US 12,390,416 B2
Chewable pharmaceutical dosage forms
Manesh A Dixit, Miami Lakes, FL (US); Rahul Botkar, Maharashtra (IN); and Partha S Sen, Valsad (IN)
Assigned to USPHARMA LTD, Miami Lakes, FL (US)
Filed by USpharma Ltd, Miami Lakes, FL (US)
Filed on Feb. 24, 2022, as Appl. No. 17/679,192.
Application 17/679,192 is a continuation in part of application No. 16/515,982, filed on Jul. 18, 2019, granted, now 11,273,123.
Claims priority of provisional application 62/831,500, filed on Apr. 9, 2019.
Claims priority of provisional application 62/700,149, filed on Jul. 18, 2018.
Prior Publication US 2022/0183970 A1, Jun. 16, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 45/06 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/26 (2006.01)
CPC A61K 9/0056 (2013.01) [A61K 9/06 (2013.01); A61K 45/06 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/26 (2013.01)] 15 Claims
 
1. A process for manufacture of a translucent chewable gel that is pharmaceutically suitable for oral administration comprising the steps of:
(a) preparing a mixture comprising water, a tonicity modifying agent, at least one taste enhancing agent, carrageenan, a buffering agent, a sugar, a non-crystallizing polyol solution, a functional/active ingredient, and a complexing agent; wherein said mixture has a pH of at least 5,
(b) heating said mixture to a temperature in the range of about 90° C. to about 105° C. until the heated mixture has a total solid content in the range of about 65 brix to about 75 brix to form a gummy mixture; and
(c) transferring the gummy mixture to a forming device, allowing the gummy mixture to cool in the forming device to form said chewable gel, and removing the chewable gel from the forming device after a period of time of less than 30-minutes.