Tag: pharmaceutical quality assurance]

Managing Over-Compression in Tablets with High-Dose APIs

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Managing Over-Compression in Tablets with High-Dose APIs Managing Over-Compression in Tablets with High-Dose APIs Introduction: The pharmaceutical industry is increasingly challenged with the development and manufacturing of tablets that contain high-dose Active Pharmaceutical Ingredients (APIs). While these tablets are crucial for ensuring therapeutic efficacy, they come with a unique set of challenges, particularly in terms…

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Solid Dosage form, Tablets

Difficulty in validating capsule filling processes for multi-dose formulations.

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Difficulty in validating capsule filling processes for multi-dose formulations. Difficulty in validating capsule filling processes for multi-dose formulations. Introduction: In the pharmaceutical industry, capsule filling processes for multi-dose formulations present unique challenges that require careful validation to ensure product quality and patient safety. As capsules remain a popular dosage form due to their convenience, stability,…

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

Real-Time Adjustment of Compression Force for Uniform Tablet Hardness

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Real-Time Adjustment of Compression Force for Uniform Tablet Hardness Real-Time Adjustment of Compression Force for Uniform Tablet Hardness Introduction: In the pharmaceutical industry, ensuring the uniformity and quality of tablets is paramount. Among the various factors that influence tablet quality, the hardness of tablets is crucial as it affects not only the mechanical strength but…

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Solid Dosage form, Tablets

Preventing Layer Cracking in Multi-Layer Tablets During Storage

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Preventing Layer Cracking in Multi-Layer Tablets During Storage Preventing Layer Cracking in Multi-Layer Tablets During Storage Introduction: Multi-layer tablets are an increasingly popular pharmaceutical dosage form due to their ability to deliver multiple active ingredients with different release profiles in a single dosage unit. Despite their benefits, these tablets are susceptible to layer cracking during…

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Solid Dosage form, Tablets

Inadequate systems for monitoring capsule defect trends over time.

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Inadequate systems for monitoring capsule defect trends over time. Inadequate systems for monitoring capsule defect trends over time. Introduction: The pharmaceutical industry is under constant pressure to maintain high standards of quality and safety, particularly when it comes to solid oral dosage forms such as capsules. Capsules, which can be either hard or soft gelatin,…

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

Difficulty in testing for uniformity of multi-particulate capsule formulations.

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Difficulty in testing for uniformity of multi-particulate capsule formulations. Difficulty in testing for uniformity of multi-particulate capsule formulations. Introduction: In the pharmaceutical industry, ensuring the uniformity of dosage units is crucial for both efficacy and safety. Multi-particulate capsule formulations are increasingly popular due to their flexibility in delivering a consistent dose of active pharmaceutical ingredients…

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

Managing Material Shrinkage in Heat-Sealed Tablet Pouches

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Managing Material Shrinkage in Heat-Sealed Tablet Pouches Managing Material Shrinkage in Heat-Sealed Tablet Pouches Introduction: In the pharmaceutical industry, the packaging of solid dosage forms such as tablets is crucial for maintaining their integrity, efficacy, and shelf life. Heat-sealed tablet pouches are a popular choice due to their protective properties and ease of use. However,…

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Solid Dosage form, Tablets

Managing Variability in Dissolution Testing for Immediate Release Tablets

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Managing Variability in Dissolution Testing for Immediate Release Tablets Managing Variability in Dissolution Testing for Immediate Release Tablets Introduction: Dissolution testing is a critical quality control measure in the pharmaceutical industry, particularly for immediate release tablets. This test ensures that the tablet releases its active ingredients at the desired rate and extent, which is crucial…

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Solid Dosage form, Tablets

Addressing Non-Conformance in Weight Variation Tests During QA Audits

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Addressing Non-Conformance in Weight Variation Tests During QA Audits Addressing Non-Conformance in Weight Variation Tests During QA Audits Introduction: In the realm of pharmaceutical manufacturing, ensuring the quality and consistency of solid dosage forms like tablets is paramount. One critical parameter assessed during quality assurance (QA) audits is the weight variation of tablets. Consistent tablet…

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Solid Dosage form, Tablets

Troubleshooting Layer Cracks in Bilayer Tablets During Validation

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Troubleshooting Layer Cracks in Bilayer Tablets During Validation Troubleshooting Layer Cracks in Bilayer Tablets During Validation Introduction: Bilayer tablets have gained significant traction in the pharmaceutical industry due to their ability to deliver multiple drugs with distinct release profiles in a single dosage form. However, during the manufacturing process, these tablets can present unique challenges,…

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Solid Dosage form, Tablets

Managing Hardness Failures in Bilayer Tablets During Testing

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Managing Hardness Failures in Bilayer Tablets During Testing Managing Hardness Failures in Bilayer Tablets During Testing Introduction: In the pharmaceutical industry, bilayer tablets have emerged as a sophisticated solution for delivering multiple drugs or varied release profiles within a single dosage form. This innovation not only enhances patient compliance but also optimizes therapeutic efficacy by…

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Solid Dosage form, Tablets

Troubleshooting Over-Spray in Sugar-Coating Machines

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Troubleshooting Over-Spray in Sugar-Coating Machines Troubleshooting Over-Spray in Sugar-Coating Machines Introduction: Sugar-coating is a traditional and widely used technique in the pharmaceutical industry to enhance the appearance, taste, and stability of tablets. However, one of the common challenges faced during the sugar-coating process is over-spray, which can lead to product imperfections and inefficiencies. This blog…

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Solid Dosage form, Tablets