SUMMARY REPORT

The Effect of Excipients on Performance of LipoSan Ultra™
 

Excipients are normally inert materials that are used in capsules and tablets as binders, lubricants, fillers, disintegrants and flow agents. In some cases, however, certain excipients can potentially affect the bioavailability and performance of specific dietary supplement actives. With this in mind, we evaluated a variety of commonly used excipients for their effect on the in-vitro fat binding performance of LipoSan Ultra™, Vanson HaloSource's rapidly soluble, patented form of chitosan that exhibits significantly enhanced fat binding. A summary of our findings follows:

MAGNESIUM STEARATE
Our results clearly demonstrate that the use of magnesium stearate in excess of 1% (w/w) dramatically reduces the ability of LipoSan Ultra™ to bind fat. Approximately 62% of LipoSan Ultra™'s fat binding capacity is lost when 2% to 5% (w/w) magnesium stearate is incorporated into the finished product blend. Magnesium stearate has an even greater effect on regular dietary chitosan. The negative impact of magnesium stearate is explained by its hydrophobic, fatty nature and by its ability to coat the chitosan fibers during dry blending. This causes a decrease in fat binding by both LipoSan Ultra™ and regular chitosan by reducing their respective solubility in stomach acid. A similar result would be expected from any fatty material, such as stearic acid, that can coat the fibers and reduce solubility.

CALCIUM PHOSPHATE
To test the effect of calcium phosphate on fat binding, we blended LipoSan Ultra™ with increasing levels of calcium phosphate ranging from 20 % - 60 % by weight. At 20% calcium phosphate, fat binding capacity was reduced by almost 30%. At 40% and above, the reduction in fat binding capacity was in the 85% to 90% range. The observed reduction in fat binding is attributed to the precipitation from solution of insoluble salts formed between the polyvalent phosphate anion and the positively charged chitosan fibers. Based on this result, we do not recommend the use of any excipient that would contribute a polyvalent anion on solution in stomach acid.

EXCIPIENTS THAT TESTED ACCEPTABLY
The following excipients were shown to have little or no effect on LipoSan Ultra™'s fat binding capacity as tested at Vanson HaloSource:

 

The effect, if any, of processing LipoSan Ultra™ with the above ingredients on commercial capsule and tablet equipment is not known. Please visit our Website at www.liposan.com or call us at 425.881.6464 for a copy of Vanson HaloSource's complete report entitled "The Effect of Excipients on Performance of LipoSan Ultra™".

LipoSan Ultra is a trademark of Primex ehf, Reykjavik, Iceland