Studies on the development of rapidly disintegrating hyoscine butylbromide tablets.

The objective of this study was to prepare hyoscine butylbromide (a drug with bitter taste) tablets that can rapidly disintegrate in saliva. The granules were prepared by the extrusion method using aminoalkyl methacrylate copolymers (Eudragit E-100). The drugs dissolved rapidly in medium at pH 1.2 in a dissolution test while none of the drugs dissolved from the granules (% of dissolved < 5%) even after 8 h at pH 6.8. Rapidly disintegrating tablets were prepared using prepared taste-masked granules and a mixture of excipients consisting of crystalline cellulose (Avicel PH-102) and low substituted hydroxypropylcellulose (L-HPC, LH-11).The granules and excipients were mixed well (mixingratio by weight, crystalline cellulose: L-HPC, was 8:2) with 1% magnesium stearate as a lubricant and subsequently compressed at 500-1,500 kgf in a single-punch tableting machine. The prepared tablets (compressed at 500 kgf) containing the taste-masked granules have significant strength (crushing strength was 3.5 kg), and a rapid disintegration time (within 30 sec) was observed in the saliva of healthy volunteers. None of the volunteers sensed any bitter taste after the disintegration of the tablet that contained the taste-masked granules. The results confirmed that rapidly disintegrating tablets can be prepared using these taste-masked granules and excipients that are commonly used in tablet preparation.