Tablets & Capsules


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46 November 2017 Tablets & Capsules A Abbreviated new drug application (ANDA). A request submitted to the FDA for approval of a generic drug product. It is usually not required to include preclinical and clinical data to establish safety and effectiveness. Instead, a generic drug applicant must scientifically demonstrate that its product is bioequivalent. Active pharmaceutical ingredient (API). A substance or mixture of substances used in the manufacture of a drug product that provides the pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or affects the struc- ture or function of the body. Adhesion. A molecular attraction between different materials, such as a metal surface and powder. Agglomerate. Noun. The product of size enlargement, such as a granule. A group of particles held together at their points of contact by solid bridges. Verb. The process of forming fine particles into permanent larger shapes in which individual particles can still be distinguished. Aggregate. A group of particles held together by weak electrostatic and Van der Waals forces. Agitation. A type of particle size enlargement without the use of pressure, either by tumbling, coalescence, or particle growth. Air vents. Channels located at the cut-edge of a capsule body that allow air to escape during capsule closing. Assay. A laboratory test that identifies or measures the amount of a substance in a sample and helps determine its characteristics, such as potency and/or purity. Atomization. The process of creating a fine, controlled mist by passing air and a solution through a nozzle; used for film coating, wet granulation, and spray drying. Attrition. The process of tumbling an agglomerate to determine its resistance to surface abrasion. B Balcony-style design. A cantilever configuration of machines, such as blister packaging equipment, that facil- itates access for changeover, cleaning, and maintenance. Band. The area between opposing tablet cup profiles that is formed by the wall of a tablet die; also a liquid seal that is applied around the joint of filled two-piece capsules. Banding. The process of applying a band around the joint of two-piece capsules filled with powders or liquids to provide tamper evidence and to prevent leakage. Bar code. A way of labeling a product with a description and batch information using a series of lines of varying thicknesses that is read by a scanner. It comes in multi- ple formats, including 2-D matrix codes. Barrier. Used to describe packaging material properties that prevent moisture and/or oxygen from coming into contact with products. Batch operation. A method by which one lot of a for- mulation is processed at a time, in contrast to continuous operation. Bi-layer tablet. A tablet comprising two distinct layers. Binder. An excipient used to increase powder cohesive- ness, which increases the bonding strength of the final product. In wet granulation, they help form agglomerates. Bioavailability. A measure of the uptake of an API by the body, including the rate at which and extent to which it is absorbed or is available at the treatment site. Bioequivalence. The absence of a significant difference in the rate and extent to which an API becomes available at the site of action when two different drug products are administered at the same dose under similar conditions. The basis by which generic drug products are approved by comparing them to the brand-name product. Biopharmaceutics Classification System (BCS). A four- quadrant system of classifying the solubility and absorp- tion rate characteristics of a drug substance. Bisect/score. A groove or debossed line in the tablet sur- face that controls stress fracturing. It also allows the tablet to be split into pieces for partial dosages. Blister. A cavity formed in film or foil by heat and/or mechanical means. Blister pack. A package that comprises one or more blis- ters filled with tablets or capsules and sealed with film or foil lidstock. Body. The lower part of a two-piece capsule. It is slightly smaller in diameter and longer than the cap. Body fold. An imperfection in the capsule body caused by depositing material on it during filling. Bonding. The force of cohesion between particles. glossary of formulation, production, and packaging terms

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