Objective: In Japan, to prevent an increase in medical expenditure associated with development of super-aging society, the use of generic drugs is being promoted.  To help patients financially and meet their various other needs, generic drugs (e.g., orally disintegrating film formulations) whose dosage forms do not exist for original drugs are manufactured and distributed.  In this study, to evaluate the characteristics of an orally disintegrating film formulation, we performed dissolution, disintegration, and simulated intraoral tests of Amlodin® tablets 2.5 mg, Amlodin® OD tablets 2.5 mg, and Amlodipine OD film 2.5 mg that were manufactured by TEVA-KOWA PHARMA Co., Ltd.
Methods: Dissolution and disintegration tests were performed in line with the Japanese Pharmacopoeia, Sixteenth Edition, and the dose of amlodipine was determined by high-performance liquid chromatography.  During the simulated intraoral test, the tested drugs’ disintegration in purified water and artificial saliva was observed macroscopically, and recorded using a digital camera.
Results: Since the each formulation showed an over 85.0% rate of dissolution 15 min after the initiation of the dissolution test, no difference was found in elution behavior.  Also, in the simulated intraoral test, the film formulation began to disintegrate the earliest (2 and 10 min when using purified water and artificial saliva, respectively) among the tested drugs.
Conclusion: Our findings suggest that orally disintegrating film formulations show superior disintegration to uncoated or orally disintegrating tablets, and benefits on taking medicine was observed.

Objective: Along with the globalization of the Japanese economy, the number of international students in Japan has gradually increased.  Under these circumstances, international students to visit pharmacies for self-medication are expected to increase.  Thus, we carried out a questionnaire survey on international students conducting self-medication using non-prescription drugs, and examined its problem.
Method: To clarify the status of self-medication using OTC drugs by students studying abroad, multiple-choice and free description-style questionnaire sheets written in Japanese or English were distributed to 30 international students based in Kobe City.  The sheets were independently completed by the students, excluding those who had difficulty in sufficiently comprehending the questions and required the researcher’s oral explanations for assistance.
Result: While 90.0% of the respondents answered that they occasionally use non-prescription drugs in their own countries, only 60.0% answered that they had experience of purchasing the drugs in Japan.  When purchasing OTC drugs, 15.2% faced instructions printed on their packages.  While 30.0% regarded as important to purchase appropriate drugs in their home countries, only 23.3% sought such advice in Japan.
Conclusion: These results revealed a tendency for international students to purchase OTC drugs following pharmacists’ advice less frequently in Japan than in their home countries despite their literacy difficulties.  In the future, we hope to examine issues such as possible active communication by pharmacists and the drugstore structure, so as to promote self-medication through purchasing drugs at Japanese pharmacies.  As a result, we hope to contribute to making Japanese pharmacies more foreign user-friendly in a real sense.

Objective: For pharmacists to select a suitable auxiliary device for eye drop administration for patients who have difficulty in applying eye drops, the pharmacists need to know the characteristics and level of difficulty of using each device.
Methods: Thus, we compared the characteristics of New Rakuraku Tengan, Rakuraku Tengan III, and an eye-drop self-help device and also conducted a survey involving 40 healthy volunteers on each device’s accessibility and suitability for people with motor disabilities.
Results: New Rakuraku Tengan received the highest score for “usage was able to easily understand” (70.0% of the respondents answered positively) and “suitability for poor-sighted people” (65.0%).  Rakuraku Tengan III received the highest score for the “effectiveness of photos and illustrations in the manual” (77.5%),but was evaluated to be difficult to use.  The eye-drop self-help device received the highest score for “suitability for people with difficulty raising their shoulders and arms” (75.0%).
Results: Thus, we observed the need for pharmacists to have thorough knowledge of the products in order to recommend suitable auxiliary devices for eye drop administration for each patient.

A 54-year-old woman complained of prolonged fever. Echocardiography showed severe mitral regurgitation with vegetation, and computed tomography showed right coronary artery (RCA) fistula to the coronary sinus (CS). Blood culture revealed Strep. viridans, thus a diagnosis of active infective endocarditis was established. The patient underwent urgent surgery. Surgical findings showed that vegetation was located in A3 to P3 of the mitral valve. The patient underwent mitral valve repair using a glutalualdehyde-treated autologous pericardial patch and artificial chordea. Epicardial ligation for fistula was performed. Her postoperative course was uneventful.

