Iron and Folic Acid Bioavailability from a Multivitamin Tablet Following a Single Dose and After 28 Days of Supplementation (P24-010-19)

Objectives To determine the bioavailability of folic acid and iron from a multivitamin tablet formulation following a single dose and 28 days of supplementation. Methods The tablet formulation included iron (ferrous fumarate, 18 mg) and folic acid (400 mcg) plus 21 additional nutrients; Cmax and Tmax were determined. For the single dose study, subjects (n = 35, 45–76 y, 49% Female/51% Male) ate standardized food the previous day, then fasted (10 h) prior to the intervention. The study tablet was consumed without food 15 min following baseline blood collection. Blood was drawn at 1, 2, 4, 8, and 10 h post-ingestion of the study tablet. For the 28-day supplementation study, subjects (n = 16, 18–65 y, 81% Female/19% Male) consumed 1 tablet/day; fasting blood iron and folic acid levels were determined every 7 days. Subjects ate standardized meals the day prior to blood draws. In both studies, differences compared to baseline were determined using paired t-tests for normally distributed data. In the 28-day supplementation study, differences compared to baseline for non-normally distributed data were determined using a Wilcoxon Signed Ranks test. Results In the single dose study, iron concentration significantly increased (P < 0.05) compared to baseline at 1, 2, and 4 h with a Cmax of 130.24 ± 8.079 mcg/dL and Tmax at 160.0 ± 0.284 min. Folic acid concentration significantly increased (P < 0.05) compared to baseline at 1, 2, and 4 h with a Cmax of 23.32 ± 0.295 ng/mL and Tmax at 60.0 ± 0.254 min. In the 28-day study, blood iron concentrations significantly increased (P < 0.05) compared to baseline at days 21 and 28. Additionally, folic acid concentrations significantly increased (P < 0.05) compared to baseline at days 14, 21, and 28. Conclusions A multivitamin tablet increased blood iron and folic acid levels when delivered as a single dose or daily for 28 consecutive days. These results demonstrate that folic acid and iron are readily absorbed and bioavailable from this multivitamin tablet formulation. Funding Sources This study was funded by Pharmavite LLC.

FORMULATION AND EVALUATION OF CHEWABLE MULTIVITAMIN TABLET

Objective: The overall objective of the present study was to formulate the chewable multivitamin tablet prepared by direct compression method.Methods: The excipient used in this study are mannitol, sucrose, starch, talc, magnesium stearate, vanilla powder for the effective formulation. As it is multivitamin, ascorbic acid, riboflavin, nicotinamide, thiamine HCL are used and evaluated for precompression parameter. The chewable tablets were better presented using sweetener sucrose and vanilla powder as a flavouring agent. The formulated tablet was evaluated for post compression parameter. The chewable tablet are prepared to ensure that they are easily crushed by chewing. The tablet was evaluated for weight variation, hardness, thickness, friability, drug content. Their dissolution properties were assessed using USP (paddle apparatus).Conclusion: From the above study, we conclude that the chewable tablets were prepared by direct compression method and gave the satisfactory and acceptable result. The tablet shows immediate drug release due to direct compressed tabletResults: All the parameter were found within the specification. Drug content of ascorbic acid (103.62%-108.84%), riboflavin (99.88%-112.02%), nicotinamide (93.44%-100.31), thiamine Hcl (105.94%-108.5%) were found.