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September 15-16, 2017 | Dallas, USA
International Conference on
VITAMINS, NUTRIGENOMICS & MALNUTRITION
Insights Nutr Metab 2017
Volume 1 Issue 1
Objective:
The objective of the pharmacokinetic study was to demonstrate
efficacy and the bioavailability of new formulation of Vitamin C in gel caps,
comparing that to the controlled release formulation in vitamin C depleted
healthy volunteers.
Methodology:
Adult subjects with vitamin C levels <75 micromol/L at
screening were enrolled according to the inclusion and exclusion criteria.
Volunteers randomly assigned to one of the following groups: Vitamin C
i.v. injection 500 mg, p.o. controlled release 500 mg capsules, p.o. NovoC
Plus 2x300 mg softgel capsules dietary food supplement. The comparative
efficacy and bioavailability was assessed by the serum levels and the urinary
ascorbate levels.
Results:
Intravenous administration resulted in a shirt peak with a quick
turnover within 3 hours. Oral administration of controlled release capsules
or the new formulation of NovoC Plus softgel capsules resulted in statistically
similar extended (elongated) kinetics within 12 hour-investigational period
similar to that of the (timed) controlled release product claimed. Considering
the availability, the normalized AUC were not different, however higher
dose response were detected in serum (i.e. capacity of the given dose to
increase of ASC levels in blood) compared to levels that was achieved by the
controlled release capsules.
Conclusion & Significance:
The treatment with the new formulation NovoC
Plus resulted in similar AUC response, high bioavailability and extended
duration of vitamin C supplementation in serum compared to the (timed)
controlled release capsules. The effect presumably due to the modified/
alternative absorption kinetics resulted in the liposomal/lipoid components
of the formulation. The oral administration of the similar or lower doses
of this new formulation may give better or more time-efficient availability
of ASC in blood to support the tissues in conditions of increased amount
required or such as stress, muscular depletion in (extreme) sports or other
medical conditions.
Speaker Biography
Istvan Takacs has his academic background based on Neuroendocrine and Cell
Biology Research (Semmelweis University, Neuroendocrine research group at
Academy of Sciences Hungary; Rudolph Magnus Institute of Pharmacology, Utrecht:
The Netherlands; Dept. of Molecular and Cell Biology: Penn State University,
USA). He served as a university Lecturer (Medical School) and invited Lecturer for
graduate and postgraduate education and recently appointed as Associate Professor,
Head of Department pf Pharmaceutical Surveillance and Economy at Debrecen
University, teaching pharmacovigilance, pharmaceutical business-management, and
drug development. His clinical research experience is based on clinical operation
management and clinical quality site management including senior level consultancy
for pharmaceutical industry (research /project management, drug development,
medical affairs) and clinical operational head. His research project covered the range of
development phases (I/II to III-IV) including specific areas such as bioequivalence and
post-marketing safety trials as well.
e:
tothe.bela@pharm.unideb.huComparative pharmacokinetic evaluation of a new formulation of vitamin C gel caps
Bela E Toth
1
, Istvan Takacs
2
, Boglarka Szabo
2
, Bence Bakos
2
and
Janos Torok
3
1
University of Debrecen, Hungary
2
Semmelweis University School of Medicine, Hungary
3
Fumoprep Laboratories, Hungary