WO2009138716A1 - Compositions for the oral delivery of corticosteroids - Google Patents

Compositions for the oral delivery of corticosteroids Download PDF

Info

Publication number
WO2009138716A1
WO2009138716A1 PCT/GB2009/001150 GB2009001150W WO2009138716A1 WO 2009138716 A1 WO2009138716 A1 WO 2009138716A1 GB 2009001150 W GB2009001150 W GB 2009001150W WO 2009138716 A1 WO2009138716 A1 WO 2009138716A1
Authority
WO
WIPO (PCT)
Prior art keywords
release component
drug
sustained release
composition according
acid
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/GB2009/001150
Other languages
English (en)
French (fr)
Inventor
Peter Watts
Ann Margaret Dyer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kyowa Kirin Services Ltd
Original Assignee
Archimedes Development 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39571149&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2009138716(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to EP09746033.1A priority Critical patent/EP2278958B1/en
Priority to JP2011508995A priority patent/JP5608641B2/ja
Priority to DK09746033.1T priority patent/DK2278958T3/da
Priority to HK11112978.8A priority patent/HK1158510B/xx
Priority to CN2009801272725A priority patent/CN102088962B/zh
Application filed by Archimedes Development Ltd filed Critical Archimedes Development Ltd
Priority to US12/992,182 priority patent/US8491932B2/en
Priority to ES09746033.1T priority patent/ES2452265T3/es
Priority to PL09746033T priority patent/PL2278958T3/pl
Publication of WO2009138716A1 publication Critical patent/WO2009138716A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/5078—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 with drug-free core
    • 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
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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]

Definitions

  • the present invention relates to compositions for the treatment of diseases of the gastrointestinal tract. More particularly, the present invention relates to compositions for the oral delivery of corticosteroids.
  • the rate-controlling material comprises an alkali- containing ethylcellulose material, preferably an ammonia-containing ethylcellulose, such as Surelease®.
  • the rate-controlling material may comprise one or more ingredients.
  • a combination of ingredients that control the rate at which the drug is released may be used.
  • the time period over which the drug is released can be controlled.
  • Suitable binders include, but are not limited to povidone, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose and polyvinyl alcohol. Preferred binders include hydroxypropyl cellulose, hydroxyethyl cellulose and hydroxypropyl methylcellulose. Preferably a binder is used.
  • the coating liquid may optionally contain other ingredients such as a plasticiser (e.g. polyethylene glycol, triacetin or triethyl citrate), an anti-tack agent (e.g. talc or magnesium stearate) or a colouring agent.
  • the coating liquid contains a binder and one or more of these optional ingredients.
  • the methods described above may be used.
  • an acid may be included in the drug containg coating liquid described above.
  • the corticosteroid content of the sustained release component as a percentage by weight of the sustained release component is preferably from about 0.25 to about 70%, more preferably from about 0.5 to about 60% and most preferably from about 1 to about 50%.
  • the drug is preferably present in an amount of from about 0.25 to about 10% by weight of the sustained release component, more preferably from about 0.5 to about 7.5% and most preferably from about 1 to about 5%.
  • Preferred oral drug delivery compositions of the invention comprise a sustained release component which comprise a core comprising budesonide, an acid-containing barrier layer, which preferably comprises citric acid and a layer comprising a sustained release component comprising an ammonia-containing ethylcellulose such as Surelease® and is contained within a starch capsule, which is coated with a delayed release material which substantially prevents release of the sustained release component until the composition reaches the intestine and which preferably comprises Eudragit L100 and/or Eudragit S100.
  • the oral drug delivery compositions of the invention may additionally comprise some corticosteroid drug formulated for immediate release. By this we mean that a proportion of the corticosteroid drug, for example up to about 50%, is in a form such that it is released immediately on the delayed release component dissolving or disintegrating.
  • the present invention provides the use of: a sustained release component comprising a corticosteroid drug, an alkali-containing ethyl cellulose material and an acid; and a delayed release component which substantially prevents release of the sustained release component until the composition reaches the intestine following oral administration, or a composition of the invention in the manufacture of a medicament for the treatment of inflammatory diseases of the gastrointestinal tract, such as Crohn's disease or ulcerative colitis, or glomerulonephritis.
  • a sustained release component comprising a corticosteroid drug, an alkali-containing ethyl cellulose material and an acid
  • a delayed release component which substantially prevents release of the sustained release component until the composition reaches the intestine following oral administration, or a composition of the invention in the manufacture of a medicament for the treatment of inflammatory diseases of the gastrointestinal tract, such as Crohn's disease or ulcerative colitis, or glomerulonephritis.
  • the present invention provides a method of treating glomerulonephritis, which method comprises administering a composition of the invention to a patient.
  • the dried beads were passed through a 1.4 mm sieve and over a 0.5 mm sieve to remove any oversize and undersize particles.
  • the yield of product was 4.24 kg.
  • Example 4 Effect of including an organic acid layer on stability of coated budesonide beads

