Composition and method for treatment of diabetes
Inventors
Assignees
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Publication Number
US-9006288-B2
Publication Date
2015-04-14
Expiration Date
Abstract
The present invention relates to a method of treating an incretin related disease such as diabetes, obesity and the like by delivery of long chain fatty acid to the colon by bypassing the upper digestive tract.
Core Innovation
The invention relates to a method of treating type I diabetes, type II diabetes, hypertriglyceridemia, obesity, appetite control, metabolic syndrome, and polycystic ovary syndrome in an individual affected by a decrease or lack of release of a gut hormone secreted from L cells. It provides a way to stimulate the production of an L cell secreted gut hormone in the colon by delivering an omega-3 polyunsaturated fatty acid composition to the colon or rectum.
The concept includes selecting an omega-3 polyunsaturated fatty acid composition that causes gut hormone secretion from L-cells and formulating the composition to release in a colon targeted delivery system or in a rectal release system. The delivery approach bypasses the stomach and upper GI by delivering directly to the colon or rectum to promote L-cell gut hormone release, including GLP-1, GLP-2, PYY, and oxyntomodulin.
The disclosure further describes colon-targeted delivery system architectures, including multimatrix and matrix-within-matrix formulations, with a hydrophilic first matrix and a lipophilic phase and/or an amphiphilic phase. It also describes rectal administration options such as an enema and a suppository, along with study designs indicating that rectal PUFA and MMX-formulated PUFA can increase GLP-1 and reduce glucose and HbA1c in obese diabetic patients over short and six-week periods.
Claims Coverage
The partial claim set includes one independent claim (clm-00001). It covers a treatment method across multiple metabolic disorders by using an omega-3 polyunsaturated fatty acid composition designed for release in a colon targeted delivery system or a rectal release system to stimulate L-cell gut hormone release in the colon; the dependents specify particular delivery-system architectures and phase/matrix relationships, for a total of three claims in the provided family subset.
Stimulating L-cell gut hormone production in the colon using an omega-3 PUFA composition
A method of treating an individual affected by a decrease or lack of release of a gut hormone secreted from L cells by stimulating the production of an L cell secreted gut hormone in the colon, comprising selecting an omega-3 polyunsaturated fatty acid composition that causes gut hormone secretion from L-cells and administering sufficient composition colon or rectum sufficient to cause release of gut hormones from the L-cell in the colon to achieve a desired result.
Colon targeted delivery system as a matrix-within-matrix delivery system
The method further specifies that the colon targeted delivery system is implemented as a matrix-within-matrix delivery system.
Controlled-release formulation with hydrophilic first matrix and lipophilic/amphiphilic phases
The method specifies a controlled-release colon targeted delivery system as a formulation using a hydrophilic first matrix with a dispersed second matrix of lipophilic and amphiphilic phases, with an agent at least partially incorporated into the amphiphilic phase.
Overall, the claim coverage in the partial content centers on delivering an omega-3 polyunsaturated fatty acid composition to the colon or rectum to stimulate L-cell gut hormone release, with dependent claims narrowing the colon-targeted delivery system to a matrix-within-matrix structure and further specifying a controlled-release formulation having a hydrophilic first matrix and dispersed lipophilic/amphiphilic phases.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Rectal administration of PUFA and MMX-formulated PUFA, including designs where rectal PUFA (enema/suppository) or MMX-formulated PUFA increases GLP-1 and reduces glucose and HbA1c in obese diabetic patients over short and six-week periods.
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