CA2320087C - Treatment of chronic inflammatory disorders of the gastrointestinal tract - Google Patents
Treatment of chronic inflammatory disorders of the gastrointestinal tract Download PDFInfo
- Publication number
- CA2320087C CA2320087C CA002320087A CA2320087A CA2320087C CA 2320087 C CA2320087 C CA 2320087C CA 002320087 A CA002320087 A CA 002320087A CA 2320087 A CA2320087 A CA 2320087A CA 2320087 C CA2320087 C CA 2320087C
- Authority
- CA
- Canada
- Prior art keywords
- budesonide
- oil
- oral formulation
- treatment
- suspension
- 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.)
- Expired - Fee Related
Links
- 210000001035 gastrointestinal tract Anatomy 0.000 title description 15
- 208000037976 chronic inflammation Diseases 0.000 title description 4
- 208000037893 chronic inflammatory disorder Diseases 0.000 title description 4
- 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 abstract description 50
- 229960004436 budesonide Drugs 0.000 claims abstract description 49
- 239000000203 mixture Substances 0.000 claims abstract description 45
- 238000009472 formulation Methods 0.000 claims abstract description 40
- 206010064147 Gastrointestinal inflammation Diseases 0.000 claims abstract description 19
- 241000124008 Mammalia Species 0.000 claims abstract description 15
- 239000008157 edible vegetable oil Substances 0.000 claims abstract description 14
- 235000015112 vegetable and seed oil Nutrition 0.000 claims abstract description 9
- 239000008158 vegetable oil Substances 0.000 claims abstract description 9
- 239000000725 suspension Substances 0.000 claims description 27
- 241001465754 Metazoa Species 0.000 claims description 21
- 239000003921 oil Substances 0.000 claims description 14
- 235000019198 oils Nutrition 0.000 claims description 14
- 238000013270 controlled release Methods 0.000 claims description 8
- 239000008163 avocado oil Substances 0.000 claims description 7
- 235000021302 avocado oil Nutrition 0.000 claims description 6
- 239000011248 coating agent Substances 0.000 claims description 6
- 238000000576 coating method Methods 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- 239000003813 safflower oil Substances 0.000 claims description 4
- 235000019485 Safflower oil Nutrition 0.000 claims description 3
- 210000002429 large intestine Anatomy 0.000 claims description 3
- 235000005713 safflower oil Nutrition 0.000 claims description 3
- 210000002784 stomach Anatomy 0.000 claims description 3
- 239000004006 olive oil Substances 0.000 claims description 2
- 210000000813 small intestine Anatomy 0.000 claims description 2
- 241000251468 Actinopterygii Species 0.000 claims 1
- 235000008390 olive oil Nutrition 0.000 claims 1
- 208000024891 symptom Diseases 0.000 abstract description 19
- 238000000034 method Methods 0.000 abstract description 11
- 230000009467 reduction Effects 0.000 abstract description 6
- 230000004044 response Effects 0.000 abstract description 6
- 239000003814 drug Substances 0.000 description 21
- 229940079593 drug Drugs 0.000 description 20
- 229960005205 prednisolone Drugs 0.000 description 18
- 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 description 18
- 241000282472 Canis lupus familiaris Species 0.000 description 15
- 230000000694 effects Effects 0.000 description 15
- 241000282326 Felis catus Species 0.000 description 14
- 201000010099 disease Diseases 0.000 description 14
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 14
- 239000003246 corticosteroid Substances 0.000 description 12
- 208000022559 Inflammatory bowel disease Diseases 0.000 description 10
- 206010061218 Inflammation Diseases 0.000 description 7
- 230000004054 inflammatory process Effects 0.000 description 7
- 229960004618 prednisone Drugs 0.000 description 7
- 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 description 7
- 230000009885 systemic effect Effects 0.000 description 7
- 208000011231 Crohn disease Diseases 0.000 description 5
- 229960001334 corticosteroids Drugs 0.000 description 5
- 239000012053 oil suspension Substances 0.000 description 4