A 44-year-old man with a history of remittent fever for 6 months was given a diagnosis of inf ective endocarditis of the aortic valve related to a congenital ventricular septal defect (VSD), although no bacterial growth was obtained by blood culture. After one week of antibiotic treatment, aortic valve replacement (AVR) and patch closure of the VSD were performed after debridement of infected tissue and vegetations involving the aortic root, pulmonary and tricuspid valves, and myocardium surrounding the VSD. Antibiotic treatment was continued postoper-atively, but elevation of C-reactive protein (CRP) persisted. Blood culture disclosed Candida albicans in the blood 3 months after AVR. Fungal prosthetic valve endocarditis (PVE) was suspected, therefore, aortic root replacement with a Free Style bioprosthesis and VSD re-closure were performed followed by continued systemic antifungal treatment. Five months after reoperation, the patient was readmitted with a high fever. A pseudoaneurysm of the left common iliac artery and complete obstruction of the external iliac artery were shown by contrast-enhanced computed tomography (CT). The aneurysm was resected without revascular-ization. This case presentation concludes that long-term whole body study with contrast-enhanced CT might be necessary even though complete eradication of the infected foci of the heart has been established.

  On July 7, 2010, a 74-year-old man came to our hospital, complaining that he had a nagging pain in his chest that started the preceding day. After performing electrocardiography, blood tests and electrocardiography, we diagnosed the case as acute myocardial infarction. At first, it was thought that blood flow could be restored in due course of time, antiplatelet and anticoagulant agents were used. Intracardiac catheterization was not included in our initial treatment plan. Three days after the initiation of the treatment, the patient had pain in his left inguinocrural region. Computed tomography and magnetic resonance imaging reveled hematoma in his left iliopsoas muscle. We stopped administering antiplatelet and anticoagulant agents to him. But anemia progressed from Hb14.1g/dL to 9.8 g/dL, so blood transfusions had to be given. After that, the patient underwent a rest cure. With the passage of time, the pain and swelling of the left iliopsoas muscle went down. Regarding the cardiac condition, however, the pain in the chest did not abate even when he was taking a rest. The antiplatelet therapy was resumed, with one type of agent given at first and then with another type added. Examinations using a coronary CT and a cadiac catheter found 90% stenosis at the proximal left anterior descending coronary artery. So, a bare metal stent was placed in the near-closed artery. Ever since, there has been no recrudescence of chest pain and no recurrence of iliopsoas muscle hematoma. The extravascated blood mass seemed to be dissolved spontaneously.

  To assess the effect of pre-germinated brown rice on metabolism of glucose and lipids, blood parameters of glucose and lipids were measured before and after 3 months of intake of test rice, which was mixed with pre-germinated brown rice (PGBR) and white rice in a ratio of 1:1, in patients with diabetes mellitus type 2 (DM). Glycosylated hemoglobin A1c (HbA1c) was significantly decreased from 6.40±0.23% to 6.23±0.19 after 3 months of intake of PGBR. The fasting plasma glucose level was not changed by intake of PGBR, but serum insulin level and HOMA-IR were decreased slightly. As the decrease of LDL-cholesterol (LDL-c) and the increase of HDL-cholesterol (HDL-c) were slightly observed after 3 months of intake of PGBR, the LDL-c/HDL-c ratio was decreased significantly from 2.03±0.13 to 1.83±0.12. These changes were significantly larger in the high PGBR in take group than in the low PGBR in take group. These results suggested that the PGBR intake might have potentialities as one of therapeutic methods for diabetes mellitus type 2 and also be useful in the freatment of hypercholesterolemia.

To administer oral anticancer drugs safely, the simple suspension method has been introduced in many hospitals. Therefore, concerning drugs for which it is unclear whether or not this method is applicable, testing must be able to be conducted at any time. In this study, we investigated 20 oral anticancer drugs to expand information on the application of the simple suspension method. Disintegration/suspension and permeability tests were conducted, as described in the 3rd version of the Tube Administration Handbook for Oral Drugs. All products were disintegrated/suspended after 10 minutes. On permeability tests, there was no residue in any tube for tubal feeding. On the final evaluation, the products were regarded as suitable (grade 1). Bicalutamide tablets (80 mg, TCK and KN), which were analyzed in this study, were regarded as suitable (grade 1) on the final evaluation. On the other hand, the simple suspension method is not applicable for a brand-name drug, Casodex^® tablets (80 mg). This may be related to the different additives. Furthermore, the results suggest that, even when the simple suspension method is not applicable for a brand-name drug, it may become applicable for generic drugs. This may provide a new merit for promoting the use of generic drugs.