CA2362757A1 - Effervescent pharmaceutical formulation containing metamizole - Google Patents

Effervescent pharmaceutical formulation containing metamizole Download PDF

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Publication number
CA2362757A1
CA2362757A1 CA002362757A CA2362757A CA2362757A1 CA 2362757 A1 CA2362757 A1 CA 2362757A1 CA 002362757 A CA002362757 A CA 002362757A CA 2362757 A CA2362757 A CA 2362757A CA 2362757 A1 CA2362757 A1 CA 2362757A1
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
effervescent formulation
effervescent
metamizole
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.)
Granted
Application number
CA002362757A
Other languages
French (fr)
Other versions
CA2362757C (en
Inventor
Brigitte Freudensprung
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.)
Hexal AG
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2362757A1 publication Critical patent/CA2362757A1/en
Application granted granted Critical
Publication of CA2362757C publication Critical patent/CA2362757C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007Effervescent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4151,2-Diazoles
    • A61K31/41521,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The invention relates to a stable pharmaceutical effervescent formulation wi th metamizol and/or its pharmaceutically acceptable salts as active ingredients , wherein the pH of the corresponding solution is acidic.

Claims (15)

claims
1. ~A pharmaceutical composition in the form of an effervescent formulation, characterized by metamizole and/or its pharmaceutically acceptable salts as active ingredients.
2. ~A pharmaceutical composition in the form of an effervescent formulation as claimed in claim 1, characterized by alkali metal salts and/or ammonium salts of metamizole as active ingredients.
3. ~A pharmaceutical composition in the form of an effervescent formulation as claimed in claim 1 or 2, characterized by metamizole sodium monohydrate as active ingredient.
4. ~A pharmaceutical composition in the form of an effervescent formulation as claimed in any of the preceding claims, characterized by a content of 200-1 000 mg, in particular 400-600 mg, of metamizole and/or its pharmaceutically acceptable salts per dosage unit.
5. ~A pharmaceutical composition in the form of an effervescent formulation as claimed in claim 4, characterized by a content of 500 mg of metamizole sodium monohydrate per dosage unit.
6. ~A pharmaceutical composition in the form of an effervescent formulation as claimed in any of the preceding claims, characterized by an effervescent mixture of at least one physiologically tolerated acid or its sodium salt and of a physiologically tolerated carbonate and/or bicarbonate in ratios of amounts such that the resulting solution has a pH
of from 3 to 6.5, in particular of from 4 to 6, preferably of from 4.5 to 5.
7. A pharmaceutical composition in the form of an effervescent formulation as claimed in claim 6, characterized by citric acid or its monosodium salt is combination with sodium carbonate and sodium bicarbonate as effervescent mixture.
8. ~A pharmaceutical composition in the form of an effervescent formulation as claimed in any of the preceding claims, characterized in that the ratio by weight of the acid(s) to the carbonate and/or bicarbonate in the effervescent mixture is between 0.7 and 2.4, in particular between 1.1 and 2.2.
9.~A pharmaceutical composition in the form of an effervescent formulation as claimed in any of the preceding claims. characterised by an optional content of a sweetener.
l0. ~A pharmaceutical composition in the form of an effervescent formulation as claimed an any of the preceding claims, characterised by an optional content of a flavor.
11. ~A pharmaceutical composition in the form of an effervescent formulation as claimed in any of the preceding claims in the form of powder, tablets or granules, which can be packed in sachets, in particular in the form of tablets.
l2. ~A pharmaceutical composition in the form of an effervescent formulation, characterized by metamizole sodium monohydrate, sodium carbonate/sodium bicarbonate, tableting excipients, where appropriate flavorings and/or sweeteners, the resulting solution having a pH of 3-6.5, in particular of 4.5-5.
13. ~A pharmaceutical composition as claimed in claim 1-12, characterized in that the effervescent formulation is stable.
14. A pharmaceutical composition as claimed in claim 1-12, characterized in that the solution of the effervescent formulation is stable and clear for at least one hour.
15. A pharmaceutical composition as claimed in claim 13 or 14, characterized in that the effervescent formulation comprises no additional stabilizing substances.
CA2362757A 1999-02-11 2000-02-10 Effervescent pharmaceutical formulation containing metamizole Expired - Fee Related CA2362757C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19905581.5 1999-02-11
DE19905581 1999-02-11
PCT/EP2000/001096 WO2000047189A1 (en) 1999-02-11 2000-02-10 Pharmaceutical effervescent formulation containing metamizol

