Pharmacokinetics of a novel sustained-release vitamin C oral tablet: A single dose, randomized, double-blind, placebo-controlled trial
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Objectives To evaluate the pharmacokinetics of a novel sustained-release oral tablet (C-Fence, Inventia Healthcare Limited, Mumbai, India). Methods We conducted a randomized, placebo-controlled, parallel-design, 500 mg single-dose pharmacokinetic study of this new preparation in 18 healthy adult human subjects (nine in each group) under fasting conditions. The concentration-time profile and pharmacokinetic parameters of L-ascorbic acid, including C max (maximum plasma concentration), T max (time to reach C max ), and AUC 0-24h (area under the plasma concentration versus time curve from time 0 h to 24 h) were calculated using baseline-corrected values. Results The sustained-release tablets resulted in mean C max and AUC 0-24h , respectively, of 1.39 ± 1.21 µg/mL and 11.72 ± 10.73 µg.h/mL against 0.18 ± 0.10 µg/mL and 0.89 ± 0.27 µg.h/mL, respectively, in the placebo group. The mean T max with the sustained-release tablets was 4.3 ± 2.5 h. At 12, 16, and 24 h from dosing, the concentrations were 0.6, 0.4, and 0.3 µg/mL, respectively, above baseline values. Conclusion Novel sustained-release formulations of vitamin C are expected to help achieve plasma vitamin C values above the homeostatic saturation level and result in higher steady-state plasma concentration, which might result in better cellular uptake.
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Two studies assessed only males.
“Two studies assessed only males [27,31].”
From Enhanced Vitamin C Delivery: A Systematic Literature Review Assessing the Efficacy and Safety of Alternative Supplement Forms in Healthy Adults (2025) · cites this paper as [31]
Both studies with sustained-release vitamin C as the intervention were placebo-controlled.
“Both studies with sustained-release vitamin C as the intervention were placebo-controlled [29,31].”
From Enhanced Vitamin C Delivery: A Systematic Literature Review Assessing the Efficacy and Safety of Alternative Supplement Forms in Healthy Adults (2025) · cites this paper as [31]
In a pharmacokinetic study of 18 participants, 500 mg sustained-release vitamin C (C-Fence®) produced mean plasma vitamin C concentrations at 12, 16, and 24 h post-dose that were 0.60, 0.40, and 0.28 μg/mL above baseline, respectively.
“Mean plasma vitamin C concentrations at 12, 16, and 24 h post-dose were, respectively, 0.60, 0.40, and 0.28 μg/mL above baseline values.”
From Enhanced Vitamin C Delivery: A Systematic Literature Review Assessing the Efficacy and Safety of Alternative Supplement Forms in Healthy Adults (2025) · cites this paper as [31]
In the same study, both Cmax and AUC24 h were significantly higher with sustained-release vitamin C than with placebo.
“Both Cmax and AUC24 h were significantly higher than with placebo (p < 0.0001).”
From Enhanced Vitamin C Delivery: A Systematic Literature Review Assessing the Efficacy and Safety of Alternative Supplement Forms in Healthy Adults (2025) · cites this paper as [31]
From the NICE checklist quality assessment of thirteen RCTs, ten (77%) showed low risk of bias, two (15%) high risk, and one (8%) unclear risk.
“From the assessment of the methodological quality of thirteen RCTs, ten (77%) showed a low risk of bias [12,16,27,28,29,30,31,32,35,37,38], two (15%) showed a high risk of bias [33,36] and one (8%) showed an unclear risk of bias [34].”
From Enhanced Vitamin C Delivery: A Systematic Literature Review Assessing the Efficacy and Safety of Alternative Supplement Forms in Healthy Adults (2025) · cites this paper as [31]
Out of thirteen analyzed studies, eight (62%) did not report any adverse events for the intervention or comparators.
“Out of the thirteen analyzed studies, eight (62%) did not report any adverse events, either for the intervention or the comparators [12,27,30,31,33,35,36,37].”
From Enhanced Vitamin C Delivery: A Systematic Literature Review Assessing the Efficacy and Safety of Alternative Supplement Forms in Healthy Adults (2025) · cites this paper as [31]
The studies on sustained-release vitamin C were all against placebo, disabling any conclusion on its benefits over ascorbic acid or other advanced formulations such as Ester-C®.
“The studies on sustained-release vitamin C were all against placebo, disabling any conclusion to be made on its benefits over ascorbic acid or other, advanced formulations such as Ester-C®, etc. [29,31].”
From Enhanced Vitamin C Delivery: A Systematic Literature Review Assessing the Efficacy and Safety of Alternative Supplement Forms in Healthy Adults (2025) · cites this paper as [31]
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Calder, P. C., Kreider, R. B., & McKay, D. L. (2025) · Nutrients · doi:10.3390/nu17020279 · Cited by 12 · see citing works
- Authors
- Rajat, S., Thanawala, S., & Abiraamasundari, R.
- Affiliations
- Inventia Healthcare Ltd, Andheri (East), Mumbai, Maharashtra, India
- Inventia (India) (IN)
- Spinos Life Science Research and Private Limited, Coimbatore, Tamil Nadu, India
- Corresponding author
- Thanawala, Shefali
- Venue
- Journal of Pharmacology and Pharmacotherapeutics
- Publisher
- SAGE Publications
- Published
- 2022-06
- Volume
- 13
- Issue
- 2
- Pages
- 167-174
- ISSN
- 0976-500X (ISSN-L)
- 0976-5018
- OpenAlex
- W4286016551
- Cited by
- 4
- References
- 15
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 1
- FWCI
- 0.62
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Pharmacology and Pharmacotherapeutics (publishedVersion, cc-by-nc)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Vitamin C and Antioxidants Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Health Sciences › Medicine › Biochemistry › Antioxidant Activity and Oxidative Stress
- Keywords
- vitamin C, sustained-release formulation, oral tablets, pharmacokinetics, plasma concentration-time curve, bioavailability, healthy volunteers
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