The mechanical strength of a drug, in particular of tablets and capsules, refers to the ability of the drug to withstand physical stress during manufacture, packaging, transportation and storage without taking on an unacceptable state. This quality parameter is crucial as it has a direct impact on the dosage, stability, bioavailability and ultimately the therapeutic efficacy of the drug.

Aspects of the mechanical strength of tablets (German translation: mechanische Festigkeit von Tabletten) include:

• Resistance to crushing (German: Bruchfestigkeit): The resistance-to-crushing test measures the force required to break a tablet by applying pressure. Tablets must be resistant to crushing in order to ensure that they remain intact when removed from the packaging and until swallowed.
• Friability (German translation: Abrieb or Friabilität): Evaluates the loss of mass of a tablet when it is subjected to mechanical forces, e.g. during transport. The surface of tablets can react more or less sensitively to mechanical stress or impact, which can cause the tablet to break or chip. Low friability means that the tablet retains its appearance and mass without significant loss.
• Disintegration (translation into German: Zerfallszeit): The disintegration test determines how long tablets or capsules take to mechanically disintegrate. The faster the dosage form disintegrates, the faster the active pharmaceutical ingredient is released. Manufacturing parameters such as the pressing force during tablet production or the excipients used can inhibit or promote disintegration.

The mechanical strength has a direct effect on the quality and efficacy of a drug. Tablets and capsules must be sufficiently resistant to crushing to withstand normal handling. At the same time, they must disintegrate at the right time in the gastrointestinal tract so that the active pharmaceutical ingredient can be properly released and absorbed into the body. Mechanical strength that is either too high or too low can lead to dosing problems, lower bioavailability of the active pharmaceutical ingredient, and consequently lower therapeutic efficacy of the drug. The development and manufacture of dosage forms with ideal mechanical strength is therefore a key challenge for the pharmaceutical industry.

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