Compatibility of lysozyme chloride ointment (Reflap^® ointment, LO) was studied using two kinds of povidone-iodine sugar ointments. One was povidone-iodine sugar ointment (PSG), which was prepared in the hospital pharmacy, and the other was U-pasta KOWA ointment (UPK) which is available on the commercial market. In this study, LO was mixed with PSG or UPK in a 3: 1 ratio by weight. Lysozyme (LZ) activity and the residual percentage of available iodine were determined in the mixtures over a 28-day period, and the change in LZ was also investigated using SDS-polyacrylamide gel electrophoresis.
No changes were observed in LZ activity and LZ molecular weight in the mixtures, while the available iodine dramatically decreased with time in a dark location at room temperature. On the other hand, in a dark place at 5°C, the residual percentages of available iodine were maintained above 90% in PSG-LO stored for 14 days after mixing and in UPK-LO stored for 28 days after mixing. From the above results, it was concluded that PSG-LO remained compatible up to 14 days, and UPK-LO for at least 28 days at 5°C.

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We surveyed sheets prescribed by dermatologists in our hospital during a 6-month period to investigate the stability of the admixture of commercially available ointments and/or creams. The total prescribed sheets numbered 21, 626, with 690 admixtures being found in 676 sheets. Seventy-two percent of these admixtures were combined corticosteroid preparations with white petrolatum or urea creams. Seven kinds of well-prescribed admixtures were presumed to develop some combinational problems. These admixtures were then prepared in our department, and the rate of air inclusion into the admixtures by mixing process was measured. The quantities of the water phase separated by centrifugation employed as an indice of the destruction of emulsion after mixing were measured, with a high value being obtained with the combination of corticosteroid ointments and o/w-type urea creams (ranging 10-30%). From the visual change noted by a naked eye supplemented with microscopic examinations, the emulsion in these admixtures was found to have already been destroyed after mixing. In contrast, the admixtures utilizing corticosteroid ointments and w/o-type urea creams were physically stable for a month. We also discussed on prescriptions made by many physicians. Consequently, it is strongly hoped that the information described in the package inserts and the naming of the products will be improved in relative to their physico-chemical properties.

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The photodecomposition of alfacalcidol solutions (Alfarol^® solution) available in prescription and amber glass bottles (manufactured goods) was examined. Alfacalcidol solutions were stored under room light (fluorescent lighting, 940 lux) and near the north window for 28 days, and under ultraviolet lamp for 4 hours. Samples were withdrawn from each bottle at certain times and assayed by high-performance liquid chromatography.
Alfacalcidol was found to be unstable under the light-unshaded condition. The Residual contents of alfacalcidol in the prescription bottles were 40% and 85% after 28 days under room light and near the north window respectively, and was 25% after 4 hours under ultraviolet lamp. Therefore, we prepared an alfacarcidol and fat emulsion mixture to increase the photostability of alfacalcidol, and noted that this mixture was stable against light. For example, the residual content of alfacalcidol in the in prescription-bottled mixture was 96% after exposure to room light in a cold place (4°C) for the 28-day period.

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We designed a preparation containing both a drug and an adsorbent as a controlled-release system and selected aminophylline as a model drug for use in this study.
The preparation consisted of two components: to adsorption equilibrium existing between the drug adsorbed onto an adsorbent and free drug, and diffusion of free drug into blood capillaries via the rectal mucosae. Because of the interlocking of the two components, a continuous supply of the drug via desorption corresponding to the elimination of the drug from the blood circulation was confirmed to be possible, which resulted in maintaining a constant plasma level over a long period following rectal administration.
The in vitro release study showed that an optimal adsorbent for the preparation was activated charcoal, especially JP XI grade, and that the most adequate from for rectal administration was by enema. In the in vivo rectal absorption study using rabbits, the preparation provided by an enema enhanced the mean residence time (MRT) of aminophylline by 1.7-fold in comparison with aminophylline solution, and indicated a constant plasma level of theophylline over 6 hours.

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The effects of antiseptics used for disinfection of the hands and skin were evaluated in antiseptic-resistant strains of methicillin-resistant Staphylococcus aureus. After 10⁵ cells of bacteria wee inoculated on the hands, they were disinfected with the antiseptics in accordance with their accompanying literature. Welpas^®, ethanol for disinfection, and Isodine^® sulution (10%) killed all strains including the high-level antiseptic-resistant strain. Hibiscrub^® killed the sensitive strain, but could not completely kill the high-level resistant strain. Thirty minutes after the hands were disinfected with the antiseptics, 10⁵ cells of bacteria were again inoculated on them. Welpas killed the sensitive strain, but could not kill the high-level resistant strain. Isodine solution (10%) killed all strains tested, but Hibiscrub could not fully kill the high-level resistant strain. These results clearly confirmed that if antiseptics are not properly chosen and used effectively, antiseptic-resistant strains may readily begin growing on the hands.

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This study was designed to estimate the difference in the stability and the antibacterial activity between PVP-ISU and U-pasta^®, (UP) of Povidone-iodine sugar ointments which were prepared in our hospital and manufactured in a company. Observed were the changes in these two preparations which were preserved throughout the experimental period of 7, 30 and 60 days and at the temperatures of 20 and 40°C. The stability of each sample was investigated on pH value, available iodine, and sugar quantity. The bacteria tested were six strains of two strains each of MRSA, P. aeruginosa and P. mirabilis isolated from the decubitus of patients.
In PVP-ISU maintained for 30 days at 40°C, the findings revealed that pH value dropped from 4.0 to 2.9 and the concentrations of available iodine and sugar decreased to 74.7% and 41.1% respectively. When storing up to 60 days at 40°C, the pH value lowered to 2.7, the dissolution of sugar was remarkably witnessed, and the concentration of available iodine was recognized as being only 11%. However, all of the strains tested were killed within 10 min. On the other hand, in UP sustained for 60 days at 40°C, no remarkable changes were observed except for a slight change in the pH value (4.7→4.0).
These results suggest that PVP-ISU, in which the stabilizing agents are not contained, cannot be used for an extended time because it cannot maintain the proper stability of pH, sugar and available iodine at a high temperature (40°C). However, UP may possibly be used safely longer than 60 days even if it were stored at a high temperature (40°C).

