Issue link: http://www.e-digitaleditions.com/i/898603
50 November 2017 Tablets & Capsules Mouth-feel. A complex sensory impression obtained from the lips, teeth, tongue, and oral cavity when ingesting drugs or food. The sensory aspects are based on elasticity, taste, viscosity, and other properties of the drug or food. Multi-layer tabletting. The process of manufacturing tablets that comprise two or more distinct layers. N Neat API. An API that is not combined with excipients, usually used in clinical trial materials. New drug application (NDA). A request submitted to the FDA for approval after clinical trials have been com- pleted. It must contain data from chemistry, pharmacol- ogy, medical, biopharmaceutical, and statistical points of view. If the FDA grants approval, the product may be marketed in the USA. Non-compliance. Failure to take medication as pre- scribed, to follow a prescribed course of therapy, or to adhere to a regulatory mandate. O Occupational exposure limit (OEL). The upper level of the acceptable concentration of a hazardous substance in workplace air for a particular material or class of materi- als. The levels are usually set by national authorities and enforced by legislation. Offline analysis. Analysis of a material sample removed from a process and taken to the analyzer. Results determine what adjustments, if any, should be made to the process. Operational qualification (OQ). Validation documenta- tion that shows equipment functions according to speci- fications in the selected environment. Orally disintegrating tablet (ODT). A drug delivery sys- tem that dissolves in seconds when placed on the tongue. The system can be taken without water and improves compliance when patients have difficulty swallowing. Orange peel. An imperfection in the coating of a tablet so named because of its resemblance to the fruit, usually caused by using too much atomizing air. Original pack dispensing (OPD). The act of giving phar- maceutical products to patients without any change to their trade dress. Overcompression. The act of applying excessive com- paction force to a tablet, often resulting in defects. Overencapsulation. The process of placing a tablet or capsule within a capsule. An opaque capsule is often used to conceal an investigational drug during clinical trials so that neither the investigators nor subjects can identify the medication from the placebo or comparator they are administering or ingesting. Overload. A device on a tablet press that protects the tooling from too much pressure. Over-the-counter drug (OTC). A drug product that is safe and effective for use without a prescription. Oxygen transmission rate (OTR). The amount of oxy- gen that passes through packaging film or foil over a unit of time and under specific environmental conditions. P Particle analysis. The process of examining a particle or group of particles to determine their size, shape, or other characteristics. It is usually conducted on a sample rather than the whole bulk of material. Particle engineering. The process of changing the morphol- ogy and/or other physico-chemical properties of a powder, such as by spray drying, hot melt extrusion, or the creation of micro- or nano-particles, usually for the purposes of improv- ing solution rate or solubility for better bioavailability. Particle size distribution. The relative amount of parti- cles present according to spherical diameter, mass, or other unit of measure. Peeling. An imperfection in which a film coating flakes off the tablet core, often because of poor surface tension. Performance qualification (PQ). Validation documenta- tion that shows equipment consistently produces prod- ucts that meet pre-determined specifications and have suitable quality attributes. Permeability. The degree to which film or foil allows dissolved substances to pass through; used to describe moisture or oxygen transmission. Phase I. Clinical trial studies in which a new drug prod- uct or treatment is administered to a small group of patients or healthy volunteers to evaluate its safety, deter- mine a safe dosage range, and identify any side effects. Phase II. Clinical trial studies in which a new drug product or treatment is administered to a larger group of patients with the disease or condition for which treatment is sought to gauge its effectiveness and to further evaluate its safety. Phase III. Clinical trial studies in which a new drug product or treatment is administered to larger groups of patients to confirm its effectiveness, monitor its side effects, compare it to commonly used treatments, and collect information showing that the new drug product or treatment can be used safely. When this phase is complete, a request for mar- keting approval can be submitted to the FDA. Phase IV. Human studies performed after the drug prod- uct or treatment has been marketed. These studies can be used to gather more information on the drug's effect on various populations, to detect any side effects associated with its long-term use, or to identify additional uses. Physical-chemical identifiers (PCIDs). Inactive ingredients that are added to solid dosage forms and/or packaging and that can be detected and authenticated to deter counterfeit- ing. Ingredients include inks, molecular taggants, pigments, and flavors. Picking. An imperfection caused by powders sticking to a punch surface during tabletting, often resulting in voids where letters and numbers with islands (enclosed areas)— such as A, O, P, 6, and 8—used to be.