Tips for Tablets

API degradation refers to the chemical or physical breakdown of the active pharmaceutical ingredient (API) in a tablet over time. In slow-release tablets, degradation can affect the controlled-release mechanism, reducing efficacy and compromising patient safety. Factors like moisture, heat, pH, and API-excipient interactions often contribute to degradation, making it essential to identify and resolve these issues effectively.
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Multilayer tablets are designed to deliver different active pharmaceutical ingredients (APIs) or controlled-release profiles in a single dosage form. However, their layered structure makes them more prone to stability issues, such as delamination, cracking, or incompatibility between layers. Optimizing stability is critical to ensure the performance, safety, and shelf life of multilayer tablets.
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Temperature sensitivity in coated tablets refers to the impact of temperature fluctuations on their stability, performance, and appearance. Excessive heat or cold can cause coating defects such as cracking, peeling, or stickiness, and may also degrade the active pharmaceutical ingredients (APIs). Properly managing temperature sensitivity is critical to maintaining tablet efficacy, stability, and compliance with regulatory standards.
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Light-induced degradation occurs when exposure to UV or visible light causes the active pharmaceutical ingredients (APIs) or excipients in tablets to break down. This degradation can lead to reduced potency, discoloration, or the formation of harmful byproducts, ultimately compromising the tablet’s efficacy and safety.
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Slow-release tablets are designed to release their active pharmaceutical ingredients (APIs) over a prolonged period. High-humidity conditions can compromise their stability, leading to swelling, degradation, or dissolution profile changes. These issues can affect the therapeutic efficacy and shelf life of the tablets, making it essential to implement strategies to stabilize them in humid environments.
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Moisture absorption in immediate-release tablets can compromise their stability, efficacy, and performance. Hygroscopic ingredients or improper packaging can lead to swelling, sticking, dissolution variability, and even microbial contamination. Since immediate-release tablets are designed to disintegrate rapidly upon administration, moisture uptake during storage can alter their disintegration profile, affecting therapeutic outcomes.
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Tablet discoloration refers to any unwanted change in the color of tablets during storage or handling. This issue can compromise the product’s appearance, stability, and consumer acceptance. Discoloration may result from chemical degradation, moisture absorption, light exposure, or interactions between active pharmaceutical ingredients (APIs) and excipients.
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Accelerated stability testing is a critical step in pharmaceutical development used to evaluate a tablet’s stability under controlled environmental conditions, such as elevated temperature and humidity. The goal is to predict the product’s shelf life and identify potential degradation pathways in a shorter time frame compared to real-time stability testing.
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Tablet brittleness occurs when tablets lose their mechanical strength during storage, making them prone to cracking, chipping, or breaking. This issue compromises tablet quality, stability, and efficacy. Brittleness can arise due to several factors, such as moisture loss, improper formulation, environmental conditions, and degradation of binding agents.
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Hygroscopic ingredients absorb moisture from the environment, which can lead to tablet degradation, reduced shelf life, caking, or loss of mechanical integrity. Stabilizing such tablets is essential to ensure efficacy, compliance with regulatory standards, and long-term storage stability.
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Low yield in tablet production occurs when the actual output of tablets is significantly less than the expected or theoretical yield. This issue impacts efficiency, increases production costs, and may lead to regulatory non-compliance due to material losses or quality deviations.
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Powder loss refers to the wastage of materials during the tablet manufacturing process. This can occur at various stages, including blending, granulation, compression, and packaging. Excessive powder loss leads to higher production costs, reduced efficiency, and challenges in maintaining uniformity and compliance with regulatory standards.
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