Aug 01, 2004

absorption The process of a drug's movement from the administration site into systemic circulation.

accelerated stability tests Studies in which the product is stored under stress conditions (usually 45°C and high humidity) over three to six months and observed for signs of degradation; used to predict long-term storage patterns.

acute During lyophilization, this describes the processing stage that includes both freezing and drying by pressure, but before the temperature is raised. In medicine, it describes a disorder that is usually severe and of short duration (viral fever, bacterial food poisoning), as opposed to a long-term, chronic disease, such as diabetes.

adsorption Adherence of molecules in solution or suspension to cells or other molecules — or to the walls of a vial or drug delivery device.

aggregate A clustered mass.

amorphous Having no apparent shape or order; noncrystalline.

aqueous solution A solution that resembles or is made with water.

bioavailability Extent to which (sometimes the rate at which) the active drug ingredient enters systemic circulation, thereby gaining access to its site of action.

bolus A rounded mass; oral medication formed into a large soft pill; a concentrated mass of injected medication.

buffer (buffering agent) A substance or mixture of substances (such as bicarbonates and some proteins in biological fluids) that in solution tend to stabilize the hydrogen-ion concentration by neutralizing within limits both the acids and the bases, making the solution resistant to pH changes.

bulk active ingredient Any substance or mixture of substances used in the manufacture of a therapeutic that furnishes the pharmacological activity of the drug product.

bulking agent An additive that increases the volume of a solution.

cake The freeze-dried solid portion of a formulation that remains after as much water as possible has been removed.

calorimetry Analytical measurement of quantities of heat.

campaigned production A cost-effective, multistep production method for producing more than one product with the same equipment and in the same facilities; continuous production of successive batches.

characterization Precisely deciphering and describing a molecular entity's physical, chemical, and biological properties, as appropriate.

charge The electrical state of an atom or molecule (positive, negative, or neutral) according to the ratio of protons (positively charged) to electrons (negatively charged).

chelator A molecule used to bind a metal ion with more than one organic group to form a highly stable, ring-like formation.

chromatography Techniques used to separate molecules based on their relative affinity for various liquid or gas mediums.

circular dichroism (CD) The absorption of left and right circularly polarized light; a property of molecules that are optically active. CD spectroscopy is a form of light-absorption spectroscopy that measures the difference in CD by a substance. The spectra can be analyzed to learn the different structural types in a protein: alpha helix, parallel and antiparallel beta sheet, turn, and so on.

coacervation The process of forming a coacervate (a mass of small particles bound together by electrostatic attraction) by the partial mixing of two or more liquids.

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