• Evaluating and comparing release profiles of four different non-prescription niacin formulations

      Shah, Sarthak; Uddin, Mohammad N. (2021)
      Niacin, nicotinic acid or vitamin B3 is critical portion of a balanced nutritional diet. None of the niacin's dissolution profiles were evaluated and compared in literature. Niacin, a supplement, is not subjected to Federal Drug Administration (FDA) monitoring. The study compared several different formulations such as immediate release (IR) powder, IR tablet, timed release (TR) capsule, extended release (ER) capsule, and controlled release (CR) tablet to validate the claims for each formulation provided by the manufacturer. In our in vitro study, dissolution apparatus was used. Two different media were prepared, simulated gastric fluid (SGF) at pH 1 and simulated intestinal fluid (SIF) at pH 7. UV/VIS Spectrophotometry for analysis was used. In IR form, maximum concentration was 80% concentration of the label's claim. In ER, in pH 7, drug remained constant at about 50% niacin concentration over 24-hour period. In TR, in both pH conditions, the maximal niacin release concentration was about 65-70%. In Slo-Niacin tablets, release rates were consistent in both pH 1 and pH 7. Our findings illustrate that the four release forms (IR, ER, TR, CR) and their modified drug formulations are aligned with their release definitions. Further research is encouraged and should evaluate other non-FDA formulations.