The newly issued patent describes the basic composition and process of manufacturing high-molecular-weight and low-molecular-weight pectins from Aloe vera.
The claims of this patent are applicable to any use of DelSite's Aloe pectins, including use in pharmaceutical compositions such as proteins, peptides, vaccine antigens and other pharmacological substances.
Pectin is a plant cell wall component abundant in soft plant tissues under conditions of fast growth and high moisture content. In cell walls, pectins are present in the form of a calcium complex.
The involvement of calcium crosslinking is substantiated by the fact that chelating agents facilitate the release of pectin from cell walls.
Pectins are traditionally used as food additives. However, their use has extended into pharmaceutical areas as well. Pectins have long been used as an anti-diarrhoea agent and can improve intestinal functions. The anti-diarrhoea effect is thought to be in part due to pectin's anti-microbial activity.
"GelSite polymer has unique functional properties such as the ability to stabilise many proteins that make it an attractive basis for novel drug delivery systems, including the GelVac nasal powder vaccine delivery system," said Kenneth Yates, president of DelSite Biotechnologies.
GelSite polymer is a naturally sourced, high molecular weight anionic polysaccharide that is water-based and is capable of in situ gelation, (changing either a solid or liquid formulation into a gel upon contact with body fluids leading to controlled-release of active biomolecules).
GelSite is not an adjuvant and is a member of a family of plant polysaccharides classified by the FDA as Generally Regarded As Safe (GRAS).
The European Patent (EP 1 086 141 B1), titled "Aloe Pectins," describes Pectin's effectiveness against gastrointestinal ulcers and enterocolitis.
Pectins also influences cell proliferation in the intestines. They also have a blood cholesterol-lowering effect and exhibit inhibition of atherosclerosis.
This effect is the result of interactions between pectins and bile salts. Pectins have also been shown to affect the fibrin network in hypercholesterolaemic individuals.
Recently, so-called modified citrus pectins, which are small molecules (.about.10 kDa) obtained by alkaline degradation, have been found to be effective in the prevention of cancer cell metastasis in laboratory animals.
The polymer is currently manufactured to cGMP standards at Carrington's wholly owned subsidiary, Sabila Industrial, S.A., in Costa Rica.
A Drug Master File (DMF) for use of GelSite polymer in mucosal applications was recently filed with the FDA. Currently, preclinical development is progressing for a GelVac nasal powder avian influenza (bird flu) vaccine.