Incompatibility of a triple hemostatic granule Coagumin (containing ethamsylate, phytonadione and aminocaproic acid) with 20 drugs which are often-to-be used in combination with Coagumin was studied. The observation continued for 14 days. Coagumin was slightly moistened in any of the worst condition (temperature 30°, relative humidity 92%) and moderate condition (20°, 75%). When combined with 13 of the 20 drugs (including adrenochrome monosemicarbazone), Coagumin showed signs of incompatibility including color change and moistening. These phenomena may primarily be attributed to aminocaproic acid, an ingredient of Coagumin. No chemical change was observed in the decomposition test by thin-layer chromatography in the combined drugs which had showed a visible change in the above experiment.

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In vitro dissolution test in column-type method or rotating basket method and disintegration test were carried out for slowly dissolving experimental benzoic acid tablets (I) and commercial prednisolone tablets (II). Plain net was tried for prevention of adhesion of tablets on the bottom of the column, but that increased the values.(II) were apt to float in the column. To prevent floating, the tablets were covered with a convex net, and the coefficient of variation values decreased. The dissolution rate of (I) has a correlation with revolution per min. in the rotating basket method and with flow rate in the column-type method. The column-type method enables to record a differential curves of dissolution and is so sensitive as to detect fine differences between tablets. At the same time the method requires long time of experiment and sometimes causes clogging of filter which results in the change in the flow rate of materials.

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Bactericidal effects of five disinfectants were evaluated in terms of phenol coefficient. In the study, several strains of Pseudomonas aeruginosa, P. maltophilia, P. cepacia and Achromobacter xylosoxidans were used. Bactericidal activities of phenol, saponated cresol solution and povidone iodide solution were not so strong, but the range of difference of phenol coefficients by strain was limited. 10% benzethonium chloride solution and 5% chlorhexidine solution generally showed stronger activity than the remaining three disinfectants. But the bactericidal effect of the two solutions varied depending upon the strains of the organisms. Chlorhexidine solution in the currently prevailing concentration was found to be ineffective against P. cepacia.

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Leaching of constituents from the polypropylene container for large-volume parenteral drug products under clinical condition, and adsorption of vitamin injection to polypropylene container were investigated. In one test, five solvens (distilled water, isotonic sodium chloride solution, 5% glucose solution, 5% ethanol, buffer) were added to some pieces of polypropylene in a test tube, and ultraviolet absorption was measured 24 hours after. In another test, diluted vitamin injection solution was poured on polypropylene pieces and ultraviolet absorption was determined after the same interval. No untoward effect was observed in any of these tests.

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No visible change was recognized in urokinase when dissolved in amino acid infusion. But the fibrinolytic activity of urokinase decreased immediately and gradually after the dissolution in any test by the tube, standard plate and Chandler's loop methods. It was found that the decrease in the fibrinolytic activity was due to lysine and sodium sulfite contained in the amino acid infusion. Then, the activity of urokinase was determined by the tube method after urokinase solution containing lysine or sodium sulfite was dialyzed. Urokinase in the presence of lysine showed activity stronger, to some extent, than the control, while the substance in the presence of sodium sulfite demonstrated great, irreversible loss of the activity.

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Qualitative evaluation of suppositories was conducted by means of a simple test on in vitro disintegration time. Twenty kinds of commercial suppositories were selected as samples. Length and diameter of 20 each suppositories of the samples were measured with slide calipers. In the disintegration test, observation was continued for 6 hours on 10 suppositories of each sample soaked in the isotonic sodium chloride solution kept at a fixed temperature. Suppositories on hydrophobic bases were completely disintegrated within 20 minutes, and those on hydrophilic bases underwent a rapid change in the early stage but most of them did not show complete disintegration within the observation time.

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5-Fluorouracil injection and cepharanthin injection, when mixed, produce turbidity. The phenomenon can be prevented from occurring by adding before mixing commercial phytonadione injection (Kativ-N) to cepharanthin injection, In this study, change in activity of 5-fluorouracil, primary agent, was bioassayed in several formulae combining the above three injections. Upon statistical analysis of the test results, it has been found out that the activity of 5-fluorouracil does not change for 6 hours after combination.

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Drug products in tablet or capsule are composed not only of active ingredients but also of various additives. This study was carried out under the notion that it is desirable to minimize the amount of additives in the products. In the study the ratio of content (weight in percent) of active ingredients of different tablets and capsules on the market was calculated from mean weight of the proucts and contents of active ingredients.

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The number of glass particles arising in parenteral solution upon cutting of ampules was determined with use of 5-ml transparent and brown ampules. Cutting by “cracking” produced most satisfactory results of all methods devised. It was found as a result of the investigation by X-ray fluoroscopy that the solution contained in the ampules was almost completely free from particles from a file used for cutting. Mice injected intravenously into the tail with large amount of glass particles from ampule died of shock due to multiple pulmonary thrombosis. Tubercles caused by glass particles were observed in mice which survived the experiment without acute symptoms.

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A pharmaceutical study was conduced on commercially available tablets and capsules containing, respectively, 5 or 10 mg of medazepam. The variation of the average weight was less in tablets than in capsules. The disintegration time was shorter and its variation smaller in capsules than in tablets. In the quantative test, capsuels showed medazepam content which was 4-6% higher than that of tablets. The dissolution rate reached the maximum at the time of disintegration: to about 100% in 5 minutes with capsules, and about 95% in 20 minutes with tablets.

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A pharmaceutical study was carried out on three kinds of tablets on the market (A, B and C) containing, respectively, 10 mg of oxazepam. The variation of the average weight was widest in tablet B, followed by C and A, in that order. Disintegration took place rapidly in all of the three tablets, but dissolution slowly. The dissolution rate in the primary solution in 60 minutes was 95% with tablet C, 90% with A, and 75% with B. Oxazepam content was not less than 96% in each tablet. In the test with rabbits, no significant difference in blood concentration of oxazepam was observed between the tablets.

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