Precision Multi-Formula Coating for ODFs — Powered by CN117323228A

HUANGHAI’s patented Slitting-Type Film Coating Device (CN117323228A) is a pharmaceutical-grade innovation designed to enable the simultaneous coating of multiple formulations on a single oral dissolvable film (ODF) base — ideal for combination therapies, fixed-dose regimens, and functional health products.

The Challenge in Multi-Formula ODF Production

Producing multi-API or layered oral films is inherently complex. Traditional methods often involve multiple coating runs or secondary shaping, which leads to:

• Increased raw material waste
• Inconsistent API dosage ratios
• Higher energy and labor costs
• Lower manufacturing yield and throughput

HUANGHAI’s Solution: Strip-Based Coating Innovation

Our patented system enables simultaneous slitting and coating of multiple film lanes in one continuous pass — streamlining production and preserving formulation integrity. Key features include:

• Independent formulation channels with dedicated feed grooves
• Adjustable strip width and layout based on target dosage
• One-step transition from coating to cutting, without reshaping
• Real-time control of strip dimensions and output parameters

The result: One film, multiple formulations, zero compromise.

Application Scenarios

This system is ideal for:

• Fixed-dose combination (FDC) prescription drugs
• Layer-sensitive or incompatible APIs
• Custom release profiles within a single film
• Precision nutraceuticals or cannabinoid formulations

Key Benefits

• Save 20–30% in material loss via simultaneous coating
• Preserve exact API ratios per lane/strip
• Reduce equipment runs and downstream processing
• GMP-compliant design, scalable to commercial volumes

Why HUANGHAI

With over 40 years of experience in pharmaceutical manufacturing systems, HUANGHAI is more than a machine supplier — we are a strategic development partner. This patented technology was developed in collaboration with formulation scientists to meet real-world production needs in both China and global markets.

Patent Reference

• Patent No.: CN117323228A
• Title: Slitting-type Film Coating Device and Film Agent Preparation Method
• Applicant: Shanghai Modern Pharmaceutical Engineering Research Center, HUANGHAI
• Publication Date: Jan 2, 2024
• View Full Patent on Google Patents →

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.