MANUFACTURING DEFECTS OF TABLETS - A REVIEW

Abstract

Tablet defects can come from any of the unit operation upstream and from the tablet press. The raw materials may be of poor quality or do not meet specification, causing excessive fines that lead to a host of defects. The formulation may be the source of defects if the material do not compress well or the processing step specified within the formulation fail to produce a powder a good flow, compressibility, and ejection properties. The processing and granulation of powder is often the source of defect. Every product behaves differently on a tablet press, even if it’s the same product run on a different day. The variation often stems from changes in the properties of the raw materials—active ingredients and excipients- from batch to batch. Naturally, the goal is to minimize these changes. Tablet press operators, however, don’t have any control over formulation and granulation. Tablet specifications are tight, and the list of possible defects is long: Variable weight, sticking, picking, capping, lamination, variable hardness, among others. This article focuses on these variations. It pinpoints the possible causes of these defects and offers advice on preventing and fixing the source of the problems. Key words: capping, mixing, granules, punches, compression, cracking