Relative oral bioavailability of three formulations of vitamin D3: An open-label, three-treatment study

Krishnakumar M. Nandgaye; Rajaram S. Samant; Santoshi B. Kadam; Prashant J. Palkar

doi:10.18203/2319-2003.ijbcp20185172

Authors

Krishnakumar M. Nandgaye Department of Medical Services, Akumentis Healthcare Ltd., G-Corp Tech Park, Kasarvadavali, Near Hypercity, Ghodbunder Road, Thane (West), Maharashtra, India
Rajaram S. Samant CEO and Chief Mentor, Akumentis Healthcare Ltd., G-Corp Tech Park, Kasarvadavali, Near Hypercity, Ghodbunder Road, Thane (West), Maharashtra, India
Santoshi B. Kadam Department of Medical Services, Akumentis Healthcare Ltd., G-Corp Tech Park, Kasarvadavali, Near Hypercity, Ghodbunder Road, Thane (West), Maharashtra, India
Prashant J. Palkar Department of Medical Services, Akumentis Healthcare Ltd., G-Corp Tech Park, Kasarvadavali, Near Hypercity, Ghodbunder Road, Thane (West), Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20185172

Keywords:

Nanotechnology, Oral solution, Relative bioavailability, Vitamin D3

Abstract

Background: Supplementation of vitamin D₂ or vitamin D₃ is recommended for vitamin D deficiency. Weekly supplementation of 60,000 IU of vitamin D₃ increases serum 25(OH) D to optimal values. Various marketed forms of vitamin D₃ include tablets, capsule, granules and oral solution. The main objective of this study is to compare the relative bioavailability of vitamin D₃ oral solution with vitamin D₃ tablet and capsule.

Methods: This is an open-label, randomized, single-dose, three-treatment study to compare the relative bioavailability of vitamin D₃ oral solution with capsule and tablet. Subjects (n=70) were supplemented with single dose of one of these formulations and their blood sample were assessed for C_max, AUC_0-28d and T_max.

Results: The logarithmic transformed data of pharmacokinetic parameters were analyzed for 90% Confidence Intervals (CI) using ANOVA. The mean (90% CI) values of vitamin D₃ oral solution against tablet for the ratio of C_max and AUC_0-28d were 113.00 (105.32-121.23) and 105.54 (97.95-113.72) respectively. The mean (90% CI) values of vitamin D₃ oral solution against capsule for the ratio of C_max and AUC_0-28d were 115.02 (106.38 - 124.37) and 112.33 (104.44 - 120.81) respectively. These values were within the bioequivalence range of 80-125%.

Conclusions: It is concluded that vitamin D₃ Oral Solution formulated with nanotechnology is bioequivalent to vitamin D₃ tablet and capsule. However, oral solution of vitamin D₃ shows higher C_max and AUC when compared to tablet and capsule formulations.

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