Controlled-release melatonin compositions and related methods
This disclosure relates to controlled-release melatonin compositions and related methods. In one embodiment, a controlled-release medicament composition comprises melatonin dispersed in a controlled melatonin release portion comprising a polymer matrix, the polymer matrix adapted to encapsulate the melatonin in a melatonin solubility enhancing pH environment and to maintain the melatonin solubility enhancing pH environment when the composition is located in a melatonin solubility diminishing pH environment for allowing an effective amount of melatonin to be released into the melatonin solubility diminishing pH environment.
1. A controlled-release medicament composition comprising melatonin dispersed in a controlled melatonin release portion comprising a polymer matrix, the polymer matrix adapted to encapsulate the melatonin in a melatonin solubility enhancing pH environment and to maintain the melatonin solubility enhancing pH environment when the composition is located in a melatonin solubility diminishing pH environment for allowing an effective amount of melatonin to be released into the melatonin solubility diminishing pH environment;
wherein the composition is in an oral dosage form that can be administered to a patient;
wherein the dosage form releases approximately 50% of the melatonin within approximately 1-3 hours after being administered to the patient and releases approximately 50-90% of the remaining melatonin between approximately 3-9 hours after being administered to the patient; and
wherein the melatonin solubility enhancing pH environment is an acidic pH environment having a pH of 2-4.
2. The composition of claim 1 , wherein the polymer matrix forms a hydrogel.
3. The composition of claim 1 , wherein the acidic pH environment is provided by an acidic substance in the polymer matrix.
4. The composition of claim 3 , wherein the acidic substance is at least one of citric acid, succinic acid, tartaric acid, phosphoric acid, or hydrochloric acid.
5. The composition of claim 3 , wherein the acidic substance is citric acid.
6. The composition of claim 1 , wherein the controlled melatonin release portion further comprises polyethylene glycol.
7. The composition of claim 6 , wherein the polyethylene glycol is PEG 8000.
8. A controlled-release oral dosage form medicament composition consisting essentially of melatonin dispersed in a controlled melatonin release portion comprising a polymer matrix encapsulating the melatonin in an acidic environment and maintaining the acidic environment when the composition is in a small intestine for releasing an effective amount of melatonin therein;
wherein the composition releases approximately 50% of the melatonin within 1-3 hours after oral ingestion and releases approximately 50%-90% of the remaining melatonin between about 3-9 hours after oral ingestion and wherein the pH of the acidic environment is 2-4.