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Title:
PHARMACEUTICAL COMPOSITIONS COMPRISING PARACETAMOL AND PROCESS FOR PREPARING THE SAME
Document Type and Number:
WIPO Patent Application WO/2012/001494
Kind Code:
A3
Abstract:
Disclosed herein are injectable compositions containing high concentration of paracetamol or its pharmaceutically acceptable salts wherein the concentration of paracetamol or its pharmaceutically acceptable salt is >150mg/ml in a judiciously tailored solvent system comprising glycofurol, ethanol, water or a solvent system comprising glycofurol, ethanol, polyethylene glycol, water. The viscosity of the said injectables is <28 cps. Further disclosed is the process for preparing the said injectables. The injectables can be administered by intramuscular route, intravenous route or as intravenous infusion after diluting in one of the routinely used intravenous fluids, infusion solutions of antibacterial, antifungal and amoebicidal drugs and along with anxiolytics (Midazolam injection ) or narcotic analgesics (Fentanyl Citrate injection etc) as they remain stable, clear and transparent atleast for 6 hours after dilution.

Inventors:
PATEL KETAN R (IN)
PATEL MILAN R (IN)
SHAH PRAKASHCHANDRA J (IN)
Application Number:
PCT/IB2011/001519
Publication Date:
May 18, 2012
Filing Date:
June 29, 2011
Export Citation:
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Assignee:
TROIKAA PHARMACEUTICALS LTD (IN)
PATEL KETAN R (IN)
PATEL MILAN R (IN)
SHAH PRAKASHCHANDRA J (IN)
International Classes:
A61K9/00; A61K31/167; A61K9/08; A61K47/10; A61K47/22
Domestic Patent References:
WO2000007588A12000-02-17
WO2001008662A12001-02-08
WO2009047634A22009-04-16
Foreign References:
US6028222A2000-02-22
Other References:
VROMANS H ET AL: "Effect of solvents on rectal absorption rate of paracetamol in man: an in vitro approach", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER BV, NL, vol. 26, no. 1-2, 1 September 1985 (1985-09-01), pages 5 - 13, XP025499140, ISSN: 0378-5173, [retrieved on 19850901], DOI: 10.1016/0378-5173(85)90195-4
DATABASE CA [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; CHIMANLAL, SHAH ARUN ET AL: "A pharmaceutical formulation for paracetamol injection", XP002671423, retrieved from STN Database accession no. 2010:279099
Attorney, Agent or Firm:
NAIR, Manoj, Vasudevan et al. (709/710 Tolstoy House,15-17 Tolstoy Marg, New Delhi 1, IN)
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