Formulation and Optimization of Controlled Release Naproxen Sodium Matrix Tablets Using Kollidon SR ®
by Mythri Kodidela
Developed under the guidance of:
Dr. Mali Gupta
Pharmaceutical Sciences
A controlled release (CR) dosage form is a system that can deliver a drug at a controlled rate for an extended period of time. However, it is challenging to manufacture a controlled release dosage form, using a soluble drug such as Naproxen sodium. The primary objective of the present study is to design a controlled release dosage form for Naproxen sodium that manifests a desirable drug release profile with thorough adherence to official monographs. Kollidon sustained release (SR) ® by itself can be used as a release retarding agent to formulate matrix tablets by direct compression. Due to the possibility of initial burst effect release with Kollidon SR® alone, HPMC K 15M may also be incorporated in small amounts into the matrix to modify the release of drug. Another objective is to study the effect of HPMC K15 M on the release of drug from Kollidon SR® matrix tablets. Dissolution studies will be carried out using a USP approved dissolution test method (USP II paddle method) using 900 mL phosphate buffer of pH 6.8 for 12 hours to study the drug release profiles. An optimized formulation will be chosen, manufactured and tested for compliance with USP and EP specifications. Manufactured matrix tablets will also be tested for their thickness, hardness, friability, weight variation and content uniformity.
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