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Development and characterization of an oral controlled-release delivery system for melatonin

  • Beom Jin Lee
  • , Keith A. Parrott
  • , James W. Ayres
  • , Robert L. Sack

Research output: Contribution to journalArticlepeer-review

Abstract

Sugar spheres loaded with melatonin (MT) were coated with Aquacoat® to control the release rate of MT. Dissolution of MT was evaluated using the USP basket method. With 18-20 mesh beads, T(50%) (time to release 50% of drug) for 5%, 10%, and 20% coatings was 10 min, 35 min, and 60 min, respectively. A desired release pattern over 8 hours was obtained with 20% coating on 8-10 mesh beads. T(50%) for 5%, 10%, and 20% coatings was about 1, 2, and 4 hours, respectively. MT in 20% coated beads was quite stable during storage at room temperature with less than 5% MT degraded during 6 months of storage. Dissolution profiles from 8-10 mesh beads with a 20% coating were unchanged after 6 months of storage at room temperature. Administration of the dosage form to human subjects maintained MT plasma concentrations over 100 pg/ml for approximately 8 hours.

Original languageEnglish (US)
Pages (from-to)269-274
Number of pages6
JournalDrug Development and Industrial Pharmacy
Volume22
Issue number3
DOIs
StatePublished - 1996
Externally publishedYes

Funding

This work was partially supported by the Gustavus and Louise Pfeiffer Research Foundation. The authors thank Wanda Parrott, Faculty Research Assistant, Oregon State University, for editorial assistance and Carol Roberts, College of Pharmacy, for her patience and assistance in preparation of this manuscript. This work was presented as a poster at the 1993 American Association of Pharmaceutical Scientists Western Regional meeting held in Reno, Nevada.

Funders
Gustavus and Louise Pfeiffer Research Foundation

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmaceutical Science
    • Drug Discovery
    • Organic Chemistry

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