A platform direct compression formulation for low dose sustained-release tablets enabled by a dual particle engineering approach

Diagram of direct compression formulation — Direct compression formulation for low dose sustained-release tablets

Content uniformity (CU) is a well-recognized challenge for low-dose direct compression (DC) tablet formulations. Using a dual particle engineering approach that involves a) forming a segregation-resistant drug-carrier composite to improve CU and b) nanocoating HPMC to enhance flowability, we have developed a platform DC formulation for preparing low-dose drug sustained-release (SR) tablets with excellent CU. In addition to demonstrated robustness in manufacturability, this platform formulation has the flexibility for modifying drug release rate. Thus, it is useful for expedited and material-sparing development of low dose SR tablets using the economical DC process.

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Good drug content uniformity achieved by loading drug to a porous carrier.
Manufacturability is insensitive to drug loading and release controlling polymer.
A wide range of drug dissolution is achieved by adjusting amount of HPMC.

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