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.

For a full overview of the certifications and compliance standards our equipment meets, see our Certifications & Compliance page.

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.

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Frequently Asked Questions

Q: What is the difference between an ODF film and a transdermal patch?

A: Oral Dissolving Films (ODF) are placed on or under the tongue and dissolve within seconds to minutes, delivering APIs directly through the oral mucosa or via swallowing. Transdermal patches adhere to the skin and deliver APIs through the dermal layers into systemic circulation over hours to days. Despite different delivery routes, both are manufactured using similar solvent-cast film coating processes. Huanghai's MJ150 ODF machine supports both applications on a single platform with approximately 2 working days of changeover time.

Q: What production output can I expect from a Huanghai ODF machine?

A: The MJ150 produces 20,000 films/hour at commercial scale. The MJ150-L targets R&D and pilot production at 8,000–10,000 films/hour. For fully integrated lines, pair either machine with the MJF180 automatic cutting and packaging system (11,900 films/hr) or the more affordable EZ320 (9,000 films/hr). A complete MJ150 + MJF180 line can produce over 150 million finished pouches annually on a single-shift basis. Contact us for pricing and configuration details.

Q: What drying technology does Huanghai use for ODF production?

A: Huanghai uses patented gradient hot-air drying (Patent CN201668734U), which applies a smooth progressive temperature drop rather than stepwise oven zones used by competitors. This results in more uniform film thickness, reduced edge curl, and better API distribution across the film web. An optional far-infrared heating module adds 20–30% drying efficiency for solvent-based formulations. This patented drying system is one of the key technical advantages that justifies Huanghai's position as the preferred ODF equipment supplier to Sinopharm, Shanghai Pharma, and Fosun Pharma.

Q: What are the GMP requirements for ODF production equipment?

A: ODF manufacturing equipment must comply with cGMP (21 CFR Parts 210/211) for US market products, and equivalent standards (EU GMP Annex 1, ChGMP) for other markets. Key requirements: material contact surfaces must be 316L stainless steel or equivalent; CIP/SIP capability or documented cleaning validation; data integrity controls meeting ALCOA+ principles (audit trails, access control). Huanghai ODF machines meet these standards—all product contact surfaces use pharmaceutical-grade materials, and the control system includes operator access logs and parameter change records. Request our GMP compliance documentation.

Q: Can Huanghai machines produce stripe-coated or multi-formula ODF films?

A: Yes. Huanghai holds a patent for multi-formula stripe coating (Patent CN117323228A), enabling two different API formulations to be applied side-by-side in a single coating pass. This eliminates the need for multiple coating/drying cycles when producing combination-drug ODF products. Competitors require manual multi-layer coating with drying intervals between each formula. This capability is particularly valuable for fixed-dose combination products (e.g., dual-API ODFs for cardiovascular or CNS indications) where coating efficiency directly impacts production economics.