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Active Pharmaceutical Ingredients: Development, by Stanley Nusim

By Stanley Nusim

Concentrating on the 3 most important elements that effectively carry an API to market-process improvement, production, and governmental rules and approval-this reference serves as a step by step advisor to the making plans and transparent figuring out of the majority production of APIs. This advisor bargains present and well timed discussions of the method improvement cycle, layout engineering, the approval procedure, qc and coverage, and validation, in addition to plant production actions together with fabrics administration, upkeep, and defense.

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Extra info for Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (Drugs and the Pharmaceutical Sciences)

Sample text

Herein, however, the term bulk drug is used instead as descriptive of the physical and chemical character of the subject material, with its biological activity taken as obvious. Indeed, the conventional term for Process Development 17 Figure 4 The domains of chemical (bulk drug) and pharmaceutical (dosage form) processing, with the chemical processing domain defined by the shaded area of the diagram. the other ingredients added to formulate the dosage form is still inactive pharmaceutical ingredients.

9. Fits nicely with existing plant running a related process. The relative priorities of these factors vary widely, as they are seldom all present; neither are they fully independent from each other. For example, directness of synthesis may come at the price of a very expensive reactant, or would require that a very hazardous intermediate be made and perhaps isolated. Or perhaps the greenest route seems least feasible. Additionally, the selection may be constrained by compelling demands of the drug development program: for example, the most attractive route would take longer to be ready for preparative work and development; it has to defer to the lesser route that can prepare bulk drug now—not an uncommon juncture and decision, although it can be subsequently reversed.

The development stage, in which the preparative work is scaled up and the synthesis effort goes into 24 Rosas high gear, aimed at the manufacturing route and process. It is in this stage that the chemical engineering effort is applied in earnest, first to support the scaled-up preparative work and then to address the scale-up issues of the manufacturing route. Ideally, the chemical engineering contribution starts early, so as to appropriately influence the seminal choices being made by the process chemists as to route.

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