Abstract
The process of non-aqueous spheronization was investigated for the in situ formation of an enteric coprecipitate of nifedipine with hydroxypropylmethylcellulose phthalate (HP-55) in spherical pellets. Isolated coprecipitates formed were evaluated by differential scanning calorimetry. The use of various spheronization aids such as lactose, kaolin, Aerosil 972 and 200, Bentone 27, liquid paraffin and magnesium stearate was studied using non-factorial and factorial experiments subject to statistical analysis. Products obtained were evaluated by sieve, packing density and image analysis, scanning electron microscopy and dissolution testing. The final product formed containing sodium lauryl sulphate 2% as wetting agent and sodium starch glycolate 5% as disintegrant processed with optimum solvent level, gave a high yield of acceptable spheres which showed poor drug release at low pH and enhanced release at the pH of the upper small intestine. The mechanism of pellet formation observed differed from that of conventional aqueous spheronization.
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