ABSTRACT
<b>Objective: </b>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.<br><b>Methods: </b>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.<br><b>Results: </b>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.<br><b>Conclusion: </b>Our findings suggest that orally disintegrating film formulations show superior disintegration to uncoated or orally disintegrating tablets, and benefits on taking medicine was observed.
ABSTRACT
<b>Objective: </b>Oral mucositis is one of the serious and frequent acute side effects due to chemoradiotherapy (CRT) for head and neck cancer. In this study, we prepared an oral rinse as a hospital preparation for the treatment of oral mucositis, which was a suspension of polaprezinc (PZ), a zinc-containing therapeutic agent for gastric ulcer, in carboxyvinyl polymer (CP), a water-soluble large molecule.<br><b>Methods: </b>We carried out stability tests of the PZ-CP oral rinse, and investigated its effects on the radiation-induced oral mucositis in patients who received CRT for head and neck cancer.<br><b>Results: </b>In the stability test, the pH, viscosity, adhesion and PZ content in the preparations did not change throughout 28 days after preparation. In the clinical evaluation on the basis of the distribution of the Grade of oral mucositis, the Grade of oral mucositis in the PZ group was significantly lower than in the control group at 6 and 7 weeks (<i>p</i>=0.016, <i>p</i>=0.018). The incidence of severe oral mucositis of Grade 3 was 15.0% (3 cases) in the PZ group and 41.7% (10 cases) in the control group at 6 weeks, and was 15.0% (3 cases) in the PZ group and 33.3% (8 cases) in the control group at 7 weeks.<br><b>Conclusion: </b>These results suggest that PZ-CP oral rinse inhibits the aggravation of oral mucositis induced by CRT or promotes its healing.
ABSTRACT
<b>Objective: </b>The Hyogo Hospital Pharmaceutical Society has been conducting an original pharmacy postgraduate education program, “lifelong learning program (to nurture pharmacy specialists)”, since 2002 using the Internet. To understand the status of using this program, this study employed a questionnaire survey involving all registered members.<br><b>Methods: </b>Subjects were all members (1,870) of the society. Questionnaires were distributed and collected by mail.<br><b>Results: </b>Only 20.1% of the members had experience of using the program, and the frequency of using it was less than once per 6-12 months in 60% of the members. Their level of awareness concerning the acquisition of credits for lifelong learning was 36.9%. The program category they wished to take was an infection-related program in 26.1% of the members, which was the highest.<br><b>Conclusion: </b>As reasons for only a small number of members using the program, the following are considered: loss of user’s ID and password required to login, and lack of awareness concerning the acquisition of credits for lifelong learning offered by the Japanese Society of Hospital Pharmacists. As future issues, we must encourage members to obtain a new password and be proactively involved in preparing new program categories that the members wish to take, in order to promote the continuous use of the program.
ABSTRACT
<b>Objective: </b>In The Hospital of Hyogo College of Medicine, a oral rinse containing polaprezinc (PZ), a zinc-containing drug for gastric ulcers, was used as a hospital preparation to treat radiotherapy-related oral mucositis, and its efficacy was reported. However, the dispersibility of PZ for carboxymethylcellulose sodium (CMC), which was used as the base of the oral rinse, was unfavorable, raising an issue. In this study, we newly prepared a PZ oral rinse containing carboxyvinyl polymer (CP) as a base, and examined its usefulness.<br><b>Methods: </b>A questionnaire survey regarding the usefulness involving 10 healthy volunteers and a pharmaceutical test were conducted.<br><b>Results: </b>The results of the questionnaire survey showed that the optimal concentration of CP was 0.5%. There were no serial changes in the pH, adhesiveness, or PZ content for 7 days after preparation. Furthermore, there were no differences between CMC and CP. The dispersibility of PZ in the oral rinse containing CP as a base was more favorable than that in the oral rinse containing CMC.<br><b>Conclusion: </b>The results of this study suggest that the PZ oral rinse containing 0.5% CP as a base is useful, and that its stability is similar to that of the oral rinse containing CMC as a base.