Tablets & Capsules

2017 Annual Buyers Guide

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dependent and is usually preceded by elastic deforma- tion. Highly plastic materials in tabletting may demon- strate tablet properties dependent on machine speed. Porcine. Originating from pigs; used to describe gelatin made from pig products. Pouch. A flexible package for medications. Pre-lock. Small indentations around the perimeter of a cap- sule cap that keep empty two-piece capsules in a semi- closed position until the capsule filler separates the capsules. Prescription drug. A drug that requires a written order by a medical physician or veterinarian to a pharmacist before dispensation or sale. Process analytical technology (PAT). A system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and per- formance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. Punch cup. The depression, or concavity, of the punch tip. It forms the tablet face. Punch tip edge. The cup-edge that adds to the overall length of a punch. The weakest area of the punch tip to sustain the force of compression. Punch-to-die clearance. The gap between the punch and die. It is determined by subtracting the diameter of the punch tip from the minimum internal diameter of the die cavity. Q Quality assurance (QA). Procedures established to ensure a clinical trial or manufacturing process is properly documented and meets standards and regulatory require- ments. Quality control (QC). Regulatory inspection and analy- sis to check performance, compare it with standards, and adjust the process to ensure that specifications are met. R Radio frequency identification (RFID). A technology that uses tags to emit data as radio signals and transmit them to a reader. It is an alternative to bar coding and does not require direct contact or line-of-sight scanning. Relieved area. A purposely weakened area of a package that makes it easy to open. Roller compaction. The process of densifying dry powders by compressing them between rolls, usually used to achieve more uniform distribution of a formulation's ingredients. Roller compactor. A device that compresses dry powders. S Sample. A representative portion of a bulk material. Scale-up. The process of converting a small-volume process to large-volume production. Screening. The process of reducing agglomerates, sorting particles by size, and removing oversized particles and con- taminants using a woven metal screen or perforated plate. Senior-friendly. Used to describe packaging that is easy for elderly patients to read, handle, and open. It is a mea- sured part of the Consumer Product Safety Commission's child-resistant protocol. Shingle. An effect caused by tablets stacking or backing up on the die table during ejection instead of them push- ing each other off the tablet press. Sieving. Used for particle size and size-distribution analysis, the method uses one or more shallow, round pans that have mesh openings or perforations of a known size at their base. The pans are stacked so that the smallest openings are at the bottom. A weighed sample is fed into the top sieve, vibrated or tapped, and then the material remaining on each sieve is weighed to determine the particle size distribution. Slug. A large compact made in a specialized tablet press for the purpose of dry granulation. Softgel. A one-piece capsule made from gelatin or suit- able polymer, such as modified starch, usually filled with liquid formulations. Softgel encapsulation. The process of forming and fill- ing softgels with pharmaceutical or dietary-supplement formulations. Solid dosage form. A non-liquid dose that includes tablets and capsules, including liquid-filled capsules. Split. A defect caused by a misjoined capsule cap and body, which usually results in leakage. Spray drying. The process of forming fine, granular solids or bead-like agglomerates by spraying a liquid or semi-liquid suspension or slurry into the top of a tall chamber in the presence of drying gases to evaporate the moisture. Stability testing. A technique for determining how drug products degrade when stored at different humidities and temperatures. Sticking. The adhesion of powders to a punch surface during tabletting. Strip pack. An inexpensive package for individual solid dosage forms. Surface abrasion. The loss of powder particles from a tablet surface due to attrition during transfer and han- dling after compression. Surfactant. A substance that decreases the surface tension of a liquid. When used above the critical micelle concen- tration, it can increase drug solubility. Sustained release. A method of drug delivery by which API release occurs over an extended period after adminis- tration. The method reduces the dosing frequency com- pared to a traditional method, such as immediate release. T Tablet. A compacted, molded formulation in its final dosage form. Tablet breaking force. The pressure that causes a fracture when applied to a specific plane of a tablet. g l o s s a r y o f t e r m s Tablets & Capsules November 2016 51

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