Chitosan based co-processed excipient for improved tableting

Abstract

Chitosan is a multipurpose polymer with immense utility in pharmaceutical drug delivery systems. Low density, poor flowability and inadequate compression characteristics have limited its use as a tablet excipient. To address these limitations, a new tri-component excipient system composed of chitosan, mannitol and crospovidone was developed using spray drying technique. Mannitol was utilized for its ability to act as a bulking agent and to harness its unique characteristics such as a low hygroscopicity, strong inertness towards other excipients, whereas crospovidone was used as the disintegrant. Central composite response surface model was employed to obtain optimum combination of these components. Resulting coprocessed excipient showed remarkable improvement in density and flowability as confirmed by SeDeM diagram expert system. Heckel and Kawakita analysis predicted superior compression features of developed excipient for tableting. Furthermore, the applicability of developed excipient was studied by formulating paracetamol tablet as a model formulation by direct compression. Co-process excipient consisting of 50% chitosan, 43% mannitol and 6.5% crospovidone provided tablets with desired hardness of 100 N having disintegration time less than 25 s. Therefore, developed multifunctional coprocessed excipient exhibited promising results with potential for scale up and wide applicability in drug delivery.