TY - JOUR
T1 - Development and characterization of an oral controlled-release delivery system for melatonin
AU - Lee, Beom Jin
AU - Parrott, Keith A.
AU - Ayres, James W.
AU - Sack, Robert L.
N1 - Funding Information:
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.
PY - 1996
Y1 - 1996
N2 - 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.
AB - 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.
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U2 - 10.3109/03639049609058571
DO - 10.3109/03639049609058571
M3 - Article
AN - SCOPUS:0029928448
VL - 22
SP - 269
EP - 274
JO - Drug Development and Industrial Pharmacy
JF - Drug Development and Industrial Pharmacy
SN - 0363-9045
IS - 3
ER -