Khan, Jiyauddin
(2010)
Development And Evaluation Of Matrix Controlled Release Formulations Of Ketoprofen.
PhD thesis, Universiti Sains Malaysia.
Abstract
The present study was conducted to investigate the suitability of various hydrophilic
and hydrophobic polymers or their combination, as matrix forming materials for the
development of a controlled release tablet formulation of ketoprofen with in vitro
and in vivo performance comparable to that of the marketed preparation Apo-Keto
SR® tablets. In this regard a number of matrix controlled release formulations of
ketoprofen tablets were developed using different hydrophilic, hydrophobic and
mixtures of both polymeric materials. All the formulations were prepared by direct
compression method. Their in vitro dissolution profiles were compared to that of the
commercially available reference product Apo-Keto SR® tablet. Similarity factor (f2),
values between test formulations and reference product were also calculated to select
the optimum formulation. Out of all the matrix formulations studied, tablets
containing 20% HPC (GXF) as matrix former showed comparable dissolution profile
to that of the reference. The f2 value between reference and matrix tablets with 20%
HPC (GXF) was 78.0%, and hence it was selected for further investigation. The drug
release from reference and matrix with 20% HPC (GXF) formulation was governed
by both diffusion and erosion (anomalous) mechanism as per Korsmeyer-Peppas
equation. Moreover, the optimized formulation was found to be stable for a period of
12 months upon storage at 25ºC of room temperature for a long term of stability.
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