Gummy Drug Delivery Systems Show Promise for Patient Compliance, Face Manufacturing Challenges

Key Insights

• Gummies have emerged as the second-best selling delivery format in the vitamins and supplements market, showing potential for pharmaceutical applications to improve patient compliance.
• Manufacturing gummy-based pharmaceuticals faces significant technical challenges, including API stabilization, taste masking, and the need for precise temperature control during production.
• While no FDA-approved gummy-based drugs exist yet, the regulatory environment shows potential openness, with Seattle Gummy Company achieving the first IND approval for an allergy medication in 2020.

At the ongoing CPHI Europe conference in Milan, industry experts highlighted the growing potential of gummy formulations as an innovative drug delivery system, particularly for patients who struggle with traditional dosage forms. Mitchell Slade, President at PLD Gummy Co, revealed that gummies have secured the second position in the vitamins, minerals, and supplements (VMS) market, suggesting promising applications in the pharmaceutical sector.

Technical Challenges in Gummy Drug Development

The development of pharmaceutical gummies faces several critical manufacturing hurdles. Primary challenges include:

• API stabilization in complex liquid matrices
• Effective taste masking while maintaining regulatory compliance
• Temperature control to prevent skin formation
• Achieving uniform drug distribution through three-way mixing processes
• Maintaining consistent texture and stability

Evolution in Manufacturing Processes

The industry is witnessing a significant shift from gelatin to pectin-based formulations. This transition requires careful attention to pH and viscosity control to ensure product consistency across batches. Slade emphasized that incorrect handling of pectin can result in unfavorable jelly-like consistencies that compromise stability.

Quality Control and Scale-up Considerations

Manufacturers are adopting strategic approaches to ensure product quality:

• Implementation of starchless processes to minimize cross-contamination
• Small batch testing before scaling to commercial production
• Conservative selection of flavors and colors to maintain pharmaceutical appearance
• Precise coating procedures to balance taste masking with regulatory requirements

Regulatory Landscape and Future Prospects

While the pharmaceutical gummy sector remains largely unexplored from a regulatory standpoint, early indicators suggest potential acceptance. Seattle Gummy Company's achievement of the first Investigational New Drug (IND) approval for their allergy medication (IND 140312) in October 2020 marks a significant milestone. The FDA's current stance, characterized by non-intervention with existing gummy drug products, may indicate a gradually accepting regulatory environment.

The development of gummy-based pharmaceuticals represents a potential breakthrough in patient compliance, particularly beneficial for populations who struggle with conventional dosage forms. However, successful commercialization will require overcoming significant technical challenges while maintaining strict pharmaceutical quality standards.