The College of Pharmacy discussed the MSc thesis entitled “Formulation and Characterization of Bilastine-Cyclodextrin Inclusion Complex as an Oral Solid Dosage Form” by the student Sura Salam Hatam and the supervisor, Assistant Professor Eman Bakr Al-Khedairy, at the Pharmaceutics Department. The study aimed to enhance the solubility and dissolution rate of bilastine by complexation technique using beta cyclodextrin and its derivatives: hydroxypropyl beta cyclodextrin, methyl beta cyclodextrin, and sulfobutyl ether beta cyclodextrin. The study included the preparation of binary and ternary complexes using different hydrophilic polymers by kneading, solvent evaporation, co-grinding, and microwave methods. The resulting complexes were characterized for their percentage yield, drug content, solubility, and dissolution rate in comparison to the pure drug to select the best complex to be incorporated in an oral fast-dissolving film. The study concluded that the ternary complex consisting of BLA, methyl beta-cyclodextrin, and soluplus prepared by the solvent evaporation method exhibited the highest solubility and the fastest release rate, where 90% of bilastine was released within the first 15 minutes with a percentage yield of 89.3% and 100% drug content. Furthermore, the oral fast-dissolving film showed a homogenous, clear film with accepted folding endurance, the shortest disintegration time, and complete release within five minutes with accepted stability at room temperature. The study concluded that improving the solubility and dissolution of BLA was achieved with the utilization of a ternary inclusion complex formation, which could be easily formulated as OFDFs. The study recommended using a complex with cyclodextrin or its derivative as a technique to enhance the solubility of poorly soluble drugs to be incorporated in the required dosage form.
