Tablet hardness testing ensures that tablets meet quality standards by balancing their mechanical strength with dissolution properties. This critical step prevents fragile tablets from breaking and overly hard tablets from compromising drug effectiveness.
What is Tablet Hardness Testing?
Tablet hardness testing measures the force needed to break a tablet. It ensures tablets are durable during production and transport while dissolving properly in the body to release active ingredients.
Why is Hardness Testing Important?
1. Prevents Breakage: Ensures tablets survive packaging and shipping.
2. Controls Drug Release: Influences how quickly the medication dissolves.
3. Ensures Compliance: Meets regulatory standards like USP <1217>.
Role of the Tablet Press Machine
The tablet press machine is key to controlling hardness. Adjusting compression force helps achieve the desired strength while maintaining other parameters like thickness.
Consequences of Neglecting Hardness Testing
1. Cracked or broken tablets during handling.
2. Delayed or inconsistent drug dissolution.
3. Regulatory non-compliance, leading to recalls.
Leading Manufacturers of Tablet Hardness Testers
Here are some reputable manufacturers offering a range of tablet hardness testers:
1. ERWEKA
Offers a variety of tablet hardness testers, from manual to fully automated systems, compliant with USP standards.
2. SOTAX
Provides precision Dr. Schleuniger® measuring technology for testing up to five physical parameters of tablets and capsules.
3. Teledyne
Offers both manual and automated tablet hardness testers designed to determine the mechanical properties of drug products.
4. Copley Scientific
Provides portable and simple-to-use tablet hardness testers ideal for quick checks of compression force in production areas.
5. Qualitest
Offers digital shore durometer hardness testers with manual and support-assisted operation for precise hardness testing.
Tablet hardness testing is a cornerstone of pharmaceutical quality control. Paired with optimized tablet press settings, it ensures high-quality, durable tablets that meet both consumer and regulatory expectations.