Pharmaceutical Manufacturing: The Challenge of Setting Effective Product Specifications
3 Mar 2014Setting meaningful and realistic specifications is an essential element of Quality by Design (QbD). Well-defined specifications control product performance since they derive from correlations between clinical behaviour and the variables measured routinely during processing and for QC. This paper examines the process of setting specifications, taking as an example particle size, a critically important parameter for many pharmaceutical formulations.
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Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Particle CharacterizationParticle characterization instruments are used to determine particle size distribution, shape, surface area, zeta potential, density and porosity of particles and materials. Multiple tecchniques are available for determining particle size, shape and count including dynamic light scattering (DLS), laser diffraction, electrozone (Coulter technique), imaging particle analysis and single particle optical sensing. Determine the density of your material with a gas pycnometer or examine its surface area and porosity with gas adsorption analyzers and mercury porosimeters. Find the best particle characterization instruments in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Drug DosageDosage is the size or frequency of the administration of a drug. Determination of the dosage of a drug is critical in pharmaceutical development to ensure the optimum balance between efficacy and toxicity.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.