Tablet hardness testing

Tablet Hardness Testing is a crucial process in the pharmaceutical industry to ensure the quality and functionality of tablet products. It is a measure of the tablet's mechanical integrity.

Overview

Tablet hardness testing, also known as tablet breaking force, measures the structural integrity of a tablet under conditions of storage, transportation, and handling before usage. The hardness of a tablet can influence several factors such as disintegration, dissolution, friability, and wear resistance.

Importance

The hardness of a tablet is an essential parameter during the formulation and production of tablets. It can affect the tablet's disintegration, dissolution rate, friability, and wear resistance. Too hard tablets may not disintegrate properly, affecting the release of the medicinal components, while too soft tablets may break apart or wear down during handling and transportation.

Testing Methods

There are several methods for testing tablet hardness, including the Monsanto Hardness Tester, the Strong-Cobb Hardness Tester, and the Pfizer Hardness Tester. These devices apply a force to the tablet and measure the force required to break the tablet. The hardness is usually reported in Kilopond (kp) or Newton (N).

Factors Influencing Tablet Hardness

Several factors can influence the hardness of a tablet, including the compression force, the granulation process, the type of excipients, and the manufacturing process. Understanding these factors is crucial for the formulation and production of effective tablet products.

Regulation

Tablet hardness testing is regulated by several organizations, including the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). These organizations provide guidelines for tablet hardness testing to ensure the quality and safety of tablet products.

See Also

• Tablet (pharmacy)
• Pharmaceutical formulation
• Pharmaceutical manufacturing