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Development and Validation of a Sensitive LC-MS/MS Method for Determination of Betamethasone in Human Plasma. Application to a Pharmacokinetic Study of Healthy Mexican Subjects

[ Vol. 15 , Issue. 1 ]

Author(s):

Omar Patiño-Rodríguez, Abraham Escobedo-Moratilla, Rosa María Martínez-Medina, Irma Torres-Roque, Maricela Martínez-Delgado and José Pérez-Urizar *   Pages 2 - 8 ( 7 )

Abstract:


Background: Synthetic glucocorticoids like Betamethasone (BE) are used in the treatment of inflammatory diseases due to its effective and potent effect. BE is available in three different esters: dipropionate (BD), sodium phosphate (BP), and acetate (BA). BD/BP combined in suspension has antiinflammatory, anti-allergic, and anti-rheumatic effects. The aim of this study was to describe the bioavailability of a single-dose of the injectable formulation of BP/BD in healthy Mexican subjects.

Methods: This was a randomized, open-label, longitudinal, not therapeutic, single-dose trial of an intramuscular administration of BD/BP (5 mg/2 mg), in healthy Mexican subjects under fasting condition. Twenty-six healthy Mexicans volunteers of both genders who were between the ages of 18 and 45 were enrolled in the study.

Results: From non-compartmental estimation of data, it was observed that the BE highest mean concentration was 15.70 ± 3.93 ng/mL reaching it in 2.83 ± 1.35 h. The values of elimination half-life were 10.89 ± 2.02 h. No clinically significant adverse effects were presented during the study.

Conclusion: The reported PK parameters for BE suggest that the BD/BP suspension has a similar release velocity in Mexican healthy subjects compared with previous studies.

Keywords:

LC-MS/MS, betamethasone, dipropionate, sodium phosphate, pharmacokinetics, glucocorticoid, human plasma.

Affiliation:

Dixpertia, Investigación Biofarmacéutica y Farmacológica S. C. San Luis Potosí, SLP, Dixpertia, Investigación Biofarmacéutica y Farmacológica S. C. San Luis Potosí, SLP, Laboratorio de Farmacología, Facultad de Ciencias Químicas, UASLP, San Luis Potosí, SLP, Dixpertia, Investigación Biofarmacéutica y Farmacológica S. C. San Luis Potosí, SLP, Dixpertia, Investigación Biofarmacéutica y Farmacológica S. C. San Luis Potosí, SLP, Laboratorio de Farmacología, Facultad de Ciencias Químicas, UASLP, San Luis Potosí, SLP



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