1.Investigation of the Characteristics of Orally Disintegrating Film Formulation
Masahiro Nakayama ; Masashi Hamada ; Kayo Fukatsu ; Muneo Kadobayashi ; Masako Ohno ; Satoko Katsuragi ; Manabu Amano ; Masahiro Moriyama
Japanese Journal of Drug Informatics 2015;17(1):11-14
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.
2.Status of Self-Medication with OTC Drugs by International Students
Masahiro Murakami ; Satoko Katsuragi ; Kana Yukihiro ; Masako Ohno ; Manabu Amano ; Masahiro Moriyama
Japanese Journal of Drug Informatics 2015;17(3):133-139
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
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.
3.Usability of Auxiliary Devices for Eye Drop Administration
Masahiro Murakami ; Yuri Miura ; Satoko Katsuragi ; Masako Ohno ; Manabu Amano ; Masahiro Moriyama
Japanese Journal of Drug Informatics 2015;17(3):140-144
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.
4.Examination Regarding the Simple Suspension Method using Oral Anticancer Drugs
Masahiro Murakami ; Yoshihiko Ikemoto ; Narumi Toya ; Mihi Paku ; Miyuki Okuyama ; Kazuko Hatakeyama ; Satoko Katsuragi ; Masako Ohno ; Hiroyuki Hichiya ; Yoshito Zamami ; Chikaaki Muro ; Takeshi Kimura ; Naomi Kurata ; Manabu Amano
Japanese Journal of Social Pharmacy 2016;35(1):34-37
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.