European Journal of Biomedical and Pharmaceutical Sciences

FORMULATION DEVELOPMENT AND EVALUATION OF OXYMORPHONE HCL SOFT GELATIN CAPSULES

S. Gumudavelli*

ABSTRACT

The objective of this work is to develop simple, elegant, liquid-filled immediate release soft gelatin capsules containing Oxymorphone HCl intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The present work describes the design of formulation and manufacturing process of Oxymorphone HCl 30 mg capsules. Manufacturing of Oxymorphone HCl Capsules, 30 mg, consists of two concurrent manufacturing processes: gel mass and fill material, which converge during the encapsulation process. Capsule fill material was formulated using tartaric acid and low molecular polyethylene glycol 400 matrix system. The gel mass was prepared in gelatin as shell forming material, and glycerin was used as plasticizer at a 1: 0.5 ratio. The prepared soft gelatin capsules were evaluated for water content in fill material, loss on drying of shell, weight variation, burst strength, assay, and dissolution. The capsules had a fill weight of 350 mg, disintegration time less than 10 minutes, and drug release rate >95% in 20 minutes. Furthermore, Texture analysis showed the capsules had burst strength of 145.0 N with an elasticity value of 3.03 mm. With this we, conclude that Oxymorphone HCl immediate release soft gelatin capsules can be manufactured at commercial scale with similar composition and improved quality attributes of other existing solid dosage forms such as tablets.

Keywords: Oxymorphone HCl, Soft Gelatin Capsules, Encapsulation.