CA2484494A1 - High dose ibandronate formulation - Google Patents

High dose ibandronate formulation Download PDF

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Publication number
CA2484494A1
CA2484494A1 CA002484494A CA2484494A CA2484494A1 CA 2484494 A1 CA2484494 A1 CA 2484494A1 CA 002484494 A CA002484494 A CA 002484494A CA 2484494 A CA2484494 A CA 2484494A CA 2484494 A1 CA2484494 A1 CA 2484494A1
Authority
CA
Canada
Prior art keywords
high dose
formulation
ibandronate formulation
dose ibandronate
bisphosphonates
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.)
Granted
Application number
CA002484494A
Other languages
French (fr)
Other versions
CA2484494C (en
Inventor
Hans-G. Kaestle
Bernard Meyer
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.)
F Hoffmann La Roche AG
Original Assignee
F. Hoffmann-La Roche Ag
Hans-G. Kaestle
Bernard Meyer
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=32524013&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2484494(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by F. Hoffmann-La Roche Ag, Hans-G. Kaestle, Bernard Meyer filed Critical F. Hoffmann-La Roche Ag
Publication of CA2484494A1 publication Critical patent/CA2484494A1/en
Application granted granted Critical
Publication of CA2484494C publication Critical patent/CA2484494C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis

Abstract

The invention relates to a high dose oral formulation of bisphosphonates and to a process for the preparation of such formulations.
CA002484494A 2002-12-20 2003-08-07 High dose ibandronate formulation Expired - Fee Related CA2484494C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP02028745.4 2002-12-20
EP02028745 2002-12-20
PCT/EP2003/008732 WO2004056373A1 (en) 2002-12-20 2003-08-07 High dose ibandronate formulation

Publications (2)

Publication Number Publication Date
CA2484494A1 true CA2484494A1 (en) 2004-07-08
CA2484494C CA2484494C (en) 2009-05-12

Family

ID=32524013

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002484494A Expired - Fee Related CA2484494C (en) 2002-12-20 2003-08-07 High dose ibandronate formulation

Country Status (36)

Country Link
US (1) US7923028B2 (en)
EP (2) EP1596870B2 (en)
JP (1) JP4427453B2 (en)
KR (1) KR100694550B1 (en)
CN (1) CN1649598B (en)
AR (2) AR037560A1 (en)
AT (1) ATE369139T1 (en)
AU (1) AU2003250218B2 (en)
BR (1) BR0309691A (en)
CA (1) CA2484494C (en)
CR (1) CR7549A (en)
CY (2) CY1107757T1 (en)
DE (1) DE60315514T3 (en)
DK (2) DK1790347T3 (en)
EC (1) ECSP045418A (en)
EG (1) EG26027A (en)
ES (2) ES2291749T5 (en)
HK (1) HK1080714A1 (en)
HR (1) HRP20041013B1 (en)
IL (2) IL164956A (en)
JO (1) JO2663B1 (en)
MX (1) MXPA04010866A (en)
MY (1) MY143550A (en)
NO (1) NO329690B1 (en)
NZ (2) NZ536273A (en)
PA (1) PA8580601A1 (en)
PE (1) PE20040416A1 (en)
PL (1) PL212072B1 (en)
PT (2) PT1596870E (en)
RU (1) RU2315603C2 (en)
SG (1) SG174628A1 (en)
SI (2) SI1596870T2 (en)
TW (1) TWI342215B (en)
UY (1) UY27942A1 (en)
WO (1) WO2004056373A1 (en)
ZA (1) ZA200408822B (en)

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CN102000094B (en) * 2010-09-27 2013-03-27 天津南开允公医药科技有限公司 Ibandronic acid-containing medicinal composition and preparation process thereof
KR101244414B1 (en) * 2010-11-05 2013-03-18 주식회사 바이오파마티스 A composition for treating or preventing osteoporosis comprising ibandronic acid and a method of preparing the same
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US9854831B2 (en) * 2012-01-20 2018-01-02 Altria Client Services Llc Oral product
WO2017208070A1 (en) 2016-05-31 2017-12-07 Grünenthal GmbH Bisphosphonic acid and coformers with lysin, glycin, nicotinamide for treating psoriatic arthritis

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