Tag: Drug stability testing

Guidelines for Good Tablet Manufacturing Practices Good Tablet Manufacturing Practices (GTMP) are a set of guidelines and standards established to ensure the quality, safety, and efficacy of pharmaceutical tablets. Compliance with GTMP is essential to meet regulatory requirements, maintain product consistency, and protect public health. Here are some of the key guidelines for good tablet…

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Different Methods of Tablet Coating Tablet coating is a process used to apply a thin layer of coating material onto the surface of tablets. The coating can serve various purposes, including improving tablet appearance, taste masking, providing gastro-resistance, or modifying drug release characteristics. There are different methods of tablet coating, each with its own advantages…

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Tablet Stability Testing Tablet stability testing is a critical aspect of pharmaceutical development and quality control. It involves evaluating the chemical, physical, and microbiological properties of tablets over time to ensure their quality, safety, and effectiveness throughout their shelf life. The stability testing process follows established guidelines and regulatory requirements to assess how the tablets…

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Role of Lubricants in Tablet Compression Lubricants play a crucial role in tablet compression, as they are essential for ensuring the smooth and efficient operation of the tablet manufacturing process. Lubricants are inactive ingredients added to the tablet formulation to reduce friction between the tablet blend and the surfaces of the tablet press during compression….

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Identification and Rectification of Tablet Defects Tablet defects can arise during tablet manufacturing due to various factors, including formulation issues, process challenges, equipment problems, and environmental conditions. Identifying and rectifying tablet defects are crucial to ensure the production of high-quality tablets that meet the required specifications and regulatory standards. Here are the steps involved in…

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Key Elements of Tablet Formulation Development Process The tablet formulation development process is a critical stage in the pharmaceutical product development life cycle. It involves designing a tablet formulation that ensures the stability, bioavailability, safety, and effectiveness of the drug product. The process requires careful consideration of various factors and the integration of scientific principles…

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Critical Factors Affecting Tablet Uniformity during Production Achieving tablet uniformity during production is essential to ensure that each tablet in a batch contains the correct amount of active pharmaceutical ingredient (API) and other excipients. Tablet uniformity directly impacts the drug’s efficacy, safety, and patient compliance. Several critical factors can influence tablet uniformity during production, and…

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Tablet Dissolution Testing Tablet dissolution testing is a critical quality control test used to assess the rate at which a tablet disintegrates and releases its active pharmaceutical ingredient (API) in a specified dissolution medium. It provides valuable information about the tablet’s drug release profile, which is essential for ensuring the tablet’s bioavailability and effectiveness. Here’s…

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Preparation of Enteric-Coated Tablets Introduction to Enteric-Coated Tablets Enteric-coated tablets are designed to bypass the acidic environment of the stomach and release the medication in the alkaline environment of the small intestine. This coating is essential for drugs that are sensitive to stomach acid or cause gastric irritation. The enteric coating allows for delayed or…

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Tablet Weight Uniformity and Acceptance Criteria Tablet weight uniformity is a critical quality control parameter in tablet manufacturing. It refers to the consistency of the weight of individual tablets within a batch. Ensuring tablet weight uniformity is essential because variations in tablet weight can lead to differences in drug content, which can affect the drug’s…

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Process of Direct Compression for Tablet Manufacturing Introduction to Direct Compression Direct compression is a widely used method for tablet manufacturing in the pharmaceutical industry. It involves the direct compression of a blend of active pharmaceutical ingredients (APIs) and excipients into a tablet without the need for granulation or additional processing steps. This process is…

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