Tag: EMA regulations

Problems with maintaining uniform mixing of lipid-based formulations.

April 21, 2025 Admin

Problems with maintaining uniform mixing of lipid-based formulations. Problems with maintaining uniform mixing of lipid-based formulations Introduction: Lipid-based formulations have garnered significant attention in the pharmaceutical industry due to their ability to enhance the solubility and bioavailability of poorly water-soluble drugs. These formulations utilize lipids as carriers, which can improve drug absorption and provide a…

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

Poor validation of analytical methods for capsule testing.

April 18, 2025 Admin

Poor validation of analytical methods for capsule testing. Poor validation of analytical methods for capsule testing. Introduction: The validation of analytical methods is a critical component of pharmaceutical development and manufacturing, especially for solid oral dosage forms like capsules. Both hard and soft gelatin capsules require precise and reliable analytical methods to ensure their safety,…

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

Problems with validating capsule sealing for capsules with delayed-release profiles.

April 3, 2025 Admin

Problems with validating capsule sealing for capsules with delayed-release profiles. Problems with Validating Capsule Sealing for Capsules with Delayed-Release Profiles Introduction: In the pharmaceutical industry, the demand for delayed-release capsules has been on the rise due to their ability to deliver active ingredients at specific sites within the gastrointestinal tract. These capsules are crucial for…

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

Managing Cleaning Validation Failures for Immediate Release Tablet Equipment

March 2, 2025 Admin

Managing Cleaning Validation Failures for Immediate Release Tablet Equipment Managing Cleaning Validation Failures for Immediate Release Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical to product quality and safety. Particularly for immediate release tablets, stringent cleaning protocols prevent cross-contamination and guarantee that residue levels remain within acceptable limits….

Solid Dosage form, Tablets