4Ī limitation of lactose is the propensity of the material to react with primary and secondary amine drugs via a Maillard reaction to produce colored products. It is essentially non-hygroscopic and is therefore extremely robust in direct compression. Granulated lactose is a very good alternative to spray dried lactose because it contains no amorphous component. Increasing the relative humidity can cause an increase in the water content of amorphous lactose and with this, an increase in plasticity and compactibility. Spray dried lactose exhibits very good flow and compaction properties but is sensitive to the effect of relative humidity. In addition, two crystalline anhydrous α-lactose types are known, a stable and an unstable (hygroscopic) form. Most well known are α-lactose monohydrate and β-lactose. Crystalline lactose can exist in a number of distinct forms. Lactose in solid form can be either in a crystalline state or in an amorphous state. Pharmaceutical lactose is one of the most versatile excipients and is available in numerous physical forms. It is desirably good flowability, high compactibility, good recompactability for dry granulation, good blending properties without drug segregation as well as physical and chemical stability, including drug chemical compatibility. The quality and effectiveness of the medicine depends greatly on how the excipient performs. 1Īll medicines depend on excipients to stabilize and deliver their active ingredients. However, the success of the direct compression process is especially affected by material properties such as fluidity and compactability. This method provides advantages such as less number of processing steps, a simplified validation, removes heat and moisture from the process and improves the stability of the drug. The pharmaceutical industry has shifted toward direct compression to produce tablets. Excipient variability and feeding set-up are therefore two factors to be considered when optimizing feeding consistency.The tablet is the preferred pharmaceutical dosage form because of its advantages for the patient, a precise dosing, easy mass production and cost effectiveness. However, for a stretched feeder set-up with 11 mm double concave screws rotating at 514 rpm, variability in material properties introduces additional variation in the obtained feed factor. Results show that for an optimized feeder set-up with 22 mm double concave screws rotating at 342 rpm, the batch-to-batch variation was negligible compared to the natural feeding variability. For the first time, over 200 batches were evaluated regarding the impact of batch-to-batch variability upon feeding performance in volumetric mode. Spray dried lactose SuperTab 11SD was selected as a material, as it is one of the most widely used filler-binders for direct compression of tablets and can make up to 70% of the tablet content.

In this paper, it is investigated how and to what extent variability of lactose can impact the feeding performance in different feeder set-ups. The performance of feeders defines the content of components that are fed into the system and therefore the composition that ends up in the formulation. Feeding is the first unit of operation in a continuous manufacturing line and is critical for the final product quality. With the emergence of quality by design (QbD), it becomes imperative to gain understanding of the impact of batch-to-batch variability of raw materials on the performance of processes.

Lactose supertab 11sd