Pediatric Mini-Tablets: Predicting the Hidden Risk of Fill Errors.

ABSTRACT: Compressed mini-tablets in sachets or capsules are an increasingly prevalent oral solid dosage form for pediatric products. While resembling adult tablets, additional care is required to control weight and potency (blend uniformity) variation due to their small size (≤2.5 mm average diameter). Additionally, sachet fill count errors complicate dose accuracy as they are difficult to resolve with weight-checking equipment. This study quantified the probability of failing content uniformity (CU) specifications (which results in the inability to release a batch) defined in USP <905> using a Monte Carlo computational model. Failure risk was modeled as a function of sachet fill count, mini-tablet weight, potency distribution, and fill error frequency. The model allows product developers to (1) de

SUBMITTER: Gerberich BG 

PROVIDER: S-EPMC9961976 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature