• 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.
    • Microparticulate vaccine for transdermal measles immunization

      Joshi, Devyani; Gala, Rikhav; Uddin, Mohammad N.; D'Souza, Martin J. (2021)
      Measles is a major global cause of death. Since children are primary targets for vaccine, we aimed at delivering the vaccine via needle-free transdermal route. Vaccine microparticles were formulated using Buchi spray dryer B-290. The induction of immune response by the microparticles was confirmed by Griess's assay. Expression of antigen-presenting molecules, MHC I, MHC II, and co-stimulatory molecules CD80, CD40 was assessed using flow cytometry. Cytotoxicity of microparticles was assessed by MTT assay. In vivo efficacy of was studied in the mouse model. For transdermal immunization, P.L.E.A.S.E. ablative laser was used. It creates micropores of defined size on the skin for transdermal immunization. The animals were administered with a prime and a booster dose. The serum was collected, and IgG and IgM antibody titers were measured. Microparticulate vaccine showed significantly higher release of nitric oxide compared to the blank microparticles. It resulted in significantly higher cell-surface expression of MHC I, MHC II, CD80 and CD40. The vaccine and adjuvant microparticles were non-cytotoxic. The in vivo studies demonstrated elevated humoral immune responses in the mice receiving vaccine and adjuvant microparticles via both, subcutaneous and transdermal routes. The microparticles augment the immunogenic properties of vaccine. Transdermal administration produced comparable results as of the subcutaneous administration indicating the potential of the transdermal vaccination.