Physical testing refers to the monitoring of physical characteristics of a drug product or drug components and can be categorized into microscopic and macroscopic physical characteristics. At the microscopic level, the particle size and morphology are measured by dynamic light scattering, which affect the absorption, dissolution, and content uniformity in the bulk. At the macroscopic level, drugs are typically manufactured in oral dosage forms such as tablets and capsules, or liquid forms such as oral liquid forms, topical/ointments, and injectables. Macroscopic physical testing examines the physical attributes of the drug form, such as dissolution, disintegration, powder flowability, liquid viscosity, tablet dimensions, friability, and tablet breaking force. Physical testing is performed on raw materials, intermediaries, and final product stages.
Physical Testing
Physical testing refers to the monitoring of physical characteristics of a drug product or drug components and can be categorized into microscopic and macroscopic physical characteristics. At the microscopic level, the particle size and morphology are measured by dynamic light scattering, which affect the absorption, dissolution, and content uniformity in the bulk. At the macroscopic level, drugs are typically manufactured in oral dosage forms such as tablets and capsules, or liquid forms such as oral liquid forms, topical/ointments, and injectables. Macroscopic physical testing examines the physical attributes of the drug form, such as dissolution, disintegration, powder flowability, liquid viscosity, tablet dimensions, friability, and tablet breaking force. Physical testing is performed on raw materials, intermediaries, and final product stages.
Particle size determination by Laser Diffraction and Dynamic Light Scattering has been an industry standard for the past decade. The pharmaceutical industry measures particle size to control product quality and efficacy.
Application
- USP <429> Laser Diffraction Measurement of Particle Size
- USP <788> Particulate Matter in Injections
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Dissolution, or drug release, measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.
Application
- USP <711> Dissolution
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Disintegration is the process of breaking down a solid dosage form into granules of a specified size, under a specified condition. When dosage forms are disintegrated, dissolution rate increases.
Application
- USP <701> Disintegration
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Various forms of solid dosage forms will be tested on tablet breaking force, friability, powder flow and melting point as required by Pharmacopeias.
Application
- USP <1217> Tablet Breaking Force
- USP <1216> Tablet Friability
- USP <1174> Powder Flow
- USP <741> Melting Range or Temperature
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The viscosity will affect the flow behavior of pharmaceutical products. It is relevant to the pumping, filling and finish and injectability, and is characterized for liquid or semi-solid drugs.
Application
- USP <911> Viscosity-Capillary Viscometer methods
- USP <912> Rotational Rheometer Methods
- USP <913> Rolling Ball Rheometer Methods
- USP <914> Pressure Driven Methods
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