Application of a factorial design study to the coating of four drug substances in a fluidised bed
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The purpose of this investigation is the coating of powders in a fluidised bed.
A 2n factorial design is developed in order to find the experimental conditions with the greatest influence on the quality of the coating. Therefore experiments are performed on lactose 80 mesh, taken as a model substance, with cellulose acetate phthalate as the coating material. Five factors are investigated at two levels. From the experiments the factors and interactions having a significant effect can be selected: the temperature of the inlet air, the concentration of the coating solution, the addition of talc as a filler to the coating solution and the interactions between spraying pressure-spraying rate and between spraying pressure-concentration.
The fluidised bed technique is then applied to the coating of four drugs which need different coatings. For carnidazol an enteric coated granulation is required. Ferrous aspartate has to be protected from oxidation. Piracetam and etabenzarone hydrochloride require a taste masking coating. The results illustrate well the usefulness of the preliminary factorial design.
KeywordsTalc Ethylcellulose Piracetam Coating Solution Cellulose Acetate Phthalate
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