Pharmaceutical Formulations and Engineering

Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally administered drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to make the distinction that a tablet contains a variety of other potentially inert substances apart from the drug itself, and studies have to be carried out to ensure that the encapsulated drug is compatible with these other substances in a way that does not cause harm, whether direct or indirect. Formulation studies also consider such factors as particle size, polymorphism, pH, and solubility, as all of these can influence bioavailability and hence the activity of a drug. 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. Statistics are critical to the Pharmaceutical industry, from clinical operations through manufacturing. However, clinical and manufacturing statistics represent entirely different worlds. Where they might be well staffed on the clinical side, some Pharmaceutical companies today aren’t hiring qualified staff to analyze operations data, resulting in misapplied tools, inadequate CAPAs and superficial root cause analysis, all of which lead to financial loss and noncompliance

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