Variations in content uniformity can cause more problems in low dose drugs than high dose drugs especially if the drug is potent and has a narrow therapeutic index. The study was aimed at investigating the method of incorporation of low dose drugsin formulation and its effect on distribution of Active Pharmaceutical Ingredient (API) in granules. Mixing of API and diluent(s) as well as dissolving the API in binder solution prior to massing of diluent were the two methods of incorporation used. The content of drugs in the various granule sizes was determined by UV spectrophotometer. The result showed that when salbutamol sulphate powder was dissolved in binder solution, increased content was observed as compared to mixing it with the diluent before massing. But the opposite was seen with folic acid powder. Method of incorporation of API contributes to the distribution of low dose drugs in granules.
