Soft gel capsules improve melatonin's bioavailability in humans.
Expert Opin Drug Metab Toxicol
; 10(9): 1193-8, 2014 Sep.
Article
in En
| MEDLINE
| ID: mdl-25046730
ABSTRACT
OBJECTIVE:
Oral bioavailability is one of the most important properties in drug design and development. A poor oral bioavailability can result in low efficacy and unpredictable response to a drug. Several dosages of melatonin have been used for various investigations to clarify its bioavailability in humans. Aiming to search for a pharmaceutical form, which is better absorbed, the pharmacokinetic (PK) profile of the new manufactured melatonin soft gelatin (soft gel) capsule form has been evaluated and compared with the commercially available melatonin powder. RESEARCH DESIGN ANDMETHODS:
A total of 60 healthy volunteers received 1, 3 mg of melatonin powder and 1 mg of melatonin in soft gel capsules. PK profiles were obtained by analysis of melatonin plasma concentration, and the respective melatonin bioavailability was compared.RESULTS:
Melatonin soft gel capsule form showed similar PK parameters compared with the highest doses of melatonin in powder form, but its bioavailability was improved.CONCLUSIONS:
Soft gel capsules improved the bioavailability of melatonin in humans even when administered dose was reduced. Considering the number of conditions in which melatonin supplementation is recommended, this evidence could support a broader use of melatonin in clinical practice.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Central Nervous System Depressants
/
Melatonin
Type of study:
Clinical_trials
Language:
En
Journal:
Expert Opin Drug Metab Toxicol
Year:
2014
Type:
Article
Affiliation country:
Italy