Three kinds of digoxin rectal suppositories were made from cacao butter containing 5% sucrose fatty acid esters with HLB value of approximately 15 (SFAE-15) and 11 (SFAE-11). SFAE-15 and SFAE-11 were combined in the following ratios: 25 to 75 (HLB 12, formula 2); 50 to 50 (HLB 13, formula 3); and 75 to 25 (HLB 14, formula 4). Digoxin suppository containing only polysorbate 60 (formula 1) was used as the standard. Physical properties such as melting point, dissolution time and hardness were determined. For each formulation blood samples were drawn from four rabbits 0.5, 1.5, 3.0, 4.5, 7.0 and 9.5 hours after rectal administration of the suppository. Digoxin levels in the plasma were determined by a radioimmunoassay method. As an expression of the bioavailability of digoxin suppository, the areas under the plasma digoxin concentration-time curves over the 0-to 9.5-hour period were compared. The relative areas under the concetration-time curve for formulas 2, 3 and 4 were 2.50, 2.25 and 2.99, respectively. The patterns of digoxin absorption from suppositories 2 and 4 were different among the rabbits. According to formula 3, the patterns of digoxin absorption after rectal administration were very similar to each other. In the digoxin suppositories combining SFAE-15 and SFAE-11, second rises of digoxin levels in the plasma were observed.

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Glutaraldehyde, a disinfectant of HB virus approved by WHO, on spot use in hospital, mar be likely to cause a cross-contamination with other disinfectants and its content and potency may possibly be decreased to some degree when used for inactivation of HBs antigen positiveblood. The following tests were performed.
(1) 2% Glutaraldehyde and some other disinfectant used in a hospital were combined at theratio of 99: 1 or 90: 1. Little reduction was observed both in the content and the disinfection, potency.
(2) 2% Glutaraldehyde was mixed with a blood at the ratio of 9: 1 and8: 2. No reduction was seen in the duration of potency when compared with each control. In the mixtures at theratio of 7: 3, 6: 4 and 5: 5, the potency lasted longer than that of each control.
It was concluded that a notable decrease in the disinfection potency is not caused unless the mixed volume of blood exceeds 10%.

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Physicochemical properties of four commercial lactase preparations (Galantase, Organase, Lactyme and Lamitase) and an investigational new drug (ORG-FG) were compared. Lactyme showed better results than any other drug in any study and Galantase was not suitable for dispensing. It is recommended that enzyme assay be carried out under the following conditions: reaction temperature 30° and reaction time 10 minutes a sample concentration be measured at OD of 0.30-0.50.

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Five lactase preparations (Galantase, Organase, Lactyme, Lamitase and ORG-FG) were compared in terms of enzyme assay and stability. Optimal pH of all the preparations was about 4.5-4.7, when ONPG, lactose and commercial milk were used as substrates. Active pH range of Galantase was 4.0-5.5, while that of the others was 3.5-5.5. Hydrolysis rate of Galantase against lactose was slightly lower than that against ONPG, as compared with the others. Evident difference was observed between Galantase ane Lactyme in pH and thermal stabilities, whereas the other products indicated similar properties to each other.

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Dissolution and other pharmaceutical properties of four kinds of oral potassium products stored under two different conditions were examined. The potassium products examined were tablets of aspartate (A) and gluconate (B), sustained release tablet and enteric coated granule of chloride (C and D, respectively). One of the storage conditions was standing in desiccator at room temperature for 30 days (ordinary condition) and the other at RH 92% at 30° for 30 days (accelerated condition).
Despite the labeling of enteric coating, the dissolution of D into the first fluid in J. P. IX disintegration test showed apparently a sustained release profile. When stored under the accelerated condition, D as well as A showed significantly more rapid dissolution than when stored under the ordinay condition. No change was observed in B and. C.
The effects of two apparatus (J. P. IX disintegration test test apparatus and Desaga Resomat II 147003) on dissolution time were observed in B, C and D, and both 50% and 90% dissolution times were reduced significantly when J. P. IX apparatus was used. This suggested that vigorous mixing with the J. P. IX apparatus facilitated disintegration of dosage form to accelerate dissolution of the component. The properties other than dissolution, i. e., weight, hardness, fineness and content, were almost satisfactory under the ordinay and accelerated conditions. Under the accelerated condition, A was found insufficient moistureproof inner package.

