Using a Mass Balance to Determine the Potency Loss during the Production of a Pharmaceutical Blend

Abstract

The manufacture of a blend containing the active pharmaceutical ingredient (API) and inert excipients is a precursor for the production of most pharmaceutical capsules and tablets. However, if there is a net water gain or preferential loss of API during production, the potency of the final drug product may be less than the target value. We use a mass balance to predict the mean potency loss during the production of a blend via wet granulation and fluidized bed drying. The result is an explicit analytical equation for the change in blend potency a function of net water gain, solids losses (both regular and high-potency), and the fraction of excipients added extragranularly. This model predicts that each 1% gain in moisture content (as determined by a loss on drying test) will decrease the API concentration of the final blend at least 1% LC. The effect of pre-blend solid losses increases with their degree of superpotency. This work supports Quality by Design by providing a rational method to set the process design space to minimize blend potency losses. When an overage is necessary, the model can help justify it by providing a quantitative, first-principles understanding of the sources of potency loss. The analysis is applicable to other manufacturing processes where the primary sources of potency loss are net water gain and/or mass losses.

Valorisation of chicken eggshell as a novel food ingredient in madeleine cake: an exploratory study amongst young adults

“…The processing of raw chicken eggshell waste into CESP has resulted in 6.5% of losses relative to its initial weight. Losses of CESP could be justified by their fine particle size at around 0.08 mm that were likely to be lost Pie chart represents percentage of young adults willing to purchase food products containing food waste Exploratory study on waste derived ingredient through existing airflow in the miller (Mackaplow, 2010). Water activity values of the madeleine cakes fortified with CESP were found to be ranged between 0.70 and 0.80 (data not shown) and were not significantly different from each other (p > 0.05).…”