Abstract
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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