Dairy industry side-stream lactose as a surrogate for commercial products during major supply disruptions

Drug shortages are a current issue and often originate from problems in raw material supply. Even though they are more related to active ingredients the reason could be the lack of excipient(s) due to a major disruption to normal supply chains. Lactose is one of the most used excipients in oral solid dosage forms such as tablets. The aim of this study was to utilize lactose from a dairy side-stream in wet granulation and tableting and evaluate its behaviour in a formulation in comparison to a commercial reference. The possibility to use this type of lactose would be a sustainable option to ensure domestic availability during crises. The study design included different lactose proportions of fillers as well as liquid to solid ratios to investigate whether the resulting granules show similar responses when using side-stream or commercial lactose. The responses to changes were rather similar regardless of the lactose grade but liquid to solid ratio needed to be decreased (0.6 to 0.8. vs. 0.4 to 0.6) when using side-stream lactose. The formulations using side-stream lactose exhibited adequate flowability (3rd best classification in Ph.Eur) which was slightly inferior to that with commercial but tabletability was better due to its amorphous nature. However, disintegration (about 20 min vs. 2 min) and drug release (60-80 % vs. 100 %) were slower when using the side-stream lactose. This was most likely due to remaining milk proteinsin the lactose. Overall, the side-stream lactose provided promise for the use of such a side-stream material during supply disruptions.