020-11-10	composição farmacêutica cronoterapêutica.
HK1079431B (en)	2012-05-25	Zoledronic acid for preventing or reducing secondary fractures after hip fracture
ITSELF	0	THE PATH T0@»~, THE UNIQUE