Atsuhiko Nishitani

Pharmaceutical study of sodium valproate preparations.

Compatibility of sodium valproate (VPA) fine granules with 48 drugs was investigated by sensory test, and VPA residual potency (%) was measured by nonaqueous titration and gas chromatography. The data on change in compatibiiity with time were analyzed by scoring and were subject to a time series analysis. Change in compatibility was observed in 23 of the 48 drugs under the severe conditions (30°, RH92%), and in 12 drugs under the medium conditions (20°, RH75%). In gas chromatography, when combined with ascorbic acid, residual potency (%) of VPA began to decrease sharply on the first day, thus suggesting that such combination be avoided. There is not always correlation between change in appearance and the results of nonaqueous titration and gas chromatography. Since VPA may be administered for as long as 30 days, caution should be exercised in mixing this drug with other agents.

Pharmaceutical study of Domperidone preparation.

In order to obtain information on the stability of Domperidone Dry Syrup, we studied its compatibility with commonly used drugs which were used in this test in powder (55 samples) or aqueous suspension (32 samples).Compatibility of this drug with 55 powder products was studied in terms of changes in appearance by sensory test. Under severe conditions, 49 samples became moistened, while 25 were discolored in 14 days. Under moderate conditions, 10 samples became moistened and 9 were discolored. The residual potency of the syrup under moderate conditions showed no notable changes in 14 days.In the test using 32 kinds of aqueous suspensions, changes in appearance, pH and redispersibility were checked. 5 samples under severe conditions showed changes in appearance, while all the samples did not change their pH value under severe and moderate conditions. In the redispersibility test, 3 samples showed poor results under severe and moderate conditions.

Pharmaceutical study of antipyretic-analgesic drugs (acetaminophen)

Compatibility of acetaminophen granules with 34 drugs was investigated by sensory test, while residual activity of acetaminophen in these admixtures was measured by absorptiometry to study the relation between the compatibility and residual activity (%). The data on change in compatibility with time were analyzed by scoring and were subject to a time series analysis (by 2 mean vector). A significant change in compatibility was observed in admixture with antipyrin, Neodrin S®, ephedrine hydrochloride, Hibon fine glanules®, and Narcotin® in the wetting, and with antipyrine and sulpyrine in the discoloration under the severe conditions (30°C, RH 92%). It was also observed in admixtures with antipyrine in the wetting and discoloration under the moderate conditions (20°C, RH 75%). Residual activity of acetaminophen with time was almost stable when tested alone and in mixtures.No evident mutual relation was observed between compatibility and residual quantity.

Pharmaceutical Study of Antihistamine Preparations

In order to obtain information on the stability of Lacretin dry syrup (long-acting antihistamine preparation), we studied its compatibility with drugs in common use. Two presentations of the mixtures were investigated: powder and liquid preparations. 34 kinds of powder preparations were selected for the compatibility study, and change in appearance was examined bysensory evaluation method. Under severe conditions (30°C, RH 92%), these samples began to change in appearance 5 days after the start of the test, and 30 samples showed an apparent change after 14 days. Under moderate conditions (20°C, RH 75%), only 3 samples produced a change in appearance. Under favorable conditions (5°C, RH 52%), no changes were observed.30 kinds of liquid preparations were investigated for change in appearance and pH. Further, 9 samples in the state of suspension at the time of preparation were tested for redispersion. Formerly, in accordance with the test method based on the criterion on compatibility of internal liquid medicines proposed by the JPA Preparation Technique Committee, we had a trouble to manipulate test tubes at 5-second intervals. In the present experiment, we used a new automatic instrument with good reproducibility. In the redispersion test, 4 samples were found to be incompatible.

Sensory Evaluation of Practicableness of Powder Preparations for Dispensing (1)

There are many factors affecting practicableness of powder preparations for dispensing, such as angle of repose, angle of spatula, compressibility, flocculation, uniformity, particle diameter, specific gravity and porosity. In this study, the practicableness of powders for dividing with Konishis automatic powder divider or pile packer and for weighing was examined by sensory evaluation. It was found out that there is a significant relationship between practicableness for dispensing and the factors above mentioned. The practicableness was also studied in terms of the powder fluidity index of Ralph L. Carr. Dividing and folding services have become convenient with an introduction of imporved automatic dividers or change of dosage form from powder to granules or fine granules. But there are some problems in dispensing granules and fine granules. Fluidity and other properties concern directly not only with the practicableness for weighing but with mixing and dividing errors and practicablen

Statistical Analysis of Gustation and Color Tone of Syrups by Sensory Evaluation (II)

Gustation and color tone of syrups on the market were analyzed by sensory evaluation. Method of preparation, color tone, viscosity, sweetness and other conditions of syrups were, as a matter of course, different by manufacturers. In this study, syrups diluted under a common condition were analyzed by binomial probability paper in statistical sensory evaluation. Color tone and dilution expressed in sensory value correlated with those in measured value. Sweetness, though different among syrups of different manufacturers, was found to be influenced by viscosity and dilution.