Publications (2)

Publication Number Publication Date
CA2362757A1 true CA2362757A1 (en) 2000-08-17
CA2362757C CA2362757C (en) 2010-08-24

Family

ID=7897089

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2362757A Expired - Fee Related CA2362757C (en) 1999-02-11 2000-02-10 Effervescent pharmaceutical formulation containing metamizole

Country Status (13)

Country Link
EP (1) EP1150660B1 (en)
JP (1) JP2002536401A (en)
AT (1) ATE258046T1 (en)
AU (1) AU777234B2 (en)
BR (1) BR0008442B1 (en)
CA (1) CA2362757C (en)
DE (1) DE50005076D1 (en)
ES (1) ES2215025T3 (en)
HU (1) HUP0200336A3 (en)
PL (1) PL201844B1 (en)
PT (1) PT1150660E (en)
TR (1) TR200102279T2 (en)
WO (1) WO2000047189A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103610656A (en) * 2013-12-05 2014-03-05 昆明振华制药厂有限公司 Preparation method of analgin tablet
CN104434862A (en) * 2014-11-06 2015-03-25 石家庄正大鸿福牧业有限公司 Veterinary metamizole sodium effervescent tablets and preparation method thereof
US20160317662A1 (en) * 2013-12-16 2016-11-03 Hypermarcas S.A. Stable oral pharmaceutical composition

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BG112443A (en) 2017-01-19 2018-07-31 Adifarm Ead Effervescent composition containing metamizole sodium monohydrate and preparation method
EP3928766A1 (en) 2020-06-26 2021-12-29 Usso Barnas Pharmaceutical composition and use thereof

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DD41306A (en) *
JPS52156915A (en) * 1976-06-19 1977-12-27 Hokuriku Pharmaceutical Production of stable injection without blood solubulizing property
IT1265342B1 (en) * 1993-07-19 1996-11-22 Iscofar S A S Di Paolo Ghirard PHARMACEUTICAL COMPOSITIONS BASED ON GLYCINE DERIVATIVES
DE59712694D1 (en) * 1997-04-18 2006-08-24 Fritz Stanislaus STABILIZED MEDICAMENT CONTAINING CYSTEINYL DERIVATIVES
DE19822036A1 (en) * 1998-05-15 1999-11-18 Bayer Ag Effervescent pharmaceutical composition with improved stability

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103610656A (en) * 2013-12-05 2014-03-05 昆明振华制药厂有限公司 Preparation method of analgin tablet
US20160317662A1 (en) * 2013-12-16 2016-11-03 Hypermarcas S.A. Stable oral pharmaceutical composition
CN104434862A (en) * 2014-11-06 2015-03-25 石家庄正大鸿福牧业有限公司 Veterinary metamizole sodium effervescent tablets and preparation method thereof

Also Published As

Publication number Publication date
HUP0200336A3 (en) 2005-04-28
BR0008442A (en) 2001-10-09
TR200102279T2 (en) 2001-11-21
ATE258046T1 (en) 2004-02-15
ES2215025T3 (en) 2004-10-01
EP1150660B1 (en) 2004-01-21
EP1150660A1 (en) 2001-11-07
HUP0200336A2 (en) 2002-06-29
DE50005076D1 (en) 2004-02-26
JP2002536401A (en) 2002-10-29
AU777234B2 (en) 2004-10-07
CA2362757C (en) 2010-08-24
BR0008442B1 (en) 2014-04-01
PT1150660E (en) 2004-06-30
PL350413A1 (en) 2002-12-02
PL201844B1 (en) 2009-05-29
WO2000047189A1 (en) 2000-08-17
AU2804000A (en) 2000-08-29

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MKLA Lapsed

Effective date: 20140211