Tag: pharmaceutical process validation

Troubleshooting Brittleness in High-Dose Tablets During Compression Validation

May 17, 2025 Admin

Troubleshooting Brittleness in High-Dose Tablets During Compression Validation Troubleshooting Brittleness in High-Dose Tablets During Compression Validation Introduction: In the pharmaceutical industry, tablet formulation and manufacturing represent critical processes that significantly impact the quality, efficacy, and safety of the final product. High-dose tablets are particularly challenging to develop due to the increased risks of brittleness, which…

Solid Dosage form, Tablets

Poor reproducibility in capsule drying validation results for multi-layer formulations.

April 19, 2025 Admin

Poor reproducibility in capsule drying validation results for multi-layer formulations. Poor reproducibility in capsule drying validation results for multi-layer formulations. Introduction: The pharmaceutical industry continuously strives to enhance the quality and efficacy of solid oral dosage forms, including capsules. Among these, multi-layer formulations have gained popularity due to their ability to deliver complex dosing regimens…

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

Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation

April 17, 2025 Admin

Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation Introduction: The pharmaceutical industry demands precision and excellence, especially when it comes to manufacturing solid dosage forms like tablets. One crucial aspect of this process is the coating of tablets, which serves not only aesthetic…

Solid Dosage form, Tablets

Inadequate systems for monitoring the alignment of capsule parts during validation.

April 15, 2025 Admin

Inadequate systems for monitoring the alignment of capsule parts during validation. Inadequate systems for monitoring the alignment of capsule parts during validation. Introduction: In the pharmaceutical industry, the integrity of solid oral dosage forms, such as capsules, is paramount to ensuring the efficacy and safety of medications. Among the critical steps in capsule manufacturing is…

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

Challenges in validating capsule filling for powders with poor flow properties.

April 3, 2025 Admin

Challenges in validating capsule filling for powders with poor flow properties. Challenges in Validating Capsule Filling for Powders with Poor Flow Properties Introduction: In the realm of solid oral dosage forms, capsules stand out for their versatility and patient compliance. However, ensuring consistent and accurate filling of capsules, especially when dealing with powders possessing poor…

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

Addressing Granule Segregation During Roller Compaction

March 19, 2025 Admin

Addressing Granule Segregation During Roller Compaction Addressing Granule Segregation During Roller Compaction Introduction: In the realm of pharmaceutical manufacturing, ensuring the uniformity and quality of solid dosage forms such as tablets is crucial. Roller compaction is a dry granulation process commonly used to improve the flow properties and compressibility of powders. However, one of the…

Solid Dosage form, Tablets

Challenges in validating capsule drying processes for multi-dose formulations.

March 5, 2025 Admin

Challenges in validating capsule drying processes for multi-dose formulations. Challenges in validating capsule drying processes for multi-dose formulations. Introduction: In the pharmaceutical industry, the validation of capsule drying processes for multi-dose formulations is a critical component in ensuring the quality and efficacy of the final product. As capsules are widely used due to their versatility…

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