Tag: pharmaceutical quality control

Troubleshooting Brittleness in Coated Tablets During Validation Testing

May 21, 2025 Admin

Troubleshooting Brittleness in Coated Tablets During Validation Testing Troubleshooting Brittleness in Coated Tablets During Validation Testing Introduction: In the pharmaceutical industry, tablets are a common and vital dosage form. They offer precise dosing, ease of administration, and stability. However, the process of coating tablets, which enhances their appearance, taste, and stability, can introduce challenges. One…

Solid Dosage form, Tablets

Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets

May 19, 2025 Admin

Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets Introduction: The pharmaceutical industry is committed to ensuring that medications are safe, effective, and of the highest quality. One critical aspect of this commitment is dissolution testing, particularly for enteric-coated tablets. These tablets…

Solid Dosage form, Tablets

Managing Layer Separation in Bilayer Tablets Under Accelerated Conditions

May 18, 2025 Admin

Managing Layer Separation in Bilayer Tablets Under Accelerated Conditions Managing Layer Separation in Bilayer Tablets Under Accelerated Conditions Introduction: Bilayer tablets are increasingly utilized in the pharmaceutical industry to deliver multiple drugs or different release profiles in a single dosage form. This innovative approach not only enhances patient compliance but also offers significant benefits in…

Solid Dosage form, Tablets

Troubleshooting Non-Adherence to Visual Inspection Standards During Equipment Validation

May 18, 2025 Admin

Troubleshooting Non-Adherence to Visual Inspection Standards During Equipment Validation Troubleshooting Non-Adherence to Visual Inspection Standards During Equipment Validation Introduction: In the pharmaceutical manufacturing industry, particularly in the production of solid dosage forms like tablets, maintaining rigorous quality control is paramount. One of the key components of quality assurance is adhering to visual inspection standards during…

Solid Dosage form, Tablets

Troubleshooting Brittleness in High-Dose Tablets During Compression Validation

May 17, 2025 Admin

Troubleshooting Brittleness in High-Dose Tablets During Compression Validation Troubleshooting Brittleness in High-Dose Tablets During Compression Validation Introduction: In the pharmaceutical industry, tablet formulation and manufacturing represent critical processes that significantly impact the quality, efficacy, and safety of the final product. High-dose tablets are particularly challenging to develop due to the increased risks of brittleness, which…

Solid Dosage form, Tablets

Ensuring Adequate Process Controls for Hygroscopic Tablet Production

May 14, 2025 Admin

Ensuring Adequate Process Controls for Hygroscopic Tablet Production Ensuring Adequate Process Controls for Hygroscopic Tablet Production Introduction: Hygroscopic tablets, known for their ability to absorb moisture from the environment, pose unique challenges in pharmaceutical manufacturing. Ensuring adequate process controls during their production is crucial for maintaining product stability, efficacy, and quality. This comprehensive guide delves…

Solid Dosage form, Tablets

Managing Brittleness in Hygroscopic Tablets Stored Under Dry Conditions

May 14, 2025 Admin

Managing Brittleness in Hygroscopic Tablets Stored Under Dry Conditions Managing Brittleness in Hygroscopic Tablets Stored Under Dry Conditions Introduction: In the pharmaceutical industry, maintaining the integrity of solid dosage forms is crucial for ensuring efficacy and safety. Among these forms, hygroscopic tablets present unique challenges due to their affinity for moisture, which can significantly affect…

Solid Dosage form, Tablets

Ensuring Consistency in Hardness Testing During Validation of Compression Lines

May 11, 2025 Admin

Ensuring Consistency in Hardness Testing During Validation of Compression Lines Ensuring Consistency in Hardness Testing During Validation of Compression Lines Introduction: The pharmaceutical industry places a significant emphasis on the quality and consistency of solid dosage forms, particularly tablets. Tablet hardness is a critical quality attribute that influences not only the tablet’s mechanical strength but…

Solid Dosage form, Tablets

Developing Validation Protocols for Tablet Compression Processes

May 10, 2025 Admin

Developing Validation Protocols for Tablet Compression Processes Developing Validation Protocols for Tablet Compression Processes Introduction: The pharmaceutical industry is tasked with ensuring that medications are both safe and effective for consumer use. Part of this responsibility involves the validation of various processes, including the tablet compression process—a critical step in the manufacturing of solid dosage…

Solid Dosage form, Tablets

Investigating Coating Adhesion Failures in Enteric-Coated Tablets During Testing

May 10, 2025 Admin

Investigating Coating Adhesion Failures in Enteric-Coated Tablets During Testing Investigating Coating Adhesion Failures in Enteric-Coated Tablets During Testing Introduction: Enteric-coated tablets are designed to withstand the acidic environment of the stomach and dissolve in the more neutral environment of the intestines. This targeted drug delivery system is crucial for drugs that are sensitive to stomach…

Solid Dosage form, Tablets

Managing Deviations in Batch Records for Enteric-Coated Tablets

May 9, 2025 Admin

Managing Deviations in Batch Records for Enteric-Coated Tablets Managing Deviations in Batch Records for Enteric-Coated Tablets Introduction: In the pharmaceutical industry, maintaining the integrity of batch records is crucial for ensuring the quality and compliance of drug products. Enteric-coated tablets, designed to withstand the acidic environment of the stomach and dissolve in the more neutral…

Solid Dosage form, Tablets

Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity

May 6, 2025 Admin

Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity Introduction: Extended release tablets are a cornerstone of modern pharmaceutical formulations, offering controlled release of active pharmaceutical ingredients (APIs) over time to improve patient compliance and therapeutic efficacy. However, when these tablets are…

Solid Dosage form, Tablets