Taj khan H*, Hindustan Abdul Ahad, Naresh G, Sreekanth K
PG Department of Pharmaceutics, Balaji college of pharmacy, Ananthapuramu-515 001, Andhra Pradesh, India
The study was undertaken with an aim to develop an optimized formulation of anti-Alzheimer, Donepezil HCl by oral drug delivery. Preformulation studies were conducted to know the drug excipients compatibilities. Based on the results, suitable excipients were selected for formulation development. Tablets were prepared by using wet granulation method. During development of formula, flow properties of the blend and weight variation, hardness, thickness, disintegration time were evaluated for core tablets. Finished products were evaluated for assay and in vitro release studies. The developed trials were tested for in vitro dissolution profile and compared with the reference product. The in vitro dissolution profile of F-6 was nearly similar to that of reference. The optimized batch tablets were packed in HDPE containers and performed stability studies at 40°C/75%RH. Stability samples were evaluated initially and after two months. The results were compared with the predetermined specifications. All the results were found to be satisfactory. Hence the designed and developed formula of Donepezil was stable. The objective of the present project was successfully achieved by developing the product, giving the same release profile to that of innovators product.
Keywords: Donepezil HCl, tablets, immediate release, evaluation