International Journal of Drug Delivery Technology
Volume 14, Issue 3

Superporous Hydrogels as Super Disintegrants in Formulating Oral Disintegrating Tablets of Clozapine for the Treatment of Schizophrenia

Ramesh Babu Kota*, Saravanan Kaliyaperumal

Department of Pharmacy, Bhagwant Global University, Kotdwar, Uttarakhand, India. 

Received: 24th February, 2024; Revised: 28th March, 2024; Accepted: 10th August, 2024; Available Online: 25th September, 2024 

ABSTRACT

In this study, clozapine was formulated as orally disintegrating tablets (ODTs) using a direct compression method, incorporating super porous hydrogels as superdisintegrants. The disintegration time, hardness, friability, and stability of these ODT formulations were systematically evaluated, along with detailed dissolution profiles. Surprisingly, friability measurements revealed values below 1%. All tablet formulations disintegrated completely within 1 minute, meeting the 3-minute disintegration time criterion specified by the USP for ODTs. Moreover, over 85% of the labeled clozapine content was dissolved within 15 minutes from the ODTs. FTIR analysis indicated no interaction or alterations between the active ingredient and excipients. Consequently, the ODT formulations prepared using super porous hydrogels as superdisintegrants represent a promising strategy. This approach could significantly aid in the development and manufacturing of generic clozapine products.

Keywords: Clozapine, Superporous hydrogels, Oral disintegrating tablets, USP.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.3.66

How to cite this article: Kota RB, Kaliyaperumal S. Superporous Hydrogels as Super Disintegrants in Formulating Oral Disintegrating Tablets of Clozapine for the Treatment of Schizophrenia. International Journal of Drug Delivery Technology. 2024;14(3):1716-1721.

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