Evaluation of the Effect of Ethyl Acrylate-Methyl Methacrylate Copolymer in Racecadotril Dispersible Tablet.

Abstract

Objectives: Racecadotril is an anti-diarrheal drug that has the indication to reduce the secretion of water and electrolytes into the intestine. It has an unpleasant taste, when administered orally. The presenting study developed a pharmaceutical racecadotril dispersible tablet, which masked the unpleasent taste using wet granulation method. For this reason, the effect of the number of ethylacrylate-methylmethacrylate copolymers (Eudragit^® NE 30D) in taste masking and in vitro dissolution of the finished product was investigated.

Materials and methods: Taste-masked racecadotril granules were prepared using Eudragit^® NE 30D and the ratio between the amounts of racecadotril and Eudragit^® NE 30D involved in the formulation was optimized. The products obtained in the dispersible tablet dosage form were evaluated in terms of taste and in vitro dissolution studies. In vitro dissolution profiles of the products obtained in this study were compared with reference product Tiorfan^® granules for oral suspension manufactured by Bioprojet Pharma (Paris, France). A method of apparatus II (paddle), 900 mL, pH 4.5 acetate buffer + 1% sodium dodecyl sulfate (SDS) and 100 rpm at 37.0 ± 0.5°C was adopted.

Results: Results of the studies have shown that the formulation should have Eudragit^® NE 30D higher than 1% by weight of racecadotril to satisfy the taste-masking ability and the formulation should have Eudragit^® NE 30D equal or lower than 10% by weight of racecadotril to have better release characteristic to be compatible with reference product.

Conclusion: Our results demonstrated that a chemically long-term stable racecadotril dispersible tablet product, whose taste is efficiently masked using wet granulation method with an acceptable release profile was obtained with Eudragit^® NE 30D ratio higher than 1% and equal or lower than 10% by weight of racecadotril. The developed formulation can increase patient compliance.