WO2003004008A3 - Pharmaceutical composition for prophylaxis and treatment of calcium metabolism disorders comprising clodronate in combination with glyceryl palmitostearate - Google Patents

Pharmaceutical composition for prophylaxis and treatment of calcium metabolism disorders comprising clodronate in combination with glyceryl palmitostearate Download PDF

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Publication number
WO2003004008A3
WO2003004008A3 PCT/RO2002/000017 RO0200017W WO03004008A3 WO 2003004008 A3 WO2003004008 A3 WO 2003004008A3 RO 0200017 W RO0200017 W RO 0200017W WO 03004008 A3 WO03004008 A3 WO 03004008A3
Authority
WO
WIPO (PCT)
Prior art keywords
prophylaxis
treatment
pharmaceutical composition
clodronate
metabolism disorders
Prior art date
Application number
PCT/RO2002/000017
Other languages
French (fr)
Other versions
WO2003004008A2 (en
Inventor
Lelia-Georgeta Lazar
Tincuta Dinu
Cornelia Stancu
Irinel Badea
Maria Rotaru
Veronica Draghici
Original Assignee
S C Sindan S R L
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 S C Sindan S R L filed Critical S C Sindan S R L
Priority to AU2002326251A priority Critical patent/AU2002326251A1/en
Priority to EP02760933A priority patent/EP1408934A2/en
Publication of WO2003004008A2 publication Critical patent/WO2003004008A2/en
Publication of WO2003004008A3 publication Critical patent/WO2003004008A3/en

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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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Rheumatology (AREA)
  • Epidemiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The object of the present invention is a pharmaceutical composition for oral use, in the form of hard gelatin capsules, which contains an excipient from the triglyceride class, for example atomized glyceryl palmitostearate, with double role, of lubricant and binder. The composition is used for the treatment and prophylaxis of calcium metabolism disorders, such as bone resorbtion, hypercalcemia and osteoporosis and contains as active ingredient a derivate of bisphosphonic acid, for example disodium clodronate. The active ingredient disodium clodronate tetrahydrate, granulated by fluidized bed method, is released from the preparation in a proportion of at least 75 % during the first 5 minutes and at least 95 % in 30 minutes.
PCT/RO2002/000017 2001-07-04 2002-07-02 Pharmaceutical composition for prophylaxis and treatment of calcium metabolism disorders comprising clodronate in combination with glyceryl palmitostearate WO2003004008A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2002326251A AU2002326251A1 (en) 2001-07-04 2002-07-02 Pharmaceutical composition for prophylaxis and treatment of calcium metabolism disorders comprising clodronate in combination with glyceryl palmitostearate
EP02760933A EP1408934A2 (en) 2001-07-04 2002-07-02 Pharmaceutical composition for prophylaxis and treatment of calcium metabolism disorders comprising clodronate in combination with glyceryl palmitostearate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RO01-00780 2001-07-04
ROA200100780A RO121891B1 (en) 2001-07-04 2001-07-04 Pharmaceutical composition for the prophylaxis and treatment of calcium metabolism disorders and process for preparing the same

Publications (2)

Publication Number Publication Date
WO2003004008A2 WO2003004008A2 (en) 2003-01-16
WO2003004008A3 true WO2003004008A3 (en) 2003-05-01

Family

ID=20129443

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RO2002/000017 WO2003004008A2 (en) 2001-07-04 2002-07-02 Pharmaceutical composition for prophylaxis and treatment of calcium metabolism disorders comprising clodronate in combination with glyceryl palmitostearate

Country Status (4)

Country Link
EP (1) EP1408934A2 (en)
AU (1) AU2002326251A1 (en)
RO (1) RO121891B1 (en)
WO (1) WO2003004008A2 (en)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995013054A1 (en) * 1993-11-12 1995-05-18 Leiras Oy Process for preparing a clodronate preparation

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE60711T1 (en) 1986-12-20 1991-02-15 Boehringer Mannheim Gmbh PHARMACEUTICALS CONTAINING CLODRONATE AND METHOD OF MANUFACTURE THE SAME.

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995013054A1 (en) * 1993-11-12 1995-05-18 Leiras Oy Process for preparing a clodronate preparation

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
"http://www.gattefosse.com/pharma/products/precirol.htm", INTERNET ARCHIVE, XP002225325, Retrieved from the Internet <URL:http://web.archive.org/web/*/http://www.gattefosse.com/pharma/products/precirol.htm> [retrieved on 20021217] *
"Precirol ato 5", GATTEFOSSE PRODUCT SHEET, 25 April 2001 (2001-04-25), XP002225324, Retrieved from the Internet <URL:http://web.archive.org/web/20010715051137/http://www.gattefosse.com/pharma/products/precirol.htm> [retrieved on 20021217] *
See also references of EP1408934A2 *

Also Published As

Publication number Publication date
EP1408934A2 (en) 2004-04-21
RO121891B1 (en) 2008-07-30
WO2003004008A2 (en) 2003-01-16
AU2002326251A1 (en) 2003-01-21

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