FORMULATION AND EVALUATION OF SOLID DISPERSED SUBLINGUAL FILMS OF RILPIVIRINE HYDROCHLORIDE

Devmurari Rutvikbhai Jagdishbhai*, Bhavana A. Patel

ABSTRACT

The results of this study demonstrate that Pullulan can be effectively used as a film-forming polymer, with PEG 400 serving as a plasticizer for the formulation of fast- dissolving sublingual films containing Rilpivirine Hydrochloride. The optimized batch exhibited acceptable mechanical properties, along with an in-vitro disintegration time of 33 seconds. A drug release study was conducted across 9 batches to identify the best polymer and plasticizer combination. Among all batches, T1, which used Pullulan and PEG 400, showed more than 85% drug release within 15 minutes. Based on the trial batch results, a factorial design approach was employed for formulation optimization, with Pullulan and PEG 400 selected as independent factors. Pullulan and PEG 400 were chosen for further formulation optimization using a 32 full factorial design, revealing that increasing the amounts of Pullulan and PEG 400 increased folding endurance and disintegration time, while decreasing drug release. The optimized batch, O1, exhibited acceptable mechanical properties with an in-vitro disintegration time of 28 seconds, indicating suitability for immediate release of Rilpivirine for systemic use due to its maximum drug release. Stability studies of batch O1 was performed and found satisfactory. Hence, O1 batch is optimized batch.

Keywords: Rilpivirine Hydrochloride, Pullulan, PEG 400.