ES2530791T3 - Formulación de ibandronato de altas dosis - Google Patents

Formulación de ibandronato de altas dosis Download PDF

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Publication number
ES2530791T3
ES2530791T3 ES07005463T ES07005463T ES2530791T3 ES 2530791 T3 ES2530791 T3 ES 2530791T3 ES 07005463 T ES07005463 T ES 07005463T ES 07005463 T ES07005463 T ES 07005463T ES 2530791 T3 ES2530791 T3 ES 2530791T3
Authority
ES
Spain
Prior art keywords
weight
ibandronate
high dose
active substance
dose formulation
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 - Lifetime
Application number
ES07005463T
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English (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
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Filing date
Publication date
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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=ES2530791(T3) "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 filed Critical F Hoffmann La Roche AG
Application granted granted Critical
Publication of ES2530791T3 publication Critical patent/ES2530791T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)
  • Materials For Medical Uses (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Abstract

Un comprimido que contiene como sustancia activa hasta 250 mg de bisfosfonatos o sales o hidratos fisiológicamente seguros del mismo para aplicación oral en donde el grano de comprimido consiste en 30,0 a 36,0 % de sustancia activa 4,0 a 6,0% por peso de enlazante; 39,6 a 59,4 por peso de relleno; 4,5 a 5,5% por peso de desintegrante; 1,8 a 2,2% por peso de lubricante; y 0,9 a 1,1% por peso de regulador de flujo, caracterizado porque el desintegrante se adiciona en el granulado junto con la sustancia activa y con una parte del material de relleno.
ES07005463T 2002-12-20 2003-08-07 Formulación de ibandronato de altas dosis Expired - Lifetime ES2530791T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP02028745 2002-12-20

Publications (1)

Publication Number Publication Date
ES2530791T3 true ES2530791T3 (es) 2015-03-05

Family

ID=32524013

Family Applications (2)

Application Number Title Priority Date Filing Date
ES03813545T Expired - Lifetime ES2291749T5 (es) 2002-12-20 2003-08-07 Formulación de altas dosis de ibandronato.
ES07005463T Expired - Lifetime ES2530791T3 (es) 2002-12-20 2003-08-07 Formulación de ibandronato de altas dosis

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES03813545T Expired - Lifetime ES2291749T5 (es) 2002-12-20 2003-08-07 Formulación de altas dosis de ibandronato.

Country Status (36)

Country Link
US (1) US7923028B2 (es)
EP (2) EP1596870B2 (es)
JP (1) JP4427453B2 (es)
KR (1) KR100694550B1 (es)
CN (1) CN1649598B (es)
AR (2) AR037560A1 (es)
AT (1) ATE369139T1 (es)
AU (1) AU2003250218B2 (es)
BR (1) BR0309691A (es)
CA (1) CA2484494C (es)
CR (1) CR7549A (es)
CY (2) CY1107757T1 (es)
DE (1) DE60315514T3 (es)
DK (2) DK1790347T3 (es)
EC (1) ECSP045418A (es)
EG (1) EG26027A (es)
ES (2) ES2291749T5 (es)
HK (1) HK1080714A1 (es)
HR (1) HRP20041013B1 (es)
IL (2) IL164956A (es)
JO (1) JO2663B1 (es)
MX (1) MXPA04010866A (es)
MY (1) MY143550A (es)
NO (1) NO329690B1 (es)
NZ (2) NZ536273A (es)
PA (1) PA8580601A1 (es)
PE (1) PE20040416A1 (es)
PL (1) PL212072B1 (es)
PT (2) PT1790347E (es)
RU (1) RU2315603C2 (es)
SG (1) SG174628A1 (es)
SI (2) SI1790347T1 (es)
TW (1) TWI342215B (es)
UY (1) UY27942A1 (es)
WO (1) WO2004056373A1 (es)
ZA (1) ZA200408822B (es)

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