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PCT/GB2009/001150 2008-05-12 2009-05-07 Compositions for the oral delivery of corticosteroids Ceased WO2009138716A1 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
PL09746033T PL2278958T3 (pl) 2008-05-12 2009-05-07 Kompozycje do doustnego dostarczania kortykosteroidów
JP2011508995A JP5608641B2 (ja) 2008-05-12 2009-05-07 副腎皮質ステロイドの経口送達のための組成物
DK09746033.1T DK2278958T3 (da) 2008-05-12 2009-05-07 Sammensætninger til oral frigivelse af kortikosteroider
HK11112978.8A HK1158510B (en) 2008-05-12 2009-05-07 Compositions for the oral delivery of corticosteroids
CN2009801272725A CN102088962B (zh) 2008-05-12 2009-05-07 用于皮质类固醇口服给药的组合物
EP09746033.1A EP2278958B1 (en) 2008-05-12 2009-05-07 Compositions for the oral delivery of corticosteroids
US12/992,182 US8491932B2 (en) 2008-05-12 2009-05-07 Compositions for the oral delivery of corticosteroids
ES09746033.1T ES2452265T3 (es) 2008-05-12 2009-05-07 Composiciones para la administración oral de corticosteroides

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0808537.5 2008-05-12
GBGB0808537.5A GB0808537D0 (en) 2008-05-12 2008-05-12 Compositions

Publications (1)

Publication Number Publication Date
WO2009138716A1 true WO2009138716A1 (en) 2009-11-19

Family

ID=39571149

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2009/001150 Ceased WO2009138716A1 (en) 2008-05-12 2009-05-07 Compositions for the oral delivery of corticosteroids

Country Status (9)

Country Link
US (1) US8491932B2 (enExample)
EP (1) EP2278958B1 (enExample)
JP (1) JP5608641B2 (enExample)
CN (1) CN102088962B (enExample)
DK (1) DK2278958T3 (enExample)
ES (1) ES2452265T3 (enExample)
GB (1) GB0808537D0 (enExample)
PL (1) PL2278958T3 (enExample)
WO (1) WO2009138716A1 (enExample)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2419443C1 (ru) * 2009-12-08 2011-05-27 Государственное образовательное учреждение высшего профессионального образования "Санкт-Петербургская государственная медицинская академия им. И.И. Мечникова Федерального агентства по здравоохранению и социальному развитию" Способ лечения больных язвенным колитом
WO2017042835A1 (en) * 2015-09-11 2017-03-16 Sun Pharmaceutical Industries Ltd. Oral pharmaceutical dosage forms of budesonide
EP3187171A1 (en) 2012-04-30 2017-07-05 Tillotts Pharma AG A delayed release drug formulation
EP3257501A1 (en) * 2016-06-14 2017-12-20 Tillotts Pharma AG Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material, and an enteric core coating
WO2018111326A1 (en) * 2016-12-14 2018-06-21 Progenity Inc. Methods and ingestible devices for the regio-specific release of immunosuppressants at the site of gastrointestinal tract disease
EP3613414A1 (de) 2018-08-24 2020-02-26 Dr. Falk Pharma Gmbh Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon
US10799515B2 (en) 2013-10-29 2020-10-13 Tillotts Pharma Ag Delayed release drug formulation
US11523772B2 (en) 2016-12-14 2022-12-13 Biora Therapeutics, Inc. Treatment of a disease of the gastrointestinal tract with an immunosuppressant
WO2023139285A1 (en) 2022-01-24 2023-07-27 Calliditas Therapeutics Ab Pharmaceutical composition comprising budesonide for treating iga nephropathy
WO2024013154A1 (en) 2022-07-15 2024-01-18 Synthon B.V. Budesonide two layers capsule formulation

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104257669A (zh) * 2014-09-25 2015-01-07 合肥平光制药有限公司 一种用于向肠道递送水杨酸类药物的口服给药组合物
EP3641734A4 (en) * 2017-06-23 2021-03-17 Sun Pharma Advanced Research Company Limited ANTI-ABUSE ORAL SOLID DOSAGE FORM
CN110200947A (zh) * 2019-06-27 2019-09-06 深圳市泛谷药业股份有限公司 一种安非他酮肠溶缓释微丸胶囊及其制备方法
CN112999229B (zh) * 2019-12-19 2023-01-24 江苏恒瑞医药股份有限公司 一种包含布地奈德的口服药物组合物
CN117157079A (zh) * 2021-04-20 2023-12-01 江苏恒瑞医药股份有限公司 一种口服肠溶皮质类固醇的药物组合物
EP4327806A4 (en) 2021-04-20 2024-10-23 Jiangsu Hengrui Pharmaceuticals Co., Ltd. CAPSULE FOR SPECIFIC MEDICATION DELIVERY AND MANUFACTURING PROCESS THEREFOR