- 238000012545 processing Methods 0.000 description 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 206010047700 Vomiting Diseases 0.000 description 3
- 239000002775 capsule Substances 0.000 description 3
- 210000003238 esophagus Anatomy 0.000 description 3
- 235000013305 food Nutrition 0.000 description 3
- 238000012423 maintenance Methods 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 230000035945 sensitivity Effects 0.000 description 3
- 150000003431 steroids Chemical class 0.000 description 3
- 230000008673 vomiting Effects 0.000 description 3
- 206010009900 Colitis ulcerative Diseases 0.000 description 2
- 206010012735 Diarrhoea Diseases 0.000 description 2
- 208000018522 Gastrointestinal disease Diseases 0.000 description 2
- 206010062016 Immunosuppression Diseases 0.000 description 2
- 201000006704 Ulcerative Colitis Diseases 0.000 description 2
- 230000036528 appetite Effects 0.000 description 2
- 235000019789 appetite Nutrition 0.000 description 2
- 231100000749 chronicity Toxicity 0.000 description 2
- 206010009887 colitis Diseases 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 230000003118 histopathologic effect Effects 0.000 description 2
- 230000001506 immunosuppresive effect Effects 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 235000019629 palatability Nutrition 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 241000894007 species Species 0.000 description 2
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- 206010001382 Adrenal suppression Diseases 0.000 description 1
- 201000004384 Alopecia Diseases 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- 244000020518 Carthamus tinctorius Species 0.000 description 1
- 235000003255 Carthamus tinctorius Nutrition 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 241000792859 Enema Species 0.000 description 1
- 241000283086 Equidae Species 0.000 description 1
- 208000012895 Gastric disease Diseases 0.000 description 1
- 240000007817 Olea europaea Species 0.000 description 1
- 206010033645 Pancreatitis Diseases 0.000 description 1
- 241001494479 Pecora Species 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- 240000008042 Zea mays Species 0.000 description 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000001919 adrenal effect Effects 0.000 description 1
- 239000010775 animal oil Substances 0.000 description 1
- 229940124599 anti-inflammatory drug Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000001574 biopsy Methods 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 210000001072 colon Anatomy 0.000 description 1
- 230000000112 colonic effect Effects 0.000 description 1
- 235000005822 corn Nutrition 0.000 description 1
- 239000002285 corn oil Substances 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 235000019007 dietary guidelines Nutrition 0.000 description 1
- 208000010643 digestive system disease Diseases 0.000 description 1
- 230000003292 diminished effect Effects 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 230000002183 duodenal effect Effects 0.000 description 1
- 230000002996 emotional effect Effects 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 238000001839 endoscopy Methods 0.000 description 1
- 239000007920 enema Substances 0.000 description 1
- 229940095399 enema Drugs 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 229940013317 fish oils Drugs 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 208000024963 hair loss Diseases 0.000 description 1
- 230000003676 hair loss Effects 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 230000006698 induction Effects 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 208000028774 intestinal disease Diseases 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000003801 milling Methods 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 238000002559 palpation Methods 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 230000004043 responsiveness Effects 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 239000003981 vehicle Substances 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
