Why Dissolution Testing Matters for Supplement Brands
At SREKE, we understand that dissolution testing is a critical quality control step in the manufacturing of tablets and capsules. This process evaluates how quickly a solid dosage form releases its active ingredients under simulated physiological conditions. For supplement brand owners, consistent dissolution ensures product efficacy, regulatory compliance, and consumer trust.
According to USP <711> (United States Pharmacopeia), dissolution testing helps verify batch-to-batch consistency and supports bioavailability claims. We follow strict GMP guidelines to ensure every capsule or tablet meets international standards before release.
Key Manufacturing Considerations at SREKE
- Formulation Stability: Our R&D team optimizes excipients and binding agents to achieve target dissolution profiles without compromising shelf life.
- Equipment Calibration: We use calibrated dissolution apparatus (Apparatus 1 & 2) compliant with ISO/IEC 17025 standards.
- Sampling Protocols: Samples are collected at predefined time points (e.g., 15, 30, 45, 60 minutes) using automated systems to reduce human error.
- Data Documentation: All results are recorded in electronic batch records aligned with FDA 21 CFR Part 11 requirements.
How SREKE Helps You Get to Market Faster
We streamline the development and production cycle by integrating dissolution testing into our early-stage formulation phase. This proactive approach reduces rework and accelerates approval timelines. Our typical lead time from prototype to commercial-scale production is 8–12 weeks, depending on complexity and packaging needs.
With MOQs as low as 50,000 units for softgels and tablets, we support both startups and established brands. Our packaging solutions include child-resistant bottles, blister packs, and custom labeling compliant with EFSA and FDA requirements.
Industry Trends and Market Opportunities
Consumers increasingly demand transparency in supplement performance. Brands that provide third-party verification of dissolution rates gain a competitive edge. At SREKE, we offer optional CoA (Certificate of Analysis) packages including HPLC dissolution data—ideal for private-label products targeting premium markets.
Sustainable formulations are also rising in popularity. We assist clients in developing plant-based binders and water-soluble coatings that maintain dissolution efficiency while aligning with clean-label trends.
Frequently Asked Questions
What is the difference between disintegration and dissolution testing?
Disintegration measures how long it takes a tablet to break apart physically, while dissolution quantifies the rate at which the active ingredient dissolves into solution. Both tests are important, but dissolution is more predictive of absorption in the body.
Do you perform dissolution testing for all tablet types?
Yes, we conduct dissolution testing for immediate-release, extended-release, chewable, and sublingual formulations. Custom protocols can be developed based on your target market’s regulatory expectations.
Can you help with regulatory submissions involving dissolution data?
Absolutely. We provide full documentation packages suitable for DSHEA, EU Novel Food, or Health Canada submissions. Our team collaborates with legal consultants to ensure your materials meet jurisdiction-specific criteria.
Is dissolution testing included in your standard quality control?
Dissolution testing is part of our comprehensive QC suite. It’s automatically triggered during batch release when specified in your product dossier or requested as an add-on service.
Ready to launch your supplement brand? SREKE provides GMP-certified OEM/ODM manufacturing for softgels, capsules, tablets, powders, gummies, and liquids. Contact us for a free quote or email [email protected] — we respond within 24 hours.