Formulation Challenges and Process Solutions for Multi-API Oral Dissolvable Films (ODFs)

Introduction
With the growing demand for multifunctional products in both the supplement and pharmaceutical markets, multi-API oral dissolvable films (ODFs) have become an industry hotspot. From vitamin-mineral combination films to drug-excipient synergistic release films, these products face significant challenges in formulation stability, dosage uniformity, and regulatory compliance. To successfully commercialize this dosage form, manufacturers need not only a scientifically designed formulation, but also high-standard equipment that meets both supplement and pharmaceutical-grade GMP requirements.

1. Three Key Formulation Challenges

1. API Compatibility
   Different active ingredients vary greatly in their physicochemical properties, which can lead to degradation, crystallization, discoloration, or other adverse reactions.
2. Differences in Dissolution and Release Rates
   Some ingredients dissolve quickly while others are slower, potentially affecting overall absorption performance.
3. Achieving Uniform Distribution
   Maintaining an even distribution of multiple ingredients in a film only 0.1–0.3 mm thick requires highly precise coating and stable drying processes.

2. Process Solutions

• Multi-formulation Coating Technology – Utilizing dual tanks or multi-channel coating heads to apply different formulations in separate zones, minimizing interference between APIs.
• Stepwise Drying with Temperature Gradients – Preventing ingredient migration or precipitation during drying to maintain content uniformity.
• In-line Quality Monitoring – Equipping the line with thickness measurement and vision inspection systems for full traceability and quality assurance.

3. HUANGHAI’s Equipment Advantages

The HUANGHAI multi-formulation coating system exceeds standard food-grade requirements and fully meets supplement and pharmaceutical-grade GMP standards:

• All materials, design, and cleanability meet pharmaceutical GMP specifications
• Suitable for direct use in drug registration, export filings, and “Blue Hat” supplement registration
• Integrates multi-formulation coating, gradient drying, and in-line inspection in a single solution — proven in both domestic and international pharmaceutical and nutraceutical facilities

Conclusion

Multi-API ODFs represent the synergy of advanced formulation and precision manufacturing. Choosing equipment that meets pharmaceutical-grade compliance not only ensures product quality but also gives companies a competitive edge in global markets.