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Many currently available Coenzyme Q10 dosage forms exhibit negligible dissolution indicating potentially poor bioavailability. In order to improve its dissolution profile and thereby its absorption, a new process (Bio-Solv®) was employed to produce Q-Gel® Softsules. This novel formulation in the form of a softgelatin capsule passed the USP Dissolution requirement for nutritional supplements. When compared with other commercially available dosage forms for relative bioavailability in human subjects, Q-Gel® was found to be vastly superior (a 6 fold increase in plasma CoQ10 values over baseline, and several fold greater relative bioavailability over other dosage forms tested).

Coenzyme Q10 (Ubiquinone) is a lipid-soluble compound found in the mitochondria of all living cells. It also occurs in the food chain and is endogenously produced in the liver. There are conditions in which adequate production of CoQlO in the body is impaired, and in such situations supplementation with CoQ10 has been shown to be very beneficial.

CoQlO, being lipid soluble, follows the same pathway as that of fats for its absorption in the body. This involves emulsification in the intestine (with the help of bile salts) and the formation of micelles prior to absorption. Among the other factors affecting the absorption of exogenously administered CoQlO are its particle size, degree of solubilization, and the type of food ingested with the supplement.

Although CoQlO is classified as a lipid soluble substance, its degree of solubility is extremely limited. Commercially available CoQlO capsules contain either oil-based suspensions (softgels), or dry powder blends (hard gels). When tested in the laboratory, these products show a total lack of dissolution according to current USP methodology. Such lack of dissolution properties are often indicative of poor absorption and bioavailability.

In order to improve the dissolution profile and bioavailability of CoQl0, Tishcon Corp. has acquired an exclusive technology (formulation/process) from BioSytes, USA, Inc. This novel Bio-Solv® process has provided the key to the solubilization of CoQlO. Q-Gel® softsules® based on the Bio-Solv® formulation and process exhibit complete dissolution, which is indicative of improved absorption/bioavailability.

A human study was subsequently carried out to compare the relative bioavailability of Q-Gel® with other currently available dosage forms (softgels, tablets and capsules), and the data obtained from the study clearly demonstrate that Q-Gel® is vastly superior (several times higher relative bioavailability than all other dosage forms tested). These data were presented at the Annual Meeting of the American Society for Nutritional Sciences/Experimental Biology in New Orleans on April 9, 1997.

(Chopra, R., Goldman, R., Bhagavan, H.N., and Sinatra, S. Anew Coen