Tips for: Solid Oral Dosage Forms

Granule caking occurs when wet granules clump together excessively during the wet granulation process in high-shear mixers, resulting in uneven particle sizes and reduced flowability. This problem can compromise tablet uniformity, compressibility, and overall product quality. Understanding and addressing the root causes of caking is crucial for optimizing the granulation process.
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Wet granulation is a process of agglomerating powder particles using a liquid binder to create granules with improved flowability, compressibility, and uniformity. It ensures consistent tablet quality by addressing challenges like segregation and uneven distribution of active pharmaceutical ingredients (APIs). Optimizing wet granulation is critical for achieving uniform tablet blends and maintaining product efficacy.
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Mottling refers to the uneven distribution of color on the surface of film-coated tablets, resulting in a patchy or blotchy appearance. This defect is often caused by improper pigment dispersion, formulation issues, or process inconsistencies. Mottling affects the aesthetic quality of tablets and can raise concerns about product quality among consumers and regulators.
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Edge chipping in coated tablets refers to the flaking or breaking of the tablet’s edges, often caused by mechanical stress, improper coating parameters, or inadequate formulation. This issue compromises the aesthetic and functional quality of the tablet, leading to increased rejection rates and reduced patient compliance.
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Solvent residues in film-coated tablets can affect product quality, stability, and safety. They may result from incomplete solvent evaporation during the coating process, leading to potential regulatory non-compliance or patient health risks. Proper management of solvent residues ensures consistent quality, compliance, and safety while maintaining therapeutic efficacy.
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Optimizing coating parameters is essential for achieving consistent quality, minimizing defects, and ensuring cost-efficiency in high-volume tablet production. Poorly adjusted parameters can lead to issues such as uneven coating, excessive weight gain, or high rejection rates. By refining these parameters, manufacturers can enhance product quality while maximizing throughput.
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The aesthetic quality of film-coated tablets is essential for consumer acceptance and product differentiation. Issues like uneven coating, color variations, and surface defects can compromise the appearance and perceived quality of the product. Addressing these issues ensures consistent branding, patient compliance, and regulatory acceptance.
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Coating thickness plays a crucial role in regulating the release rate of active pharmaceutical ingredients (APIs) in slow-release tablets. Inconsistent or excessive thickness can lead to unpredictable drug release profiles, reduced efficacy, and patient non-compliance. Precise control over coating thickness ensures consistent therapeutic outcomes and compliance with regulatory standards.
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Tablet sticking occurs when tablets adhere to each other or to the coating pan during the film or sugar coating process. This issue can compromise tablet quality, resulting in uneven coating, surface defects, or batch rejection. Causes include over-wetting, inadequate drying, improper coating formulation, or incorrect process parameters.
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