Design And Development of Co-Processed Chitin-Lactose Monohydrate as An Excipient for Oral Dispersible Tablets

This study describes the preparation, characterization and performance of a novel excipient for use in oral-dispersible tablets (ODT). The excipient (Cop–CLM) consists of chitin and lactose monohydrate. Specific benefits of co-processed excipients include improved flow, compressibility, disintegrating effect, and masking undesirable properties of individual excipients. The excipient with optimal physicochemical properties was obtained at a chitin: lactose monohydrate ratio of 1:2 (w/w) and produced by direct mixing. Physical properties of Co-processed chitin-lactose monohydrate (1:2 w/w) powder showed good flowability and compressibility. Differential scanning calorimetry (DSC), Fourier Transform-Infrared (FT-IR) techniques were used to characterize Cop-CLM, in addition to characterization of a powder and ODT dosage form. Heckel plot of Cop-CLM showed higher value of K (0.647) than lactose monohydrate (0.355) and chitin (0.255), which indicates more plastic material. Ondansetron ODTs were prepared, using Cop-CLM displayed excellent physiochemical properties like fast disintegration, wetting time and exceptional binding in comparison with commercially available ODT. This study concludes that Cop-CLM results in a unique multifunctional base which can successfully be used in the formulation of oral-dispersible and fast immediate release tablets.