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Friability. The degree to which particles become de tached from an agglomerate. Tablets are often subject to this type of test. G Gelatin. A translucent, colorless, nearly tasteless solid substance that is extracted from the collagen found in animals' connective issue. It is commonly used to make softgels and the shell of two-piece capsules. Gelcap. A gelatin-coated tablet that is tamper-evident and easy to swallow. Generally recognized as safe (GRAS). A designation given to a substance that is considered safe by the FDA to add to food and is thus exempted from the Federal Food, Drug, and Cosmetic Act food-additive tolerance requirements. Generic. A copy of a prescription or OTC drug product that does not have patent protection. Good manufacturing practice (GMP). Principles and procedures that specify that the design, operation, prac- tice, and sanitization involved in solid dosage manufac- turing comply with quality standards. Granulation. The process of adhering particles together to form granules. Granule. Particles of powder bonded together. Gravimetric feeding. The process of metering material according to mass, which is determined by a weighing device. Guidance. Final guidelines issued by the FDA that repre- sents its current thinking on an industry topic. The guidelines are developed in response to comments and questions the FDA received regarding the topic, usually after having issued a draft guidance. H Harmonization. A project that brings together the regu- latory authorities of Europe, Japan, and the USA and experts from the pharmaceutical industry in these regions to achieve greater agreement and uniformity in the inter- pretation and application of technical guidelines and requirements of pharmaceutical practices. Goals include the reduction or elimination of duplicate tests and certifi- cations during research, development, and manufacture. Hot melt extrusion (HME). The creation of a solid solu- tion in which the API is dissolved in thermoplastic excipients using a screw extruder. Hygroscopicity. A material's ability to absorb moisture from its surroundings. I Immediate release. A method of drug delivery in which the tablet or capsule dissolves in the gastrointestinal tract without delay, allowing fast uptake of the API. Induction sealing. A non-contact method of heating a foil liner or inner-seal to hermetically seal the top of filled and capped plastic or glass bottles. Also known as cap sealing. Inline or online analysis. Analysis of a sample conducted without interrupting a process that usually allows quick, real-time adjustments to be made to the process. Installation qualification (IQ). Validation documenta- tion that shows equipment has been installed properly. Intrinsic dissolution. Determination of a mass dissolved in a system with contact surface area. Usually expressed in terms of milligram per unit of time per cubic centimeter. Investigational new drug application (INDA). A request submitted to the FDA that must be approved before clin- ical trials of a new drug begin. It must contain a full description of the new drug, including the structural for- mula, animal-test results, and manufacturing information. In vitro-in vivo correlation. A predictive mathematical model describing the relationship between the biological and physicochemical properties of a dosage form. L Laminating. An imperfection caused by parts of a tablet sep- arating in the band area or where the cups meet the band. Leaker. A liquid-filled two-piece capsule or softgel that leaks its contents. Lidstock. Material used to seal blisters to prevent or minimize moisture and/or gas permeation. Locking ring. A mechanical fit of a capsule cap and body that secures filled two-piece capsules after closing. Loss-in-weight feeding. The process of gravimetrically metering material by measuring the weight loss from a hopper. Lot number. A number assigned to a production batch or segment that allows all of the product's components to be traced. Lubricant. A mold release agent blended into powders to prevent them from sticking to a tablet punch and dies. Magnesium stearate is the most common agent. M Marine. Originating from the sea; used to describe gelatin made from fish products. Micro-encapsulation. The process of enveloping one substance with another on an extremely small scale. The core substance can be a solid or a liquid, and the enrob- ing substance is a film-forming polymer. It is often used for controlled-release formulations. Micronization. The process of reducing the particle size of powders to the single to tens of micrometers. Milling. The process of de-agglomerating or reducing the particle size of powders manually or by machine. Moisture vapor transmission rate (MVTR). The amount of humidity that passes through packaging film or foil over a unit of time and under specific environmental conditions. Monograph. Published, official standards in a national pharmacopoeia that define the testing requirements and acceptance criteria of pharmaceutical and other sub- stances or preparations. Tablets & Capsules November 2017 49 g l o s s a r y o f t e r m s