	US 12,440,472 B2
	Stable tryptamine oral films
Mobarik Bilal, Blainville (CA); and Nadine Paiement, St-Laurent (CA)
Filed by INTELGENX CORP., St-Laurent (CA)
Filed on Jun. 16, 2022, as Appl. No. 17/842,372.
Claims priority of provisional application 63/211,401, filed on Jun. 16, 2021.
Prior Publication US 2022/0409584 A1, Dec. 29, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4045 (2006.01); A61K 9/00 (2006.01); A61K 9/70 (2006.01); A61K 31/675 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); A61K 47/32 (2006.01); A61K 47/38 (2006.01)

CPC A61K 31/4045 (2013.01) [A61K 9/0056 (2013.01); A61K 9/70 (2013.01); A61K 31/675 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/186 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01); A61K 47/38 (2013.01)]

18 Claims

1. A method comprising orally administering to a subject an oral dissolvable film comprising:

(i) a flowable water-soluble or water-swellable film-forming matrix that includes at least one polymer,

(ii) psilocybin, psilocin, baeocystin, or a combination thereof; and

(iii) a stabilizing inorganic acid;

wherein, the psilocybin, psilocin, baeocystin, or combination thereof is present in a combined amount of 1 to 30 mg,

wherein the ratio between psilocybin and psilocin to the inorganic acid is 1:0.5 to 1:2 w/w and wherein the surface pH of the film is between 2 and 4.5.