Pharmaceutical Technology - October 2021


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24 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Excipients A new era for supply chain management Supply chains for established processes nec- essarily evolve over time, as the marketplace changes. Legacy processes are often running with materials that have changed incrementally over the years, and efficiency losses due to sub-op- timal processing performance may be largely hidden. For example, the full impact of a slow downward drift in tableting speed only becomes evident when production figures are compared with those of a decade ago. For off-patent drugs and for those manufacturing generic drugs or over-the-counter (OTC) products, the economic impact of deteriorating ef f iciency is particu- larly difficult to sustain, and financial pressures have long been an important stimulus to switch- ing supplies. However, the pandemic has brought new moti- vation to supply chain management. For example, regional variations in disease levels and manu- facturing output, as well as the need to increase manufacture in line with demand on a regional basis, may now be an important trigger for re- valuation of supply chains. More broadly, recent events look likely to accelerate pre-existing trends towards national self-sufficiency in critical thera- peutic areas, and an associated reshaping of the supply network. Finally, many manufacturers are facing the task of rapidly deploying existing plants to make alternative ingredients or drugs for which demand has soared. For powder pro- cesses, such efforts are reliant on being able to match raw materials and ingredients with pro- cessing equipment that is suitable for them, and on identifying the physical properties that define process performance in a given unit and accept- able ranges for them. Same specification, different powder Successfully switching suppliers relies on being able to identif y materials that will perform as well, if not better than a current ingredient or feedstock. This identification is the purpose of a specification. A robust specification defines acceptable ra nges for a l l t he proper ties t hat inf luence performance, thereby safeguarding consistent behavior. Using existing plants to manufacture an alternative product is similarly dependent on establishing specifications for ma- terials that are well-matched to specific pieces of equipment. Developing a robust specification for powders is more difficult than for other materials. Along- side compositional data, notably impurity levels, a powder specification typically includes just a few physical properties. Particle size information is common, as are bulk density values, which often relate to packaging and the quantity of material delivered, and sometimes a simple f lowability metric is also included; but there tends to be lit- tle else. This lack of information is problematic because these data alone are often insufficient to securely differentiate a powder with acceptable performance, notably with the f lowability, com- pressibility, or permeability required for efficient processing or use. It is not uncommon for a pow- der to meet a defined specification and then go on to perform poorly, for example, to exhibit erratic f low through the process or to fail to compress to form a stable tablet because the specification fails to capture a critical aspect of behavior. How powder testing can help Robust specifications for powders must include both particle and bulk powder properties. Though

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