Next Generation of ODF Solutions
Next Generation of ODF Solutions
Beyond Equipment — Full-Spectrum Support from Formula to Film
Developing high-performance oral dissolvable films (ODFs) — especially multi-ingredient, pediatric, or dual-release formats — requires more than just coating machinery. At HUANGHAI, we combine engineering with formulation R&D to help you go from lab concept to GMP-scale production.
Limitations in Traditional ODF Production
- Multi-API complexity: Difficult to ensure even distribution or avoid chemical interactions between layers.
- Layer-by-layer coating: Requires full drying between passes, risking delamination or poor adhesion.
- No formulation support: Most suppliers do not assist in film matrix design or excipient optimization.
HUANGHAI's Integrated Solution: From R&D to Scale-Up
- Formulation Co-Development: Collaborate with our R&D team to select excipients, optimize film-forming properties, and validate process parameters.
- Multi-Layer Coating Capabilities: Support for dual-layer or sequential API coating with precise thickness and bonding control.
- Pilot-to-Production Scaling: Pilot systems with industrial logic, enabling seamless tech transfer to full GMP lines.
- Stability-Oriented Drying Design: Control humidity and drying profiles to protect sensitive actives and preserve film integrity.
HUANGHAI vs. Traditional ODF Solutions
The table below summarizes how our approach differs from standard ODF equipment manufacturers:
| Aspect | Traditional Equipment | HUANGHAI Solution |
|---|---|---|
| Scope of Service | Equipment only | Equipment + Formulation + Scale-Up |
| Multi-API Handling | Basic layering by client | Integrated design with bonding optimization |
| Formulation Involvement | Not included | Available via R&D collaboration |
| Drying Control | Fixed zones | Custom profiles + humidity monitoring |
| Pilot Testing | Not supported | Full-featured pilot system |
| Tech Transfer | Client-managed | Assisted with industrial parameters |
| Best Fit Use Cases | Simple OTC ODFs | Complex, pediatric, dual-release formats |
Applications & Collaboration Models
Whether you’re developing pediatric film products, oral strips with complex APIs, or regulatory-compliant nutraceuticals, HUANGHAI can support your journey — from formulation refinement to commercial launch.
Explore Our ODF Equipment
We offer modular equipment systems designed for both pilot trials and high-volume production. Learn more about our key products below:
MJF180 ODF Film Cutting & Packaging Machine
Precision slitting with On-Demand Heat Sealing technology (Gen 2) for high-speed, synchronized pouch packaging.
View ProductMJ150 Solvent-Based ODF & Transdermal Coating Machine
High-volume coating system with precise control over thickness, drying, and speed.
View ProductMJ150-L ODF Pilot Coating Machine
Optimized for R&D trials and formulation testing with full industrial logic.
View ProductFrequently 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.