Attainment of highly uniform solid drug dispersions employing molecular scale drug entrapment in polymeric latices

The uniformity of distribution attainable for an amine drug in solid dispersions prepared using a molecular scale entrapment procedure was investigated. Excellent reproducibility of drug content throughout the entire entrapment product was demonstrated in both flocculated (high drug levels) and deflocculated (low drug levels) systems. Drug content and content uniformity were found to be predictable for deflocculated systems, even at high drug dilution ratios. Milling or particle-size fractionation appeared to have no effect on the distribution of drug throughout the solid dispersion entrapment products. Dry blending was inferior to molecular scale drug entrapment in distributing small quantities of drug uniformly.