Tips for: Solid Oral Dosage Forms

Gel formation in matrix-based slow-release tablets is a critical component of the drug release mechanism. Hydrophilic polymers such as HPMC or carbopol form a gel layer upon contact with gastrointestinal fluids, controlling the release of the active pharmaceutical ingredient (API). However, irregular gel formation can result in inconsistent release profiles, dose dumping, or incomplete drug release.
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Bioavailability refers to the proportion of a drug that reaches systemic circulation in its active form. In slow-release tablets, maintaining high bioavailability is challenging due to prolonged release, potential API degradation, and absorption limitations. Improving bioavailability ensures therapeutic efficacy and patient compliance, especially for poorly soluble or permeability-limited drugs.
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The coating thickness of a controlled-release tablet directly affects its drug release profile, stability, and overall efficacy. An optimal thickness ensures consistent API release while protecting the tablet core from environmental factors such as moisture, light, and heat. Overly thin coatings may lead to dose dumping, while overly thick coatings can delay or hinder drug release.
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High humidity can compromise the stability of slow-release tablets, leading to changes in drug release profiles, reduced efficacy, and potential degradation of active pharmaceutical ingredients (APIs). Humidity may cause tablet swelling, layer separation, or loss of structural integrity, making it crucial to address these challenges during manufacturing, packaging, and storage.
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Multi-phase slow-release tablets are designed to deliver the active pharmaceutical ingredient (API) in distinct phases, ensuring sustained therapeutic effects over a prolonged period. These formulations combine immediate-release and controlled-release mechanisms to provide rapid onset of action followed by extended drug delivery.
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Dose dumping refers to the unintended rapid release of the active pharmaceutical ingredient (API) from a slow-release tablet, leading to a sudden spike in drug concentration in the bloodstream. This can result in toxicity, reduced efficacy, and compromised patient safety. Preventing dose dumping is crucial to maintaining the therapeutic benefits of slow-release tablets.
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Tablet disintegration testing ensures that tablets break down effectively to release the active pharmaceutical ingredient (API) for absorption. This test is particularly important for Immediate-Release Tablets and Orally Disintegrating Tablets (ODTs), where rapid action is essential. Even formulations like Film-Coated Tablets and Compression-Coated Tablets require precise disintegration performance to meet therapeutic objectives.
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In tablet manufacturing, defects like capping and lamination are common quality issues. These occur during the tablet compression process and can compromise the integrity, functionality, and appearance of tablets. Capping refers to the separation of the top or bottom layer of the tablet, while lamination involves splitting the tablet into multiple layers.
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Tablet coating is a critical process in pharmaceutical manufacturing that enhances the functionality, stability, and patient compliance of oral medications. Coated tablets, such as Film-Coated Tablets, Sugar-Coated Tablets, Enteric-Coated Tablets, and advanced formulations like Compression-Coated Tablets, are tailored to meet specific therapeutic and commercial needs. Additionally, Immediate-Release Tablets can also benefit from specific coating techniques for improved disintegration and taste masking.
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Controlled API release ensures that the active pharmaceutical ingredient (API) is delivered at a consistent rate over an extended period, maintaining therapeutic levels in the bloodstream and improving patient compliance. For slow-release formulations, achieving precise control over release profiles is critical to prevent dose dumping, ensure efficacy, and minimize side effects.
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Drug layer erosion in slow-release tablets disrupts the controlled release mechanism, leading to inconsistent drug delivery, reduced efficacy, and potential dose dumping. This issue arises due to improper formulation, process parameters, or environmental factors, necessitating effective troubleshooting to ensure product quality and therapeutic performance.
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Polymers are key components in slow-release tablet formulations, controlling the release rate of the active pharmaceutical ingredient (API) to maintain therapeutic efficacy over extended periods. Selecting the right polymer ensures consistent drug delivery, stability, and patient compliance. Poor polymer choice can lead to dose dumping, variability, or inadequate release profiles.
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