Development and evaluation of taste-masked pellets loaded with Matricaria chamomilla L. extract

Abbreviations: Mch, Matricaria chamomilla L.; SLS, Sodium Lauryl Sulfate; MS, Magnesium Stearate; PVP, Polyvinyl Pyrrolidone; SSG, Sodium Starch Glycolate; DEx, Dry Extract; TPC, Total Phenol Content; TFC, Flavonoid Aspect CI, Carr’s Background: Remarkable properties of Matricaria chamomilla L. (Mch) have caused it to be considered widely in the treatment of different ailments including gastrointestinal disorders. Objective: In the present study, the Mch extract-loaded coated pellets were developed with the aim to mask its bitter taste and to improve its dosing flexibility and patient compliance, especially in children. Methods: The plant extract was obtained by maceration with ethanol 70 % and dried using rotary evaporating and freeze drying methods. Then it was used for pellet preparation along with different proportions of various additives such as Avicel, starch and lactose by extrusion-spheronization technique. The pellets were analyzed for their size, sphericity, aspect ratio and friability. The optimized formulation, subjected for coating by Eudragit E, was evaluated for taste-masking efficiency, dissolution and morphology. Results: The optimized pellets were produced with particle size, sphericity and aspect ratio equal to 1.13 mm, 0.924 and 1.172, respectively. Low friability, suitable flow properties (carr’s index = 3.01 %) as well as dissolution led this sample to be considered for taste-masking coating. Based on in vitro dissolution studies, although the coating layer significantly decreased the release of the components at higher pH compared to the uncoated particles, acceptable dissolution was observed at pH 1.2. Appropriate taste-masking of the product was also confirmed by in vivo analysis. Conclusion: The taste-masked Mch-loaded pellets with suitable characteristics could be an appropriate delivery system with improved patient compliance.