Why Dissolution Curves Are the Lifeline of Drug Registration

For modern oral dosage forms—such as oral films (ODFs), sustained-release tablets, and controlled-release pellets—dissolution behavior is a key indicator of therapeutic effectiveness. A well-documented dissolution profile is not just a quality metric; it's a mandatory requirement for product registration. Inadequate or non-compliant dissolution testing can significantly delay or derail your approval process.

Common Pitfalls in Dissolution Testing

• Confusing "stirring" with true dissolution, resulting in invalid data.
• Using equipment lacking proper temperature control or automated sampling capabilities.
• Sampling frequency that fails to match the drug’s pharmacokinetic timeline.
• Software incapable of producing clear dissolution curves or exporting analyzable data.

What Do Pharmacopeias and Regulatory Authorities Require?

• Sampling points must fully reflect the drug’s therapeutic window.
• Consistent temperature control, uniform dissolution media, and accurate agitation speed are non-negotiable.
• Full graph generation, data logging, and export functions are expected.
• Automation and low-interference sampling are preferred to improve reproducibility.

HUANGHAI’s Dissolution Testers: Designed for Compliance

• Available in 6, 8, and 12-vessel configurations, aligned with major pharmacopoeias (USP, EP, ChP).
• Dual-channel temperature control systems with ±0.3°C accuracy.
• Integrated analysis software automatically generates time–concentration curves.
• Supports custom pharmacopoeial parameters and automatic pass/fail analysis.
• Ideal for use alongside our ODF film manufacturing systems, enabling full traceability from coating to QC.

🔗 Learn more: Dissolution Testing Instruments

Conclusion

In global drug registration, compliance isn't optional—it's essential. High-quality dissolution data offers regulatory confidence and market access. Choosing the right dissolution tester isn't just a QA decision; it's a strategic investment toward international success.