Ask an Expert: How Can Organizations Improve Manufacturing Efficiency and Reduce Variability of Pharmaceutical Formulations in Continuous Manufacturing Processes?

Today, classical pharmaceutical manufacturing consists of a series of batch-related processes, such as blending excipients and APIs, additional API processing (e.g., dry amorphization), tableting, coating, etc. Continuous manufacturing (CM) has the potential to drive productivity and improve safety and product quality in the pharmaceutical sector, but the successful shift from batch processes requires a robust foundation of knowledge.

 A quality-by-design (QbD) development program supported by an appropriate Process Analytical Technology (PAT) strategy is essential in understanding and controlling excipient impact on continuous manufacturing and drug product quality and performance.

 The selection of excipients is crucial, especially in the continuous manufacturing process. Reducing the number of excipients can help make the process more efficient and robust. Selecting multifunctional mesoporous excipients--like silica gels--as one of the blend components, can provide a more efficient way forward to successfully transfer classic batch processes into a working continuous process.

 In a continuous process, ingredients need to be fed at an appropriate rate and in the correct ratio. When there are many different ingredients, it can be challenging and costly to have feeders dedicated to each component. To reduce the number of feeders that must be aligned, multifunctional mesoporous excipients offer an effective solution, and reduce the number of variables and opportunities for variability in a process. Multifunctional excipients like mesoporous silica gel can play a role in many aspects or sub-processes of continuous production, including (Numbered steps reflected in above image):

1. Improving flowability and uniformity with less dusting during the excipient blending process
2. Avoiding tribo-electrostatic charging and improving API stability by moisture protection of API blend while blending
3. Improving solubility and bioavailability through additional API processing while keeping the extrusion-based process clean
4. Increasing tablet hardness and reducing friability while applying lower compression forces during the tableting process
5. Generating better physical stability with shorter drying times and reducing the tackiness in tablet film coating process

Multifunctional excipients are an essential part of a successful, robust formulation and process. Advanced mesoporous silica gel-based excipients-- with their versatility and enhanced multifunctionality--accelerate the development of continuous manufacturing.