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The quality of five brands (A to E) of sugar-coated tablets containing 5 or 10 mg of medazepam was studied in terms of pharmaceutical properties. Although all the products tested met the requirements for the disintegration test according to J.P. IX, the disintegration time of Product D was 3 to 4 times longer than those of the other products. In the dissolution test, the results obtained by the rotating basket method were similar to those by the paddle method. A good correlation was noted between the dissolution rate and the disintegration time. The dissolution rates of four brands reached about 100% within 30 minutes, except the rate of Product D which was only 7% even after 60 minutes, possibly due to obstruction of the dissolution by the layer of sugar coating.

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The quality of dl-α-tocopheryl nicotinate capsules (A to D) of four manufacturers was evaluated in the tests on dissolution, weight variation, disintegration and content. Weight variation, disintegration time as well as mean value of content were measured according to J. P. IX. The solvent containing 250ml of the first fluid (disintegration, J. P. IX.) and 750ml of 99.5% ethanol was used as dissolution medium. 50% dissolution time (T₅₀) and maximum dissolution percentage were compared using Apparatus 1 (rotating basket method) and Apparatus 2 (paddle method) described in U. S. P. XX. T₅₀ of preparations A, B, and D by the rotating basket method were 16.8-20.0 min, whereas those of the paddle method were 10.0-15.0 min; T₅₀ of preparation C was 19.2 min in both methods. The maximum dissolution percentage of each preparation did not vary between the different methods. Weight variation of these preparations was 1.1-2.8%, while disintegration time was 6.7-8.9 min. These results met the requirements specified in J. P. IX. Content was 108-117%.

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High-speed liquid chromatography (HSLC) was used for the stability test of ascorbic acid dipalmitate (AsA-DP) in ointments and ointment bases, under the following conditions: model, JASCO FLC-350; detector, UVIDEC-I; wavelength, 254 nm; column, ZORBAX ODS (4.6×250 mm); mobile phase, MeOH; flow rate, 1ml/min; pressure, 100kg/cm²; chart speed, 0.5cm/min (at room temperature). The extracted AsA-DP was directly injected into the HSLC column. The amount of AsA-DP was determined from the peak height on the chromatogram. Absorption ointment, hydrophilic ointment, hydrophilic petrolatum, and 14 kinds of ointment bases containing 1% AsA-DP were exposed to air at 40° where their stability to oxidation was measured with HSLC. The results were as follows:
1) The decomposition in ointments and ointment bases was pseudo-first order. 2) AsA-DP in ointments was stable in order of hydrophilic petrolatum, hydrophilic ointment and absorption ointment. 3) AsA-DP in stearyl alcohol, cetanol, and sorbitan sesquioleate was unstable, while that in white petrolatum, liquid paraffin, and stearic acid was very stable. 4) The decomposition product of AsA-DP in ointments and ointment bases was ascorbic acid-6-monopalmitate.

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Compatibility of commercial gentamicin injection (GC) with six drugs for inhalation (Alevaire, Bisolvon, Asthone, Asthpul, Alotec and Venetlin) was investigated on 15 models of mixture in terms of change in appearance, pH and residual potency in microbioassay. It was found that in all these models the potency of GC deteriorated 0-3 days after mixture.

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The equipments such as vacuum cleaner and air conditioner may produce much stir in the air of the dispensing room, giving effect to the number of airborne bacteria. The number of falling bacteria was determined in the periods in and out of operation of the machines. Following results were obtained:
1) The operation of an air conditioner caused a decrease in the number of falling bacteria onto the dispensing table, to 1/2-1/4 in the hours from 11: 30 to 13: 30 when pharmacists' working volume gets maximum. 2) Vacuum cleaner was more effective in decreasing the number of falling bacteria, to 1/3-1/5 in the same hours. The effect increased in the concurrent use of both equipments. The bacterial number generally increase in parallel with the working volume and the movement of personnel in the room. But these equipments, operated at the same time, prevented the increase. 3) of the total number of the falling Of bacteria, 75-80% were gram-positive cocci, nearly all of which were staphylococci and micrococci. In contrast, gram-positive bacilli composed only 9-10%. Gram-negative cocci and bacilli accounted for only 1-2%, major species being Neisseria in the former and Enterobacter in the latter.

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The compatibility of gentamicin sulfate injection (Gentacin containing 60 mg of gentamicin sulfate in 1.5 ml of water) with 13 kinds of commercial infusions was studied. One ampule of Gentacin was added to each infusion and the mixtures were allowed to stand for 24 hours at 25°. The determination of gentamicin potency was made microbiologically, and pH value and appearance were recorded 0, 6 and 24. hours after mixing. No change was observed in the experiments, indicating that Gentacin is compatible with the commercial infusions examined.

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