Pellet coating by air suspension technique using a mini-model coating unit.

Abstract

Air suspension coating is widely used in the pharmaceutical industry, as an attractive alternative to pan coating in that it can successfully coat small particles, pellets and tablets irrespective of size or shape with a wide variety of coating materials. The commercially available air suspension coating equipments require at least one kilogram of material for optimum efficiency of their working. Therefore, it is felt that there is a potential need for a small, compact air suspension coating instrument, which can work with gram quantities of material. The main objective of the present work is to design and evaluate a laboratory model top spray air suspension coating instrument. The performance of the instrument was evaluated for both, drug loading on to non-pareil pellets and coating of drug-loaded pellets. Terbutaline sulphate was selected as model drug, while Surelease (aqueous polymeric dispersion of ethyl cellulose) as representative coating material. The drug loading efficiency of the instrument was found to be around 82% with a pellet load of 10 g. The drug loading efficiency was found to be satisfactory and reproducible. Scanning electron micrographs of coated pellets indicated that coating was homogenous and uniform around the pellets. The maximum deviations observed in the in vitro drug release studies were +/- 2.7397% of the mean percent quantity of drug released, which is low enough for the coating to be considered uniform and reproducible. Reproducibility of the coating process was further confirmed by determining the 95% confidence interval for average difference in cumulative percentage drug release between two runs of each batch, which was found to be less than 5% set as the maximum allowable difference. The release data obtained were found to show best fit with first order kinetic model. A significant influence of coating thickness on the drug release rate was observed. From the results and observations of this work, it may be concluded that the mini-model air suspension coating instrument designed, may be a useful piece of equipment for preparing coated multiparticulate dosage forms in small quantities for sustained drug delivery, especially in research works.