Abstract

The objective of the present study was to develop film forming polymeric solution for the topical release of diclofenac sodium through the skin. A film forming polymeric solution of diclofenac sodium was prepared by using hydroxypropyl methylcellulose E5, hydroxypropyl methylcellulose E15 and hydroxypropyl methylcellulose E50 as a film forming polymer in different concentrations and dibutyl phthalate used as plasticizer. The prepared solution was tested for pH, viscosity, drying time, outward stickiness, thickness, weight uniformity, folding endurance, drug content uniformity followed by in vitro diffusion study. All the formulations showed the results within acceptable range for various tests. Formulations exhibited pH within the range of 5.7 to 6.1. Drying time of all the formulation ranged between 12±0.6 to 21±0.6 min. It was observed that formulation F1-F4 showed low outward stickiness, F5 and F6 showed medium, F7 to F9 showed high outward stickiness. The weight, thickness and folding endurance of the films were found to be consistent. Percentage cumulative drug release was found to be in the range of 72.05±0.4 to 93.35±13. Formulation F3 showed shortest drying time of 12 min, low outward stickiness, controlled drug release 88.14±2.46 % up to 6 h compared to the other formulations. Hence it was selected has optimized formulation. Kinetics study revealed that drug release from the polymeric solution followed non-Fickian. It can be concluded that topical film forming solution of diclofenac sodium formulated with hydroxypropyl methylcellulose E5, hydroxypropyl methylcellulose E15 and hydroxypropyl methylcellulose E50 as a film forming polymers, appears to be a promising option for the treatment of pain and inflammation.