LYOPHILIZED ORALLY DISINTEGRATING TABLET FORMULATIONS OF d-LYSERGIC ACID DIETHYLAMIDE FOR THERAPEUTIC APPLICATIONS
A solid oral immediate release formulation of LSD, wherein the composition is produced by lyophilization of a feedstock in a pre-formed mold to form an orally disintegrating tablet. A method of making a solid oral immediate release formulation of LSD by lyophilizing a flash frozen stock solution of LSD and excipients, including a non-gelling matrix former, filler, and binder in a pre-formed mold, and forming an orally disintegrating tablet. A method of treating an individual by administering a solid oral immediate release formulation of LSD, wherein the composition is produced by lyophilization of a feedstock in a pre-formed mold to form an orally disintegrating tablet and treating the individual.
1 .- 22 . (canceled)
23 . A tablet comprising:
i. lysergic acid diethylamide (LSD), or a salt thereof;
ii. a non-gelling matrix former;
iii. a binder; and
iv. a filler.
24 . The tablet of claim 23 , wherein the tablet comprises a tartrate salt of LSD.
25 . The tablet of claim 24 , wherein the tablet comprises d-LSD D-tartrate.
26 . The tablet of claim 23 , wherein the non-gelling matrix former is a non-gelling gelatin, maltodextrin, modified starches, starch ethers, low molecular weight dextrans, or low to intermediate molecular weight cellulose gums.
27 . The tablet of claim 26 , wherein the non-gelling matrix former is maltodextrin.
28 . The tablet of claim 23 , wherein the binder is acacia gum, methylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, tragacanth, polyvinyl pyrrolidone, or starch.
29 . The tablet of claim 28 , wherein the binder is hydroxypropyl methylcellulose.
30 . The tablet of claim 23 , wherein the filler is lactose, mannitol, dicalcium phosphate, calcium sulfate, starch, cellulose, kaolin, sodium chloride, sorbitol, trehalose, or sucrose.
31 . The tablet of claim 30 , wherein the filler is mannitol.
32 . The tablet of claim 23 , wherein the tablet is an orally disintegrating tablet.
33 . A method of treating generalized anxiety disorder, comprising administering to a subject in need thereof a tablet of claim 23 .
34 . A tablet comprising:
i. lysergic acid diethylamide (LSD), or a salt thereof;
ii. maltodextrin;
iii. hydroxypropyl methylcellulose; and
iv. mannitol;
wherein the relative amounts (by weight) of LSD, or a salt thereof, maltodextrin, hydroxypropyl methylcellulose, and mannitol are <1:2-10:1-5:2-10, respectively.
35 . The tablet of claim 34 , wherein tablet comprises a tartrate salt of LSD.
36 . The tablet of claim 35 , wherein the tablet comprises d-LSD D-tartrate.
37 . The tablet of claim 34 , wherein the tablet is an orally disintegrating tablet.
38 . The tablet of claim 35 , wherein the tablet is an orally disintegrating tablet.
39 . The tablet of claim 36 , wherein the tablet is an orally disintegrating tablet.
40 . A method of making a tablet, comprising flash freezing a stock solution comprising:
i. LSD, or a salt thereof;
ii. a non-gelling matrix former;
iii. a binder;
iv. a filler; and
iv. water.