Pharmaceutical manufacturing

The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.

While a laboratory may use dry ice as a cooling agent for reaction selectivity, this process gets complicated on an industrial scale.

Finally, lower temperatures can result in crusting of reagents, intermediates, and byproducts to the reaction vessel over time, which will impact the purity of the product.

In an even wider scope, the location of the chemical plant can play a role in the ambient temperature of the reaction vessel.

The range of materials that may be blended (excipients, API), presents a number of variables which must be addressed to achieve target product quality attributes.

[9][10] Hot melt extrusion is utilized in pharmaceutical solid oral dose processing to enable delivery of drugs with poor solubility and bioavailability.

Hot melt extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier increasing dissolution rates and bioavailability.

A Site Master File is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations.