Evaluation of Quality of Arotinolol Hydrochloride Tablets-Comparison between Branded and Generic Products-

Yamasaki, Keishi; Furuya, Yumiko; Takemoto, Mizue; Setoguchi, Nao; Hidaka, Muneaki; Iwakiri, Tomomi; Okumura, Manabu; Kodama, Hirofumi; Arimori, Kazuhiko

doi:10.5649/jjphcs.32.898

Jpn. J. Pharm. Health Care Sci.

2006

DOI: 10.5649/jjphcs.32.898

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Evaluation of Quality of Arotinolol Hydrochloride Tablets-Comparison between Branded and Generic Products-

Keishi Yamasaki¹,

Yumiko Furuya²,

Mizue Takemoto³

et al.

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Cited by 3 publications

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Equivalence Studies of Pravastatin Original and Generic Drugs by Dissolution Test

Nakauchi

Takeuchi²,

Okamoto³

et al. 2012

YAKUGAKU ZASSHI

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There are various opinions regarding the diŠerent functions of original and generic drugs. We used the paddle method to perform dissolution tests on pravastatin sodium tablets (10 mg) to investigate the causes for these diŠerences. We used water and buŠer solutions adjusted to pH 1.2 (JP1) and pH 6.8 (JP2), which are described in the Japanese Pharmacopoeia. The pravastatin concentration was measured by UV spectroscopy and HPLC. There were signiˆcant diŠerences in the percentages dissolved of original and generic drugs after 5 and 10 min. On the other hand, the dissolution behaviors using water and JP2 measured by HPLC were similar to the results obtained by UV spectroscopy. However, the percentage dissolved of pravastatin using JP1 decreased with time because pravastatin degraded in JP1. There were also signiˆcant diŠerences in the pravastatin concentrations of the original and generic drugs at 5, 15, 30, and 45 min. Based on the above results, since the original drug has a slower dissolution rate than the generic drugs, it is necessary to be cautious about the degradation of pravastatin in the stomach and the bioavailability of pravastatin due to the diŠerent dissolution rates and the diŠerent residual amount of pravastatin in the stomach.

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Equivalence Studies of Pravastatin Original and Generic Drugs by Dissolution Test

Nakauchi

Takeuchi²,

Okamoto³

et al. 2012

YAKUGAKU ZASSHI

View full text Add to dashboard Cite

show abstract

Generics Should be Evaluated from an Overall Perspective-Characteristics of Benidipine Hydrochloride Tablets whose Dosage Form has been Changed and Comparison of Branded and Generic Products Regarding Drug Information Supplied-

Ichihara¹,

Okumura²,

Yoshida³

et al. 2008

Jpn. J. Pharm. Health Care Sci.

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Comparison of the Pravastatin Original and Generic Drugs in the Simple Suspension Method

Yano¹,

Ikarashi²,

K³

et al. 2008

Jpn. J. Pharm. Health Care Sci.

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Evaluation of Quality of Arotinolol Hydrochloride Tablets-Comparison between Branded and Generic Products-

Cited by 3 publications

References 4 publications

Equivalence Studies of Pravastatin Original and Generic Drugs by Dissolution Test

Equivalence Studies of Pravastatin Original and Generic Drugs by Dissolution Test

Generics Should be Evaluated from an Overall Perspective-Characteristics of Benidipine Hydrochloride Tablets whose Dosage Form has been Changed and Comparison of Branded and Generic Products Regarding Drug Information Supplied-

Comparison of the Pravastatin Original and Generic Drugs in the Simple Suspension Method

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