PROCESS OF MANUFACTURING MODIFIED RELEASE TABLET PREPARATIONS OF VALPROIC ACID DERIVATIVES

Abstract

This invention discloses a process for manufacturing modified release tablets through a granulation method with functional separation between the internal and external phases. Where the preparation has an active ingredient release profile of <20% within 60 minutes and more than 75% within 1440 minutes in a phosphate buffer solution dissolution medium. This invention produces a balance between internal osmotic pressure and external diffusion barriers, thereby providing a stable active ingredient release profile, preventing dose dumping, and overcoming technical constraints in the form of hygroscopicity and sticking in the mass production process.