Common Manufacturing Defects in Tablets and Remedies

Are you struggling with common manufacturing defects in tablets? Imperfections like uneven colour distribution, chipped edges, and pesky cracks are quite common in the world of tablet manufacturing. We will figure out remedies to overcome the common manufacturing defects in tablets. In this blog, we will discuss the Common Manufacturing Defects in Tablets and Remedies. 

Manufacturing Defects in Tablets and Remedies

While manufacturing the tablets, several defects can occur that affect their quality and working. These defects can arise from different factors. Listed below are different Manufacturing Defects in Tablets and Remedies. 

1. Capping 

Capping is one of the most common problems that arises most of the time while manufacturing tablets. When capping arises, the tablet may lose its structural integrity, affecting its functionality, appearance, and patient acceptability.

Causes Of Capping

• Imperfect granule flow leads to unequal material distribution.
• Inadequate compression force creates a weak bond between the granules.
• Lacking good binding properties during tablet formulations.

Its Remedies

• A compression force needs to be perfectly implemented to enhance the bonding of the granules.
• Customise the excipient composition or Incorporate suitable binders to improve the formulation binding properties.
• Optimize granulation parameters or Decrease granule size to improve the granule flowability.

2. Lamination

Lamination arises when tablets laminate or split into layers, either completely or partially. It can result in tablets with various straight layers, compromising their dosing accuracy, structural integrity, and efficacy.

Causes of Lamination

• Inadequate Bonding between the granule layers.
• Excessive amount of moisture decreases the granules’ adhesive properties.
• Air redemption creates a barrier between the granule layers.
• Inadequate compression force creates a weak bond between the granule layers.

Its Remedies

• Use proper granulation methods to evenly distribute binder, moisture, and granule size.
• Regulate and Monitor the moisture levels during the granulation process.
• To remove excess air from the granules use granulation equipment.
• Exert an adequate amount of compression force to customize compaction and bonding between the layers of the granule.

3. Sticking

Sticking is one of the most common problems that arise most of the time during tablet manufacturing. It occurs when the tablet material sticks to the dies and punches instead of being separated smoothly. This can cause problems in damage to the tablets, tablet ejection, and poor tablet quality.

Causes of Sticking

• Improper lubrication of the tablet material and the compression tooling.
• Various ingredients contain sticky or hygroscopic ingredients.
• The dies and punches have rough finishes on the surface.
• Improper Dwell time, resulting in inadequate granule consolidation
• Worn-out or Misalignment tooling causes unequal distribution of compression force.

Its Remedies

• Select lubricants suited for compression tooling and manufacturing.
• Customize the formulation by adding required excipients or customize the composition.
• clean, Inspect, and maintain the tooling regularly.
• Customize compression force and dwell time.
• Perform tooling calibration regularly or exchange the worn-out tooling.

4. Picking

Picking is a kind of sticking. It arises when the formulation is left behind on the punch surfaces with imperfect designs. Picking can lead to incomplete tablets, tablet surface damage, or weight and appearance variations.

Causes of Picking

• Inadequate lubrication adds friction between the tablet and the embossed letters or logos on the perforation surfaces.
• The composition contains cohesive or sticky components.
• The dwell time, i.e. the time when the punches remain in contact with the tablet material is insufficient.

Its Remedies

• Perform proper lubrication to prevent adhesion and reduce friction.
• Customize the ingredients by adding the appropriate ratio.
• Modify dwell time and compression force.

5. Flashing 

Flashing is one of the common tablet manufacturing defects. It arises as a thin, unwanted edge around the tablet’s perimeter. Flashing occurs when the granules get compressed under high pressure and undergo plastic deformation. This defect can occur in any tablet shape.

Causes of Flashing

• During compression, there is excess tablet material in the mould cavity.
• The tablet composition does not evenly fill the entire oral cavity.
• During manufacturing, a proper compression force is not applied.
• The top and bottom holes may be misaligned or the die tips are worn.

Its Remedies

• Adjust the component amount of material filled in the oral cavity.
• Use reliable and consistent feeding systems to ensure even filling.
• Customize the pressure and manufacturing time to prevent excess material from wasting.
• Ensure proper alignment and regular inspection and maintenance of crimping tools.

