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S-adenosylmethionine formulations with enhanced bioavailability

A kind of adenosylmethionine, physiological technology, applied in the field of S-adenosylmethionine formulation with enhanced bioavailability, can solve the insufficient absorption of rat hepatocytes, insufficient transport of monolayer SAMe And other issues

Inactive Publication Date: 2012-09-26
MSI METHYLATION SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Recent reports investigating SAMe uptake by cultured cells found that SAMe was insufficiently transported by monolayers of Caco-2 cells and inadequately taken up by cultured rat hepatocytes

Method used

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  • S-adenosylmethionine formulations with enhanced bioavailability
  • S-adenosylmethionine formulations with enhanced bioavailability
  • S-adenosylmethionine formulations with enhanced bioavailability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0127] Altered SAMe coating composition leads to GI segment-specific SAMe absorption

[0128] To better understand the absorption profile of SAMe in vivo, standard, uncoated SAMe-containing tablets were first produced and then coated with a segment-specific coating targeting one of three different regions of the GI tract.

[0129] Uncoated SAMe tablets comprising microcrystalline cellulose, croscarmellose, colloidal silicon dioxide and magnesium stearate were prepared using standard procedures known to those skilled in the art. In order to improve the compressibility of the composition, SAMe powder was granulated using a dry compression method. Each excipient is divided between inner-granule and outer-granule stages. The final tableting blend is compressed using a rotary tablet press equipped with an elongated oval tool in one position and occluded in the remaining position. Keep the relative ambient humidity around 30% or lower, and the ambient temperature between 20 and ...

Embodiment 2

[0136] In vivo analysis of absorption enhancers

[0137] The use of absorption enhancers as novel formulations to increase the absorption and thus bioavailability of SAMe is accomplished by either co-formulating SAMe with one or more absorption enhancers, or co-administering SAMe with one or more absorption enhancers. Co-administration does not have to be at the same time, as it may be more effective to administer the absorption enhancer within a reasonable time before or after administration of the proprietary formulation of SAMe.

[0138] Identification of suitable absorption enhancers can be found in the art or can be accomplished in vivo. The in vivo activity of compositions comprising SAMe and one or more absorption enhancers can be measured after administration to an animal model. Preferably, the animal model comprises a pharmacokinetic (PK) model in which the candidate formulation is administered to a non-rodent (e.g., dog, pig, minipig, or primate) using a pharmacol...

Embodiment 3

[0143] In vivo screening of absorption enhancers

[0144] In addition to the above, identification of suitable absorption enhancers can also be accomplished using simple, standard in vivo screening assays. In the present invention, the permeability of SAMe through a Caco-2 cell monolayer treated with an absorption enhancer is used to determine increased SAMe uptake by the Caco-2 cell monolayer compared to an untreated Caco-2 cell monolayer amount of medicine. The Caco-2 cell line is derived from human colorectal carcinoma and its in vivo cell culture model that is widely used for the study of gastrointestinal drug absorption (Stewart, B., (1995) Pharm. Res. 12:693). In these models, pure cell lines are grown on semipermeable membranes. Drug formulations are placed on the apical or basolateral side of the cell monolayer and transport is determined via measurement of drug concentration on the other side of the membrane.

[0145] The Caco-2 cell line used here is from the Am...

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Abstract

The invention relates to compositions and methods to enhance the absorption of S- adenosylmethionine (SAMe) and to methods of treating various disorders or diseases using non-parenteral SAMe formulations with enhanced-absorption and improved bioavailability. The enhanced bioavailability formulations may be used to treat a variety of diseases or disorders, such as for example, psychiatric disorders including, generalized anxiety disorder, obsessive compulsive disorder, post traumatic stress disorder, panic disorder, depressive disorders (e.g. major clinical depression) and dysthymia; as well as treating liver disorders, cancer, autoimmune disorders, inflammatory disorders, joint disorders, gastrointestinal disorders and cardiovascular disease.

Description

[0001] Relevant instructions [0002] This application claims priority to US Provisional Patent Application Serial No. 61 / 229,194, filed July 28, 2009, which is incorporated herein by reference in its entirety. technical field [0003] The present invention relates to compositions and methods for improved bioavailability of S-adenylate-L-methionine ("SAM-e" or "SAMe"). More particularly, the present invention relates to formulations that regulate the absorption of exogenous SAMe in the gastrointestinal tract, and that provide, by oral administration or similar methods, SAMe plasma concentrations from which sufficient physiological effects can be expected. The present invention is directed to methods of treating a disease or disorder and / or improving the nutritional status of a subject in a subject by administering a formulation capable of improving gastrointestinal absorption of SAMe, wherein one or more absorption-promoting technology for enhanced gastrointestinal absorption...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7076A61K47/06
CPCA61K9/2013A23V2002/00A61K9/2054A61K47/14A61K47/40A61K47/12A61K47/186A61K31/7076A61K9/2846A61P1/00A61P1/06A61P1/16A61P19/02A61P25/00A61P25/16A61P25/18A61P25/22A61P25/24A61P25/28A61P25/30A61P25/32A61P29/00A61P35/00A61P43/00A61P9/00A23V2250/312A61K47/06
Inventor I·D·麦唐纳N·哈里森A·塔卡奇-科克斯A·普拉克A·布拉策克-威尔什
Owner MSI METHYLATION SCI
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