Impact of variables on buccal mucoadhesive film-forming spray for clotrimazole.

Buccal spray is an attractive dosage form for its ease of application, especially for infant and geriatric patients. The aim in this work was to optimize and prepare a clotrimazole buccal spray through exploring the role of main variables producing a mucoadhesive film, to evaluate its effectiveness against Candida albicans. The method of preparation involved solubilizing the drug using a suitable amount of PEG as well as PG, utilizing different most commonly applied bioadhesive polymers to achieve buccal mucoadhesion and compromising the viscosity. The solution was conserved in a plastic container with a metered dose designed to give 0.2 ml per puff. The optimized formula containing 0.5% polyvinyl alcohol, 60% PEG, and 15% PG exhibited suitable pH (6.16 ± 0.002), high drug release (100% ±1.098% within 90 min), drug content (104.1% ±2.001%), volume per actuation (0.19 ± 0.010 ml), spray of angle (47.2° ±0.896°) and acceptable viscosity (74 ± 1.3 cp), superior anti-Candida activity than commercial product with no irritation. Overall, choosing suitable additives can compromise the viscosity and have a great effect in obtaining the required dose upon a certain accurate value of actuations utilizing metered dose spray, enabling the product to flow out as ultrafine droplets instantly spread and adhere to buccal mucosa, improving residence time and diffusion, hence enhancing the efficacy of clotrimazole against candidiasis.