Design and Development of Polymer Based Fast Disintegrating Wafers of Selective Antihypertensive Agent
International journal of pharmaceutical sciences review and research
The objective of present investigation is to Design and develop the Polymer based fast disintegrating oral wafers of antihypertensive agent by solvent casting method and to study the effect of various Film Formers, Plasticizers and super disintegrants. Polymer based fast disintegrating oral wafers of Amlodipine besylate were prepared by Solvent casting method. Initially different batches were prepared using natural (Pullulan, Sodium alginate) and synthetic polymers (HPMC E5, HPMC E15) using
... erent super disintegrants and evaluated for appearance, disintegration time and folding endurance. The present study consist of nine different formulations were prepared by varying conc. of various super disintegrants (i.e. Croscarmellose sodium, Sodium starch glycolate, Crospovidone (Polyplasdone XL10) and different plasticizers (Polyethylene glycol 400, Triethyl citrate, Dibutyl phthalate). The formulations were prepared by using hydrophilic Polymer (Pullulan). The optimized batch containing Pullulan, Triethtyl citrate and Cross Carmellose was selected. Formulations were evaluated for thickness, folding endurance, disintegration, % drug content, in vitro release study and Permeation study. Drug excipients compatibility study and FTIR spectra revealed that, there was no interaction between Amlodipine and excipients. The Pullulan is the biopolymer which showed the excellent film forming capacity and also it produced the wafer with smooth appearance and maximum stability. The Triethyl citrate gives better folding endurance and flexibility than that of PEG 400 and Dibutyl phthalate. The optimized Formulation F4 having concentration of Cross Carmellose sodium 11.25% with excellent film former Pullulan was having in vitro disintegration time below 40 seconds and shows 98.55% Cumulative drug release within 5 min. The F4 batch is stable for 90 days and there was no any significant change in evaluation parameters like appearance, disintegration time, surface pH and % CDR. It was concluded that Amlodipine besylate was successfully formulated in fast disintegrating wafers which were found to be having good mouth feel, faster disintegration and better drug release and stability.