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Tablets & Capsules November 2018 53 Telescope. A defect caused by a capsule body extending up and over the cap, which can result in leakage. Titration dosing. A method in which a dose of medication is adjusted for a patient, calculated by determining the level of the pharmacological response and changing the dose appropriately. Tooling. A set of punches and dies to be used in a tablet press. Transmission. The act of moisture and/or gas passing through a packaging film or foil. Trial size. A sample of a drug given to a patient by a physi- cian in a blister, strip pack, or small bottle. Also known as a physician sample. Tri-layer tablet. A tablet comprising three distinct layers. Tuck. A defect caused by a capsule cap folding under itself during closing. 21 CFR Part 11. Title 21, Code of Federal Regulations, Part 11. US regulations that establish criteria under which some electronic records and electronic signatures are considered by the FDA as equivalent to paper records and handwritten signatures. Twinning. The bonding of tablets with large, flat surfaces during the coating process. Two-piece capsule. A shell of fixed size made of gelatin or cellulose with or without the addition of colorants used to deliver pharmaceutical and dietary-supplement formulations. It comprises an upper part (the cap), which fits over a longer lower part (the body). The parts are separated for filling and then rejoined. U Unit-dose packaging. A blister pack that holds the required amount of drug products a patient takes for a single bout of treatment. Unit of use. A drug product packaged according to the amount required for treatment. V Validation. A documented program that provides a high degree of assurance that a specific process, method, or sys- tem will consistently yield a result that meets predetermined specifications and quality attributes. Viscosity. The measurement of a material's resistance to flow. Volumetric feeding. The process of metering material according to volume, which is determined by the size and speed of the dispensing device. W Wallet. A package that comprises a blister pack sealed into a fold-over card. Wash-in-place (WIP). A method of cleansing most contam- inants from the interior surfaces of process equipment with- out disassembling it. Wet granulation. The process of adhering particles to one another using water solutions or pastes comprising binders. The wet mass is broken up and then dried to form granules of the appropriate size. Organic solvents, such as ethanol, can be used if moisture-labile materials are used. Compiled and adapted by the editors with the help and kind permission of: Colin M. Minchom Cordack Brian E. Jones Brian Jones Associates Donald K. Lightfoot Consultant Edward Bauer Edward J. Bauer and Associates John A. McCarty McCarty Pharma Consultants Joy A. Joseph JQM Systems Mike Tousey Techceuticals Stephen W. Lee CapsCanada Vivian A. Gray V.A. Gray Consulting g l o s s a r y o f t e r m s