Current Issues in Pharmacy and Medical Sciences · Published 2026-06-29 · DOI 10.12923/cipms-2026-0017
Bartłomiej Kubiak, Tomasz Bołtromiuk, Katarzyna Sulikowska, Maciej Gajda, Katarzyna Rudzińska, Łukasz Dobrzyński
This study presents the formulation and evaluation of orally disintegrating tablets (ODTs) containing high concentrations of micronized lurasidone hydrochloride, an atypical antipsychotic agent. The research focuses on optimizing two key material attributes: particle size distribution (PSD) and specific surface area (SSA). These optimizations enhance granulation performance and tablet quality. Fluidized-bed granulation was employed alongside dry coating techniques and various glidants to improve powder flowability and reduce cohesion. Comprehensive characterization included pre- and post-compression parameters such as visual evaluation, sieve analysis, weight variation, hardness, tensile strength, friability, disintegration, and dissolution testing. The results demonstrated that API batches with D50 > 3.5 µm achieved 85% drug release within 15 minutes. No significant differences were observed between formulations containing different glidants, indicating flexibility in excipient selection. These results underscore the importance of controlling PSD and SSA and employing effective dry coating and fluidization strategies to produce robust and reproducible ODTs. The developed tablets improve patient compliance and therapeutic efficacy for psychotic disorders and provide valuable insights for the future development of patient-friendly dosage forms.
Abstract from DOAJ. Public domain (CC0 1.0).
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Kubiak, B., Bołtromiuk, T., Sulikowska, K., et al. (2026). Formulation and evaluation of orally disintegrating tablet containing a high concentration of micronized Lurasidone. Current Issues in Pharmacy and Medical Sciences. https://doi.org/10.12923/cipms-2026-0017