TW550091B - Rapamycin formulations for oral administration - Google Patents

Rapamycin formulations for oral administration Download PDF

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Publication number
TW550091B
TW550091B TW087103043A TW87103043A TW550091B TW 550091 B TW550091 B TW 550091B TW 087103043 A TW087103043 A TW 087103043A TW 87103043 A TW87103043 A TW 87103043A TW 550091 B TW550091 B TW 550091B
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rapamycin
sugar overcoat
sugar coating
sugar
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TW087103043A
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English (en)
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Arwinder S Nagi
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Wyeth Corp
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    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • 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
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/2893—Tablet coating processes
    • 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
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  • Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
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Description

550091 六、申請專利範圍 (e)蔗糖含量係占糖衣之95-99%重量比。 6. 如申請專利範圍第1項之雷帕黴素配方，其中： (a) 雷帕黴素含量爲0.5毫克， (b) 普隆尼克F68含量爲0.25毫克， (c) 普維隆含量係占糖衣之0.5%重量比， (d) 微晶纖維素係占糖衣之1%重量比，及 (e) 蔗糖含量係占糖衣之96-99%重量比。 7. 如申請專利範圍第1項之雷帕黴素配方，其中： (a) 雷帕黴素含量爲3毫克， (b) 普隆尼克F68含量爲1.5毫克， (〇普維隆含量係占糖衣之0.5%重量比， (d) 微晶纖維素係占糖衣之1%重量比，及 (e) 蔗糖含量係占糖衣之90-96^1重量比。 8. 如申請專利範圍第1項之雷帕黴素配方，其中： (a) 雷帕黴素含量爲5毫克， (b) 普隆尼克F68含量爲2.5毫克， (c) 普維隆含量係占糖衣之0.5%重量比， (d) 微晶纖維素係占糖衣之1%重量比，及 (e) 蔗糖含量係占糖衣之80-96%重量比。 9. 如申請專利範圍第1項之雷帕黴素配方，其中： (a) 雷帕黴素含量爲7.5毫克， (b) 普隆尼克F68含量爲3.75毫克， (c) 普維隆含量係占糖衣之0.5%重量比，
550091 六、申請專利範圍 (d) 微晶纖維素係占糖衣之1%重量比，及 (e) 蔗糖含量係占糖衣之75-90%重量比。 10·如申請專利範圍第1項之雷帕黴素配方，其中： (a) 雷帕黴素含量爲1〇毫克， (b) 普隆尼克F68含量爲5毫克， (c) 普維隆含量係占糖衣之0.5%重量比， (d) 微晶纖維素係占糖衣之1%重量比，及 (e) 蔗糖含量係占糖衣之65-90%重量比。 11. 一種製備口服用雷帕黴素配方之方法，該方法包含採用 下列步驟製備糖衣， (a) 製備重量比2:1之雷帕黴素：普隆尼克F68之分散 液； (b) 加入占該糖衣35-99%重量比範圍之蔗糖至分散液並 攪拌至溶解爲止； (c) 加入占該糖衣0.2-1.0%重量比範圍之普維隆，並混 合至徹底濕潤，且持續激烈混合至普維隆溶解爲止； (d) 加入占該糖衣0.1-3%重量比範圍之微晶纖維素，並 徹底混合至濕潤； (e) 加入水並徹底混合；以及 (f) 所得溶液逐份噴塗於醫藥惰性蕊上，以及於兩次噴 塗間風乾。 12. 如申請專利範圍第11項之方法，其又包含於添加糖至分 散液前或後添加一種或多種黏結劑至分散液。
TW087103043A 1997-03-14 1998-03-03 Rapamycin formulations for oral administration TW550091B (en)

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US81501597A 1997-03-14 1997-03-14

