WO2005032513A3 - Pantoprazole multiparticulate formulations - Google Patents

Pantoprazole multiparticulate formulations Download PDF

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Publication number
WO2005032513A3
WO2005032513A3 PCT/US2004/033058 US2004033058W WO2005032513A3 WO 2005032513 A3 WO2005032513 A3 WO 2005032513A3 US 2004033058 W US2004033058 W US 2004033058W WO 2005032513 A3 WO2005032513 A3 WO 2005032513A3
Authority
WO
WIPO (PCT)
Prior art keywords
coat
pantoprazole
hypromellose
multiparticulate formulations
multiparticulates
Prior art date
Application number
PCT/US2004/033058
Other languages
French (fr)
Other versions
WO2005032513A2 (en
Inventor
Ramana Rao Sripriya Venkata
Syed M Shah
Hanumantharao Tatapudy
Richard William Saunders
Mahdi Fawzi
Arwinder Nagi
Shailesh Singh
Sumon A Hasan
Original Assignee
Wyeth Corp
Ramana Rao Sripriya Venkata
Syed M Shah
Hanumantharao Tatapudy
Richard William Saunders
Mahdi Fawzi
Arwinder Nagi
Shailesh Singh
Sumon A Hasan
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=34421667&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2005032513(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to EP04789540.4A priority Critical patent/EP1667660B1/en
Priority to YUP-2006/0238A priority patent/RS20060238A/en
Priority to AU2004278037A priority patent/AU2004278037B2/en
Priority to US10/574,210 priority patent/US7838027B2/en
Priority to JP2006534330A priority patent/JP4789806B2/en
Priority to ES04789540.4T priority patent/ES2529570T3/en
Priority to UAA200604671A priority patent/UA83255C2/en
Priority to PL04789540T priority patent/PL1667660T3/en
Priority to BRPI0415014A priority patent/BRPI0415014A8/en
Application filed by Wyeth Corp, Ramana Rao Sripriya Venkata, Syed M Shah, Hanumantharao Tatapudy, Richard William Saunders, Mahdi Fawzi, Arwinder Nagi, Shailesh Singh, Sumon A Hasan filed Critical Wyeth Corp
Priority to RS20060238A priority patent/RS54699B1/en
Priority to CN200480035251.8A priority patent/CN1886119B/en
Priority to CA2539982A priority patent/CA2539982C/en
Priority to MXPA06003602 priority patent/MX266708B/en
Priority to KR1020067008414A priority patent/KR101141508B1/en
Priority to ZA2006/02682A priority patent/ZA200602682B/en
Publication of WO2005032513A2 publication Critical patent/WO2005032513A2/en
Publication of WO2005032513A3 publication Critical patent/WO2005032513A3/en
Priority to IL174432A priority patent/IL174432A/en
Priority to NO20061471A priority patent/NO339714B1/en
Priority to HK06109106.6A priority patent/HK1086766A1/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
    • 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
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic 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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Abstract

Pantoprazole sodium multiparticulates are described which avoid sticking to nasogastric and gastronomy tubes. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a distintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose (hypromellose) and water, an enteric coat on the sub-coat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose (hypromellose) and water.
PCT/US2004/033058 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations WO2005032513A2 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
ZA2006/02682A ZA200602682B (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
CN200480035251.8A CN1886119B (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
RS20060238A RS54699B1 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
CA2539982A CA2539982C (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
YUP-2006/0238A RS20060238A (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
ES04789540.4T ES2529570T3 (en) 2003-10-01 2004-09-30 Multiparticulate formulations of pantoprazole
UAA200604671A UA83255C2 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
PL04789540T PL1667660T3 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
BRPI0415014A BRPI0415014A8 (en) 2003-10-01 2004-09-30 PANTOPRAZOLE MULTIPARTICLE FORMULATIONS, CAPSULES AND PACKAGING THAT COMPRISE THEM, METHOD OF PRODUCTION OF THE FORMULATIONS, USE AND COMPOSITION
EP04789540.4A EP1667660B1 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
AU2004278037A AU2004278037B2 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
JP2006534330A JP4789806B2 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulation
US10/574,210 US7838027B2 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
MXPA06003602 MX266708B (en) 2003-10-01 2004-09-30 FORMULATIONS OF PANTOPRAZOL MICROPARTICLES.
KR1020067008414A KR101141508B1 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations
IL174432A IL174432A (en) 2003-10-01 2006-03-21 Pantoprazole multiparticulate formulations
NO20061471A NO339714B1 (en) 2003-10-01 2006-03-31 Multiparticle pantoprazole and its use
HK06109106.6A HK1086766A1 (en) 2003-10-01 2006-08-16 Pantoprazole multiparticulate formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US50781003P 2003-10-01 2003-10-01
US60/507,810 2003-10-01

Publications (2)

Publication Number Publication Date
WO2005032513A2 WO2005032513A2 (en) 2005-04-14
WO2005032513A3 true WO2005032513A3 (en) 2005-08-18

Family

ID=34421667

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/033058 WO2005032513A2 (en) 2003-10-01 2004-09-30 Pantoprazole multiparticulate formulations

Country Status (29)

Country Link
US (4) US7544370B2 (en)
EP (1) EP1667660B1 (en)
JP (1) JP4789806B2 (en)
KR (1) KR101141508B1 (en)
CN (1) CN1886119B (en)
AR (1) AR045956A1 (en)
AU (1) AU2004278037B2 (en)
BR (1) BRPI0415014A8 (en)
CA (1) CA2539982C (en)
CO (1) CO5690538A2 (en)
CR (1) CR8318A (en)
EC (1) ECSP066538A (en)
ES (1) ES2529570T3 (en)
GT (1) GT200400194A (en)
HK (1) HK1086766A1 (en)
IL (1) IL174432A (en)
MX (1) MX266708B (en)
MY (1) MY147180A (en)
NO (1) NO339714B1 (en)
NZ (1) NZ581267A (en)
PE (1) PE20050960A1 (en)
PL (1) PL1667660T3 (en)
RS (2) RS54699B1 (en)
RU (1) RU2361574C2 (en)
SG (1) SG146656A1 (en)
TW (1) TWI372066B (en)
UA (1) UA83255C2 (en)
WO (1) WO2005032513A2 (en)
ZA (1) ZA200602682B (en)

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