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.
