Tag: USP Guidelines

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

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

Investigating API Potency Retention in Immediate Release Tablets Over Time

May 11, 2025 Admin

Investigating API Potency Retention in Immediate Release Tablets Over Time Investigating API Potency Retention in Immediate Release Tablets Over Time Introduction: In the pharmaceutical industry, ensuring the efficacy and safety of medicinal products is paramount. One critical aspect of this is the potency retention of the Active Pharmaceutical Ingredient (API) in immediate release tablets over…

Solid Dosage form, Tablets

Ensuring Moisture Protection in Primary Packaging for Enteric-Coated Tablets

May 8, 2025 Admin

Ensuring Moisture Protection in Primary Packaging for Enteric-Coated Tablets Ensuring Moisture Protection in Primary Packaging for Enteric-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of enteric-coated tablets is critical. These tablets are specifically designed to pass through the stomach intact and dissolve in the intestine. Moisture exposure can compromise the integrity…

Solid Dosage form, Tablets

Poor reproducibility in dissolution testing results for capsules stored under stressed conditions.

May 3, 2025 Admin

Poor reproducibility in dissolution testing results for capsules stored under stressed conditions. Poor reproducibility in dissolution testing results for capsules stored under stressed conditions. Introduction: Dissolution testing is a critical quality control procedure in the pharmaceutical industry, especially for solid oral dosage forms such as capsules. It ensures that the drug releases at the intended…

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

Challenges in testing capsules with delayed-release profiles.

April 6, 2025 Admin

Challenges in testing capsules with delayed-release profiles. Challenges in testing capsules with delayed-release profiles. Introduction: Delayed-release capsules are a crucial innovation in pharmaceutical science, allowing for the targeted delivery of medications to specific areas of the gastrointestinal tract. By releasing the active ingredient at a predetermined time or location, these capsules enhance the drug’s efficacy…

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

Inadequate protocols for evaluating shell-to-fill interaction effects.

April 5, 2025 Admin

Inadequate protocols for evaluating shell-to-fill interaction effects. Inadequate Protocols for Evaluating Shell-to-Fill Interaction Effects in Capsules Introduction: In the pharmaceutical industry, solid oral dosage forms such as capsules are a staple due to their ease of administration and versatility. Capsules, which can be either hard or soft gelatin, serve as a vehicle to deliver active…

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

Problems with ensuring consistent gelatin plasticizer levels during validation.

April 2, 2025 Admin

Problems with ensuring consistent gelatin plasticizer levels during validation. Problems with Ensuring Consistent Gelatin Plasticizer Levels During Validation Introduction: The pharmaceutical industry faces numerous challenges when it comes to the formulation and validation of solid oral dosage forms, particularly capsules. Among these challenges, ensuring consistent gelatin plasticizer levels is critical in maintaining the quality and…

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

Difficulty in ensuring proper calibration of HVAC flow sensors.

March 23, 2025 Admin

Difficulty in ensuring proper calibration of HVAC flow sensors. Difficulty in Ensuring Proper Calibration of HVAC Flow Sensors Introduction: In pharmaceutical manufacturing, maintaining a controlled environment is crucial to ensure product quality and safety. Heating, Ventilation, and Air Conditioning (HVAC) systems play a pivotal role in regulating these environments. Central to the efficacy of an…

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

Troubleshooting Failures in Content Uniformity Tests for Film-Coated Tablets

March 20, 2025 Admin

Troubleshooting Failures in Content Uniformity Tests for Film-Coated Tablets Troubleshooting Failures in Content Uniformity Tests for Film-Coated Tablets Introduction: Content uniformity is a critical quality attribute in the manufacturing of film-coated tablets. Ensuring that each tablet contains the appropriate amount of active pharmaceutical ingredient (API) is essential for efficacy, safety, and regulatory compliance. Content uniformity…

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

Poor reproducibility in monitoring capsule disintegration times.

March 16, 2025 Admin

Poor reproducibility in monitoring capsule disintegration times. Poor reproducibility in monitoring capsule disintegration times. Introduction: In the realm of pharmaceutical research and manufacturing, ensuring the quality and efficacy of solid oral dosage forms is paramount. Among these, capsules, both hard and soft gelatin, are widely used due to their convenience and efficacy in drug delivery….

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