Common Tablet Defects in Pharmaceutical Manufacturing: Causes and Romaco’s Expert Solutions

Tablet manufacturers, particularly in the pharmaceutical industry, strive to produce the ideal tablet of the highest quality. They, however, struggle with problems such as capping, lamination, and sticking during the production process.

In addition to these challenges, additional issues may surface when tablets are coated for taste enhancement and protection of the active ingredients, or when the release characteristics are modified. Breakage, peeling, or logo bridging can greatly affect the cosmetic appearance, the physical and chemical stability, as well as efficacy of the tablet.

With the appropriate setting and equipment preparation, these defects can easily be reduced or even completely avoided, resulting in high quality, safe, and effective medicines.

Overview of common tablet defects

Here are some examples of tablet defects that have the potential to significantly impact product quality, efficacy, and patient safety:

• Capping: Partial or complete detachment of the tablet top
• Lamination: Separation of the tablet into two or more layers
• Picking: Removal of small particles from the tablet surface
• Sticking: Tablets adhering to the die wall or punch faces
• Thickness & Weight deviation: Inconsistent tablet weight outside acceptable limits
• Hardness variation: Inconsistent tablet hardness, impacting disintegration and dissolution

Overview of common tablet coating defects

The following are some of the most common tablet coating defects, which can also impact product appearance, release, and patient acceptability.

• Breakage: Tablets fracturing during coating or handling
• Peeling: Detachment of the coating from the tablet core
• Logo bridging: Coating film spanning across embossed logo details
• Logo filling: Coating accumulating and obscuring embossed logo
• Color variation: Coated tablets do not have the same color
• Twinning: Two or more tablets sticking together during coating

Factors leading to tablet defects

Some causes of defects in tablets include formulation errors, machinery failures, variability, and operator mistakes. Factors such as high moisture content, low flowability, low binder content, wrongly selected excipients, old dies, incorrect settings on the machines, and changes in temperature are some of the causes of bad tablets.

Romaco’s solutions to encounter tablet defects

Romaco, the pioneer in the pharmaceutical processing and packaging company, offers an entire range of technologies for fixing these defects, which include advanced tablet presses with precise force control, coating systems using fluid bed or special spraying technology, as well as expert services including consulting, process improvement and additional technical support. All these measures help reduce capping, lamination and sticking while assistance is provided to avoid chipping, picking and orange peel effect.

Strategies to prevent tablet defects

Tablet quality and reliability can be assured with a set of measures aimed at preventing defects in tablet production. These measures are extensive formulation development, routine servicing of equipment, operator training, and the application of quality control procedures. At quality control, various factors such as excipient selection, particle size distribution, and moisture content control are performed. Training of operators is also very important, and employees must be trained in the use and handling of the equipment. We also suggest conducting testing at various stages of production and for finished products to mitigate problems as early as possible.

Taking comprehensive measures to identify the root causes of tablet defects and implementing corrective actions help manufacturers achieve improvements in product quality, reduction in losses, and an increase in the safety of patients. With its sophisticated technology and extensive services, Romaco is well-positioned to help pharmaceutical companies in achieving their goals.