j. res. pharm.

Journal of Research in Pharmacy

2630-6344

Marmara University

10.12991/jrespharm.1634650

Pharmaceutical Delivery Technologies

İlaç Dağıtım Teknolojileri

Formulation and characterization of bilastine - cyclodextrin inclusion complex loaded as an oral fast dissolving film

Hatam

Sura Salam

Babylon Health Directorate, Ministry of Health and Environment Al-khedairy

Eman

Department of Pharmaceutics, College of Pharmacy, University of Baghdad,

03 03 2025

29 1 370 377 02 27 2024 03 21 2024

2010

Journal of Research in Pharmacy

Oral fast dissolving films (OFDFs) are the most innovative oral solid pharmaceutical dosage form, especially for elderly and pediatric patients who may have dysphagia. Bilastine (BLA), is a second – generation antihistamine used to manage allergy symptoms; it is very slightly soluble in water. The main objective of this research was to enhance the solubility and dissolution rate of BLA by complexation technique. Ternary complex of BLA: methyl β- cyclodextrin (M-β-CD): soluplus® 5% w/w was prepared via solvent evaporation technique as a trial to enhance its solubility to be prepared as OFDF by incorporated into aqueous polymeric solution. Seven formulas of OFDFs were prepared using the solvent casting method using Polyvinyl alcohol, Hydroxy propyl methyl cellulose E5, and Pullulan as polymers that form film, PEG 400, and glycerin as plasticizers. The prepared films were estimated for their physical, and mechanical properties, drug content, and dissolution rate. The results showed that,the prepared complex enhanced the solubility of the BLA in water (11 times more than the pure BLA in distilled water) and it was easily utilized for the preparation of the OFDFs. The PVA-based formulation in the presence of glycerin as a plasticizer (F4), showed a homogenous clear film with accepted folding endurance (300), the shortest disintegration time (16.66 seconds), and complete release within five minutes. In conclusion, complexation of BLA with M-β CD was an efficient method for enhancing its solubility and dissolution rate to be easily prepared as OFDF with acceptable physical properties.

Bilastine Cyclodextrin-complex Methyl-β-cyclodextrin oral fast- dissolving films ternary complex

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