Effects of humidity on the stability of nifedipine soft capsules were studied. Three commercial products were subjected to the test.
Humidity conditions were set to be 55% and 80% of relative humidity and light resistant desiccators, where the samples were kept for 3 months under the same conditions as those previously reported. Changes of amount of both the contents of nifedipine soft capsules and nifedipine (Np) in the capsule shells were followed by high-performance liquid chromatography.
Samples kept with PTP were stable, showing only slight decrease of the contents under both conditions. However, in the samples removed from PTP, it was observed that the amount of Np in the capsule shells increased with the decrease of the content and that Np oozed out the surface of the capsules at 80% of relative humidity. Differences of the amounts of Np which migrated from the content to the capsule shells were observed among the three products. It was also discussed that the migration was highly affected not only by the external environmental factors such as humidity but also by the factors of capsule preparations.

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Stabilities of injectable solutions of five cephem antibiotics (cefmenoxime, latamoxef, cefoperazone, cefotiam, and cefotaxime) at 5 and 25.0°C after dissolution were investigated. The amounts of tetrazoles produced by the degradation of these drugs were also determined.
These drugs were found to be stable, and the amounts of tetrazoles liberated were only slight at 5°C. On the other hand, differences in the stability among the drugs were apparent at 25.0°C. The residual concentrations of drugs after 24 hours ranged from 98.3%(cefoperazone) to 85.2%(cefotaxime) of the initial concentrations at 25.0°C. Furthermore, more tetrazoles were produced with the decrease in the amounts of unhydrolyzed drugs. Nineteen mg of methylthiotetrazole was found in latamoxef solution (1g/vial) and 56mg of dimethylaminoethylthiotetrazole was found in cefotiam solution (1g/vial) after 24 hours.

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1, 9-Nonanedial (NDL) and 2-methyl-1, 8-octanedial (NDL: 2-methyl-1, 8-octanedial= 1: 1, INDL) belong to dialdehyde compounds as well as glutaraldehydes, and it is presumed to show the similar reactivity to Hepatitis B virus. Hepatitis B virus surface antigen (HBsAg) was treated with 0.04 mM NDL, 0.04 mM INDL, 0.04 mM glutaraldehyde and 10% formalinsolution, and the titer was determined according to the method of radioimmunoassay. HB s Ag s were as follows: PLC/ PRF/ 5 cells cultured medium, purifiedHBsAs coated beads and HBeAg positive sera.
NDL, INDL and glutaraldehyde (ajusted to pH 8.0 respectively) indicated the reduction of antigenicity of HB s Ag (cultured medium and beads), but formalin did not. Moreover, NDL reduced the titer of HB s Ag (HB e Ag positive sera) to half for at least 10 minutes.
These results suggest that NDL and INDL may be employed for disinfectant to Hepatitis B virus.

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The effects of pH on dissolution of forty commercial cardiovascular preparations (antiarrhythmic, diuretic and antihypertensive drugs) were studied in vitro. The dissolution rates were determined by a paddle method in the medium of pH 1.2 and 4.0.
Etafenone film coat tablet (Eft), befunolol capsule (Bc), disopyramide capsule (Dc), furosemide tablet (Ft) and pindolol tablet (Pt) showed significant differences in the dissolution rate after 30 minutes at pH 1.2 and 4.0. The differences in the dissolution rate of Eft, Bc, and Dc were due to disintegration process of capsule or film coat. Therefore, those results may be characteristics of those commercial brands.
Ft and Pt were more studied using other four and two brands, respectively. In case of furosemide which had poor solubility at lower pH, the dissolution rate of all brands increased as pH (1.2, 4.0 and 5.8) of medium increased. One of three brands af Pt showed dissolution rate of 83%(pH 1.2) and 27%(pH 4.0) after 30 minutes, but the others showed those of about 100% at both pH. The dissolution of those preparations probably depends on pH values in vivo as well as in vitro.

