Direct compression can have uniformity problems.

• A. False
• B. True
• C. Not sure
• D. It depends on the batch

Answer: (B)

Direct compression relies on forming tablets from a blend of drug and excipients without a granulation step, so achieving uniform distribution of the drug is highly dependent on powder properties and blending performance. If the API and the excipients differ in particle size, density, or cohesiveness, the powder can segregate during mixing, handling, or die-filling, leading to some tablets with more drug and others with less. Without granulation to promote a more uniform matrix, the blend’s flow and compressibility largely determine weight and content uniformity. Moisture, static, and high drug loads can further worsen uniformity. With careful formulation, proper blending, flow aids, and process controls, these issues can be mitigated, but the inherent risk remains, so the statement is true.