WO2005092297A3 - A stable pharmaceutical composition comprising an acid labile drug - Google Patents

A stable pharmaceutical composition comprising an acid labile drug Download PDF

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Publication number
WO2005092297A3
WO2005092297A3 PCT/US2005/006589 US2005006589W WO2005092297A3 WO 2005092297 A3 WO2005092297 A3 WO 2005092297A3 US 2005006589 W US2005006589 W US 2005006589W WO 2005092297 A3 WO2005092297 A3 WO 2005092297A3
Authority
WO
WIPO (PCT)
Prior art keywords
acid labile
pharmaceutical composition
labile drug
stable pharmaceutical
provides
Prior art date
Application number
PCT/US2005/006589
Other languages
French (fr)
Other versions
WO2005092297A2 (en
Inventor
Capua Simona Di
Nava Shterman
Limor Ari Pardo
Esther Itach
Original Assignee
Teva Pharma
Capua Simona Di
Nava Shterman
Limor Ari Pardo
Esther Itach
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 Teva Pharma, Capua Simona Di, Nava Shterman, Limor Ari Pardo, Esther Itach filed Critical Teva Pharma
Priority to JP2007501900A priority Critical patent/JP2007526319A/en
Priority to MXPA06009991A priority patent/MXPA06009991A/en
Priority to EP05724184A priority patent/EP1720527A2/en
Priority to CA002558535A priority patent/CA2558535A1/en
Publication of WO2005092297A2 publication Critical patent/WO2005092297A2/en
Priority to IL177869A priority patent/IL177869A0/en
Publication of WO2005092297A3 publication Critical patent/WO2005092297A3/en

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
    • A61K9/50—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
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Abstract

The present invention provides a stable pharmaceutical composition of an acid labile drug such as a pharmaceutically active substituted benzimidazole compound, comprising: a) an inner core coated with the acid labile drug; b) a first intermediate coating devoid of an alkaline stabilizing agent and the benzimidazole compound; c) a second intermediate coating comprising an alkaline stabilizing agent; and, d) an outer enteric layer. The present invention also provides a method of preparing the same.
PCT/US2005/006589 2004-03-03 2005-03-02 A stable pharmaceutical composition comprising an acid labile drug WO2005092297A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2007501900A JP2007526319A (en) 2004-03-03 2005-03-02 Stable pharmaceutical composition comprising an acid labile drug
MXPA06009991A MXPA06009991A (en) 2004-03-03 2005-03-02 A stable pharmaceutical composition comprising an acid labile drug.
EP05724184A EP1720527A2 (en) 2004-03-03 2005-03-02 A stable pharmaceutical composition comprising an acid labile drug
CA002558535A CA2558535A1 (en) 2004-03-03 2005-03-02 A stable pharmaceutical composition comprising an acid labile drug
IL177869A IL177869A0 (en) 2004-03-03 2006-09-03 A stable pharmaceutical composition comprising an acid labile drug

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US54965304P 2004-03-03 2004-03-03
US60/549,653 2004-03-03

Publications (2)

Publication Number Publication Date
WO2005092297A2 WO2005092297A2 (en) 2005-10-06
WO2005092297A3 true WO2005092297A3 (en) 2006-10-12

Family

ID=34961526

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/006589 WO2005092297A2 (en) 2004-03-03 2005-03-02 A stable pharmaceutical composition comprising an acid labile drug

Country Status (8)

Country Link
US (2) US20050214372A1 (en)
EP (1) EP1720527A2 (en)
JP (1) JP2007526319A (en)
CN (1) CN1964704A (en)
CA (1) CA2558535A1 (en)
IL (1) IL177869A0 (en)
MX (1) MXPA06009991A (en)
WO (1) WO2005092297A2 (en)

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Also Published As

Publication number Publication date
WO2005092297A2 (en) 2005-10-06
MXPA06009991A (en) 2007-04-10
CN1964704A (en) 2007-05-16
JP2007526319A (en) 2007-09-13
IL177869A0 (en) 2006-12-31
US20050214371A1 (en) 2005-09-29
EP1720527A2 (en) 2006-11-15
US20050214372A1 (en) 2005-09-29
CA2558535A1 (en) 2005-10-06

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