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Quality by Design: The Winning Formula for Film Coating

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Colorcon regularly identifies and addresses the critical quality attributes (CQAs) for our film coated products, such as presence and type of coating defects (measured as % defect level), coated tablet disintegration time, and tablet appearance (color uniformity, smoothness and gloss). The main drawbacks for any tablet manufacturer that attempts to develop their own film coating in-house concern quality issues related to raw materials, appearance, color variation, stability, or batch-to-batch consistency. A fully formulated Opadry film coating system will address these issues; however, the final finish can only be as good as the quality and control of the coating process itself. It’s important to understand and manage critical process parameters (CPPs) that can include: dispersion spray rate, spray distribution, process temperatures, airflow, coating solids concentration, pan loading and pan speed.

Fortunately, Colorcon has been producing Opadry® ,complete film coating systems and optimizing coating processes for more than 50 years; always with the final finish in mind. Along the way, we have developed best-in-class processes for ensuring the quality and consistency of fully formulated film coating systems. While the benefit of these coatings is often considered in productivity and cost-saving metrics, the quality assurances and risk mitigation associated with development, manufacture, and performance should not be understated. Let’s delve a little into the various formulation controls, materials and supply chain, operational processes and testing requirements that guarantee exceptional and repeatable coating performance, batch after batch.

Formulation Controls & Development

There are four Quality by Design (QbD) principles that ensure consistent color and coating performance can be achieved with each batch.

  1. Design of experiment (DOE) for coating formulation and process optimization. From development to launch, all Opadry systems undergo a rigorous stage gate process to assess, implement, and ensure optimum functionality.
  2. Process validation ensures that every new Opadry system meets the required quality specifications, through every scale of manufacture, at any of our seven interchangeable manufacturing plants around the world.
  3. Stability testing following ICH guidelines ensures consistent and stable product appearance, color, dispersion properties, coating performance over the specified shelf life of the product.
  4. A unique master formulation serves as a global reference for creating all subsequent batch records no matter where they are being produced around the world

Materials Assurance

The supplier network is crucial for the film coating ingredients. Suppliers should be evaluated on their capabilities, use of appropriate Good Manufacturing Practices, business continuity planning and be routinely monitored for ongoing performance. Once our incoming materials are received, samples are sent to Quality Control for analytical and microbiological testing before being approved for use in manufacturing.

There are industry guidelines in place to ensure that product and product testing operate within a certified Quality Management System. Colorcon, for example, stays in line with the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients and ISO9001 facility certifications.

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Final Product Testing

Color uniformity is one of the most difficult product stewardship attributes to achieve, but our instrumental and visual color difference tests ensure a consistent color every time. Instrumental tests confirm that the hydrated powder meets the formula standard color, measurable on a reflectance spectrophotometer. Visual color difference tests compare past batch history to ensure lot-to-lot consistency and confirmation of instrumental color data.

Then there’s dispersion testing, which checks for a uniform appearance in powder and hydrated forms. Making sure the color, odor, and homogeneity of a powder blend conform to the item specification can be confirmed with appearance testing.

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Connect with Colorcon to Get the Perfect Finish

If your final product quality is falling short due to a film coating that neglects crucial quality standards, then perhaps it’s time to Connect with Colorcon to dive deeper into the Quality by Design practices that uphold our range of fully formulated film coating systems #Making Coating Consistent