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WO2006100527A1 - Comprime effervescent contenant de l’alendronate sodique, utilisation et procede associes - Google Patents

Comprime effervescent contenant de l’alendronate sodique, utilisation et procede associes Download PDF

Info

Publication number
WO2006100527A1
WO2006100527A1 PCT/GR2005/000008 GR2005000008W WO2006100527A1 WO 2006100527 A1 WO2006100527 A1 WO 2006100527A1 GR 2005000008 W GR2005000008 W GR 2005000008W WO 2006100527 A1 WO2006100527 A1 WO 2006100527A1
Authority
WO
WIPO (PCT)
Prior art keywords
sodium
anhydrous
composition
alendronate
mixing
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.)
Ceased
Application number
PCT/GR2005/000008
Other languages
English (en)
Inventor
Ioulia Tseti
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.)
Uni Pharma Kleon Tsetis Pharmaceutical Laboratories SA
Original Assignee
Uni Pharma Kleon Tsetis Pharmaceutical Laboratories SA
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 Uni Pharma Kleon Tsetis Pharmaceutical Laboratories SA filed Critical Uni Pharma Kleon Tsetis Pharmaceutical Laboratories SA
Priority to PCT/GR2005/000008 priority Critical patent/WO2006100527A1/fr
Publication of WO2006100527A1 publication Critical patent/WO2006100527A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • 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
    • 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

Definitions

  • the present invention relates to the use of effervescent tablet of Sodium Alendronate for an oral osteoporosis treatment in post menopausal women.
  • the currently marketed formulation is a tablet and the patient is instructed to take the tablet with a full glass of water.
  • Many people suffer from gastrointestinal disorders and particularly from heartburn due to gastro-esophagical reflux.
  • the present invention is directed to a new pharmaceutical formulation comprising Sodium Alendronate in the form of effervescent tablet to be taken orally and offering a considerable advantage: avoidance of gastro-intestinal disorders, to the limits of the possible.
  • the effervescent tablet of the present invention comprises in addition to the agents producing effervescence a sufficient amount of buffer such that the pH of the obtained aqueous liquid is between approximately 5-7 and particularly 5,9, so that after ingestion the pH of the gastric juice (pH 1,2) raises to a pH of at least 4.
  • Another aspect of this invention is that the absorption of the active ingredient is faster when compared to tablet form; consequently an enhanced bioavailability of the active ingredient is probable.
  • Method of effervescent tablet preparation Method and process of the preparation of the effervescent tablets are performed in 2 main stages :
  • the effervescent tablet of the present invention is prepared by the following process comprising the steps of :
  • the effervescent tablet according to the invention has the following composition : Active ingredient
  • Lactose monohydrate 31 OOOmg PVP 30 (Povidone) 8,000mg

Landscapes

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

Abstract

La présente invention concerne un comprimé effervescent à usage buccal comprenant de l’alendronate sodique, destiné à traiter et prévenir l’ostéoporose chez les patients ayant du mal à avaler des comprimés classiques.
PCT/GR2005/000008 2005-03-24 2005-03-24 Comprime effervescent contenant de l’alendronate sodique, utilisation et procede associes Ceased WO2006100527A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/GR2005/000008 WO2006100527A1 (fr) 2005-03-24 2005-03-24 Comprime effervescent contenant de l’alendronate sodique, utilisation et procede associes

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/GR2005/000008 WO2006100527A1 (fr) 2005-03-24 2005-03-24 Comprime effervescent contenant de l’alendronate sodique, utilisation et procede associes

Publications (1)

Publication Number Publication Date
WO2006100527A1 true WO2006100527A1 (fr) 2006-09-28

Family

ID=34962994

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GR2005/000008 Ceased WO2006100527A1 (fr) 2005-03-24 2005-03-24 Comprime effervescent contenant de l’alendronate sodique, utilisation et procede associes

Country Status (1)

Country Link
WO (1) WO2006100527A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090317460A1 (en) * 2006-08-24 2009-12-24 Arrow International Limited Solid dosage form
FR2954320A1 (fr) * 2009-12-17 2011-06-24 Cll Pharma Composition pharmaceutique orale suprabiodisponible contenant un acide biphosphonique ou un de ses sels
CN105796595A (zh) * 2016-04-06 2016-07-27 海南师范大学 稀土阿伦膦酸盐在制备治疗骨质疏松症药物上的应用

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2153225A (en) * 1984-01-12 1985-08-21 Gentili Ist Spa Effervescent preparations containing diphosphonates
US5405994A (en) * 1992-08-05 1995-04-11 Sanofi Disodium 4-chlorophenylthiomethylenebisphosphonate monohydrate, its preparation and pharmaceutical compositions in which it is present
WO1995028936A1 (fr) * 1994-04-21 1995-11-02 Merck & Co., Inc. Emploi de biphosphonates inhibant la resorption osseuse consecutive a l'implantation d'une prothese orthopedique
WO1997044017A1 (fr) * 1996-05-17 1997-11-27 Merck & Co., Inc. Formulation de bisphosphonate efferverscente
WO2003086415A1 (fr) * 2002-04-05 2003-10-23 Merck & Co., Inc. Procede d'inhibition de resorption osseuse a l'aide d'une formulation a base d'alendronate et de vitamine d
WO2004035004A2 (fr) * 2002-10-17 2004-04-29 Effrx, Inc. Compositions effervescentes comprenant des bisphosphonates, et procedes correspondants

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2153225A (en) * 1984-01-12 1985-08-21 Gentili Ist Spa Effervescent preparations containing diphosphonates
US5405994A (en) * 1992-08-05 1995-04-11 Sanofi Disodium 4-chlorophenylthiomethylenebisphosphonate monohydrate, its preparation and pharmaceutical compositions in which it is present
WO1995028936A1 (fr) * 1994-04-21 1995-11-02 Merck & Co., Inc. Emploi de biphosphonates inhibant la resorption osseuse consecutive a l'implantation d'une prothese orthopedique
WO1997044017A1 (fr) * 1996-05-17 1997-11-27 Merck & Co., Inc. Formulation de bisphosphonate efferverscente
WO2003086415A1 (fr) * 2002-04-05 2003-10-23 Merck & Co., Inc. Procede d'inhibition de resorption osseuse a l'aide d'une formulation a base d'alendronate et de vitamine d
WO2004035004A2 (fr) * 2002-10-17 2004-04-29 Effrx, Inc. Compositions effervescentes comprenant des bisphosphonates, et procedes correspondants

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090317460A1 (en) * 2006-08-24 2009-12-24 Arrow International Limited Solid dosage form
US8697124B2 (en) * 2006-08-24 2014-04-15 Arrow International Limited Solid dosage form of coated bisphosphonate particles
US10420725B2 (en) 2006-08-24 2019-09-24 Allergan Pharmaceuticals International Limited Solid dosage form of coated bisphosphonate particles
FR2954320A1 (fr) * 2009-12-17 2011-06-24 Cll Pharma Composition pharmaceutique orale suprabiodisponible contenant un acide biphosphonique ou un de ses sels
WO2011080413A1 (fr) * 2009-12-17 2011-07-07 Cll Pharma Composition pharmaceutique orale solide suprabiodisponible contenant un acide biphosphonique ou un de ses sels
CN105796595A (zh) * 2016-04-06 2016-07-27 海南师范大学 稀土阿伦膦酸盐在制备治疗骨质疏松症药物上的应用

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