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Novel low dose pharmaceutical compositions comprising nimesulide, preparation and use thereof

A low-dose, solvate technology, applied in the field of preparation of this dosage form, can solve the problems of poor water solubility and wettability

Inactive Publication Date: 2009-05-13
PANACEA BIOTEC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The poor water solubility and wettability of the drug poses problems for the preparation of drug formulations with good release and invariable bioavailability

Method used

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  • Novel low dose pharmaceutical compositions comprising nimesulide, preparation and use thereof
  • Novel low dose pharmaceutical compositions comprising nimesulide, preparation and use thereof
  • Novel low dose pharmaceutical compositions comprising nimesulide, preparation and use thereof

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Embodiment Construction

[0022] Nimesulide is routinely administered as 100-200 mg tablets or capsules twice a day, or as a 50 mg / ml suspension for the treatment of inflammatory conditions, pain, arthritis and the like. High dose compositions of nimesulide are associated with dose-related side effects such as gastric or hepatotoxicity, even some heart diseases or any other condition due to enzymatic inhibition of cyclooxygenase. The inventors attempted to reduce or at least alleviate the dose-related side effects associated with nimesulide by reducing the normally administered dose of nimesulide. In addition, low dose compositions have improved solubility, thus improved bioavailability, and are easier to formulate. In addition, the novel composition requires a smaller amount of excipients and therefore has a smaller size than conventionally available dosage forms, which in turn leads to better acceptance by patients. Preferably, the compositions of the present invention do not require the use of any ...

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Abstract

Low dose pharmaceutical dosage form comprising nimesulide or its pharmaceutically acceptable salts, esters, solvates or hydrates thereof, along with one or more pharmaceutically acceptable excipient(s) are provided. The present invention also provides process of preparing such dosage forms and therapeutic methods of using such dosage forms. The low dose compositions 10 are designed to exhibit such bioavailability, which is effective in the treatment of NSAID indicated disorders particularly, which require long-term treatment regimens such as arthritis. Such compositions reduce the cost of therapy in diseases, which require long-term therapies, are easy to manufacture, and also result in the reduction of dose related side effects associated with nimesulide therapy.

Description

technical field [0001] The present invention relates to a novel low-dose pharmaceutical dosage form comprising nimesulide or a pharmaceutically acceptable salt, ester, prodrug, solvate, hydrate or derivative thereof and one or more pharmaceutically acceptable excipients. The invention also provides methods of making such dosage forms and methods of treatment using such dosage forms. The low dose compositions are intended to demonstrate effective bioavailability in the treatment of NSAID indications, especially in treatments requiring long-term treatment regimens such as arthritis. The composition reduces the cost of treatment for diseases requiring long-term treatment, is easy to manufacture, and also leads to a reduction in dose-related side effects associated with nimesulide treatment. Background technique [0002] Cyclooxygenase-1 (COX-1) is an enzyme commonly found in various areas of the body, including inflammatory and gastric sites. The COX-1 enzyme of the stomach p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/18A61K31/085
CPCA61K9/0019A61K9/2866A61K31/18A61K9/4858A61K9/0095A61K9/2018A61K9/2846A61K9/485A61P25/00A61P29/00A61P43/00A61K31/085
Inventor 拉杰什·贾殷库尔·昌德·吉恩达尔
Owner PANACEA BIOTEC
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