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Modified release bi-layered tablet of melatonin using beta-cyclodextrin
A Kumar1, S P Agarwal, R Khanna
1Department of Pharmaceutics, Jamia Hamdard (Hamdard University), Hamdard Nagar, New Delhi, India.
Die Pharmazie
|October 9, 2003
Summary
This study developed a novel bi-layered melatonin tablet for modified release. The formulation demonstrated stable drug release and physical characteristics under accelerated stability conditions.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Melatonin is a hormone regulating sleep-wake cycles.
- Modified-release formulations aim to improve drug efficacy and patient compliance.
Purpose of the Study:
- To develop and characterize a bi-layered modified-release melatonin tablet.
- To evaluate the in vitro release profile and accelerated stability of the developed formulation.
Main Methods:
- Preparation of a bi-layered tablet with a fast-release melatonin-beta-cyclodextrin complex and a slow-release melatonin matrix (HPMC K15M and Carbopol 971 P).
- In vitro drug release studies.
- Accelerated stability testing at 40°C and 75% relative humidity for 3 months.
Main Results:
- The formulation exhibited an initial burst release followed by a near zero-order release pattern over 8 hours.
- The drug content, physical attributes, and release profile remained consistent after accelerated stability testing.
Conclusions:
- The developed bi-layered melatonin tablet offers a promising modified-release profile.
- The formulation demonstrates good stability, suggesting potential for therapeutic application.