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US6239120B1 (en) 1998-03-17 2001-05-29 Pharmalink Ab Method and means for treating glomerulonephritis
US6534549B1 (en) 1997-10-23 2003-03-18 Btg International Limited Controlled release formulations

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Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2419443C1 (ru) * 2009-12-08 2011-05-27 Государственное образовательное учреждение высшего профессионального образования "Санкт-Петербургская государственная медицинская академия им. И.И. Мечникова Федерального агентства по здравоохранению и социальному развитию" Способ лечения больных язвенным колитом
US11517534B2 (en) 2012-04-30 2022-12-06 Tillotts Pharma Ag Delayed release drug formulation
EP3187171A1 (en) 2012-04-30 2017-07-05 Tillotts Pharma AG A delayed release drug formulation
EP3278792A1 (en) 2012-04-30 2018-02-07 Tillotts Pharma AG A delayed release drug formulation
EP3187171B1 (en) * 2012-04-30 2024-09-25 Tillotts Pharma AG A delayed release drug formulation
US11534406B2 (en) 2012-04-30 2022-12-27 Tillotts Pharma Ag Delayed release drug formulation
US10799515B2 (en) 2013-10-29 2020-10-13 Tillotts Pharma Ag Delayed release drug formulation
WO2017042835A1 (en) * 2015-09-11 2017-03-16 Sun Pharmaceutical Industries Ltd. Oral pharmaceutical dosage forms of budesonide
EP3257501A1 (en) * 2016-06-14 2017-12-20 Tillotts Pharma AG Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material, and an enteric core coating
WO2017216088A1 (en) * 2016-06-14 2017-12-21 Tillotts Pharma Ag Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material, and an enteric core coating
US20190336449A1 (en) * 2016-06-14 2019-11-07 Tillotts Pharma Ag Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material and an enteric core coating
WO2018111326A1 (en) * 2016-12-14 2018-06-21 Progenity Inc. Methods and ingestible devices for the regio-specific release of immunosuppressants at the site of gastrointestinal tract disease
US11523772B2 (en) 2016-12-14 2022-12-13 Biora Therapeutics, Inc. Treatment of a disease of the gastrointestinal tract with an immunosuppressant
US12150775B2 (en) 2016-12-14 2024-11-26 Biora Therapeutics, Inc. Treatment of a disease of the gastrointestinal tract with an immunosuppressant
WO2020039017A1 (de) 2018-08-24 2020-02-27 Dr. Falk Pharma Gmbh Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon
EP3613414A1 (de) 2018-08-24 2020-02-26 Dr. Falk Pharma Gmbh Pellets mit mehrschichtiger struktur zur verzögerten freisetzung des wirkstoffs im distalen kolon
WO2023139285A1 (en) 2022-01-24 2023-07-27 Calliditas Therapeutics Ab Pharmaceutical composition comprising budesonide for treating iga nephropathy
US20230293444A1 (en) * 2022-01-24 2023-09-21 Calliditas Therapeutics Ab New pharmaceutical compositions
US11896719B2 (en) 2022-01-24 2024-02-13 Calliditas Therapeutics Ab Pharmaceutical compositions
US12171882B2 (en) 2022-01-24 2024-12-24 Calliditas Therapeutics Ab Pharmaceutical compositions
US12171883B2 (en) 2022-01-24 2024-12-24 Calliditas Therapeutics Ab Pharmaceutical compositions
US12311057B2 (en) 2022-01-24 2025-05-27 Calliditas Therapeutics Ab Pharmaceutical compositions
TWI896928B (zh) * 2022-01-24 2025-09-11 瑞典商卡利迪塔斯療法公司 新穎醫藥組成物
WO2024013154A1 (en) 2022-07-15 2024-01-18 Synthon B.V. Budesonide two layers capsule formulation

Also Published As

Publication number Publication date
JP2011519967A (ja) 2011-07-14
CN102088962A (zh) 2011-06-08
CN102088962B (zh) 2013-07-31
JP5608641B2 (ja) 2014-10-15
GB0808537D0 (en) 2008-06-18
EP2278958A1 (en) 2011-02-02
PL2278958T3 (pl) 2014-05-30
HK1158510A1 (en) 2012-07-20
DK2278958T3 (da) 2014-01-20
EP2278958B1 (en) 2014-01-01
ES2452265T3 (es) 2014-03-31
US20110104269A1 (en) 2011-05-05
US8491932B2 (en) 2013-07-23

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