COMPARATIVE STUDY OF DICLOFENAC SODIUM, ACETAMINOPHEN AND THEIR COMBINATION FOR ENHANCED PAIN RELIEF

Abstract

This study introduces the detailed formulation, valuation, and analytical evaluation of topical ointment formulations prepared for the treatment of musculoskeletal conditions, mainly lower back pain and osteoarthritic pain. The research involves a blank ointment base (S Oint), Diclofenac Sodium Ointment (Dic Oint), Acetaminophen Ointment (Acet Oint), and a mixture formulation with both Diclofenac Sodium and Acetaminophen (AD Oint). All formulations were prepared with pharmaceutically acceptable excipients and underwent confirmatory analytical and physicochemical studies to ascertain their stability, compatibility, and appropriateness for topical therapeutic use. The assessment process involved pH testing, viscosity determination, spreadability determination, FTIR and UV spectroscopic testing, microbial limit tests, in vitro drug release studies by the Franz Diffusion Cell, and skin irritation testing. The AD Oint performed better in its spreadability (~99%), prolonged drug release (85%), and drug content uniformity (101.2%) than Dic Oint (99.4%) and Acet Oint (96.7%). FTIR spectra ensured drug–excipient compatibility with no indication of degradation. UV spectroscopy ensured successful incorporation and chemical stability of the APIs in all formulations. All ointments had pH values within the skin-compatible range (4.5–5.5), and no irritation was detected up to 72 hours after application. Of the four, the combination ointment (AD Oint) showed the best therapeutic potential and formulation quality, showed its efficacy and safety as a topical agent for local treatment of chronic inflammation and pain.