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.
PY - 1996/1/1
Y1 - 1996/1/1
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.
UR - http://www.scopus.com/inward/record.url?scp=0029928448&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0029928448&partnerID=8YFLogxK
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 -