NDLI: Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Salem, Isam I. Najib, Naji M.
Spatial Coverage	Jordan
Description	Country affiliation: Jordan Author Affiliation: Salem II ( International Pharmaceutical Research Center (IPRC), Amman, Jordan.)
Abstract	BACKGROUND: Betamethasone is used for its antiinflammatory and immunosuppressive effects in disorders of many organ systems. However, the pharmacokinetic properties of betamethasone in plasma after intramuscular injection of betamethasone sodium phosphate and betamethasone acetate dual-acting suspension need further investigation. OBJECTIVES: The main aim of this study was to determine the pharmacokinetic parameters of betamethasone, betamethasone acetate, and betamethasone phosphate after the administration of a single intramuscular dose of the dual-acting suspension to healthy human volunteers. METHODS: Two different studies were conducted in healthy males. Volunteers were judged healthy based on their medical history, physical examination, and laboratory test results. Before confinement, all volunteers were tested for freedom from alcohol and drugs of abuse. Following a 10-hour overnight fasting, a single dose of 1 mL of the dual-acting suspension containing 3 mg of betamethasone phosphate and 3 mg of betamethasone acetate was administered by intramuscular injection. Blood sampling covered 48 hours. The plasma samples obtained in the second study were stabilized to enable pharmacokinetic profiling of betamethasone esters. RESULTS: Twenty-four healthy males with mean (SD) age of 27 (6.62) years participated in each study. No incidences of serious adverse events were recorded during the studies. Six mild adverse events were reported in 2 subjects in the second study. One subject suffered from pain at the injection site and insomnia, and another subject complained of heartburn and drowsiness. Betamethasone phosphate appeared to be readily absorbed with a mean AUC(0-t) of 96.01 ng/h/mL and an AUC(0-∞) of 97.96 (23.38) ng/h/mL. Betamethasone peak plasma concentration reached a mean t(½) of 12.92 hours. Betamethasone acetate was not detected in the volunteers' plasma in either study (total of 2208 plasma samples). CONCLUSION: The observed pharmacokinetic parameters suggested that the acetate ester, and not the phosphate ester, of betamethasone acts as a prodrug or reservoir for betamethasone, conferring on it sustained- and extended-release characteristics.
File Format	HTM / HTML
ISSN	01492918
Issue Number	1
Volume Number	34
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2012-01-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Betamethasone Analogs & Derivatives Glucocorticoids Administration & Dosage Pharmacokinetics Adult Area Under Curve Blood Chemistry, Pharmaceutical Delayed-action Preparations Half-life Humans Injections, Intramuscular Jordan Male Metabolic Clearance Rate Models, Biological Young Adult Clinical Trial Comparative Study Journal Article
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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