Tips for Tablets

Batch uniformity refers to the consistent distribution of active pharmaceutical ingredients (APIs) and excipients within a powder blend used for tablet production. Achieving uniformity ensures that each tablet contains the intended dosage of APIs, which is crucial for efficacy, safety, and regulatory compliance.
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Granulation inconsistencies occur when granules produced during tablet manufacturing exhibit irregularities in size, density, or moisture content. These inconsistencies lead to issues such as poor powder flow, segregation, uneven die filling, and compromised tablet quality. Addressing granulation problems is critical to ensuring uniformity, efficiency, and compliance in tablet production.
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Tablet sticking occurs when powder adheres to the surface of punches during the compression process. This issue results in defective tablets with uneven surfaces, poor aesthetics, and potentially compromised dosage accuracy. Sticking can disrupt production, increase downtime for cleaning, and result in significant material waste.
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Particle size is a critical factor in tablet manufacturing, influencing powder flowability, compressibility, and tablet quality. Irregular or inappropriate particle size distribution can lead to defects such as poor flow, inconsistent die filling, weight variation, and weak tablets.
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Static build-up occurs when electrical charges accumulate on the surface of materials during the tablet manufacturing process. This is particularly common in dry environments and with fine powders. Static electricity can disrupt the manufacturing process, leading to powder clumping, inconsistent flow, sticking to equipment surfaces, and uneven die filling.
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Over-lubrication occurs when excessive lubricants, such as magnesium stearate or talc, are added or mixed for too long with tablet granules. While lubricants are essential for reducing friction during compression and ejection, over-lubrication can weaken tablet hardness, slow disintegration, and negatively impact dissolution rates.
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Poor powder flow is a common challenge in tablet manufacturing. It can lead to inconsistent die filling, weight variation, and even machine downtime. This issue typically arises due to factors such as irregular particle size, high moisture content, static buildup, or insufficient lubrication.
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Segregation refers to the separation of different components in a powder blend, leading to inconsistencies in tablet composition. This occurs when powders of varying particle sizes, densities, or shapes are mixed but fail to remain homogeneously distributed. Segregation can result in uneven API (Active Pharmaceutical Ingredient) distribution, causing substandard tablets that may fail quality control tests.
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Double-impression occurs when a tablet receives an unintended duplicate marking during the compression process. This defect is primarily associated with improperly functioning punches, where one or both punches move freely in the die and imprint a second time. Double-impression affects the tablet’s aesthetics and can result in regulatory non-compliance.
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Air entrapment occurs when air pockets are trapped inside the core of a tablet during the compression process. This issue can lead to defects such as capping, lamination, or weakened mechanical strength. Entrapped air prevents proper bonding between powder particles, reducing the overall quality of the tablet and its ability to meet pharmacopoeial standards.
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Tablet breakage is a common issue in high-speed tablet compression, where tablets crack, chip, or break during production or handling. The high speeds involved in modern tablet presses exert significant stress on both the formulation and the machine components, increasing the risk of defects.
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Tablet hardness plays a crucial role in immediate-release formulations. It directly affects the mechanical strength of the tablet, its disintegration time, and the release of active pharmaceutical ingredients (APIs). Hardness that is too low may result in tablets breaking during handling or packaging, while excessive hardness can slow disintegration and delay drug release, defeating the purpose of immediate release.
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