STABILITY AND DISSOLUTION PROFILE OF TABLETS OF DICLOFENAC SODIUM DISPERSIONS WITH PARKIA BIGLOBOSA-DERIVED POLYMERS
Keywords:
Parkia biglobosa, Mucilage, Solid dispersion, Kneading, Direct compressionAbstract
Background: Solid dispersion techniques is a method of enhancing dissolution of poorly
water-soluble drug. The kneading method is a simple cost-effective way of preparing solid
dispersions. Formulating tablet of solid disperse drug is a means enhancing patient access and
acceptability of the product; using natural polymeric material like Parkia biglobosa derived
polymer can lead to a cost effective and biocompatible product.
Aim: This work aims to present solid dispersion of diclofenac sodium with Parkia biglobosa
derived polymeric material prepared by kneading technique as tablet and evaluate the stability
and tableting properties of the formed tablets.
Method: A direct compressible tablet was formulated using Avicel 101 as a direct
compressible excipient. The tablets were evaluated for their tableting properties and dissolution
testing in Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). The impact of
high temperature and long-time storage for six months on the stability of the formulation was
also evaluated.
Results: The tablets formulated were found to be of excellent tableting properties, agreeing
with official specifications. Tablets of the Modified Parkia biglobosa Mucilage (MPBM)
showed a 12% drug release in the SGF sustained for about one hour. This is a 2-fold
improvement in release profile compare to the diclofenac tablet formulated. The tablets
formulated with PBM, MPBM and Polyvinylpyrrolidone (PVP) polymers release more than
45% of diclofenac sodium within 15 mins in the SIF.
Conclusion: Formulated Tablets showed excellent tableting properties with MPBM-K tablet
showing a two-fold enhancement of the dissolution rate. The formulated tablets were stable at
45 0 C for 24 h and over a period of 6 months storage with no significant change in drug content
under these conditions with p-values of 0.201, 0.706, 0.611, 0.322 and 0.142, 0.787, 0.475 and
1.00 respectively which are greater than 0.05.