FORMULATION AND EVALUATION OF HARD GELATIN CAPSULE OF POMALIDOMIDE

The present study was undertaken with the objective of formulating and evaluating hard gelatin capsules of Pomalidomide for oral drug delivery. Pomalidomide is an immunomodulatory agent used in the management of multiple myeloma and possesses challenging aqueous solubility characteristics, which may affect its dissolution and oral drug-release behaviour. The study focused on developing a suitable capsule formulation and evaluating its physicochemical and in vitro drug-release characteristics. Hard gelatin capsules containing Pomalidomide were prepared using suitable pharmaceutical excipients selected to provide satisfactory flow, filling, capsule integrity, and drug-release characteristics. The prepared formulations were evaluated for appearance, weight variation, dimensions, mechanical strength, friability, and in vitro dissolution. The optimized formulation showed a uniform appearance and satisfactory physical characteristics. The capsules exhibited satisfactory mechanical integrity. The in vitro dissolution study demonstrated a progressive increase in drug release with time. The optimized formulation showed 84.16% drug release at 30 min and 97.10 % at 45 min. Based on the overall evaluation, the optimized Pomalidomide hard gelatin capsule formulation exhibited satisfactory physical properties and reproducible in vitro drug-release characteristics. The developed formulation may therefore serve as a promising laboratory-scale approach for oral delivery of Pomalidomide. Further studies involving stability, scale-up, and in vivo evaluation are recommended to establish the formulation's long-term performance and suitability. Keywords: Pomalidomide; Hard gelatin capsule; Oral drug delivery; Formulation development; Dissolution; Drug release; Pharmaceutical evaluation; Weight variation; Mechanical strength.