Three brands of chenodeoxycholic acid (RE, CH, CO) were compared by the following tests: net weight variation, content uniformity (by neutralization titration and HPLC methods), dissolution, impurity content (determination of ursodesoxycholic acid and cholic acid by HPLC, and of acetic acid ethyl ester and ethanol supposed to be residual solvents by gas chromatography), and cholesterol solubilization in vitro.
The results are as follows: 1) All the 3 preparations showed little weight and content variations, suggesting their exact filling amount; especially, RE indicated the smallest content of vehicle and the lowest deviation. 2) RE showed the most rapid dissolution, while CH and CO seemed to dissolve slowly, because they were filled by compression in #3 capsules. 3) Ursodesoxycholic acid and cholic acid were detected as impurities in the 3 preparations, and acetic acid ethyl ester in CH and CO. The quantities of these impurities were minute. 4) No difference in cholesterol solubilization was found among the 3 preparations.

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Liposome-entrapped adriamycin (ADM-Lip) as hospital pharmacy product for injection was investigated for improving therapeutic effects of adriamycin. ADM-Lip was prepared from egg phosphatidylcholine, cholesterol and stearylamine (molar ratio, 3: 3: 1), and separated from free adriamycin by dialysis. It was stable in dialysate of 0.01 M phosphate buffer with 0.85% NaCl (pH 7.4) at 37°. ADM-Lip increased the octanol-water partition coefficients to about 30 times as compared with those of the free form. Size of most ADM-Lip particles was less than 0.4μm and, therefore, ADM-Lip could be prepared as sterile injection by filtration through 0.45μm membrane filter.

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Trend of the labeling of the drug code on ethical ointments in tube (including creams and jellies) was investigated by means of questionnaires. Drug codes were indicated at 37.5% of 456 preparations surveyed. While 69.9% of the companies selling or manufacturing ointment products did not put the drug code on any of their preparations, 15.1% of the companies labeled the drug code on all of their products. The larger the number of products per company became, the higher the rate of preparations wearing the drug code was. Drug codes were printed on labels in 65.9% of the preparations, and on the tube in 32.9%. More than 37% of the companies surveyed had no plan to use the drug code for their ointment products.
It is generally recognized that the drug code is useful to identify such preparations as tablets and capsules. Therefore, wider labeling of the code on ointments is desired.

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The correlation between the size of commercial capsules and that of drop holes of the capsule supply apparatus was studied by a geometric analysis on automatic tablet packaging machine (type OMP-CAT-150). The following results were obtained from the calculation of the sizes of capsules and drop holes: 1) Suitable ranges of length and diameter of capsules were formularized under the setting of constant height and diameter of drop holes, as follows:
{8-2√6/5}·b<B<b-√2b·B-b²+B/2-a<A<a
where A, B, a and b are capsule length, capsule diameter, drop hole height and hole diameter, respectively. 2) Commercial capsules are classified into six groups by their size. It can, therefore, be expected that the automatic tablet packaging machine is miniaturized by reducing the varieties of capsule supply apparatus.

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Non-sealed tablets and capsules are used often in Unit Dose Package (UDP) prepared in hospital pharmacy. Their stability was examined in terms of hardness, weight and friability at 25° and relative humidity of 75%. In most uncoated tablets and film-coated tablets, their hardness decreased largely in several days, and their weight increased. All capsules increased their weight by more than 1%, but sugarcoated tablets showed little change in hardness and weight. Change in hardness showed a significant relation to change in weight and in friability; therefore, in the quality control of non-sealed tablets, hardness may be a simple and important index. Non-sealed tablets and capsules increased their stability when stored in packing paper for UDP, but should be preserved carefully in case of storage for a long time. When exposed to fluorescent light (1, 000 lux), about 10% of samples showed a change in appearance after 8 days. Under the same conditions, phytonadione uncoated tablets (5 mg) decreased their contents to 63% after 4 weeks; decrease was far smaller, to 83%, when the tablets were stored under a light-resistant cover.

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Stability of betamethasone-17-valerate (BM-17-V) in admixtures of Rinderon-VG ointment with other ointment or cream was studied. Determination of BM-17-V was made by high performance liquid chromatography, and the result of determination, as well as change in pH value and appearance, was recorded immediately after admixing, and 2, 4 and 8 weeks after storage at room temperature. Further, stability of BM-17-V and change in appearance were studied 1 week after storage at 37°. Significant change was not observed in any test item, thus indicating that Rinderon-VG ointment is compatible with other ointment or cream examined.

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Stability of aminoglycosides (AG) in anemopathy was investigated in regard to change in appearance and in pH, smell and residual potency by compatibility tests using Alevaire, and influence of ultrasonic nebulization. In this study, commercially available injections of gentamicin (GC), kanamycin (KC), streptomycin (SC), amikacin (BK), dibekacin (PM) and tobramycin (TC) were used. The results are summarized as follows:
1) No changes in appearance and pH were observed in all the solutions of AG mixed with Alevaire. BK and PM kept primary potency for 168 hours after mixing, but the potency of GC began to decrease 24 hours after, and also that of KC, SC and TC decreased slightly 6 to 168 hours after. 2) AG was stable even under the influence of ultrasonic nebulization, though a bad smell was given out from additives in AG injections due to their decomposition.
From these results, it is emphasized that: 1) AG should be mixed just before use, and 2) attention should be paid to odor and taste, as well as residual potency.

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Viability of 6 kinds of glucose nonfermentative gram-negative bacilli was studied in 9 different infusions. Pseudomonas cepacia and Achromobacter xylosoxidans multiplied in 6 infusions (Intralipos 10%, distilled water, isotonic sodium chloride, Ringer's solution, 5% dextrose and Solita T3), but died in 3 (50% dextrose, Proteamin XT and Paremental A). On the other hand, P. aeruginosa proliferated only in Intralipos 10% and in isotonic sodium chloride, and Flavobacterium meningosepticum, P. maltophilia and Acinetobacter calcoaceticus could not grow in all the infusions except Intralipos 10%, which permitted the most rapid growth of all species tested.
The capacity of glucose nonfermentative gram-negative rods to proliferate to high levels in intravenous infusions might be related in part to the significant increase in sepsis cases caused by these organisms.

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The quality of 3 kinds of commercial prednisolone intact tablets was evaluated by weight variation, content uniformity and dissolution, and that of tablet halves, prepared by manual division of tablets along the score, by weight variation and dissolution. These tests were made according to the method prescribed in JP X. Following results were obtained: 1) All of the 3 kinds of intact tablets met the quality standard prescribed in JP X. 2) In each of the 3 kinds of tablets, no difference was found in dissolution patterns between intact tablets and tablet halves. 3) In each of the 3 kinds, percentage range of weight variation was wider in tablet halves than in intact tablets.

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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.

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