Feasibility of Manufacturing A Solid Dosage Form Using A Liquid Nonvolatile Drug Carrier: A Physico-Chemical Characterization

Abstract

Experiments were performed to determine the formulation and manufacturing feasibility of three model solid capsule formulations using a spray-on liquid drug carrier. Methylparaben was used as a model low-dose drug in the liquid drug carrier. Formulations containing different amounts of liquid drug carrier were successfully encapsulated on the H&K 400 capsule filling machine. The formulations contained varying ratios of liquid (methylparaben-propylene carbonate solution) to solid (compressible sugar, NF), which ranged from 10.0 – 20.0 μL/450 mg. Physical characteristics (i.e. weight variation, dissolution, etc.) of the filled capsules were evaluated. The 20.0 μL liquid/450 mg solid ratio was found to be the best hard gelatin capsule formulation based upon its rapid dissolution profile and was equivalent to all other formulations tested with respect to weight variation and content uniformity.