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The pharmacokinetic parameters of valproic acid (VPA) transferred via the placenta were clinically investigated in a newborn infant born to an epileptic mother. The newborn, delivered at about 37-week gestation, was a healthy male (birth weight 2, 500g). The Apgar score was 6. The serum levels of VPA between 6 hours and 8 days after birth were monitored by the FPIA method. The elimination pattern was mono-exponential, and the pharmacokinetic parameters were t 1/ 2= 45.7 hr and Kel= 0.0152 hr^-1 according to the one compartment model.

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In the previous paper, the mechanism of isosorbide dinitrate (ISDN) loss into the administration set was studied from equilibrium and kinetic approaches. The purpose of this study was to define the factors effecting the loss of nitroglycerin (GTN) from intravenous solutions and then to compare the results with those of ISDN loss described in the previous paper. ISDN and GTN concentrations were measured by high-performance liquid chromatography. It was found that the factors effecting the loss of GTN were the containers, the length of administration set and the flow rate of intravenous solutions. When the GTN solutions was passed through the administration set at a flow rate of 1.38 ml/ min, the largest decrease in GTN concentration occurred after 5 minutes. And these findings agreed well with the results of ISDN solutions.
However, the loss of GTN from solutions after passage through the administration set was about twice larger than that of ISDN, because the rate of adsorption of GTN was much faster than that of ISDN.

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Factor of the fundamental dosage form design were studied to minimize errors in tablet discrimination. The minimum difference in size which permits discrimination between tablets was determined by using round white tablets and sugar-coated tablets in 1-mm-graduated diameters. Analyses were also made as to colors, relationships between tastes and colors, and suitable tablet sizes for grasping and swallowing.
Obtained results showed that discrimination among the three preparations (2mg, 5mg, and 10mg tablets) is possible if their diameters differed by 2 to 3mm, but that there is a strong possibility of errors when the diameter differences range only from 0 to 1 mm. Analysis of other factors also showed clear results.
These results may suggest important clues to elucidation of tablet discriminatory features, fundamental factors in dosage form and package design.

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It is known that the the hibitane concentration (H-C) is precipitated by the sulfate ion contained in the service city water. We found that the higher concentration of the surface active. agent (polyoxyethylene nonylphenylether, NP-10SM) prevented the precipitation. The H-C containing the various concentrations of the NP-10SM were diluted with the sulfate ion solution of the various concentrations. We tested the appearance and quantifiction. 1) In the appearance, the 7% NP-10SM for the 5% chlorhexidine gluconate (CHG) prevented the precipitation in the 3Oppm sulfate ion solution. The 3.75% NP-10SM for 5% CHG prevented the peccipitation in the 20 ppm sulfate ion solution after 24 hours. 2) In the quantification, the same proportion of the NP-10SM as the commercial product did not decrease a few quantities of the CHG in the 50 ppm sulfate ion solution. In the lower concentration of the NP-10SM, the quantity of CHG was decreased to 90% after 5 hours.
In our hospital, therefore, we supplied 5% H-C containing the 7% NP-10SM for the 5% CHG.

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Compatibility tests on ketoprofen injection (Kp) with eight local anesthetics (LA) were performed in terms of pH, appearance, osmotic pressure against aline, and residual Kp after mixing.
For admixing, following two methods were used.
Group A: Kp is dissolved in distilled water for injection and then admixded with LA. Group B: Kp is directly dissolved in LA. The results are as follows:
1. Mixing with following drugs should be avoided:
Group A: Percamin S, Carbocain (2%), Xylocaine E (1 and 2%), Marcain (0.25 and 0.5%), Citanest (1 and 2%). Group B: Bancain (2%), Percamin S, Carbocain (2%), Xylocaine E (1 and 2%), Xylocaine (3%), Marcain (0.5, 1 and 2%).
2. Mixing with following drugs should be made with caution.
Group A: Bancain (2%), Calbocain (1%), Xylocaine (1, 2 and 3%), Xylocaine E (0.5%). Group B: Xylocaine (1 and 2%), Xylocaine E (0.5%).

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