Development and pharmacokinetic evaluation of granisetron hydrochloride buccal tablets for optimized chemotherapy-induced nausea and vomiting (CINV) relief.

INTRODUCTION

Chemotherapy-induced nausea and vomiting (CINV) limits treatment adherence; this study aimed to develop optimized Granisetron hydrochloride buccal tablets to improve therapeutic performance and bioavailability.

METHODS

Tablets were prepared by direct compression and optimized using response surface methodology with HPMC K4M (X1) and carbomer 934P (X2). Compatibility was assessed by FT-IR and DSC, while mucoadhesion, t50, drug release, kinetics, and pharmacokinetics were evaluated.

RESULTS

No drug-excipient interactions were observed. The optimized formulation (F3; 50 mg HPMC K4M and 15 mg carbomer 934P) showed adequate mucoadhesion (8.25 ± 0.12 g), prolonged release (t50 ≈ 323 ± 0.35 min), and 70.23% ± 2.14% release at 8 h. Release followed the korsmeyer-peppas model, indicating anomalous transport. Pharmacokinetic studies showed significantly higher Cmax and AUC than oral tablets (p < 0.04).

DISCUSSION: The optimized buccal system provides controlled release and enhanced pharmacokinetic performance, suggesting a promising alternative approach for effective CINV management.