US2021121573A1PendingUtilityA1

Absorption enhancers for drug administration

Assignee: AEGIS THERAPEUTICS LLCPriority: Aug 25, 2004Filed: Jun 10, 2020Published: Apr 29, 2021
Est. expiryAug 25, 2024(expired)· nominal 20-yr term from priority
A61K 31/137A61K 9/0048A61K 9/2095A61K 31/4439A61K 31/70A61K 9/0043A61K 9/006A61K 9/0056A61K 31/138A61K 9/2018A61K 47/26
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Claims

Abstract

The present invention provides compositions and methods and for increasing the bioavailability of therapeutic agents in a subject. The compositions include at least one alkyl glycoside and at least one therapeutic agent, wherein the alkylglycoside has an alkyl chain length from about 10 to about 16 carbon atoms. In various aspects, the invention provides compositions and methods for oral delivery in the form of a tablet.

Claims

exact text as granted — not AI-modified
1 - 7 . (canceled) 
     
     
         8 . A method of modulating insulin levels in a subject, said method comprising:
 administering, to said subject in need of insulin modulation, a pharmaceutical composition comprising:
 glucagon-like peptide-1 (GLP-1), a peptide thereof, or any analog thereof, and 
 about 0.2% w/v to about 1% w/v of alkyl glycoside. 
   
     
     
         9 . The method of  claim 8 , wherein the subject has diabetes. 
     
     
         10 . The method of  claim 9 , wherein the diabetes is selected from brittle diabetes, chemical diabetes, impaired glucose tolerance, gestational diabetes, diabetes insipidus, diabetes insipidus central, diabetes insipidus nephrogenic, diabetes insipidus pituitary, latent diabetes, lipatrophic diabetes, maturity-onset diabetes of youth (MODY), diabetes mellitus (DM), diabetes mellitus adult-onset (type 2 DM), diabetes mellitus insulin-dependent (type 1 DM), diabetes mellitus non-insulin dependent (NIDDM), diabetes mellitus juvenile or juvenile-onset, diabetes mellitus ketosis-prone, diabetes mellitus ketosis-resistant, diabetes mellitus malnutrition-related (MRDM), diabetes mellitus tropical or tropical pancreatic, diabetes mellitus, preclinical diabetes, or drug induced diabetes. 
     
     
         11 . The method of  claim 10 , wherein the diabetes is type 1 DM. 
     
     
         12 . The method of  claim 10 , wherein the diabetes is type 2 DM. 
     
     
         13 . The method of  claim 8 , wherein the alkyl glycoside is selected from the group consisting of dodecyl maltoside, tridecyl maltoside, tetradecyl maltoside, sucrose mono-dodecanoate, sucrose mono-tridecanoate, and sucrose mono-tetradecanoate. 
     
     
         14 . The method of  claim 13 , wherein the alkyl glycoside is dodecyl maltoside. 
     
     
         15 . The method of  claim 8 , wherein the pharmaceutical composition comprises about 0.2% w/v to about 0.5% w/v of the alkyl glycoside. 
     
     
         16 . The method of  claim 8 , wherein the alkyl glycoside is dodecyl maltoside and the pharmaceutical composition comprises 0.2% w/v to about 0.5% w/v of dodecyl maltoside. 
     
     
         17 . The method of  claim 8 , wherein the pharmaceutical composition comprises GLP-1. 
     
     
         18 . The method of  claim 8 , wherein the pharmaceutical composition comprises a GLP-1 analog selected from the group consisting of diaglutide, albiglutide, taspoglutide, lixinsenatide, exenatide, and liraglutide. 
     
     
         19 . The method of  claim 17 , wherein the GLP-1 analog is liraglutide. 
     
     
         20 . The method of  claim 8 , wherein the pharmaceutical composition is formulated for intranasal administration and said intranasal formulation is administered to a nasal mucosal membrane of the subject. 
     
     
         21 . The method of  claim 20 , wherein about 50 μL to about 200 μL of the intranasal formulation is administered to the nasal mucosal membrane of the subject. 
     
     
         22 . The method of  claim 20 , wherein the intranasal formulation is in a format selected from a drop, a spray, an or an aerosol. 
     
     
         23 . The method of  claim 8 , further comprising administering an agent that inhibits protein degradation to the subject. 
     
     
         24 . The method of  claim 23 , wherein the agent that inhibits protein degradation is a protease or peptidase inhibitor. 
     
     
         25 . The method of  claim 8 , wherein the composition further comprises a stabilizing agent. 
     
     
         26 . The method of  claim 25 , wherein the GLP-1, peptide thereof, or analog thereof is bound to said stabilizing agent.

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