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
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US1998/002265 WO1999039699A1 (en) | 1998-02-09 | 1998-02-09 | Treatment of chronic inflammatory disorders of the gastrointestinal tract |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2320087A1 CA2320087A1 (en) | 1999-08-12 |
| CA2320087C true CA2320087C (en) | 2006-12-19 |
Family
ID=22266344
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002320087A Expired - Fee Related CA2320087C (en) | 1998-02-09 | 1998-02-09 | Treatment of chronic inflammatory disorders of the gastrointestinal tract |
Country Status (9)
| Country | Link |
|---|---|
| EP (1) | EP1052977A4 (enExample) |
| JP (1) | JP2002502812A (enExample) |
| KR (1) | KR20010040646A (enExample) |
| CN (1) | CN1149078C (enExample) |
| AU (1) | AU735084B2 (enExample) |
| CA (1) | CA2320087C (enExample) |
| IL (1) | IL137598A (enExample) |
| SE (1) | SE0002831L (enExample) |
| WO (1) | WO1999039699A1 (enExample) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100333727C (zh) * | 2004-11-25 | 2007-08-29 | 天津药业研究院有限公司 | 布地奈德靶向微丸及其制备方法 |
| MD2852C2 (ro) * | 2005-03-28 | 2006-04-30 | Георге АНГЕЛИЧ | Utilizarea budesonidei pentru tratamentul ascitei rezistente la pacienţii cu ciroză hepatică |
| US8324192B2 (en) | 2005-11-12 | 2012-12-04 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
| US8497258B2 (en) | 2005-11-12 | 2013-07-30 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
| US8679545B2 (en) | 2005-11-12 | 2014-03-25 | The Regents Of The University Of California | Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract |
| ES2423929T3 (es) * | 2007-02-16 | 2013-09-25 | Aska Pharmaceutical Co., Ltd. | Composición farmacéutica que contiene suspensión basada en aceite de partículas finas |
| LT3354276T (lt) | 2007-11-13 | 2020-04-27 | Meritage Pharma, Inc. | Kompozicijos, skirtos skrandžio ir žarnyno uždegimo gydymui |
| US9050368B2 (en) | 2007-11-13 | 2015-06-09 | Meritage Pharma, Inc. | Corticosteroid compositions |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5643602A (en) * | 1989-11-22 | 1997-07-01 | Astra Aktiebolag | Oral composition for the treatment of inflammatory bowel disease |
| WO1993011773A1 (en) * | 1991-12-18 | 1993-06-24 | Aktiebolaget Astra | New combination of formoterol and budesonide |
| GB9405304D0 (en) * | 1994-03-16 | 1994-04-27 | Scherer Ltd R P | Delivery systems for hydrophobic drugs |
| GB9409778D0 (en) * | 1994-05-16 | 1994-07-06 | Dumex Ltd As | Compositions |
| GB9412394D0 (en) * | 1994-06-21 | 1994-08-10 | Danbiosyst Uk | Colonic drug delivery composition |
| KR20000029784A (ko) * | 1996-08-02 | 2000-05-25 | 나까도미 히로다카 | 경구제제용캡슐과경구캡슐제제 |
| KR100219918B1 (ko) * | 1997-07-03 | 1999-09-01 | 김윤 | 대장선택적 약물전달용 조성물 |
-
1998
- 1998-02-09 EP EP98907382A patent/EP1052977A4/en not_active Withdrawn
- 1998-02-09 CN CNB988135329A patent/CN1149078C/zh not_active Expired - Fee Related
- 1998-02-09 CA CA002320087A patent/CA2320087C/en not_active Expired - Fee Related
- 1998-02-09 IL IL13759898A patent/IL137598A/xx not_active IP Right Cessation
- 1998-02-09 WO PCT/US1998/002265 patent/WO1999039699A1/en not_active Ceased
- 1998-02-09 AU AU63200/98A patent/AU735084B2/en not_active Ceased
- 1998-02-09 JP JP2000530199A patent/JP2002502812A/ja active Pending
- 1998-02-09 KR KR1020007008518A patent/KR20010040646A/ko not_active Withdrawn
-
2000
- 2000-08-07 SE SE0002831A patent/SE0002831L/ not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| EP1052977A4 (en) | 2006-07-12 |
| IL137598A (en) | 2005-09-25 |
| CA2320087A1 (en) | 1999-08-12 |
| AU6320098A (en) | 1999-08-23 |
| CN1284869A (zh) | 2001-02-21 |
| SE0002831L (sv) | 2000-09-28 |
| KR20010040646A (ko) | 2001-05-15 |
| EP1052977A1 (en) | 2000-11-22 |
| CN1149078C (zh) | 2004-05-12 |
| JP2002502812A (ja) | 2002-01-29 |
| SE0002831D0 (sv) | 2000-08-07 |
| WO1999039699A1 (en) | 1999-08-12 |
| AU735084B2 (en) | 2001-06-28 |
| IL137598A0 (en) | 2001-07-24 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20170209 |