The effects of hardness on disintegration and dissolution characteristics of uncoated caffeine tablets made at eight different pressure levels were studied. The disintegration times were determined using the J.P. VIII procedure with disks and the dissolution rate measurements were performed with the U.S.P.XVIII procedure (U.S.P. method) and the J.P. VIII disintegration test apparatus (J.P. method). A good correlation between the hardness and the disintegration times was obtained. The dissolution rate constants were determined from the equation of Noyes & Whitney (1897) and a good correlation between the hardness and the dissolution rate constants was obtained. The hardness governed the dissolution over all the stages from tablet to the smallest particles after the breakage by disintegration. The dissolution rates of the J.P. method were greater than those of the U.S.P. method.
Uncoated caffeine tablets of four different hardnesses were tested for dissolution rate by the Sartorius (S.S. method) and by the rotating basket method of the U.S.P. XVIII. In both methods the dissolution rate decreased with increasing hardness, and the rate obtained with the S.S. method was always less than that by the U.S.P. method. This result cannot be explained as being due only to the difference in the volume of dissolution medium. Also it was difficult to ensure that the characteristic changes in the process of dissolution paralleled the curves obtained from a plot of % caffeine dissolved vs time. Accordingly, the dissolution rate constants were calculated from the slope of each straight line in a plot of In W∞/(W∞ ‐ W) vs time.
The automatic dispensing system which is connected between the prescription ordering system and automatic tablet counting and packing system(ATC)machine has been developed in recent years.The quality control of tablets and capsules(unsealed)in ATC and the stability of these drugs after ATC package must be considered for packing these drugs in a one dose-package by automatic dispensing system.Therefore,we selected 190 drugs(tablets and capsules)from the drugs adopted in our hospital and stored in a light-resistant or moistureproof place as mentioned in package inserts,and investigated the stability of these tablets and capsules (unsealed condition)with time when they were stored in the ATC tablet cases provided in our dispensary and under the conditions of constant temperature and humidity(in a dark place,In our study,we used a new tablet case devised for improving the light-resistant and maintained appropriate conditions of temperature and humidity in the dispensary by using an air conditioning system continuously.As a result,the quality control of these drugs stored in ATC was greatly improved.The appearance of ASPARA were changed markedly under the sealed condition in ATC by temperature and humidity.We judged from our findings that the application of these three drugs to the automatic dispensing system is by far difficult since there are still problems to be solved for the quality control of these drugs.
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