Impact of compaction and re-compaction on granule properties in dry granulation process

Abstract

Dry granulation is defined as a process whereby powder of different physical properties are combined to form
denser, bigger, permanent masses with the aid of some tangible or intangible external agents. In dry-granulation
roller pressure is the driving force. Careful selection of quantitative composition of functional ingredients has big
role to play in the scalability of the manufacturing process, when drug load as high as 66.67%w/w. Metformin
hydrochloride has inherent issue of flowability and compressibility. At high drug load gives little space for other
functional inactive ingredients; hence it becomes more critical to choose efficient highly compressible diluent of
at equal quantitative ratio with dry binder. Better compressible diluents along with dry binder also add flexibility
and helps re- cycling of granules for better results. Physical property of selected individual ingredients and
mixture of ingredients has direct impaction on compressibility of granules, solid fraction, density and particle
size distribution of compressed granules. Current dry granulation study with composition of Lactose anhydrous
and Silicified Microcrystalline Cellulose along with 2% w/w hydroxy propyl cellulose gives flexibility of
recycling to high drug load Metformin hydrochloride granules, this helps to improve its tabletability.