Tag: Regulatory compliance

Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets

May 12, 2025 Admin

Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets Introduction: Enteric-coated tablets are a critical part of modern pharmacology, designed to protect active ingredients from the acidic environment of the stomach and ensure release in the more neutral pH of the intestine. This targeted delivery system…

Solid Dosage form, Tablets

Managing Layer Delamination Issues in Multi-Layer Tablets During Validation

May 12, 2025 Admin

Managing Layer Delamination Issues in Multi-Layer Tablets During Validation Managing Layer Delamination Issues in Multi-Layer Tablets During Validation Introduction: In the pharmaceutical industry, multi-layer tablets are a popular dosage form due to their ability to deliver multiple drugs or distinct release profiles in a single tablet. However, manufacturing such tablets comes with its own set…

Solid Dosage form, Tablets

Validating Cleaning Protocols for Sugar-Coating Pans

May 12, 2025 Admin

Validating Cleaning Protocols for Sugar-Coating Pans Validating Cleaning Protocols for Sugar-Coating Pans Introduction: In the pharmaceutical industry, the integrity of solid dosage forms, such as tablets, is paramount. A critical aspect of this process is ensuring that the equipment used, particularly sugar-coating pans, is thoroughly cleaned between batches. This not only prevents cross-contamination but also…

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

Managing Brittleness in High-Dose Tablets Under Stability Conditions

May 11, 2025 Admin

Managing Brittleness in High-Dose Tablets Under Stability Conditions Managing Brittleness in High-Dose Tablets Under Stability Conditions Introduction: In the pharmaceutical industry, the development of high-dose tablets presents several challenges, particularly concerning their brittleness under stability conditions. Brittleness can compromise the efficacy, safety, and quality of the medication, which is crucial for patient health. Understanding and…

Solid Dosage form, Tablets

Managing API Migration in Multi-API Tablets During Stability Testing

May 11, 2025 Admin

Managing API Migration in Multi-API Tablets During Stability Testing Managing API Migration in Multi-API Tablets During Stability Testing Introduction: In the ever-evolving world of pharmaceuticals, the development of multi-active pharmaceutical ingredient (API) tablets has gained significant momentum. These formulations offer the advantage of delivering multiple therapeutic effects in a single dose, enhancing patient compliance and…

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

Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation

May 10, 2025 Admin

Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation Introduction: In the pharmaceutical industry, multi-layer tablets are gaining prominence due to their ability to deliver multiple drugs or release profiles within a single dosage form. This complexity brings forth challenges, particularly in ensuring consistency…

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

Troubleshooting Calibration Failures in Dissolution Testing Equipment

May 10, 2025 Admin

Troubleshooting Calibration Failures in Dissolution Testing Equipment Troubleshooting Calibration Failures in Dissolution Testing Equipment Introduction: Dissolution testing is a critical process in the pharmaceutical industry, serving as a quality control measure to ensure the efficacy and safety of tablets and other solid dosage forms. Calibration of dissolution testing equipment is essential for accurate and reliable…

Solid Dosage form, Tablets

Optimizing Desiccant Placement for Sustained Release Tablet Packaging

May 9, 2025 Admin

Optimizing Desiccant Placement for Sustained Release Tablet Packaging Optimizing Desiccant Placement for Sustained Release Tablet Packaging Introduction: In the pharmaceutical industry, the integrity of drug products is paramount, particularly for sustained release tablets that require precise control over their release mechanisms. A crucial aspect of ensuring the efficacy and safety of these medications is effective…

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