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EP (1) EP0868911B1 (zh)
JP (2) JP4616426B2 (zh)
KR (1) KR100513919B1 (zh)
CN (1) CN1140268C (zh)
AR (1) AR012069A1 (zh)
AT (1) ATE223705T1 (zh)
AU (1) AU723943B2 (zh)
BR (1) BR9801120B1 (zh)
CA (1) CA2230748C (zh)
CY (1) CY2313B1 (zh)
CZ (1) CZ292949B6 (zh)
DE (1) DE69807768T2 (zh)
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ES (1) ES2183287T3 (zh)
HK (1) HK1015677A1 (zh)
HU (1) HU224701B1 (zh)
IL (1) IL123525A (zh)
NZ (1) NZ329976A (zh)
PT (1) PT868911E (zh)
RU (1) RU2220714C2 (zh)
SG (1) SG63824A1 (zh)
SI (1) SI0868911T1 (zh)
TW (1) TW550091B (zh)
UA (1) UA56143C2 (zh)
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10441584B2 (en) 2016-11-23 2019-10-15 Novartis Ag Methods of enhancing immune response
US10576076B2 (en) 2015-05-20 2020-03-03 Novartis Ag Pharmaceutical combination of everolimus with dactolisib
US10596165B2 (en) 2018-02-12 2020-03-24 resTORbio, Inc. Combination therapies

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JP4969747B2 (ja) * 2001-01-19 2012-07-04 武田薬品工業株式会社 錠剤フィルムコーティング用組成物
PT1635830E (pt) * 2002-09-17 2008-12-31 Wyeth Corp Formulação granulada do éster de rapamicina cci-779
BRPI0608573A2 (pt) * 2005-03-08 2017-07-25 Lifecycle Pharma As Composição farmacêutica, e, método para a preparação de uma composição farmacêutica.
EP2086514A2 (en) * 2006-09-26 2009-08-12 Novartis Ag Pharmaceutical compositions comprising an s1p modulator
MX2009004960A (es) * 2006-11-07 2009-06-05 Wyeth Corp Revestimientos de azucar y metodos para los mismos.
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CN110585159B (zh) * 2019-09-12 2021-11-02 杭州华东医药集团新药研究院有限公司 一种含有西罗莫司的片剂

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10576076B2 (en) 2015-05-20 2020-03-03 Novartis Ag Pharmaceutical combination of everolimus with dactolisib
US10441584B2 (en) 2016-11-23 2019-10-15 Novartis Ag Methods of enhancing immune response
US10993940B2 (en) 2016-11-23 2021-05-04 Novartis Ag Methods of enhancing immune response
US11045463B2 (en) 2016-11-23 2021-06-29 Novartis Ag Methods of enhancing immune response
US10596165B2 (en) 2018-02-12 2020-03-24 resTORbio, Inc. Combination therapies

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DE69807768D1 (de) 2002-10-17
HUP9800573A3 (en) 2000-01-28
HU224701B1 (en) 2006-01-30
BR9801120A (pt) 2000-01-11
ZA982112B (en) 1999-09-13
KR19980080222A (ko) 1998-11-25
EP0868911B1 (en) 2002-09-11
CY2313B1 (en) 2003-11-14
ATE223705T1 (de) 2002-09-15
HUP9800573A2 (hu) 1999-06-28
RU2220714C2 (ru) 2004-01-10
JPH10259131A (ja) 1998-09-29
IL123525A0 (en) 1998-10-30
AR012069A1 (es) 2000-09-27
DK0868911T3 (da) 2003-01-20
AU5838398A (en) 1998-09-17
KR100513919B1 (ko) 2006-02-28
ES2183287T3 (es) 2003-03-16
PT868911E (pt) 2002-12-31
BR9801120B1 (pt) 2009-12-01
CZ292949B6 (cs) 2004-01-14
IL123525A (en) 2002-03-10
NZ329976A (en) 1999-10-28
AU723943B2 (en) 2000-09-07
CA2230748C (en) 2010-08-03
EP0868911A3 (en) 2000-12-06
DE69807768T2 (de) 2003-02-06
JP2009298823A (ja) 2009-12-24
EP0868911A2 (en) 1998-10-07
JP4616426B2 (ja) 2011-01-19
SG63824A1 (en) 1999-03-30
CZ77198A3 (cs) 1998-09-16
HU9800573D0 (en) 1998-05-28
HK1015677A1 (en) 1999-10-22
CN1140268C (zh) 2004-03-03
CA2230748A1 (en) 1998-09-14
UA56143C2 (uk) 2003-05-15
CN1197639A (zh) 1998-11-04
SI0868911T1 (en) 2002-12-31

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