ResourceSeparations
Analytical Techniques with a Place in the Oral Solid Dosage Formulation Toolkit
27 Mar 2015In this white paper we look at the steps involved in moving from a drug substance to a successful oral solid dosage form, and at the analytical technologies that can be helpful. In particular, we focus on gathering the required information to progress pharmaceutical development within the context of the regulatory requirements and the application of quality by design.
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Size Exclusion ChromatographySize exclusion chromatography (SEC) is a liquid chromatographic technique used to separate and identify molecules based on their size, including polymers, proteins, nanoparticles & nucleic acid. SEC is further subdivided into gel filtration chromatography (GFC) and gel permeation chromatography (GPC) when an aqueous or organic mobile phase is used respectively. HPLC-based SEC systems and columns are available for analytical separation alongside SEC spin columns or filters to prep samples for many protocols. Find the best size exclusion chromatography equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.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. 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.FormulationFormulation is the process of combining active pharmaceutical ingredients with excipients to produce a drug which is both stable and active.