6. Mottling

Mottling is one of the most common tablet manufacturing defects. This refers to the unequal distribution of colour or pigmentation on the tablet surface, that results in a mottled appearance.

Causes of Mottling

• Colourants inside the tablet formulation are not thoroughly blended.
• Chemical interactions in compounds can lead to colour variations.
• Moisture within the ingredients is not absorbed evenly.
• Inappropriate drying or curing of the tablets can lead to mottling.

Its Remedies

• Use adequate blending methods to ensure constant colourant distribution.
• Monitor the compatibility of colourants with other formulation ingredients.
• Regulate and monitor the moisture content during drying, granulation, and tablet manufacturing.
• Ensure that manufacturing processes are followed or proper drying is done to ensure complete removal of the moisture.

7. Double Impression

Double Impression is one of the most typical tablet manufacturing defects. It occurs when there is more than one print on a specific tablet. Double Impression occurs when the pressure is applied multiple times to the tablet material during the manufacturing process which results in overlapping marks.

Causes of Double Impression

• It arises because of the misalignment of the punches within the die cavity.
• The lower punches rotation is not controlled properly.
• The clearance between the dies and punches is not adjusted properly.

Its Remedies

• Regularly monitor the alignment of the punches within the die cavity.
• Ensure the correct position and alignment of the punches.
• Evaluate the punch clearance, and design, and adjust punches as required.

8. Cracking

Cracking is a prevalent issue seen in tablets. It is characterized by visible fissures or cracks on the surface of the tablets, which can significantly impact the appearance, structural soundness, and overall quality of the tablets.

Causes of Cracking

• Inadequate cohesive strength from binders used in the tablet formulation.
• Application of excessive compression force during the tabletting process.
• Insufficient or improper lubrication of the tablet material.

Its Remedies

• Fine-tune the compositions and type of binder incorporated into the tablet formulation to enhance cohesive properties.
• Adjust the compression force applied during tabletting to an optimal level that prevents cracking without compromising tablet hardness.
• Select lubricants carefully that are suitable for the specific tablet material to ensure smooth tablet production and minimize cracking occurrences.

9. Black Spots

Black spots on tablets are dark or black-coloured spots found on the surface of the tablets, which impacts the appearance and quality of the tablets. These black spots commonly arise during tablet manufacturing:

Causes of Black Spots

• Contamination in the raw materials is used during tablet formulation.
• Inappropriate cleaning of equipment, compression tooling, or the manufacturing environment.
• Poor mixing of lubricants leads to black spots.
• Improper granulation in the tablet formulation process.
• Oxidation of formulation components or exposure to unfavourable conditions can cause discolouration.

Its Remedies

• Make sure the use of high-quality raw materials that are free from impurities.
• Monitor regular cleaning protocols for equipment, tooling, and manufacturing areas.
• Optimize the blending process to achieve proper dispersion of lubricants.
• Monitor and control the granulation process to prevent defects.
• Store both raw materials and finished tablets under suitable conditions to avoid oxidation and discolouration.

10. Binding

Binding in tablet production is a frequent issue where granules unexpectedly stick to the surface of the dies during compression which leads to problems like challenging tablet ejection, decreased efficiency in manufacturing, and inferior tablet quality.

Causes of Binding

• It can arise due to Inadequate lubrication between the granules and the dies.
• Excessive moisture content in the tablet content.
• Use of hygroscopic materials that make the granules sticky and prone to sticking.

Its Remedies

• Must ensure appropriate application of lubricants to both the tablet material and the dies.
• Monitor and regulate the moisture levels within the formulation.
• Adjust the formulation by incorporating non-hygroscopic excipients to mitigate binding issues.

11. Twining

Twinning is a common issue in tablet production where two distinct tablets become fused. This problem arises when tablets stick together during compression. 

Causes of Twining

• It arises due to inadequate lubrication of tablet material and compression tools.
• Improper granulation of formulations leads to excessive tablet porosity.
• Tablets with flat or parallel surfaces are more prone to twinning.
• Variations in compression force can cause tablets to merge instead of forming individually.
• The malfunctioning ejection mechanism on the tablet press exacerbates twinning.