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Dissolution profiles of newly marketed sustained-release preparations of Flemphyline^® tablets containing 100 and 200mg theophylline were compared with those of Theo-Dur^® tablets under various media and conditions. The dissolution patterns of theophylline generated by the new preparations examined in the media at pH 1.2 and 6.8 were found to be different. Differences were also apparent in the dissolution rates seen among the preparations.
The bioavailabilities following oral administration of Flemphyline tablets was studied in five volunteers by measuring the salivary concentrations and comparing them with those derived from the Theo-Dur tablets. The pharmacokinetic parameters, area under the salivary concentration-time curve up to 24h, and maximum salivary concentration for Flemphyline (100mg) and Theo-Dur were significantly larger compared to Flemphyline (200mg), but there was no difference in the times to maximum salivary concentration among them. These data suggest that each preparation examined in this study is not bioequivalent in the extent of bioavailability.

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Food ingestion does not affect the bioavailability of the nifedipine capsule, a calcium channel antagonist, but delays its absorption rate in healthy subjects. On the other hand, in two different sustained-release preparations of nifedipine, both the bioavailability and anti-hypertensive efficacy in one of them increases, whereas the other is not so much affected by meals. Furthermore, the food induces a reduction in the bioavailability of nicardipine sustained-release preparation, while those of nisordipine, benidipine and manidipine increase conversely.
Such a change in the bioavailability based on food intake may influence the anti-hypertensive efficacy after the initial dosing of the medicine but not so after multiple dosing.
In each medicine or dosage form, there are some differences in the change in the blood level and anti-hypertensive efficacy brought on by food ingestion among the drugs. In general, however, in order to improve patient compliance, we recommend that calcium channel antagonists should be taken after meals following the directions given for this medication.

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As discussed previously, clinically usable significant data on the incidence of adverse reactions were not obtained from the previous PMS materials. Prior to GPMSP's implementation from April 1993, a questionnaire was conducted in september 1992. From the answers received from 72 pharmaceutical companies, obtaining clinically usable data was considered to depend on the detailed operation of the companies.

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The correlation of air pollution between microbial levels and dust particles in suspension bas never been confirmed as data for use in the preparation of sterilized products. In our preliminary experiment in which we determined the microbial levels and dust particles in the clean room. We found that these levels in suspension in air were influenced by the behavior of the technicians while at work. Both the microbial levels and dust particles reached higher levels during the active behavior such as that required in the preparation of intravenous hyperalimentation equipment (IVH) and in putting the clean room in order after completion of the work, These were minimum during which period the air was removed from the IVH bags.

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In order to ensure that an order entry system for prescritions operates correctly and efficiently, we estimated the value of the supporting functions for prescription making. We examined the reports concerning the information supplied (e.g., drug name and directions), the functions of inspection prior to prescription making (e.g., usual dose and maximum dose), and the functions of inspection subsequent to prescription making (e.g., printing of the name of the diagnosis). In our hospital, rate of questions asked due to doubts about the prescription decreased from 4.2% to 0.6% since the order entry system was introduced. This decreasing factor of this asking rate was caused by “checking for an omission” (41%), “using information supplied” (37%), and conducting an “inspection prior to prescription making” (22%). The doctors and pharmacists concerned answered in the affirmative with regard to the supporting functions for the prescription making.
We classified the prescription-making supporting functions into three levels on the basis of importance. In our classification, we concluded that the minimum required supporting functions (fundamental functions) for the preparing of a complete prescripton were “checking for an omission”, “information about the patient”, “drug name”, “selection of the drug”, “directions”, “ unit”, and “dose and times” . In addition, we summarized our standardization of the fundamental functions using the results of this examination.

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As a contrast agent for echocardiography, an injectable suspension containing air-filled microspheres (as active ingredient) produced by sonication of 5%human serum albumin is under development. Thisagent is echogenic and produces backscattering at the interfaces of the air and blood, organs or tissues in the body during ultrasonic examination, providing a range of information including the visualization of blood flow.
Since this contrast agent contains air inside the albumin-shelled microspheres, it has been anticipated that physical shock or vibration might affect the quality of this agent. We have conducted a shipping study to investigate the influence of transportation from the manufacturer to the hospital and the storage conditions on the physicochemical properties of this agent. Despite the severe transport conditions including substantial and frequent physical shocks, changes in temperature, a high position drops, and vibration, no significant changes were found in the microspheres' physicochemical properties, demonstrating their relatively high stability. When product exceeding the shelf life by one month was subjected to the shipping study, however, precipitates were clearly observed on the bottom of the vials after transportation.

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We constructed a Kampo medical information database (DB) which contains image information. The DB is laid out by using the MEGABOX-VP database software currently available on the market. The DB has 13 character files, (such as the Kampo medical file, disease file, and side effect file), and the image file (abdominal “Sho” diagnosis file). These 14 files can be combined in the same field using the on-screen relational database and display. This database offers the advantage of easy accessibility to medical staffs engaged in administering Kampo medicine.

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We constructed a consultative system in an effect to provide quick, clear information on surgical fluid therapy to the clinical site. The program was especially designed to enable complicated conditions arising during gastrointestinal surgery to be effectively handled. Results of system application confirm the usefulness of thissystem for supporting the activities of clinical pharmacists.

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