Preparation And Characterization Of Oral Fast Dissolving Films Of Desloratadine

Objective:Preparation and physicochemical characterization of Desloratadine(DLT)loaded oral fast dissolving films(ODF).Methods:First,pre-formulation studies of DLT was conducted,including the establishment of a methodological study on the determination of DLT by High Performance Liquid Chromatography(HPLC)and the influencing factor test of DLT and the compatibility studies between raw materials and excipients.ODF was prepared by solvent casting method,and the filming agent was evaluated for its film forming property,film release property,appearance,quality difference,thickness uniformity,mechanical properties,in vitro disintegration and dissolution,and the film forming materials,plasticizers,and the effect of disintegration on the properties of the film.The Box-Behnken response surface method was used to optimize the prescriptions,and the optimal film-forming material ratio,film-forming material and drug ratio,and plasticizer content are selected.The appearance,weight difference,thickness,disintegration time,and dissolution release of DLT oral instant film was examined,and the mechanical properties of the film was examined.Results:(1)The method of determining DLT established by HPLC had a good linear relationship,and the precision and recovery rate were in line with the requirements.DLT was placed in high temperature,high humidity and strong light conditions,and it had good drug and excipient compatibility.(2)Through preliminary screening of prescriptions and optimization of prescription,it was determined that hydroxypropyl methyl cellulose and maltodextrin were used as film-forming materials in this experiment.Glycerol was used as plasticizer,and the ratio of film-forming material to drug was 16:1.(3)The differences in appearance and weight of the film prepared in this experiment were in accordance with the regulations for the fourth part of the Chinese Pharmacopoeia 2015(0125);the average thickness of the film was 50.9±6.66 ?m,and the average disintegration time was 30.5 s,and dissolution release was 100%.Conclusion:The DLT-ODF prepared in this experiment had a clean and smooth appearance.It could rapidly disintegrate,and the drug could dissolve and release quickly.The quality standard met the requirement of the pharmacopoeia.