APIs in Gummy Matrices: Revolutionizing Drug Delivery
The world of wellness is experiencing a “gummification” wave. Step into any major retailer, and you’ll see gummy-based vitamins, medications, and even prescription products lining the shelves. This trend shows no signs of slowing down in the coming years.
Eurofins’ Leadership in Alternative Dosage Forms
Eurofins, a global leader in laboratory testing, is at the forefront of evaluating innovative drug delivery systems like gummies. These chewy alternatives are increasingly being used to deliver active pharmaceutical ingredients (APIs) as a replacement for traditional forms like pills and syrups.
What Are APIs?
Active Pharmaceutical Ingredients (APIs) are the essential components in medications, whether over the counter or prescription. For instance, acetaminophen is the API in Tylenol. Traditionally, APIs have been administered through tablets, capsules, IV solutions, and syrups.
To ensure the effectiveness of alternative forms like gummies, chews, drink mixes, and lozenges, Eurofins conducts rigorous testing. Their expertise spans the entire product lifecycle, including research and development, method validation, release testing, and stability studies—all performed in accordance with Good Manufacturing Practices (GMP) and International Council for Harmonization (ICH) guidelines.
Challenges with APIs in Gummies
- Content Uniformity: Achieving consistent API distribution in gummies is more challenging compared to tablets or capsules.
- API Effectiveness: Testing the efficacy of APIs in gummy format often requires dissolution tests, which can be complicated by the gummy’s matrix. Extracting the active ingredient into a solution for lab analysis demands specialized approaches.
Eurofins’ Innovative Solutions
Eurofins tackles these challenges head-on through:
- Dissolution Feasibility Studies: These studies determine the optimal parameters for dissolution testing, such as timing, agitation speeds, and media. By identifying the most accurate conditions, Eurofins ensures reliable results.
What Clients Should Keep in Mind
- If no standard method exists for testing an alternative format, such as gummies, custom methods may need to be developed—requiring time and in-depth research.
- Consider the suitability of a gummy matrix for delivering the desired medication. Not all formats are equally effective at ensuring API absorption in the body. Clients must evaluate whether the chosen format aligns with their product’s purpose.
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