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US 2025/0144074 A1Published application
Sustained release melatonin compositions
AssigneeSociete des Produits Nestle S.A.
InventorsMd Ehtesham REZA, Vesselin Danailov MILADINOV, Richard Mark WARRINGTON
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Abstract
A composition includes melatonin encapsulated within a calcium alginate hydrogel. An orally administrable dosage form comprising such a composition held within a gel, and the gel is formed using starch as a gelling agent. Processes to produce these compositions, as well as their use in therapy, are also disclosed.
Claims30
1:
- A composition comprising melatonin encapsulated within a calcium alginate hydrogel.
2:
- The composition according to claim 1, wherein the weight ratio of the melatonin to the calcium alginate hydrogel is from 5:95 to 15:85.
3:
- The composition according to claim 1, wherein the weight ratio of the melatonin to the calcium alginate hydrogel is about 10:90.
4:
- The composition according to claim 1, comprising from 4 to 10 wt % water based on total weight of the composition.
5:
- The composition according to claim 1, comprising from 6 to 8 wt % water based on total weight of the composition.
6:
- The composition according to claim 1, further comprising sodium and lactate ions.
7:
- An orally administrable dosage form comprising a composition comprising melatonin encapsulated within a calcium alginate hydrogel, wherein the composition is held within a gel, wherein the gel is formed using starch as a gelling agent.
8:
- The dosage form according to claim 7, comprising from 1 to 3 wt % of the composition based on total weight of the dosage form.
9:
- The dosage form according to claim 7, further comprising additional melatonin which is not encapsulated within the calcium alginate hydrogel.
10:
- The dosage form according to claim 9, comprising from 0.01 to 0.03 wt % of the additional melatonin which is not encapsulated within the calcium alginate hydrogel, based on total weight of the dosage form.
11:
- The dosage form according to claim 7, wherein the starch in the gelling agent comprises potato starch.
12:
- The dosage form according to claim 7, comprising from 7 to 17 wt % of the starch based on total weight of the dosage form.
13:
- The dosage form according to claim 7, comprising from 8 to 18 wt % water based on total weight of the dosage form.
14:
- The dosage form according to claim 7 further comprising one or more sweeteners.
15:
- The dosage form according to claim 14, comprising from 52 to 82 wt % of the one or more sweeteners based on total weight of the dosage form.
16:
- The dosage form according to claim 14, wherein the one or more sweeteners are selected from the group consisting of sucrose and corn syrup.
17:
- The dosage form according to claim 16, wherein the one or more sweeteners comprises sucrose, 53 to 73 DE corn syrup, and 32 to 52 DE corn syrup.
18:
- The dosage form according to claim 17, comprising from 26 to 36 wt % of the sucrose, from 18 to 28 wt % of the 53 to 73 DE of corn syrup and from 8 to 18 wt % of the 32 to 52 DE corn syrup, based on total weight of the dosage form.
19:
- The dosage form according to claim 7, further comprising one or more acidulants.
20:
- The dosage form according to claim 19, comprising from 0.6 to 1.2 wt % of the one or more acidulants based on total weight of the dosage form.
21:
- The dosage form according to claim 19, wherein the one or more acidulants comprise citric acid.
22:
- The dosage form according to claim 7, further comprising L-theanine.
23:
- The dosage form according to claim 22, comprising from 2 to 4 wt % of the L-theanine based on total weight of the dosage form.
24:
- The dosage form according to claim 7, further comprising one or more natural flavours and/or natural colours.
25:
- The dosage form according to claim 7, further comprising a glazing agent.
26:
- A process for preparation of a composition comprising melatonin encapsulated within a calcium alginate hydrogel, the process comprising:
- i) forming a preblend of melatonin, a source of calcium ions and a source of alginate;
- ii) granulating the preblend by wet granulation to form granules of a composition comprising melatonin encapsulated within a calcium alginate hydrogel;
- and
- iii) drying the granules to a water content less than 15 wt % based on the total weight of the granules.
2 more elements
27:
- The process according to claim 26, wherein the source of calcium ions is calcium lactate, and/or the source of alginate is sodium alginate.
28:
- The process according to claim 26, wherein the wet granulation comprises spraying water at a rate from 500-2000 ml/min.
29:
- The process according to claim 26 wherein the water content of the dried granules is from 6 to 8 wt % based on the total weight of the granules.
30:
- A process for preparation of one or more orally administrable dosage forms comprising a composition comprising melatonin encapsulated within a calcium alginate hydrogel, the composition held within a gel, the process comprising:
- i) providing a mixture comprising starch and water;
- ii) heating the mixture from step i) with high shear mixing to prepare the starch for gelatinization;
- iii) cooling the mixture from step ii) to form a first product;
- iv) combining the first product of step iii) with the composition comprising melatonin encapsulated within a calcium alginate hydrogel, to form a second product;
- v) transferring the second product of step iv) into one or more moulds of a suitable size and shape for an orally administrable dosage form;
- and
- vi) curing and drying the transferred product of step iv) to provide the one or more orally administrable dosage forms comprising the composition held within the gel.
5 more elements