Search results for "Manufacturing methods"
showing 3 items of 3 documents
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin
2015
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a “worst case” approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release rib…
3D-Printed Solid Dispersion Drug Products.
2019
With the well-known advantages of additive manufacturing methods such as three-dimensional (3D) printing in drug delivery, it is disappointing that only one product has been successful in achieving regulatory approval in the past few years. Further research and development is required in this area to introduce more 3D printed products into the market. Our study investigates the potential of fixed dose combination solid dispersion drug products generated via 3D printing. Two model drugs&mdash
Discrimination of papers used in conservation and restoration by the means of the voltammetry of immobilized microparticles technique
2019
Herein, voltammetry of immobilized microparticles (VIMP) is employed for the discrimination of papers used in the conservation and restoration field. The electrochemical parameters are used for the discrimination of different samples coming from China, Japan and Korea. The method is based on the recording of the voltammetric response of microparticulate deposits from acetone extracts of paper samples deposited on a glassy carbon electrode in contact with 1.0 M H2SO4. The voltammetric responses attributed to the lignin and the oxidation products of the cellulose were collected and are discussed. The grouping of samples was obtained upon the application of the chemometric methods, as well as …