DISSOLUTION ANALYSIS OF OTC COENZYME Q10 DIETARY SUPPLEMENTS

• Main Authors: Yoo, Harrison, Teague, Amanda, Collins, Charles C
• Format: Others
• Published: Digital Commons @ East Tennessee State University 2018
• Subjects: Dissolution; CoEnzyme Q10; DDS; Supplement; HPLC; Pharmaceutics and Drug Design; Pharmacy and Pharmaceutical Sciences
• Online Access: https://dc.etsu.edu/asrf/2018/schedule/28

Introduction: Coenzyme Q10 (CoQ10) is a fat-soluble substance (ubiquinone) which has a bright orange color in appearance and is widely distributed (ubiquitous) in animals and many bacteria. CoQ10’s presence is most prevalent in mitochondria and it is involved in aerobic cellular respiration and aides in converting ingested nutrients into a readily accessible form of energy, specifically ATP (adenosine triphosphate). CoQ10 is supplied through our diets and can be found more in dark leafy green vegetables, fish and organ meats. CoQ10 supplementation should be beneficial due to its characteristic antioxidant scavenging of free radicals that our body produces while in the cellular respiration process for generating energy from nutrients. Although CoQ10 has great antioxidant benefit, a challenge remains for supplement manufacturers to deliver a sufficient does of this sparingly soluble molecule. Dietary supplements do not have the significant FDA oversight that exists for legend drugs, resulting in significant variability within and between brands. The main hypothesis of this project is that commercially available CoQ10 supplements don’t deliver a sufficient mass of CoQ10 when compared to the labelled quantity. Methods: To test this hypothesis, the group purchased and tested 14 commercially available CoQ10 supplements with each serving containing 100 mg of active, choosing a variety of drug delivery systems (DDS) and also included one in-house product, which contained 70 mg of active. The DDSs examined consisted of 7 soft shell gelatin (SSG) capsules (the most common type available), 3 hard shell gelatin (HSG) capsules, 3 tablets (tab), 1 powder, and 1 suspension. Each DDS was placed into a 500 mL volumetric flask (VF) into an aqueous of 0.1 N HCl acid and 0.1% Tween 80, using a standard FDA dissolution method. To facilitate drug release, the contents were removed from the HSG capsules; the SSG capsules were perforated; and the tabs were broken/crushed. After this, a magnetic stir bar was placed into each flask and all DDS samples were vigorously stirred for 30-45 minutes, including being inverted every 10 minutes to further facilitate dissolution of CoQ10 from each DDS. Filtered samples were obtained and the samples were analyzed by a reverse-phase High Performance Liquid Chromatography that was previously developed by this research group. Results and Conclusions: Only two of the 15 products evaluated had significant availability (mean > 50%) of CoQ10; one soft gelatin capsule (Product A, dissolved a mean of 68.57%), and the suspension (Product K, dissolved a mean of 56.71%). All of the other products averaged less than 4% dissolution of the labelled amount (range of values 0.19% to 3.64%). The in-house formulated HSG capsule (Product Q) released a mean amount equal to 8.11% of label (more than twice the percentage of the poorly performing commercial products). The consistency of the products was also variable, with product A having a range of 1.7 to 192 mg of CoQ10 released; Product K had a range of 35.8 to 76.1 mg of drug released. The group concluded that there are acceptable products available, but that most have significant performance issues.