Dissolution and Relative Bio-availability of Bio-Co-Enzyme Q10 purum
 

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 was employed to produce Bio-Coenzyme Q10 purum . This novel isolate in the form of a waxy crystalline powder or soft mass is encoupled with the respective enzymes EC:1.6.5.3 and made suitable for soft gelatin capsule (encapsulation) which can passed the USP Dissolution requirement for nutritional supplements. When compared with other commercially available dosage forms for relative bioavailability in human subjects, Bio-Coenzyme Q10 purum was found to be vastly superior (a 6 fold increase in plasma CoQ10 values over baseline, and up to 300% 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 various lipolyases) 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 CoQ1O 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 with silicon dioxide and talc 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, KAMPOYAKI RESEARCH SDN BHD (Malaysia) has acquired an exclusive technology (formulation/process) from BioTakenaka Pharm.Co, Japan. This novel Bio- Coenzyme Q10 purum process has provided the key to the solubilization of CoQlO. Bio-Coenzyme Q10 purumsoftsules® based on the Bio- Coenzyme Q10 purum 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 Coenzyme Q10 purum softgels with other currently available dosage forms (softgels, tablets and capsules), and the data obtained from the study clearly demonstrate that Coenzyme Q10 purum softgel is vastly superior (about 300% higher relative bioavailability than all other dosage forms tested). 

These data are private and unpublished and are subjected to patent pending applications April 9, 1998.(A new Coenzyme Q10 preparation with enhanced relative Bioavailability). 
Bio-CO-ENZYME Q-10 (coupled with enzymes)(ubiquinone)
Description
Appearance: Waxy Crystalline Powder,
Particle Size: 20-60 mesh
Color: White to Buff
Aroma: Neutral
Taste: Characteristic
Recognition Test:
Maximum absorbance of the oxidized solution is seen at 275+/- nm, and that of reduce solution at 290+/- nm.
Full Detailed of GC methodology of purity Bio-CoEnzyme Q10 available for confirmed order of 500kg and above

Storage:        Cool,dry area; Decomposes at around 48C (118F).

Comments:  Bio-CoEnzyme Q10 Orange ( Liquid Grade) for Cosmetic Formulations
                      available.

Analysis:
Assay Ubiquinone: NLT 99.5%
Co-Q9 (Ubiquinone homolog & enzyme*): "0.2% Min.
Moisture: NMT 0.2%
Ash: NMT 0.1%
Heavy Metals: NMT 20 ppm
Arsenic: NMT 2 ppm

Microbial:

E. Coli: Negative
Salmonella: Negative
Germs <100 cfu/gm Non-pathogenic
Yeasts/Molds < 100 cfu/gm

Enzyme coupling:

NAME:   NADH dehydrogenase (ubiquinone) flavoprotein 2 (24kD) H.sapiens [EC:1.6.5.3]
CLASS Metabolism; Energy Metabolism; Oxidative phosphorylation [MAP:00190]
Metabolism; Metabolism of Cofactors and Vitamins; Ubiquinone
biosynthesis [MAP:00130]
This information is presented in the belief that it is accurate and reliable; however, no warranty, either expressed or implied and no freedom from liability form patents, trademarks, or other limitations should be inferred. Any data listed are averages only and are not to be considered as guarantees expressed or implied, nor as a condition of sale.

 Metabolism of Cofactors and Vitamins; Ubiquinone biosynthesis [MAP:00130]

Metabolism; Metabolism of Cofactors and Vitamins; Ubiquinone   biosynthesis [MAP:00130]

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The identification via chromatography column

chromo.gif (13795 bytes)

 

1 Co-Enzyme Q9     2 Co-Enzyme Q10

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Special purpose column An SE-54 type phase developed and tested for reproducible Analysis of Bio-Coenzyme Q10. (BioTakenaka Pharm).

Phase:

bonded; poly(5% diphenyl/ 95% dimethylsiloxane)

Temp. Limits: -60 deg.Cent. to 320 deg. Cent.
McReynolds Nos: x’ y’ z’ u’s’ = 19 74 64 93 62

Length (m) d1(um) Beta

0.25mm ID Fused Silica

30                0.25                    250

 


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Part1 Part2 Part3 Co-Enzyme Q10 and The Skin