Comparative evaluation of the physicochemical properties of acetaminophen formulations

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

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 9702% 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.

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