Issue link: https://www.e-digitaleditions.com/i/751389
Tablet cup. The distance from the tablet band to the highest point, or apex, of the tablet. Tablet design. The criteria used by tool designers to cre- ate a new tablet. Tablet dry coating. The process of compressing a tablet around a tablet or a tablet around a tablet around another tablet, which forms three layers. It is usually used when a tablet reacts to heat or moisture during film coating. Also known as tablet-in-tablet or compression coating. Tablet face. The tablet surface formed by the punch tip. Tablet identification. A logo, code, or character contour applied to a tablet surface by means of debossing or embossing on tablet tooling; used to distinguish one product from another. Tablet press. A machine that compacts a mixture of pow- ders or granules into a single tablet by applying pressure. The process is carried out in a die between two punches. Tablet thickness. The combined height of the two tablet cups and the tablet band. Tabletting. A punch-and-die procedure that compacts powdered or granular solids. Tamper-evident. Used to describe packaging that has one or more safety features that indicate when it has been altered from the original condition as supplied by the manufacturer or packager. 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 medica- tion 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 physician 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 formu- lations. It comprises an upper part (the cap), which fits over a longer lower part (the body). The parts are sepa- rated 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 system will consistently yield a result that meets pre- determined 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 cont- aminants from the interior surfaces of process equipment without 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 Shire Pharmaceuticals Brian E. Jones Brian Jones Associates Penarth, UK E-mail: bjcapsules@ntlworld.com 52 November 2016 Tablets & Capsules