Pharmaceutical manufacturing

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Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.

Unit Operations

Formulation and Pre-Formulation Development

Before a drug can be manufactured at any scale, much work goes into the actual formulation of the drug. Formulation development scientists must evaluate a compound for uniformity, stability and many other factors. After the evaluation phase, a solution must be developed to deliver the drug in its required form such as solid, semi-solid, immediate or controlled release, tablet, capsule, and many other variations.[1]

Milling

During the drug manufacturing process, milling is often required in order to reduce the average particle size in a drug powder. There are a number of reasons for this, including increasing homogeneity and dosage uniformity, increasing bioavailability, and increasing the solubility of the drug compound.[2]

Granulation

Granulation can be thought of as the opposite of milling; it is the process by which small particles are bound together to form larger particles, called granules. Granulation is used for several reasons. Granulation prevents the "demixing" of components in the mixture, by creating a granule which contains all of the components in their required proportions, improves flow characteristics of powders (because small particles do not flow well), and improves compaction properties for tablet formation.[3]

See also

References

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  3. Malcolm Summers, Michael Aulton. "Dosage Form Design and Manufacture."[dead link]


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