FORMULATION AND CHARACTERIZATION OF PROCHLORPERAZINE FILMS FOR BUCCAL DELIVERY

Bunu Khatiwara*, Shithin Ann Varghese, Ayesha syed, Preeti Karwa and Sanjib Bahadur

ABSTRACT

Background and Objective: Oral drug delivery is preferred by patients of all age groups, including paediatrics and geriatrics. However, 26-50% population find it difficult to swallow tablets and capsules. One of the best routes for drug administration is through the oral cavity mucosa, it offers advantages like preventing gastrointestinal degradation, bypassing first-pass metabolism, and improving patient acceptance. Hence, aim of the study was to formulate Prochlorperazine maleate into oral thin films to increase its oral bioavailability and improve patient compliance. Materials and Methods: 32 full factorial design is applied to optimize the formulation by taking Concentration of chitosan and Concentration of Sodium carboxymethylcellulose as independent variables and swelling index and % drug release at 30 minutes as dependent variables. A total of 9 batches were formulated and measured. Statistical analysis was further validated by design expert software (version 13, Stat -Ease Inc., and Minneapolis, MN). Results and Discussion: It was observed that chitosan and Sodium CMC have influenced the design and optimization of Prochlorperazine buccal films and had significant effect on swelling index and drug release. Buccal film F7 has shown the ideal characteristics for buccal therapy of Prochlorperazine and exhibited suitable release characteristics.

Keywords: Buccal film, Prochlorperazine maleate, Mucoadhesive, Buccal drug delivery, Factorial design.