Tag: API Stability

Managing Failures in Stress Tests for Sustained Release Tablets

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Managing Failures in Stress Tests for Sustained Release Tablets Managing Failures in Stress Tests for Sustained Release Tablets Introduction: Sustained release tablets are critical in modern pharmaceutical formulations, offering controlled drug release over extended periods. These tablets enhance patient compliance by reducing the frequency of dosing and maintaining therapeutic drug levels. However, ensuring their effectiveness…

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Solid Dosage form, Tablets

Managing Failures in Moisture Content Tests for Hygroscopic APIs

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Managing Failures in Moisture Content Tests for Hygroscopic APIs Managing Failures in Moisture Content Tests for Hygroscopic APIs Introduction: In the pharmaceutical industry, Active Pharmaceutical Ingredients (APIs) form the backbone of drug manufacturing. Among these, hygroscopic APIs present unique challenges due to their inherent ability to absorb moisture from the environment. Accurate moisture content testing…

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Solid Dosage form, Tablets

Addressing Heat Sensitivity of APIs During Validation of Coated Tablets

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Addressing Heat Sensitivity of APIs During Validation of Coated Tablets Addressing Heat Sensitivity of APIs During Validation of Coated Tablets Introduction: The pharmaceutical industry continuously strives to enhance the efficacy, stability, and safety of drug products. One of the critical aspects of drug formulation is the management of active pharmaceutical ingredients (APIs) that exhibit sensitivity…

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Solid Dosage form, Tablets

Addressing Challenges in Coating Integrity Tests During Stability Studies

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Addressing Challenges in Coating Integrity Tests During Stability Studies Addressing Challenges in Coating Integrity Tests During Stability Studies Introduction: In the pharmaceutical industry, the stability of a drug product is paramount for ensuring its safety, efficacy, and quality throughout its shelf life. One crucial aspect of this stability is the integrity of tablet coatings. Coating…

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Solid Dosage form, Tablets