# US 2026/0097002 A1 · Method of treatment and device for the improved bioavailability of leukotriene receptor antagonists > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2026/0097002 A1 - Document ID: US20260097002A1 - Status: Published application - Kind: A1 - Application number: 19/335,437 - Filed: 2025-09-22 - Published: 2026-04-09 - Earliest claimed: 2022-04-26 - Assignees: Intelgenx Corp. - Applicants: Intelgenx Corp. - Inventors: Nadine PAIEMENT; Horst G. ZERBE; Justin W. CONWAY; Rodolphe OBEID - Web page: https://patentgrep.com/patent/US20260097002A1 ## CPC - A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)} - A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays} - A61K 31/381: having five-membered rings - A61K 31/404: Indoles, e.g. pindolol - A61K 31/47: Quinolines; Isoquinolines - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61P 25/00: Drugs for disorders of the nervous system - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Disclosed is a method of administration and device for the improved bioavailability of leukotriene receptor antagonists. This method and device involve an alkaline surface pH oral film dosage form designed to deliver leukotriene receptor antagonists, such as Montelukast, to the stomach in an amorphous precipitate suspended in aqueous medium. Also disclosed is a device and method for treating a disease, such as a neurodegenerative disease or condition associated with neuroinflammation induced by a leukotriene. The device is a film unit dosage form having an alkaline surface pH film layer and a safe and effective amount of Montelukast. The device is configured and formulated to predominantly achieve enteral delivery of the Montelukast. The method includes enterally delivering to a human or an animal in need of treatment, a safe and effective amount of Montelukast capable of crossing the blood-brain barrier. ## Claims ### Claim at position 1 1-31. (canceled) ### Claim 32 An oral film dosage form, comprising: a film layer having an alkaline surface pH from 7.5 to 9.5; a safe and effective amount of Montelukast in a solubilized form incorporated into the film layer; and EDTA, in a ratio of Montelukast to disodium EDTA from 32:1 to 3:2, such that the Montelukast is maintained in the solubilized form; wherein the film is buccally, orally or sublingually solubilized within 2-10 minutes. ### Claim 33 (depends on 32) The oral film dosage form of claim 32, wherein the film layer has a surface pH from 8 to 9.5. ### Claim 34 (depends on 32) The oral film dosage form of claim 32, wherein the film layer is unbuffered. ### Claim 35 (depends on 32) The oral film dosage form of claim 32, wherein the ratio of Montelukast to disodium EDTA is about 1:0.15. ### Claim 36 (depends on 32) The oral film dosage form of claim 32, wherein the Montelukast is incorporated into the film layer in an amorphous form. ### Claim 37 (depends on 32) The oral film dosage form of claim 32, wherein the Montelukast precipitates when the film layer dissolves and/or disintegrates in saliva. ### Claim 38 (depends on 32) The oral film dosage form of claim 32, wherein the film is buccally, orally or sublingually solubilized within 3-7 minutes and wherein the Montelukast precipitates in saliva. ### Claim 39 (depends on 32) The oral film dosage form of claim 32, wherein the leukotriene receptor antagonist is Montelukast is present in an amount of about 5 mg to about 15 mg. ### Claim 40 (depends on 32) The oral film dosage form of claim 32, wherein the film layer is a bioadhesive film layer. ### Claim 41 (depends on 32) The oral film dosage form of claim 32, wherein the film is 80% solubilized within 1 minute when pre-dissolved in simulated saliva. ### Claim 42 (depends on 32) The oral film dosage form of claim 32, wherein the area under the curve (AUC) is between about 3120 and about 4700 ng*h/m L. ### Claim 43 (depends on 32) The oral film dosage form of claim 32, wherein the Cmax is between about 475 and about 720 ng/ml. ### Claim 44 (depends on 32) The oral film dosage form of claim 32, wherein the ratio of Montelukast to disodium EDTA is about 13:1. ### Claim 45 (depends on 44) The oral film dosage form of claim 44, wherein the film is buccally, orally or sublingually solubilized within 2-7 minutes. ### Claim 46 (depends on 45) The multiple layer oral film dosage form of claim 45, wherein the ratio of Montelukast to disodium EDTA is about 16:1. ### Claim 47 A multiple layer oral film dosage form, comprising: a first film layer with an alkaline surface pH from 7.5 to 9.5 and containing a safe and effective amount of Montelukast in a solubilized form and disodium EDTA in a ratio of Montelukast to disodium EDTA from 32:1 to 3:2 such that the Montelukast is maintained in the solubilized form; and at least a second film layer having a composition that is different from that of the first layer. ### Claim 48 (depends on 47) The multiple layer oral film dosage form of claim 47, wherein the second film layer is a non-adhesive barrier layer that prevents or reduces ingestion of the Montelukast. ### Claim 49 (depends on 47) The multiple layer oral film dosage form of claim 47, wherein the second film layer comprises a taste-masking agent. ### Claim 50 (depends on 47) The multiple layer oral film dosage form of claim 47, wherein the second film layer comprises an active agent, the same or different from the Montelukast in the first film layer, wherein the second layer is formulated to provide a controlled release profile. ### Claim 51 A multiple layer oral film dosage form, comprising: a first film layer with an alkaline surface pH from 7.5 to 9.5 and containing a safe and effective amount of Montelukast in a solubilized form and disodium EDTA in a ratio of Montelukast to disodium EDTA from 32:1 to 3:2 such that the Montelukast is maintained in the solubilized form; and at least a second film layer having a composition that is different from that of the first layer and that is adapted to modify a buccal, oral or sublingual absorption of Montelukast in the first layer.