Abstract
FORMULATION DEVELOPMENT OF OXYCODONE 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 Oxycodone 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 Oxycodone HCl 30 mg capsules. Manufacturing of oxycodone 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 citric acid and high molecular polyethylene glycol 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 300 mg, disintegration time less than 5 minutes, and drug release rate >85% in 15 minutes. Furthermore, Texture analysis showed the capsules had burst strength of 125.0 N with an elasticity value of 2.23 mm. With this we, conclude that oxycodone 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: Oxycodone HCl, Soft Gelatin Capsules, Encapsulation.


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