COMPARISON OF 2 MICROCRYSTALLINE CELLULOSE BRANDS FOR THE DIRECT COMPRESSION OF HYDROCHLOROTHIAZIDE TABLETS

The effect of storage on tablets formulated with two different brands of coarse microcrystalline cellulose (MCC), MCC-1 and MCC-2, was studi ed. To compare the two, 25 mg hydrochlorothiazide tablets were prepare d by direct compression, using a 50 : 50 blend of MCC and anhydrous la ctose, incorporating crosslinked PVP croscarmellose, or sodium starch glycolate and magnesium stearate. Tablets (150 mg) were compressed on a rotary tablet press and were evaluated for weight, thickness, hardne ss, friability, disintegration time, and dissolution (U.S.P) initially , and after 9 months storage at room temperature. It was found that, i n a majority of the batches, tablets made with MCC-2 were significantl y harder than those made with MCC-1. This disparity in hardness appear s to be reflected in differences in disintegration time and drug disso lution rate from comparable tablet batches. MCC-2 tablets formulated w ithout disintegrant exhibited a disintegration time significantly long er (at least 50% longer) than those containing MCC-1. The trend across all of the tablet batches, regardless of disintegrant used, was that MCC-2 tablets exhibited a slower dissolution rate than their MCC-1 cou nterparts. Upon storage, statistically significant changes in hardness were seen in some MCC-2 batches, but none of the MCC-1 batches. The r esults indicate that MCC-1 and MCC-2 may not perform identically.