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Bottle. A glass or plastic container used to package solid or liquid drug products or dietary supplements. Bovine. Originating from cattle; used to describe gelatin made from cattle products. Brittleness. The extent to which a material will break with- out undergoing significant elastic or plastic deformation. Brittle materials are desirable in tabletting since brittle frac- ture is in the main independent of machine speed and pro- vides fresh surfaces for bonding after consolidation. Bulk density. The mass per unit volume of a material under specified conditions of pressure. C Calendar blister. A blister pack that shows the day and time that each dose is to be taken to help the patient comply with the physician's dosing instructions. The information can be on the blister pack or on the packag- ing surrounding it. Calibration. To standardize flow or batch measurement by correcting for deviation from a standard. Also to determine, by measuring or comparing with a standard, the correct value of each scale reading on a meter or other device or the correct value for each setting of a control knob. Cap. The upper part of a two-piece capsule. It is slightly larger in diameter and shorter than the body. Caplet. A tablet shaped like a capsule to ease swallowing. Capping. Fractures that occur between the tablet cup and the band due to poor particle adhesion, overcompression, and/or insufficient air release during compaction. Capsule filler. A machine that fills two-piece capsules with a pharmaceutical or dietary-supplement formula- tion. Also known as an encapsulation machine. Capsule filling. The process of filling a two-piece cap- sule with a pharmaceutical or dietary-supplement formu- lation. Also known as encapsulation. Carton. A sealed paperboard box that contains a blister pack and product information. Certification. A quality management process based on requirements mandated by international standards orga- nizations. Changeover. The process of changing production from one product to another. This often includes clearing the production area of supplies and components, changing size-specific machine parts, and cleaning the production area and equipment to eliminate cross-contamination. Child-resistant. Used to describe packaging that passes a test protocol required by the US Consumer Product Safety Commission to increase child safety. Clean-in-place (CIP). A method of cleansing all contam- inants from the interior surfaces of process equipment without disassembling it. Cleanroom. An enclosed space that is environmentally controlled with respect to the size and count of airborne particles, temperature, humidity, lighting, air pressure, airflow patterns, and air motion. Clinical trials. Investigations in humans to prove the safety and efficacy of new drug products in order to gain market approval. The investigation of a previously untested drug is usually divided into Phase I, II, III, and IV studies. Coacervation. The process of transforming a dissolved colloidal polymer into a solid precipitate. Coagulation. The process of converting a solution to a gel in conjunction with precipitation. Coalescence. The process of joining drops of an emul- sion to form a compact liquid phase. Coating. The process of applying a layer of material, film, or finish to a tablet, capsule, or substrate. Coating pan. A bulbous, conical, or cylindrical mixing vessel in which a material layer or film coating is applied to particles, granules, tablets, or capsules, usually involv- ing liquid and heat. Coating solution. Powders suspended in an aqueous or solvent solution; used as a carrier for film coating or wet granulation. Cohesion. A molecular attraction between like sub- stances or between molecules of the same substance. Colloids. The smallest particles in a liquid or solid phase. Compaction. The process of compressing and consoli- dating powders into a tablet, slug, or other form. Compliance. Adhering to a prescribed regimen by tak- ing medication correctly, or adhering to a regulatory mandate. Also known as adherence. Compression. The process of reducing the bulk volume of a material by applying an external force. Consolidation. The process of increasing the mechani- cal strength of a material due to particle-particle interac- tion, often as a result of an applied external force. Containment. The act of confining within a defined space a microbiological agent, potent or toxic API, or other entity that is being cultured, stored, manipulated, or transported to prevent or limit its contact with people and the environment. Continuous operation. A method or process that is repet- itive, operating over long periods without interruption, and in which materials are processed without segregation. Controlled release. A method of drug delivery by which API release is predominantly controlled by the design of the delivery system and mostly independent of external factors. Core. An uncoated tablet. Also the tablet around which a second tablet is formed in tablet-in-tablet composi- tions, known as compression coating. D De-agglomerate. The process of separating adhered gran- ules into individual granules or smaller groups of granules without reducing them to their constituent powders. Tablets & Capsules November 2017 47 g l o s s a r y o f t e r m s