The Actual of Pharmaceutical Product Lifecycle for Synthetic Drug Substance —The case of donepezil hydrochloride ‘Aricept’ which is therapeutic agent for Alzheimer type dementia—

Abstract

Donepezil hydrochloride was first synthesized by medicinal chemist in December 1986, after that, process studies such as selection of starting materials (synthesis route's decision), proposal of optimum crystalline form, reaction condition, reaction post-treatment, purification, drying, particle control method, etc. were energetically carried out by process chemist, and the industrial manufacturing process was established. This research paper describes the history of development of the manufacturing process for donepezil hydrochloride and the actual development of the drug substance throughout the product lifecycle. It also discusses whether continual improvements defined in the ICHQ10 have been achieved throughout the product lifecycle.