Improving content uniformity in low-dose DC formulations

November 06, 2025

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The case study focuses on the challenge of achieving content uniformity in tablets formulated using low-dose APIs via direct compression (DC). In such formulations, achieving uniform distribution of the active substance is difficult due to its low loading and potential segregation. The excipient composite PROSOLV® RX 90, developed by JRS Pharma, serves as an all-in-one “high functionality excipient” (HFE) for DC, integrating filler, binder, and lubricant into a single component.

Because PROSOLV® RX 90 is manufactured via a proprietary process that increases specific surface area and introduces micro-rugosity, it supports improved API distribution and flow when dealing with low dose APIs. The study with piroxicam tablets (8 mm, 100 mg and 200 mg doses) showed that using PROSOLV® RX 90 simplifies tableting, shortens development time and reduces complexity (fewer excipients to handle, less QC/storage overhead) when compared to conventional blends.

Key benefits highlighted include enhanced flow and compaction properties, less risk of segregation, and streamlined manufacturing. The authors stress that for low-dose DC tablets—where API loadings are small—selecting an excipient system designed for content uniformity and direct compression is crucial to ensure consistent tablet quality and manufacturability.