Tag: USFDA guidelines

Troubleshooting Poor Coating Adhesion in Extended Release Tablets Over Time

May 3, 2025 Admin

Troubleshooting Poor Coating Adhesion in Extended Release Tablets Over Time Troubleshooting Poor Coating Adhesion in Extended Release Tablets Over Time Introduction: Extended release tablets are a crucial aspect of modern pharmaceutical delivery systems, offering consistent therapeutic effects over extended periods. However, the integrity of their coating is paramount to ensure proper drug release and efficacy….

Solid Dosage form, Tablets

Ensuring Consistency in Disintegration Time During Long-Term Stability Studies

May 3, 2025 Admin

Ensuring Consistency in Disintegration Time During Long-Term Stability Studies Ensuring Consistency in Disintegration Time During Long-Term Stability Studies Introduction: In the realm of pharmaceuticals, ensuring consistency in the disintegration time of tablets during long-term stability studies is pivotal for guaranteeing a drug’s efficacy, safety, and patient compliance. Disintegration time is a critical quality attribute that…

Solid Dosage form, Tablets

Inadequate inspection systems for detecting visual defects in capsules.

May 1, 2025 Admin

Inadequate inspection systems for detecting visual defects in capsules. Inadequate Inspection Systems for Detecting Visual Defects in Capsules Introduction: In the pharmaceutical industry, ensuring the quality and safety of solid oral dosage forms, such as capsules, is paramount. Capsules, whether hard or soft gelatin, are popular for their convenience and effectiveness in delivering medications. However,…

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

Addressing Print Smudging on Flexible Packaging Materials

April 29, 2025 Admin

Addressing Print Smudging on Flexible Packaging Materials Addressing Print Smudging on Flexible Packaging Materials Introduction: In the pharmaceutical industry, the integrity of packaging plays a crucial role in maintaining the safety, efficacy, and compliance of pharmaceutical products. Flexible packaging materials, such as foils, films, and laminates, are commonly used due to their versatility and cost-effectiveness….

Solid Dosage form, Tablets

Difficulty in ensuring consistent gelatin viscosity during preparation.

April 29, 2025 Admin

Difficulty in ensuring consistent gelatin viscosity during preparation. Difficulty in Ensuring Consistent Gelatin Viscosity During Preparation Introduction: In the pharmaceutical industry, ensuring the consistent viscosity of gelatin during the preparation of capsules is crucial. Gelatin is a key component in both hard and soft gelatin capsules, which are popular solid oral dosage forms due to…

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

Difficulty in monitoring capsule moisture content during accelerated stability studies.

April 28, 2025 Admin

Difficulty in monitoring capsule moisture content during accelerated stability studies. Difficulty in monitoring capsule moisture content during accelerated stability studies. Introduction: Monitoring the moisture content in capsules during accelerated stability studies is a critical component in the pharmaceutical industry. These studies are essential for predicting the shelf life and ensuring the quality, safety, and efficacy…

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

Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets

April 28, 2025 Admin

Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets Introduction: Coated tablets are a widely used solid dosage form in the pharmaceutical industry, offering benefits such as improved taste masking, controlled drug release, and enhanced stability. However, achieving consistent dissolution profiles is critical as it directly impacts the…

Solid Dosage form, Tablets

Challenges in predicting the impact of packaging material permeability on capsule stability.

April 28, 2025 Admin

Challenges in predicting the impact of packaging material permeability on capsule stability. Challenges in predicting the impact of packaging material permeability on capsule stability. Introduction: In the pharmaceutical industry, ensuring the stability of capsules—whether hard or soft gelatin—is a critical component of the drug development process. Packaging plays a pivotal role in preserving the integrity…

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

Challenges in validating nitrogen systems used for capsule storage.

April 26, 2025 Admin

Challenges in validating nitrogen systems used for capsule storage. Challenges in validating nitrogen systems used for capsule storage. Introduction: In the pharmaceutical industry, the storage of solid oral dosage forms such as capsules necessitates meticulous environmental control to maintain product stability and efficacy. Nitrogen systems are frequently employed to create an inert atmosphere, thereby preventing…

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

Difficulty in ensuring proper calibration of flow meters in water distribution systems.

April 26, 2025 Admin

Difficulty in ensuring proper calibration of flow meters in water distribution systems. Difficulty in ensuring proper calibration of flow meters in water distribution systems. Introduction: Flow meters play a critical role in water distribution systems, especially within pharmaceutical manufacturing, where precision and accuracy are paramount. Ensuring the proper calibration of these devices is vital to…

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

Resolving Tablet Displacement in Blister Cavities During Packaging

April 25, 2025 Admin

Resolving Tablet Displacement in Blister Cavities During Packaging Resolving Tablet Displacement in Blister Cavities During Packaging Introduction: In the pharmaceutical industry, the packaging of solid dosage forms like tablets is a critical process that ensures product integrity, stability, and patient safety. Blister packaging is one of the most common methods used to protect tablets from…

Solid Dosage form, Tablets

High variability in capsule weight due to poor powder flow properties.

April 25, 2025 Admin

High variability in capsule weight due to poor powder flow properties. High variability in capsule weight due to poor powder flow properties. Introduction: The pharmaceutical industry consistently strives to achieve high standards of quality and efficacy in its products. Solid oral dosage forms, such as capsules, play a critical role in this landscape. However, one…

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