Tips for: Solid Oral Dosage Forms

In the pharmaceutical industry, quality control ensures that tablets meet predefined standards for safety, efficacy, and consistency. Whether producing Immediate-Release Tablets, Orally Disintegrating Tablets (ODTs), or advanced formulations like Compression-Coated Tablets and Film-Coated Tablets, robust quality control systems are vital. This step-by-step guide outlines the key processes involved in maintaining high standards throughout tablet manufacturing.
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Tablet coating is a crucial process in pharmaceutical manufacturing that enhances tablet performance, appearance, and functionality. Coating not only improves the stability and taste of the tablet but also supports targeted drug delivery. From Film-Coated Tablets to advanced Compression-Coated Tablets and Enteric-Coated Tablets, each coating type serves a specific purpose in modern drug formulation.
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Tablet damage during blister packaging is a common issue that can lead to chipped edges, broken tablets, or loss of coating integrity. Such damage not only affects the product’s appearance but also its efficacy and stability. Packaging-related tablet damage often occurs due to mechanical stress, improper equipment settings, or inadequate material selection.
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Low-dose tablets, where the active pharmaceutical ingredient (API) is present in minute quantities, pose unique challenges during granule compression. Maintaining uniformity, achieving proper compaction, and preventing segregation of APIs and excipients are critical to ensure consistent quality and efficacy. Granule compression issues in low-dose formulations can result in weight variation, inadequate hardness, or compromised drug release.
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Controlled-release coated tablets are designed to deliver the active pharmaceutical ingredient (API) at a predetermined rate, duration, and location within the gastrointestinal tract. The coating plays a vital role in regulating drug release, providing therapeutic efficacy over an extended period while minimizing side effects and dosing frequency.
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Poorly soluble drugs present significant challenges in pharmaceutical formulation due to their limited ability to dissolve in the gastrointestinal tract. For immediate-release tablets, rapid dissolution and absorption are critical to achieve the desired therapeutic effect. Enhancing the solubility and dissolution rate of such drugs is essential for effective formulation and patient outcomes.
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Powder flowability is a critical factor in tablet manufacturing as it ensures uniform die filling, consistent tablet weight, and efficient compression. Poor flow properties can lead to issues such as weight variation, segregation, and inconsistent API distribution. Enhancing powder flowability improves manufacturing efficiency and ensures high-quality tablets.
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Tablet layer separation, also known as delamination, occurs when the individual layers of a multilayer tablet fail to adhere to each other. This structural defect can lead to compromised drug efficacy, inconsistent release profiles, and regulatory non-compliance. Layer separation is often caused by factors such as poor adhesion, compression force imbalances, or incompatible formulation components.
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Excipients are inactive ingredients in pharmaceutical formulations that play essential roles in tablet manufacturing, stability, and drug release. In slow-release tablets, the choice of excipients directly impacts the controlled-release profile, stability, and therapeutic efficacy. Selecting the right excipients ensures the desired drug release rate while maintaining the tablet’s mechanical strength and stability.
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Lubricants are essential excipients used in tablet formulations to reduce friction between the tablet and the die wall during compression and ejection. However, excessive use of lubricants, such as magnesium stearate, can negatively impact tablet quality. Problems include delayed dissolution, reduced tablet hardness, poor binding, and altered API release profiles.
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Direct compression is a widely used technique in tablet manufacturing, where powdered materials are compressed directly into tablets without the need for granulation. This method is particularly popular for formulations like Immediate-Release Tablets, Orally Disintegrating Tablets (ODTs), and Film-Coated Tablets. Its simplicity, cost-effectiveness, and suitability for heat- and moisture-sensitive drugs make it a preferred choice in pharmaceutical manufacturing. However, like any method, it comes with its set of advantages and challenges.
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Tablet compression is a critical step in pharmaceutical manufacturing where powder mixtures are compacted into solid doses using a tablet press. This process ensures that tablets like Immediate-Release Tablets, Orally Disintegrating Tablets (ODTs), and Film-Coated Tablets meet desired quality standards in terms of size, shape, and hardness. For complex formulations such as Compression-Coated Tablets, precise compression is even more essential to maintain functionality.
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