Its Remedies

• Ensure proper lubrication of both the tablet material and the compression tooling.
• Monitor and control the granulation process to minimize tablet porosity.
• Optimize tablet design with features like bevelled edges or curvature to aid in tablet separation.
• Maintain consistent compression force throughout the entire tabletting process.
• Regularly inspect and maintain the ejection mechanism to ensure it functions correctly.

12. Weight Variation

Weight variation in tablets refers to inconsistencies in tablet weight either within a batch or among each tablet. This issue can significantly impact the accuracy of dosage, its effectiveness of drug delivery, and the overall quality of the tablets.

Causes of Weight Variation

• It occurs due to inadequate blending of formulation ingredients.
• Inconsistent granule size, density, or distribution.
• Variations in the dosing of tablet material during filling.
• Compression of tablets with insufficient or excessive force.
• Poor material flow leads to uneven filling of the die cavity.

Its Remedies

• Ensure thorough and uniform blending of formulation ingredients.
• Must monitor and control the granulation process carefully.
• Implement automated filling systems to ensure consistent dosing.
• Standardize compression force settings based on the formulation requirements.
• Conduct flowability tests and optimize material flow characteristics.

13. Hardness Variation

Hardness variation is a common issue in tablet manufacturing, that is characterized by inconsistent resistance to breaking or deformation when compressed. It arises from several factors:

Causes of Hardness variation:

• Inadequate blending of formulation components.
• Variations in granule size, density, or distribution.
• Fluctuations in compression force during tabletting.
• Incorrect ratios of active pharmaceutical ingredients (APIs) or excipients.
• Irregular drying or curing of granules or tablets.

Its Remedies:

• Ensure thorough and uniform mixing of all formulation ingredients.
• Optimize granulation techniques to achieve consistent granule characteristics.
• Set appropriate compression forces tailored to the formulation and tablet requirements.
• Adjust the formulation composition to achieve the correct proportions of APIs and excipients.
• Implement controlled and uniform drying or curing processes.

14. Inconsistent Thickness

Inconsistent tablet thickness is a common issue in which tablets may vary in thickness within a batch or between different tablets. Moreover, this problem can affect the tablets’ quality, functionality, and appearance.

Causes of Inconsistent Thickness

• It may occur because the tablet material may not be evenly granulated.
• The feeding system fails to ensure a consistent flow of powder into the die, leading to uneven filling.
• Incorrect compression force—either too much or too little—can result in varying tablet thickness.
• Worn-out tooling or machine malfunctions can also contribute to thickness irregularities.

Its Remedies

• Ensure the granulation process produces uniform granules.
• Use reliable feeding systems and monitor powder flow to achieve consistent filling.
• Determine the correct compression force required for the specific formulation and tablet press.
• Regularly inspect and maintain the tablet compression machine, and replace any worn punches or dies promptly.

15. Chipping

Chipping in tablets occurs when their edges break into small pieces or fragments, affecting how well the medication works, its appearance, and how easily patients can take it.

Causes of Chipping

• Tablets may not be hard enough.
• Tablets with high friability are prone to chipping, cracking, or breaking when handled.
• Poorly designed tablets with sharp edges or corners are more likely to chip.
• Tablets that are compressed inconsistently or with too much force can become weak and chip easily.
• Insufficient lubrication between the tablet material and the machinery used to make them can increase the risk of chipping.

Its Remedies

• Adjust the compression force to achieve the right tablet hardness.
• improve the strength of tablets by adjusting the formulation and how the granules are made.
• Smooth out the edges and corners of tablets to make them stronger.
• Fine-tune the compression force to make tablets more resilient.
• Ensure proper lubrication between the tablet material and the tools used to compress them to reduce friction.

Conclusion

In the above text, we discussed the top 15 Manufacturing Defects in Tablets and Remedies. The above-listed tablet manufacturing defects are quite common. In this blog, we have listed the remedies to be used for tablet manufacturing defects. Read out our complete blog to know the common Manufacturing Defects in Tablets and Remedies.

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