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Fundamentals of Tablet Compression
Author: Armin H. Gerhardt

“Pharmaceutical Processes” discusses scientific and technical principles associated with pharmaceutical unit operations useful to practitioners in compliance and validation. We intend this column to be a useful resource for daily work applications. The primary objective for this column: Useful information.

Reader comments, questions, and suggestions are needed to help us fulfill our objectives. Please send your comments and suggestions to column coordinator Armin Gerhardt at arminhg@comcast.net or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS
The following key points are discussed in this article:
•Tablet compressing is an established manufacturing process with multiple applications in pharmaceutical, dietary supplement, food, cosmetic, diagnostic, and other industries
•The most important performance characteristics of tablet dosage forms are identified
•Actual tablet compressing may be subdivided into four stages: Filling, metering, compression, and ejection
•Characteristics of an efficient compression operation are identified. These include machine assembly and operation, powder flow, machine operating parameters for specific products, and others.
•Formulation components and manufacturing processes conducted prior to compressing have significant impact on the compressing process
•Specific considerations for which compliance professionals should exercise the greatest vigilance are identified. These include obvious changes such as new suppliers of primary ingredients as well as subtle less
visible changes. A strong change control program is key to management of change.
•Annual product reviews give a broad overview of product performance. Compliance professionals should also monitor compressing performance indicators such as low yields, frequent stoppages, frequent machine adjustments, and punch breakage. Technical personnel should address these problems when their frequency becomes excessive.

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