Comparative evaluation of the physicochemical properties of acetaminophen formulations

Yutaka Inoue; Kengo Suzuki; Takashi Ikeda; Yuina Tsunoda; Takahiro Onoda; Mitsuki Sugawara; Yukie Tsuchiya; Mizuki Tsuri; Toshinari Ezawa; Ikuo Kanamoto

Authors

Yutaka Inoue Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Kengo Suzuki Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Takashi Ikeda Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Yuina Tsunoda Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Takahiro Onoda Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Mitsuki Sugawara Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Yukie Tsuchiya Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Mizuki Tsuri Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Toshinari Ezawa Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan
Ikuo Kanamoto Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University, Japan

Keywords:

acetaminophen, equivalent, Thailand, Philippines, dissolution profiles

Abstract

The current study compared the physicochemical properties of 7 Acetaminophen (AAP) formulations from Thailand (3 formulations), the Philippines (3 formulations), and Japan (1 formulation). This study assessed the appearance of formulations from Thailand (T-A, -B, and -C), the Philippines (P-A, -B, and -C), and Japan (J). This study was subjected to a hardness test, uniformity of weight test, content uniformity test, and dissolution test in accordance with the Japanese Pharmacopoeia. Results of the hardness test indicated that all of the formulations had a hardness of 70 N or greater. All formulations showed within 97–02% by uniformity of weight test. Comparison of dissolution profiles indicated that the P-B formulation had dissolution of about 77% at 15 min, and this level of elution was lower than that from other formulations (p<0.05). Unlike the P-B formulation, the other 6 formulations had around 85% or more elution of AAP in 15 min. The physical and chemical properties of the T-A, -B and -C formulations that are used in the Thailand, the P-A and -C formulations that are used in the Philippines, and the J formulation that is used in Japan complied with the Japanese Pharmacopoeia. Thus, these formulations are assumed to be equivalent.