title: Soft gel capsules improve melatonin's bioavailability in humans.
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.
  
  
  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.
authors.affiliation: Sapienza University of Rome, Department of Surgery P. Valdoni , via A. Scarpa 14, 00166 Rome , Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Proietti
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Carlomagno
authors.forename: Simona
authors.initials: S
authors.lastname: Dinicola
authors.forename: Mariano
authors.initials: M
authors.lastname: Bizzarri
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D002214:Capsules; D002492:Central Nervous System Depressants / Q000008:administration & dosage / Q000493:pharmacokinetics*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005780:Gelatin; D006801:Humans; D008297:Male; D008550:Melatonin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D002214:Capsules; D002492:Central Nervous System Depressants; D005780:Gelatin; D008550:Melatonin
keywords: bioavailability; melatonin; pharmacokinetics; soft gelatin capsules