	US 11,723,862 B2
	Dosage form with sustained release melatonin pellets
Syed M. Shah, Boca Raton, FL (US); and Daniel Hassan, Boca Raton, FL (US)
Assigned to Societe des Produits Nestle S.A., Vevey (CH)
Filed by SOCIÉTÉ DES PRODUITS NESTLÉ S.A., Vevey (CH)
Filed on Jan. 15, 2021, as Appl. No. 17/150,049.
Claims priority of provisional application 62/962,574, filed on Jan. 17, 2020.
Prior Publication US 2021/0220264 A1, Jul. 22, 2021
Int. Cl. A61K 9/16 (2006.01); A61K 9/00 (2006.01); A61K 9/50 (2006.01); A61K 31/4045 (2006.01); A61K 9/20 (2006.01); A61K 9/48 (2006.01)

CPC A61K 9/0053 (2013.01) [A61K 9/0056 (2013.01); A61K 9/0095 (2013.01); A61K 9/2054 (2013.01); A61K 9/48 (2013.01); A61K 9/5047 (2013.01); A61K 9/5078 (2013.01); A61K 31/4045 (2013.01)]

19 Claims

1. A composition comprising a therapeutically effective oral pharmaceutical dosage form comprising:

(a) an aqueous carrier material having an acidic pH; and

(b) a plurality of individual pellets having a first dose of melatonin therein, the individual pellets comprising (i) a solid core; (ii) an active coating over the solid core, the active coating including the first dose of melatonin and a hydrophilic binder; and (iii) an enteric coating over the active coating, a dissolution pH of the enteric coating being higher than the acidic pH of the aqueous carrier material,

wherein the aqueous carrier material comprises a second dose of melatonin therein, and

wherein the oral pharmaceutical dosage form is configured to release the second dose of melatonin into an oral cavity and stomach of a subject to whom the composition is administered.