Development and Optimization of the Formulation and Process Parameters for a Low Dose Chewable Tablet

Abstract

Oral administration has been the most favourable route of drug delivery as 90% of all drugs used to produce systemic effects are administered by this route. Chewable tablet is one of the recent advances in oral dosage forms. They are intended to be chewed in the mouth prior to swallowing thus it gives ease of administration to children or to the elderly who may have difficulty in swallowing an intact tablet. PHL_158 is a BCS class I drug used in motion sickness. It is absorbed throughout the GI tract hence an ideal drug for preparation of chewable tablet. Chewable dosage form provides the advantage of taking the tablet without water and hence useful in motion sickness which commonly occurs during travelling. Chewable tablets were prepared by direct compression method using mannitol, xylitol, MCC and calcarb as diuents in different combinations and ratios using Korsch XL 100. Formulation had excellent mouth feel, no grittiness was observed and desirable taste was obtained but had poor flow property and segregation issues. So to improve flow property and reduce segregation tendency it was further optimized by dry granulation technique using roller compaction. Granulation is the process in which primary powder particles are made to adhere to form larger, multiparticle entities called granules. Powders are often granulated to improve their flow behaviour. Roller compaction is a widely used process for granulation to improve flow property and prevent segregation as the drug gets compacted into granules prior to compaction. Roller compaction was carried out by Alexanderwerk roller compactor by using Box-Behnken design to minimize the number of runs. Granules obtained from dry granulation using roller compaction process had good flow property and segregation tendency was not observed. Hence it can be concluded that process parameters like flow property and segregation tendency of blend can be improved by dry granulation process using roller compaction. Use of DOE helps in accurate optimization of formulation with minimum efforts, time and energy. Thus, this study proved the necessity of optimization of process parameters for low dose chewable tablet.