Objective: The squeezing force and one-drop weight, suggested to directly influence adherence, were measured in 6 eye drop products containing a switch OTC drug, ketotifen fumarate, to investigate useful information for product selection.
Methods: The squeeze force, one drop weight, and pH were measured using a digital force gauge, analytical balance, and pH meter, respectively.  Information on additives contained in each product was collected from package inserts.  For the total number of drops, the number per 10 mL was calculated from the obtained value.
Results: The maximum squeeze force was 14.8 N of Irice AG Guard, and the one drop weight (33.2 mg) of Raferusa®AL was the minimum.  The total number of drops per 10 mL was 215 in Sutto eyes Z, being the minimum.  The pH was in the range of 5.2-5.7.  On comparison of additives among the products, a cooling agent was contained in only 2 products.
Discussion: Since the squeeze force was in the range of 5.3-14.8 N, it was less likely that the squeeze force reduces usability.  Since the one-drop weights of 2 products were more than 10 mg lower than the weights of the other products, the dose may be insufficient and the effect may not be attained.  The pH was within the acceptable range in all products.  Two products contain a cooling agent as an additive, and this has to be explained beforehand.  Information related to usability, actual feeling of the effect, and sense of the use of the products containing ketotifen fumarate was collected.

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.

In cancer chemotherapy, it is very important to take into account the patient’s background. In recent years, a simple suspension method has attracted increased attention as a method that prevents changes in the stability and safety of various drugs. However, of 135 oral anticancer drugs, only 28 have been examined using this method, as of April 2013. In this study, we carefully investigated whether 53 oral anticancer drugs could be adapted to the simple suspension method, except for the 28 drugs that had already been previously reported. The results showed that most of these oral anticancer drugs could be adapted to the simple suspension method. Of seven drugs that were not adapted, six were generic drugs. In addition, it was clear that the evaluation of bicalutamide tablets was significantly different from our expected results. In conclusion, we were able to qualitatively assess all 53 oral anticancer drugs. This is equivalent to half of 107 untested drugs. These results provide useful information to cancer patients using oral anticancer drugs prepared using the simple suspension method.

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.

To smoothly proceed with the national policies and projects concerning dementia measures, it is important that pharmacists who take care of patient in clinical practice sufficiently understand its contents. In this study, we conducted a questionnaire survey involving chain community pharmacists to investigate the level of awareness concerning these policies and projects. Subjects were 446 chain community pharmacists. The questionnaire consisted of 17 items (e.g. the level of awareness regarding the “Comprehensive Strategy to Accelerate Dementia Measures (New Orange Plan)”, “Dementia Supporters Caravan Program (Caravan Program)”, and “Dementia training certified pharmacist program (Certification program)”). The questionnaires were filled out anonymously. The levels of awareness concerning the “New Orange Plan” and “Caravan Program” were 34.7% and 48.9%, respectively. Sixty-one percent of subjects attended a “Dementia Supporter Training Lecture”, 30.4% of whom were wearing the “orange ring”. The levels of awareness and the hope of acquisition concerning the “Certification program” were 47.8% and 79.8%, respectively. To achieve the purpose of “contribution to early detection of dementia by pharmacist” of the “New Orange Plan”, it is necessary to conducting the workshop and to create an opportunity to come in contact with dementia patients. It is also important to recognize that it is necessary to enlighten the meaning of wearing an “orange ring” and to enlarge the circle of dementia supporters. In addition, it is thought that more dementia patients can be supported in the community by increasing the levels of awareness concerning the “Certification program” and giving appropriate advice and response.

Objective: In this study, pharmaceutical properties were compared between the original and generic ophthalmic solutions containing betamethasone.Methods: The squeeze force, drop weight, surface tension, pH, kinematic viscosity, and total number of drops were measured. The drop volume was calculated from the drop weight and specific gravity. Information on preservatives contained in each product was collected from package inserts.Results: There was a significant difference in the squeeze force between the original and generic drugs. The pH and kinematic viscosity did not differ between the drugs. The drop volume was in the range of 30.3 to 47.2 μL, and the surface tension ranged between 33.7 and 65.2 mN/N. The total number of drops was approximately 100 in the original drug, being the lowest.Conclusion: The results of this study showed that the squeeze forces of all generic products but RINBETA PF, which was contained in a specific container, were smaller than that of the original product. The drop volumes of 2 generic products were ≥ 15-μL smaller than that of the original product, but they were within the permissible range. The maximum difference in the surface tension was approximately 33 mN/N, suggesting that drug solution relatively frequently overflows from the eyes. The total number of drops for all generic products was greater than that for the original product, suggesting that the former can be used at a higher frequency. Based on these results, pharmacists must select products in accordance with individual patients.

Objective: Glaucoma is the most frequent cause of blindness in Japan and is primarily treated using IOP-lowering ophthalmic solutions. Although the patients themselves frequently instill ophthalmic solutions, instillation by caregivers may be necessary for various reasons. Therefore, we evaluated pharmaceutical characteristics of antiglaucoma ophthalmic solutions and their usability from the caregivers' viewpoint.Methods: Five dorzolamide hydrochloride-timolol maleate ophthalmic solutions and 2 travoprost-timolol maleate ophthalmic solutions were evaluated concerning the pharmaceutical characteristics and subjective squeezability rated by adults aged 20 years or above.Results: Among the dorzolamide hydrochloride-timolol maleate compounding ophthalmic solutions, the squeeze force was the lowest in COSOPT® ophthalmic solution (11.8 N), and DORMOLOL® combination ophthalmic solution NITTEN was rated highest, with 68.2% of the subjects placing it within the top 3 levels of a 7-level scale. Of the travoprost-timolol maleate ophthalmic solutions, the squeeze force was 9.8 N, lower than the pioneer drug, in TraTimo® combination ophthalmic solution NITTO, which was also rated in the top 3 levels by 90.3% of the subjects. A strong negative correlation was observed between the squeeze force and squeezability.Conclusion: In instillation by caregivers, the squeeze force was shown to be correlated with subjective squeezability as in instillation by patients themselves. This study provided information concerning the usability of ophthalmic solutions from the caregivers' viewpoint. For the future, it is necessary to select ophthalmic solutions from the caregivers' as well as the patients' viewpoints by utilizing information obtained in this study.