Amorphous solid dispersions (ASDs) represent an important approach for enhancing oral bioavailability for poorly water soluble compounds; however, assuring that these ASDs do not recrystallize to a significant extent during storage can be time-consuming. Therefore, various efforts have been undertaken to predict ASD crystallization levels with kinetic models. However, only limited success has been achieved due to limits on crystal content quantification methods and the complexity of crystallization kinetics. To increase the prediction accuracy, the accelerated stability assessment program (ASAP), employing isoconversion (time to hit a specification limit) and a modified Arrhenius approach, are employed here for predictive shelf-life modeling. In the current study, a model ASD was prepared by spray drying griseofulvin and HPMC-AS-LF. This ASD was stressed under a designed combinations of temperature, relative humidity and time with the conditions set to ensure stressing was carried out below the glass transition temperature (Tg) of the ASD. Crystal content quantification method by X-ray powder diffraction (XRPD) with sufficient sensitivity was developed and employed for stressed ASD. Crystallization modeling of the griseofulvin ASD using ASAPprime® demonstrated good agreement with long-term (40 °C/75 %RH) crystallinity levels and support the use of this type of accelerated stability studies for further improving ASD shelf-life prediction accuracy.

Prussian blue insoluble (PB) is an antidote for decorporation of radioactive and non-radioactive isotopes of thallium and cesium. Its dosage in the form of capsules, Radiogardase-Cs, is a United States Food and Drug Administration approved formulation since 2003. In India and many other countries, this drug is not available and in case of requirement it is imported from US or Europe. The author has worked extensively to make PB capsules available in India. The drug was recently approved by the Indian drug regulatory agency, Central Drugs Standard Control Organisation and is now available commercially in India. However this drug needs special attention as it is an orphan drug with limited requirement. The post-approval phase of this drug poses a different set of challenges and the author has highlighted some key issues with probable approaches for post-approval product management.

The efficacy and applicability of Plasma Activated Ice (PAI) -produced by cold atmospheric plasma (CAP) technology- on microorganisms and quality characteristics of perishable fresh sea bream (Sparus aurata) fillets, were evaluated. The changes in microbiological load and quality characteristics of fish fillets were investigated during storage with ice from deionized water (Control), PAI and ice from artificially produced water (Artificial) of H2O2 concentrations equal to those of PAI. Fresh sea bream fillets were packed under ice flakes (produced from PAI or Artificial or Control) on layers (as typically done in the relevant industry) and stored at 0.5 °C for 27 days. PAI application inhibited significantly the growth of microbial load of the fillets resulting in reduced growth rates while simultaneously significantly retarded the quality deterioration compared to the other disinfectant media. The use of PAI (with 10 mg/L H2O2) led to a 11-day and 6-day extension, i.e., 2-fold and a ∼ 1.5-fold extension, of the fillets shelf-life compared to the samples treated with Control and Artificial ice, respectively. The results proved the efficiency of PAI in extending the shelf-life of perishable foods during storage (or/and transportation), by validating its antimicrobial properties and cooling capacity.

The short shelf-life of PDO Tuscan bread limits its distribution to markets close to the production area, affecting its commercial success and the economic return by supply chain operators. While the application of MAP to store bread is widely accepted, the suitability of this technique to extend the shelf life of the PDO Tuscan bread is still to be explored. Furthermore, to the best of our knowledge no data are available in the literature about the use of argon as filling gas neither in pure atmosphere nor in combination with CO2. In this context, the aim of this study was to evaluate the effect of different modified packaging atmospheres on the shelf-life of sourdough bread. Slices of bread were stored individually in plastic bags at 23 °C in five different atmospheres (Ar (100%), N2 (100%), CO2 (100%), Mix CO2/N2 (70% CO2, 30% N2), Mix CO2/Ar (70% CO2, 30% Ar)), and Air was selected as a control. To select the best storage conditions, both chemical-physical, rheological, and organoleptic features were evaluated. Results showed that pure gases (CO2, N2, Ar) displayed good qualities as storage atmospheres compared to Air. In contrast, both Mix CO2/N2 and Mix CO2/Ar were the best in slowing down the staling process, thus doubling the shelf-life of bread, compared to other atmospheres. In conclusion, argon, as a preservation atmosphere, seems to be the best solution to extend the shelf-life of PDO Tuscan bread.