APIs in Gummy Matrices: Revolutionizing Drug Delivery
The wellness industry is undergoing a “gummification” revolution, with gummy-based vitamins, medications, and even prescription products becoming a staple in major retailers. This shift toward chewable alternatives is gaining momentum, reshaping how active pharmaceutical ingredients (APIs) are delivered.
Eurofins’ Leadership in Alternative Dosage Forms
Eurofins, a global leader in laboratory testing, is at the forefront of evaluating novel drug delivery systems. With nearly a century of expertise in analytical testing, we have worked with an extensive range of sample matrices, refining methodologies and technologies to meet evolving industry demands. Throughout our tenure in the food and dietary supplement sector, we have continuously optimized our testing approaches—enabling us to effectively analyze even the most complex product types, including gummies.
These chewy alternatives are increasingly being used to deliver active pharmaceutical ingredients (APIs) as a replacement for traditional forms like pills and syrups.
Understanding APIs in Drug Delivery
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 effectiveness and stability, Eurofins employs rigorous testing protocols across the product lifecycle—spanning research and development, method validation, release testing, and stability studies—all aligned with Good Manufacturing Practices (GMP) and International Council for Harmonization (ICH) guidelines.
Challenges with APIs in Gummies
While gummies offer a convenient and consumer-friendly drug delivery format, ensuring consistent API performance comes with unique challenges:
- 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 in this matrix. Extracting the active ingredient into a solution for lab analysis demands specialized approaches.
Eurofins’ Innovative Solutions
Delivering active pharmaceutical ingredients (APIs) through gummy matrices presents unique formulation and testing hurdles. To ensure consistent API distribution, stability, and efficacy, Eurofins employs cutting-edge analytical techniques tailored to the complexities of alternative dosage forms.
- Dissolution Feasibility Studies – Establishing optimal dissolution testing parameters, including timing, agitation speeds, and media selection, ensures accurate assessment of API release within gummy matrices. This process allows manufacturers to predict how the drug will behave in real-world conditions and verify that it meets therapeutic expectations.
- Custom Method Development & Validation – Since standard pharmacopeial dissolution methods may not apply to gummies, Eurofins develops and validates specialized approaches to effectively extract and analyze APIs within these complex formulations. Ensuring method reproducibility and accuracy is critical to maintaining compliance with cGMP and ICH guidelines.
- Content Uniformity Testing – Gummy formulations can pose challenges in achieving precise API distribution. Eurofins performs advanced uniformity assessments to ensure each dose consistently meets label claims, reducing variability and optimizing product efficacy.
- Stability Studies – Environmental factors like temperature, humidity, and storage conditions impact gummy-based medications differently than traditional solid dosage forms. Eurofins conducts stability testing to assess degradation risks, ensuring products maintain their potency throughout their shelf life.
By combining scientific precision, regulatory expertise, and tailored methodologies, Eurofins ensures that innovative drug delivery formats like gummies meet the highest quality standards—giving manufacturers confidence in their product performance and market readiness.
What Clients Should Keep in Mind
When exploring alternative drug delivery formats, such as gummies, it’s essential to evaluate both testing feasibility and product performance to ensure efficacy and compliance:
- 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.
Eurofins continues to pioneer solutions in alternative dosage forms, ensuring that next-generation drug delivery meets the highest quality and efficacy standards
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