Tag: pharmaceutical quality

Addressing Layer Separation in Multi-Layer Tablets During Compression

March 22, 2025 Admin

Addressing Layer Separation in Multi-Layer Tablets During Compression Addressing Layer Separation in Multi-Layer Tablets During Compression Introduction: Multi-layer tablets have become an integral part of modern pharmaceutical dosage forms, offering the ability to combine multiple active pharmaceutical ingredients (APIs) and release profiles in a single unit. This design provides enhanced patient compliance and optimized therapeutic…

Solid Dosage form, Tablets

Managing Root Cause Analysis for Failures in Stability Studies

March 22, 2025 Admin

Managing Root Cause Analysis for Failures in Stability Studies Managing Root Cause Analysis for Failures in Stability Studies Introduction: In the pharmaceutical industry, stability studies are crucial to ensuring that a drug product maintains its intended quality, safety, and efficacy throughout its shelf life. Failures in stability studies can lead to significant setbacks in drug…

Solid Dosage form, Tablets

Poor reproducibility in rinse sampling results during cleaning validation.

March 22, 2025 Admin

Poor reproducibility in rinse sampling results during cleaning validation. Poor reproducibility in rinse sampling results during cleaning validation. Introduction: In the pharmaceutical industry, ensuring that manufacturing equipment is free from contaminants is crucial for maintaining product quality and safety. Cleaning validation is a critical process that verifies the effectiveness of cleaning procedures. One of the…

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

Addressing Over-Lubrication in Powder Mixtures for Blending

March 21, 2025 Admin

Addressing Over-Lubrication in Powder Mixtures for Blending Addressing Over-Lubrication in Powder Mixtures for Blending Introduction: In the pharmaceutical industry, the formulation of solid dosage forms like tablets is a finely tuned process that requires precision and careful consideration of multiple variables. Among these, the use of lubricants in powder mixtures for blending is crucial to…

Solid Dosage form, Tablets

Root Cause Analysis for Failures in Coating Layer Adhesion Tests

March 21, 2025 Admin

Root Cause Analysis for Failures in Coating Layer Adhesion Tests Root Cause Analysis for Failures in Coating Layer Adhesion Tests Introduction: The pharmaceutical industry continually strives to optimize the quality and efficiency of its products. Among the various solid dosage forms, tablets are particularly popular due to their stability, ease of administration, and manufacturing efficiency….

Solid Dosage form, Tablets

Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets

March 21, 2025 Admin

Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets Introduction: Enteric tablets are specially designed to withstand the acidic environment of the stomach and dissolve in the more neutral pH of the intestines. This targeted dissolution is critical for drugs that are sensitive to stomach acid…

Solid Dosage form, Tablets

Preventing Cracking in Coated Tablets Due to Temperature Fluctuations

March 20, 2025 Admin

Preventing Cracking in Coated Tablets Due to Temperature Fluctuations Preventing Cracking in Coated Tablets Due to Temperature Fluctuations Introduction: In the pharmaceutical industry, the integrity of coated tablets is crucial for ensuring their efficacy and stability. Coated tablets are designed to provide a protective layer that can enhance the product’s shelf life, mask unpleasant tastes,…

Solid Dosage form, Tablets

Troubleshooting Failures in Visual Inspection Criteria During Cleaning Validation

March 20, 2025 Admin

Troubleshooting Failures in Visual Inspection Criteria During Cleaning Validation Troubleshooting Failures in Visual Inspection Criteria During Cleaning Validation Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment after processing is imperative to maintain product quality and patient safety. Cleaning validation is a critical component of Good Manufacturing Practice (GMP) compliance, particularly during the…

Solid Dosage form, Tablets

Addressing Core Crumbling in Multi-Layer Tablet Compression

March 20, 2025 Admin

Addressing Core Crumbling in Multi-Layer Tablet Compression Addressing Core Crumbling in Multi-Layer Tablet Compression Introduction: The pharmaceutical industry constantly strives to improve the quality and efficacy of solid dosage forms, particularly tablets. Multi-layer tablets have gained popularity due to their ability to deliver more than one active ingredient with different release profiles. However, the manufacturing…

Solid Dosage form, Tablets

Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets

March 20, 2025 Admin

Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of solid dosage forms such as multi-layer tablets is of paramount importance. Multi-layer tablets offer the advantage of combining different drugs or release profiles in a single…

Solid Dosage form, Tablets

Troubleshooting Cracking in Enteric-Coated Tablets During Drying

March 19, 2025 Admin

Troubleshooting Cracking in Enteric-Coated Tablets During Drying Troubleshooting Cracking in Enteric-Coated Tablets During Drying Introduction: Enteric-coated tablets are a vital component of modern pharmaceuticals, designed to withstand the acidic environment of the stomach and dissolve in the more neutral pH of the intestine. This targeted delivery is crucial for the efficacy and safety of certain…

Solid Dosage form, Tablets

Ensuring Consistency in Coating Thickness During Stress Testing

March 19, 2025 Admin

Ensuring Consistency in Coating Thickness During Stress Testing Ensuring Consistency in Coating Thickness During Stress Testing Introduction: In the pharmaceutical industry, the coating of tablets is a critical process that ensures not only the aesthetic appeal but also the functional performance of the dosage form. A consistent coating thickness is vital for maintaining the integrity…

Solid Dosage form, Tablets