Soft gel capsules improve melatonin's bioavailability in humans.
Study Goal
The researchers aimed to compare the pharmacokinetic profile and bioavailability of a new melatonin soft gel capsule form with commercially available melatonin powder.
Results Summary
The melatonin soft gel capsule showed similar pharmacokinetic parameters to higher doses of melatonin powder but with improved bioavailability, suggesting better absorption even at reduced doses.
Population
60 healthy volunteers
Effective Dosage
1 mg and 3 mg of melatonin powder, 1 mg of melatonin in soft gel capsules
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin soft gelatin (soft gel) capsule form | no change | PK parameters | healthy volunteers | similar | showed similar PK parameters compared with the highest doses of melatonin in powder form | #1 |
melatonin soft gelatin (soft gel) capsule form | increase | bioavailability | healthy volunteers | - | bioavailability was improved | #2 |
Soft gel capsules | increase | bioavailability of melatonin | humans | - | improved the bioavailability of melatonin | #3 |
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 AND METHODS: 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.