Funded in part by Sanofi, Tata Consultancy Services
An open-label, randomized, crossover study to evaluate the bioavailability of nanoemulsion versus conventional fat-soluble formulation of cholecalciferol in healthy participants
Marwaha RK, Verma M, Walekar A, Sonawane R, Trivedi C
Journal of orthopaedics · 5 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- No health outcome
Who paid for it
- Funding
- Industry funded
- Company
- Sanofi
- Company
- Tata Consultancy Services
Based on 2 listed funder(s).
Publication
- Published
- 2022-11-03 · J Orthop · vol. 35 · pp. 64–68
- Publisher
- Elsevier BV
- Cited
- 10 citations · more than 65% of similar papers · 0.8× the field average
- References
- 30 works
- Access
- Open access (hybrid journal) · CC-BY-NC-ND
- Research areas
- Advanced Drug Delivery Systems · Drug Solubulity and Delivery Systems · Protein purification and stability
- Keywords
- Bioavailability, Cmax, Cholecalciferol, Pharmacokinetics, Medicine, Crossover study, Pharmacology, Bioequivalence, Vitamin D and neurology, Internal medicine, Placebo
5 authors
From IN
- Raman Kumar Marwaha · corresponding
- Manish VermaSanofi (India)
- Ajit WalekarSanofi (India)
- Rakesh SonawaneSanofi (India)
- Chirag .S. TrivediSanofi (India)
Abstract
Background
Nanoemulsion preparations of cholecalciferol available in the market claim to have better bioavailability than the conventional fat-soluble cholecalciferol. However, limited data are available in humans for such preparations. We, therefore, compared the relative bioavailability of two formulations of 60,000 IU cholecalciferol (nanoemulsion oral solution, water-miscible vitamin D3 [test] vs soft gelatin capsules [reference]) in healthy adult participants.
Methods
In this randomized, open-label, two sequence, single-dose, two-way crossover study (CTRI/2018/05/013839), Indian participants aged 18-45 years received single dose of nanoemulsion and capsule formulations, under fasting conditions. Blood samples collected over 120 h were assessed to determine cholecalciferol concentrations. Pharmacokinetic parameters (area under the concentration-time curve up to 120 h [AUC0-120h], maximum observed drug concentration [Cmax], time to reach maximum drug concentration [Tmax], terminal half-life [T½el], and terminal elimination rate constant [Kel]) were estimated using baseline corrected data and analyzed using analysis of variance.
Results
Among the 24 eligible participants, the relative bioavailability of nanoemulsion was significantly higher than the capsules by 36% (p = 0.0001) based on AUC0-120h. Similarly, Cmax of the nanoemulsion was significantly higher by 43% (p = 0.0001) than that of the capsules. The intra-participant variability for AUC0-120h and Cmax were 23.22% and 26.51%, respectively. The Tmax, T½el, and Kel were comparable for both the formulations. No adverse effects were noted with either of the two formulations.
Conclusions
Nanoemulsion oral solution of cholecalciferol showed a greater bioavailability compared with soft gelatin capsules, under fasting conditions, in healthy human participants.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).
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