From Formulation to Commercial Scale: Co-Developing Successful ODF Projects

For oral dissolvable films (ODFs) and transdermal patches, advanced equipment alone does not guarantee project success. Stable formulations, a clear scale-up path and validation packages aligned with regulatory expectations are equally important.

HUANGHAI promotes a “formulation + process + equipment” co-development model that supports customers from laboratory trials through to commercial production. Instead of separating formulation work from equipment design, we integrate them into one development journey. An overview of this philosophy can be seen in our Pharma ODF Solutions .

Why Co-Development Matters

Traditional project paths often look like this: the customer develops a formulation on lab tools, then later purchases a coating line and dryer, and tries to “fit” the recipe onto commercial equipment. This approach can work for simple films, but it becomes fragile when APIs are heat-sensitive, dose is high, or multiple functional layers are involved.

HUANGHAI’s co-development model addresses this gap through three pillars: co-creating a stable formulation, matching process parameters across scales, and providing end-to-end validation support.

1. Co-Creating a Stable ODF Formulation

In the early formulation phase, HUANGHAI engineers work alongside the customer’s R&D team to:

• Select suitable film-forming polymers, plasticizers and functional excipients.
• Design solvent systems and solid content that support stable coating and film formation.
• Evaluate mechanical strength, flexibility and disintegration behaviour of candidate film bases.

This collaborative screening helps identify a membrane formulation that is not only pharmacologically acceptable, but also compatible with continuous coating and drying on industrial lines. For example, our vitamin D ODF manufacturing case study shows how careful control of film composition and process parameters can support sensitive ingredients.

2. Process Matching and Scale-Up

Once a robust base formulation is identified, the next challenge is scale-up. In HUANGHAI’s model, critical parameters are first verified on a pilot line that mirrors the commercial equipment: coating method, web handling and drying concept.

On the pilot line, we work with the customer to:

• Establish target coating weight and wet thickness.
• Define line speed ranges compatible with drying capacity.
• Optimize drying conditions using a continuous thermal-gradient tunnel.

After these windows are confirmed, the same logic is transferred to the industrial line. Because the process concept is consistent, parameter translation is straightforward and scale-up risk is reduced. Compared with a “formulation first, equipment later” approach, this integrated model avoids repeated trial-and-error and unplanned redesign work.

For customers planning new capacity or upgrades, our Pharmaceutical Film Manufacturing Solutions collection provides a range of ODF and patch manufacturing configurations that can be matched to project scale and complexity.

3. End-to-End Support: From Development to Validation

Co-development at HUANGHAI extends beyond R&D. We also support the downstream stages where projects often slow down: process validation and regulatory compliance.

Typical support elements include:

• Process flow diagrams from liquid preparation through coating, drying, slitting and packaging.
• Recommended control strategies for critical parameters such as coating weight, line speed and drying conditions.
• Document packs to facilitate IQ/OQ/PQ and GMP-compliant layout design.

By aligning formulation, process parameters and equipment documentation, the customer receives a coherent story for audits and regulatory submissions instead of a collection of unrelated reports.

Case Study: Turning a Failed Dual-API ODF into a High-Yield Process

In one dual-API ODF project, the customer initially tried to run the formulation on a traditional segmented system. Aggressive multi-zone drying led to layer separation between the active film and backing, causing frequent delamination and low yield.

Through joint development, HUANGHAI and the customer:

• Adjusted the ratio of film-forming components to improve interlayer adhesion.
• Optimized solvent volatility to control drying behaviour and avoid surface skinning.
• Transferred the process to a continuous thermal-gradient dryer and validated parameters on the pilot line before scale-up.

After scaling to the commercial machine using the same process concept, the line achieved over 95% good-film yield with stable appearance and mechanical strength. The validation package could directly reference the pilot work, reducing additional confirmation batches and shortening the overall project timeline.

Offline Testing and Quality Control

A frequent question in continuous ODF manufacturing is whether in-line PAT must be built into the coater for weight or content uniformity. HUANGHAI’s technical team confirms that, in most projects, content and weight control are effectively managed through laboratory sampling or dedicated offline testing instruments.

The continuous process itself is designed to deliver:

• Stable coating weight and film thickness across the web.
• Reproducible drying behaviour using a well-defined thermal gradient.

With this foundation, offline or near-line QC – such as weight checks, assay testing and mechanical measurements – is sufficient to meet regulatory expectations. Customers keep flexibility in their QC strategy while avoiding unnecessary complexity and validation burden associated with built-in PAT modules.

Conclusion: Lower Risk, Faster Path to Commercial ODF Production

From formulation design to commercial scale, HUANGHAI’s co-development model provides systematic support: stable film recipes, matched process parameters, and validation documents and regulatory guidance that fit together.

Compared with a “self-developed formula + later equipment purchase” approach, this joint model significantly reduces trial-and-error cost and project lead time, making high-end ODF and patch projects more realistic for both pharma companies and CDMOs.

To learn more about how this approach applies to your products, you can explore:

• Pharma ODF Solutions
• Pharmaceutical Film Manufacturing Solutions
• Vitamin D ODF Manufacturing Case Study

If you are planning a new ODF or transdermal project and would like to discuss a co-development route, our team is ready to help.

Contact HUANGHAI to start a conversation about your next film or patch project.