Tag: pharmaceutical compliance

Resolving Failures in Moisture Content Tests for Sugar-Coated Tablets

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Resolving Failures in Moisture Content Tests for Sugar-Coated Tablets Resolving Failures in Moisture Content Tests for Sugar-Coated Tablets Introduction: In the pharmaceutical industry, sugar-coated tablets are a popular dosage form due to their aesthetic appeal and ability to mask unpleasant tastes. However, maintaining the correct moisture content in these tablets is crucial, as it affects…

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Solid Dosage form, Tablets

Troubleshooting Over-Drying in Coated Tablets During Finishing

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Troubleshooting Over-Drying in Coated Tablets During Finishing Troubleshooting Over-Drying in Coated Tablets During Finishing Introduction: The pharmaceutical industry is continually innovating to ensure the highest quality of products. Among the various dosage forms, coated tablets are one of the most prevalent, owing to their aesthetic appeal, ease of swallowing, and controlled release capabilities. However, the…

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Solid Dosage form, Tablets

Preventing Granule Breakage During Fluid Bed Drying

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Preventing Granule Breakage During Fluid Bed Drying Preventing Granule Breakage During Fluid Bed Drying Introduction: In the pharmaceutical industry, fluid bed drying is a critical process in the production of solid dosage forms, particularly tablets. This method is favored for its efficiency in drying granules, which are the intermediate product before compression into tablets. However,…

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Solid Dosage form, Tablets

Poor reproducibility in labeling accuracy on capsule containers.

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Poor reproducibility in labeling accuracy on capsule containers. Poor Reproducibility in Labeling Accuracy on Capsule Containers Introduction: In the pharmaceutical industry, accurate labeling of capsule containers is crucial for ensuring patient safety, regulatory compliance, and brand integrity. Labels provide essential information, such as dosage instructions, expiration dates, and identification details, which are critical for both…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Resolving Failures in Disintegration Testing for Sustained Release Tablets

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Resolving Failures in Disintegration Testing for Sustained Release Tablets Resolving Failures in Disintegration Testing for Sustained Release Tablets Introduction: In the pharmaceutical industry, ensuring the efficacy and safety of solid dosage forms such as tablets is paramount. Sustained release tablets, designed to release a drug at a predetermined rate, present unique challenges in quality control,…

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Solid Dosage form, Tablets

Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets

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Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets Introduction: Enteric tablets are specially designed solid dosage forms that remain intact in the acidic environment of the stomach and dissolve in the more neutral pH of the intestine. This ensures that active pharmaceutical ingredients (APIs) are released at…

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Solid Dosage form, Tablets

Managing Documentation Errors in Stability Testing Records

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Managing Documentation Errors in Stability Testing Records Managing Documentation Errors in Stability Testing Records Introduction: In the pharmaceutical industry, stability testing is a critical process that ensures the safety, efficacy, and quality of drug products over their shelf life. Proper documentation of stability testing records is vital for maintaining compliance with regulatory standards such as…

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Solid Dosage form, Tablets

Managing Failures in Stress Testing for Controlled Release Tablets

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Managing Failures in Stress Testing for Controlled Release Tablets Managing Failures in Stress Testing for Controlled Release Tablets Introduction: In the pharmaceutical industry, controlled release tablets play a pivotal role in ensuring the precise delivery of active pharmaceutical ingredients (APIs) over an extended period. These tablets are designed to optimize therapeutic efficacy and improve patient…

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Solid Dosage form, Tablets

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

Resolving Issues in Stability Testing for Immediate Release Tablets

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Resolving Issues in Stability Testing for Immediate Release Tablets Resolving Issues in Stability Testing for Immediate Release Tablets Introduction: Stability testing is a critical component in the development and lifecycle management of pharmaceutical products. For immediate release tablets, which are designed to disintegrate and release their active ingredients promptly upon administration, ensuring stability is paramount….

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Solid Dosage form, Tablets

Addressing Deviations in Process Validation for Sugar-Coated Tablets

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Addressing Deviations in Process Validation for Sugar-Coated Tablets Addressing Deviations in Process Validation for Sugar-Coated Tablets Introduction: The pharmaceutical industry continuously strives for excellence in manufacturing practices, ensuring product quality and compliance with stringent regulations. Among various dosage forms, sugar-coated tablets remain a staple due to their ability to mask unpleasant tastes and enhance the…

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Solid Dosage form, Tablets