US 12,201,720 B2
Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release
Paras Rameshlal Jain, Dayton, NJ (US); and Sachin Vasant Chaudhari, Dayton, NJ (US)
Assigned to TRIS PHARMA INC, Monmouth Junction, NJ (US)
Filed by Tris Pharma, Inc., Monmouth Junction, NJ (US)
Filed on Apr. 21, 2022, as Appl. No. 17/725,677.
Application 17/725,677 is a continuation of application No. 16/955,392, granted, now 11,337,920, previously published as PCT/US2018/066299, filed on Dec. 18, 2018.
Claims priority of provisional application 62/607,159, filed on Dec. 18, 2017.
Prior Publication US 2022/0241190 A1, Aug. 4, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/00 (2006.01); A61K 9/10 (2006.01); A61K 9/16 (2006.01); A61K 9/50 (2006.01); A61K 31/19 (2006.01); A61K 47/50 (2017.01)
CPC A61K 9/0065 (2013.01) [A61K 9/1611 (2013.01); A61K 9/1623 (2013.01); A61K 9/1635 (2013.01); A61K 9/1652 (2013.01); A61K 9/5078 (2013.01)] 12 Claims
OG exemplary drawing
 
1. An orally administrable drug powder composition which forms a gastro-retentive RAFT having at least two trigger pulses, the composition comprising:
(a) at least one drug in a first pulse which releases in less than about 3 hours;
(b) at least one drug in a delayed trigger release form;
(c) at least one non-toxic gas generating agent; and
(d) a RAFT system, and
wherein following oral ingestion, the composition provides a self-assembling gastro-retentive RAFT having entrapped therein, the at least one drug of (a) and (b) and the gas generated in situ by the non-toxic gas generating agent, thereby providing a floating gastro-retentive RAFT having a dual pulse system wherein at least the second pulse is a trigger pulse and which retains the at least one drug in the stomach for at least about 3 hours,
wherein the at least one drug of (a) and (b) is an active pharmaceutical ingredient (API) which is a free base or acid, or a pharmaceutically acceptable salt, solvate or hydrate, thereof,
wherein the at least one drug comprises a gamma hydroxybutyrate or its salts, hydrates, tautomers, or solvates, or mixtures thereof,
wherein the at least one delayed trigger release form of (b) comprises a pH sigmoidal delayed trigger system, an erosion delayed trigger system, a pH plus swelling delayed trigger system or a swelling delayed trigger system.