Disintegration tests of coated tablets were carried out in immersion fluids of different pH values according to the modified procedure described in the Japanese Pharmacopoeia (J.P.). The apparatus used was also conformed to J. P. Consequently, 134 of 141 samples were completely disintegrated in any of the acidic fluids. But, 5 of them were not always disintegrated in such test fluids, and 2 were disintegrated by the methods other than those described in J. P. The official compendium and package inserts now in use should be supplemented with more data on disintegration.

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The serum level of antiepileptic drugs (diphenylhydantoin, phenobarbital, carbamazepine and primidone) was determined by modified Kupferberg's gas-liquid chromatography. Since the serum level of these drugs were found to be determined when they are within a therapeutic level, the test was made in children at the age of 3 to 17 years. The range of effective serum level of diphenylhydantoin was estimated at 5 to 10 μg/ml.

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The serum phenytoin level determined by enzyme immunoassy (EMIT) was compared with that by gas-liquid chromatography (GLC). There was a close correlation between EMIT and GLC, and EMIT gave better result than GLC. EMIT was carried out simply using a small quantity of untreated serum. The hemolysis of serum sample in this test was found to have no effect on EMIT. The mean phenytoin level was widely distributed, 2.33±3.54 μg/ml, and that was lower than the optimum range.

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Physical and chemical stability of suppositories containing aminophylline and various bases prepared in our hospital pharmacy was investigated. It was found that ethylenediamine in aminophylline was decreased, melting point of suppositories rose and disintegration and liquefaction time was delayed in suppositories with Witepsol base when stored at room temperature.
Thin-layer chromatography produced evidences supporting that ethylenediamine may react with some Witepsol constituents to form acid amide linkage. However, the suppositories were stable at lower temperature. Suppositories prepared with PEG base were found to be satisfactorily stable at room temperature.

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In vitro release and in vivo rectal absorption of suppositories containing aminophylline and various bases prepared in our hospital pharmacy were investigated. The release tests were conducted using three methods: cylindrical filter paper method, Sartorius solubility simulator method and disintegration test in J. P. IX. In all cases, release from PEGcontaining suppositories was better than that from Witepsol-containing products. However, this tendency was not reflected in the blood level of theophylline after rectal absorption of these suppositories.

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Increment in amount of medicines prepared in hospital pharmacy was analyzed statistically on the basis of monthly summation of the amount. The number and amount of external liquid preparations, number of ointment preparations and times of regenerations of ion-exchange resin showed close relationship with the month number. The number and amount of oral liquid preparations, number of powder preparations, that of ophthalmic solutions or nasal drops and of clinical reagents exhibited reciprocal relationships with the month number. When the residuals were determined by Run test and Durbin-Watson ratio after significant correlations were estimated with straight lines, the number of oral liquid preparations, number and amount of external liquid preparations, number of ophthalmic solutions or nasal drops, that of ointments and times of regenerations of ionexchange resin were not distributed along the straight lines.

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Syrup is originally intended to be used as unmixed and undiluted solution. In Japan, the product is mostly administered in combination with other agents and as water-diluted solution. Change upon combination and stability of Pontal Syrup was studied. Test samples were prepared by combining Pontal Syrup in daily pediatric dose with each of 15 other kinds of syrup and adding water to make 25 ml. Stability, IR spectrum, antibacterial action and other properties of the samples were tested. Upon combination with Pontal Syrup, change in appearance and reduction in potency were noted in a few agents.

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Compatibility of enteric-coated Futraful E Granules (FTEG) with 60 commercial preparations was investigated. In combination with FTEG, changes in appearance (wetness, coagulation, coloration and liquefaction) under the worst condition (30°, RH 92%) were observed in only 3 of the 60 preparations: neophylline, theocolin and sodium bicarbonate. In thin-layer chromatography, decomposed compounds producedin combination of FTFG with the 3 preparations were identified as5-fluorouracil. In the dissolution test, FTEG was not dissolved in1st fluid (J. P. IX) in the same combination. Therefore, the combination of FTEG with 2 of the 3 preparations should be avoided, but the combination with the remaining 57 preparations is possible if attention is paid topackaging, duration of administration and other conditions.

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Stability of gabexate mesilate (GM) in aqueous solution was studied. In buffer solutions at a constant pH between 1 and 7, hydrolysis of GM occurred in accordance with pseudo first-order kinetics. The stability of GM reached maximum at pH 3 and decreased with an increasing pH of buffer solution. Ionic strength did not influence the hydrolysis rate but concentration of buffer solution affected hydrolysis.

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Preparation of hyperalimentation requires complex process. In order to simplify the process, a basic solution-admixing needle, which was in the stage of development, was used for admixture of commercial basic solutions Paremental-A and-B and amino acid preparations. Study was made on microbial contamination at the time of admixture and on the preparation time. In the experiment carried out at the nurse center of Tokyo Women's Medical College Hospital, the preparation time was as unexpectedly short as about 1 minute and 30 seconds. The hyperalimentation thus prepared was kept aseptic even after storage for 7 to 14 days growth of bacteria and fungi was not observed.

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