Activity

9%, respectively. The dipstick assay was validated in three laboratories as per OIE guidelines. The storage life of dipstick was up to 7 months at 4 °C. The assay is easy to perform and the results can be interpreted with visual observation that precludes the need for absorbance reading equipment. The standardized dipstick assay was found promising for screening swine serum samples in field conditions. Timely detection of JE virus in swine will aid in predicting the outbreak in humans and thus in taking suitable preventive and control measures. Reassortment of segmented viruses can be an important source of genetic diversity underlying viral evolution and emergence. Methods for the quantification of reassortment have been described but are often cumbersome and best suited for the analysis of reassortment between highly divergent parental strains. While it is useful to understand the potential of divergent parents to reassort, outcomes of such heterologous reassortment are driven by differential selection acting on the progeny and are typically strain specific. To quantify reassortment robustly, a system free of differential selection is needed. We have generated such a system for influenza A virus and for mammalian orthoreovirus by constructing well-matched parental viruses carrying small genetic tags. The method utilizes high-resolution melt technology for the identification of reassortant viruses. Ease of sample preparation and data analysis enables streamlined genotyping of a large number of virus clones. The method described here thereby allows quantification of the efficiency of reassortment and can be applied to diverse segmented viruses. The goal of this study was to evaluate the effect of polymer substituent type on drug amorphous solubility as well as drug membrane transport rate. Two grades of hypromellose acetate succinate (HPMC-AS), AS-LF and AS-HF, were studied with four model drugs. Experimental techniques used to evaluate the drug-polymer systems including solution 1H nuclear magnetic resonance spectroscopy (NMR) and absorptive dissolution testing. AS-HF substantially reduced the drug amorphous solubility, while AS-LF had only a minor impact. By NMR spectroscopy, AS-HF was found to distribute extensively into the drug-rich phase formed via liquid-liquid phase separation. Polymer distribution into the drug-rich phase accounts for the reduction in the drug amorphous solubility. Selleck Apabetalone Absorptive dissolution testing showed that drug mass transport was lower in the presence of AS-HF compared to AS-LF for drug concentrations above the amorphous solubility. Thus, the decrease in drug amorphous solubility by AS-HF reduced drug transport. This study highlights the need to consider the polymer impact on drug amorphous solubility and subsequent drug transport, when optimizing amorphous solid dispersion formulations, with the goal of maximizing drug absorption. This review provides insight into the use of boric acid as a pharmaceutical, a buffer, and an adjuvant/excipient in pharmaceutical formulations. Boric acid is a Lewis acid with a pKa of 8.92-9.24 that is sensitive to temperature, ionic strength, and concentration. The pKa varies with concentration because of polymerization above 0.02 M. Boric acid reacts reversibly with alcohols, especially 1,2-diols including carbohydrates, with carboxylic acids, thiols, and amines. These esters/adducts, are also Lewis acids with lower pKa values. Boric acid can stabilize some materials while catalyzing the degradation of others. Boric acid is used in various dermal and women’s hygiene products because of its mild antibacterial and antifungal activity. In ophthalmic products, it is used as a buffer and in combination with other preservatives to broaden the prservative spectrum. Boric acid has been used reluctantly in parenteral products but appears to be quite safe at low doses. However, at high exposure, toxicity, including death, has been reported in humans, especially in children. Animal toxicities have also been noted, including reductions in male sperm counts. Boric acid is well absorbed on oral dosing. Its biological half-life is about 21 hours in humans and has an affinity for some tissues, especially bone. Isolators for aseptic filling of biopharmaceuticals and vaccine products are commonly sanitized by vaporized hydrogen peroxide (VHP). However, remaining traces of H2O2 may contaminate the solution and cause oxidative degradation of the pharmaceutical products. The present report aims to establish a thorough understanding of the factors influencing H2O2 adsorption on empty glass intended for pharmaceutical product filling. A lab-scale miniaturized set-up that mimics the VHP- based isolator decontamination process was used. A fractional factorial design of experiment (DoE) was performed including relative humidity (RH), VHP concentration and exposure time as variables. The results revealed that VHP concentration and RH both impacts significantly the extent of H2O2 adsorption on the surface of glass vials and rubber stoppers. The lower extent of H2O2 adsorption at elevated RH implies the existence of competitive co-adsorption. Thus, adsorbed H2O2 may be removed more efficiently from the isolator after the decontamination phase by insufflating air with a high %RH rate during the isolator’s aeration phase. The understanding gained from the present set-up can be applied to optimize the design of isolator decontamination cycles and evaluate the trade-off between process performance and the resulting product quality. Sunscreen products contain UV-filters as active ingredients for the protection of skin against UV radiation. FDA issued a new proposed rule in 2019 (84.FR.6204) for sunscreens and identified the need for additional safety data for certain UV-filters including their dermal absorption data. Dermal absorption data reveals systemic exposure of UV-filters in humans, which can be obtained from clinical maximal usage trials. FDA guidance recommends conducting in vitro skin permeation tests (IVPT) to help select formulations for maximal usage clinical trials, as IVPT results may be indicative of in vivo absorption. This case study reports in vitro methodologies used for the selection of sunscreen products for an FDA-sponsored proof-of-concept maximal usage clinical trial. An IVPT method was developed using human cadaver skin. Commercially available sunscreen products were tested to determine the skin absorption potential of common UV-filters using this IVPT. All the studied sunscreen products demonstrated a certain degree of skin absorption of UV-filters using IVPT, and a formulation rank order was obtained.