Formulation and Optimization of Fast Mouth Dissolving Tablet of Clozapine Using QbD Approach
Year: 2026
Type: article
Abstract: In the current investigations, mouth dissolving tablets (MDT) of clozapine were developed by applying the quality by design (QbD) approach. Clozapine, an atypical antipsychotic, is widely recognized as the gold standard for treatmentresistant schizophrenia, yet its clinical utility is often limited by poor patient compliance due to swallowing difficulties and delayed onset of action with conventional dosage forms. To address these challenges, the direct compression method was employed for the preparation of MDT containing clozapine using a 3² factorial design, with the quantity of drug, microcrystalline cellulose (MCC), and crosscarmellose sodium (CCS) as dependent variables. MCC and CCS were incorporated as superdisintegrants, while sodium stearyl fumarate was used as a lubricant. The developed MDT were evaluated for critical characteristics such as hardness, friability, disintegration time (DT), and in vitro drug release. Design Expert 11.0 adequately described the impact of selected variables (MCC and CCS) at various levels on the responses under study (DT and friability). The optimized batch demonstrated a disintegration time of 15–28 seconds, friability within 1%, and in vitro drug release of 75–98% after 30 minutes. Such rapid disintegration and release profiles are particularly advantageous for clozapine, as they may enhance onset of therapeutic action, improve patient adherence, and facilitate administration in individuals with swallowing difficulties—a common concern in psychiatric populations.
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W7155494841