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Original ArticleOpen Access
Comparative Studies of Quality and Bioavailability of Methotrexate in Thai Patients with Rheumatoid Arthritis
Manorot M 
,
Rojanasathien N ,
Louthrenoo W ,
Tonsuwannont W ,
Teekachunhatean S
,
Rojanasathien N ,
Louthrenoo W ,
Tonsuwannont W ,
Teekachunhatean S The bioavailability of the two generic methotrexate oral preparations (Emtrexate®, Pharmachemie
Company, Hollland and Methotrexate Remedica®, Remedica, Cyprus as the test preparations),
were compared to the innovator (Methotrexate LederJe®, Lederle, U.S.A. as the reference)
in 10 patients with rheumatoid arthritis. A single 7.5 mg oral dose of each preparation was given
to the subjects in a randomized, double-blind, three-period crossover design with a I week washout
period. Serum methotrexate concentrations were determined by using Fluorescence Polarization
Immunoassay (Abbott TDx®). No significant differences in pharmacokinetic parameters (AUC,
Cmax, and Tmax) were observed between the test and reference preparations. The mean and 90
per cent CI of the ratio Emtrexate/Methotrexate LederJe® and Methotrexate Remedica®/ Methotrexate
Lederle® of the Cmax , AUC0-8, and AUC0-α were 0.93 (0.87-1.00), 0.9 (0.82-0.98).
0.88 (0.79-0.99) and 0.97 (0.93-1.02), 0.95 (0.90-0.99), 0.94 (0.86-1.02), respectively. These
values were well within the acceptable bioequivalence range of 0.8-1.25. The mean and 90 per
cent CI of T max difference between Emtrexate®-Methotrexate Lederle® and Methotrexate
Remedica®- Methotrexate Lederle® also overlapped the stipulated bioequivalence range of the
T max differences of ± 0.25 hour. Thus, Emtrexate® and Methotrexate Remedica® were considered
bioequivalent to the reference Methotrexate Lederle® regarding the rate of absorption and the
extent of absorption.
Company, Hollland and Methotrexate Remedica®, Remedica, Cyprus as the test preparations),
were compared to the innovator (Methotrexate LederJe®, Lederle, U.S.A. as the reference)
in 10 patients with rheumatoid arthritis. A single 7.5 mg oral dose of each preparation was given
to the subjects in a randomized, double-blind, three-period crossover design with a I week washout
period. Serum methotrexate concentrations were determined by using Fluorescence Polarization
Immunoassay (Abbott TDx®). No significant differences in pharmacokinetic parameters (AUC,
Cmax, and Tmax) were observed between the test and reference preparations. The mean and 90
per cent CI of the ratio Emtrexate/Methotrexate LederJe® and Methotrexate Remedica®/ Methotrexate
Lederle® of the Cmax , AUC0-8, and AUC0-α were 0.93 (0.87-1.00), 0.9 (0.82-0.98).
0.88 (0.79-0.99) and 0.97 (0.93-1.02), 0.95 (0.90-0.99), 0.94 (0.86-1.02), respectively. These
values were well within the acceptable bioequivalence range of 0.8-1.25. The mean and 90 per
cent CI of T max difference between Emtrexate®-Methotrexate Lederle® and Methotrexate
Remedica®- Methotrexate Lederle® also overlapped the stipulated bioequivalence range of the
T max differences of ± 0.25 hour. Thus, Emtrexate® and Methotrexate Remedica® were considered
bioequivalent to the reference Methotrexate Lederle® regarding the rate of absorption and the
extent of absorption.
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