Optimization of debittering and deacidification parameters for Pomelo juice and assessment of juice quality.

Bitterness and tartness are one of the crucial reasons for the poor commerciality of Pomelo fruits. The present study intends to optimize the process variables such as resin concentration (Amberlite IRA-400) (3-10 g), time exposure (10-60 s), and stirring speed (300-1000 rpm) for removal of naringin content and tartness using response surface methodology. All the independent variables have shown a significant effect on naringin content, titrable acidity, and vitamin C content of pomelo juice. The optimized process variables for debittering and deacidification were 3.27 g resin concentration, 60 s time and 1000 rpm stirring speed, and the naringin content and titrable acidity at these optimized conditions were 0.22 mg ml-1 and 0.64% citric acid equivalent respectively. The treated juice under optimum conditions was analyzed for physicochemical properties where pH, clarity, and L* value of juice increased. In contrast, total soluble solids, vitamin C content, and a* value decreased slightly. The finding of present investigation will be helpful to improve the commercial acceptability of the sour variety of citrus fruit juice.

Liver safety assessment in clinical trials of new agents for chronic hepatitis B.

Investigational agents that reduce or eliminate covalently closed circular DNA (cccDNA) or enhance host immunity against hepatitis B virus (HBV)-infected hepatocytes are intended to induce a durable off-treatment clearance of hepatitis B surface antigen (HBsAg) (referred to as functional cure). The aim of this paper was to highlight challenges in interpreting liver safety data in clinical trials of these agents when given alone or in combination regimens. The incidence, grading and management of spontaneous serum ALT flares in untreated chronic HBV patients are reviewed along with a summary of serum ALT flares observed during the registration trials for peginterferon and nucleos(t)ide reverse transcriptase inhibitors. Recommendations regarding the detection, management and interpretation of liver safety biomarker data in future clinical trials as well as suggested inclusion and exclusion criteria for phase 1/2 vs phase 3 studies are provided. Criteria to help classify liver safety signals as being due to the intended therapeutic response, emergence of drug-resistant HBV virions, or idiosyncratic drug-induced liver injury are provided along with a review of the role of an expert hepatic adjudication panel in assessing a compound's hepatotoxicity profile. Finally, an algorithmic approach to the differential diagnosis and recommended medical evaluation and management of individual clinical trial patients that develop a liver safety signal is provided along with the rationale to collect and test research blood samples for future mechanistic studies.