A Troubleshooting Guide for Topical Drug Manufacturing - Pharmaceutical Technology

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A Troubleshooting Guide for Topical Drug Manufacturing
Consider critical process parameters and strategies to optimize the manufacturing process


Pharmaceutical Technology
Volume 36, Issue 11, pp. 46-49

Protect APIs from degradation

The manufacturing process must be designed to protect APIs from physical degradation. Some APIs, such as retinoic acid compounds, are sensitive to both ultraviolet (UV) light and oxygen. These APIs can be protected by using yellow or amber light that is free from harmful, low-wavelength UV rays and by using nitrogen, argon, or another inert gas to purge the product of oxygen.

Identify equipment constraints

The manufacturer must be able to perform all processes using its current equipment capabilities. The scale-up path for a 1:10 batch size from the pilot or clinical size to commercial level must exist with similar equipment. Guidance from FDA's Scale-Up and Postapproval Changes Semisolids (SUPAC-SS) Working Group provides the basis of comparison for the design and operating principles of equipment (1).

Consider regulatory requirements

Satisfying regulatory requirements for the scale-up or transfer of a process can be challenging. To scale up a process used for clinical batch manufacturing or transfer a commercial process to a new manufacturing site, the equipment must at least be of the same materials of construction and employ the same type of mixing, as defined in the SUPAC-SS guidance (1).

Using an outsourcing partner

The manufacturing process can influence a topical product's stability and performance. If a formulation is transferred to a contract manufacturer, changes in mixing speeds, temperature controls, and order of ingredient addition may be needed. Outsourcing formulation development and manufacturing to a contract development and manufacturing organization allows technology transfer, scale-up, and manufacturing to take place at one location, which ensures project continuity.

Michael Lowenborg is research and development manager at DPT Laboratories, 3300 Research Plaza, San Antonio, TX 78235, tel. 210.531.7125,
.

Reference

1. FDA, Nonsterile Semisolid Dosage Forms, Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Rockville, MD, May 1997).


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