Tag: pharmaceutical compliance

Resolving Failures in Disintegration Testing for High-Dose Tablets

March 10, 2025 Admin

Resolving Failures in Disintegration Testing for High-Dose Tablets Resolving Failures in Disintegration Testing for High-Dose Tablets Introduction: In the pharmaceutical industry, the production of high-dose tablets is a critical process that requires rigorous quality control measures to ensure efficacy and safety. Disintegration testing serves as a cornerstone in evaluating the performance of these tablets, as…

Solid Dosage form, Tablets

Managing Failure in Moisture Content Tests for Hygroscopic Tablets

March 10, 2025 Admin

Managing Failure in Moisture Content Tests for Hygroscopic Tablets Managing Failure in Moisture Content Tests for Hygroscopic Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of medicinal products is paramount. Hygroscopic tablets, which are prone to absorbing moisture from the environment, present unique challenges in this regard. Moisture content tests are critical…

Solid Dosage form, Tablets

Real-Time Adjustment of Granulation Parameters for Uniformity

March 9, 2025 Admin

Real-Time Adjustment of Granulation Parameters for Uniformity Real-Time Adjustment of Granulation Parameters for Uniformity Introduction: In the pharmaceutical industry, the uniformity of granulation is critical for ensuring the quality and efficacy of solid dosage forms, particularly tablets. Granulation is a pivotal step in the tablet manufacturing process, where powder particles are aggregated to form granules….

Solid Dosage form, Tablets

Troubleshooting Residual API Issues in Granulation Vessels Used for Extended Release Tablets

March 9, 2025 Admin

Troubleshooting Residual API Issues in Granulation Vessels Used for Extended Release Tablets Troubleshooting Residual API Issues in Granulation Vessels Used for Extended Release Tablets Introduction: In the pharmaceutical industry, the production of extended release tablets requires precise formulation and meticulous processing to ensure therapeutic efficacy and patient safety. Granulation vessels play a crucial role in…

Solid Dosage form, Tablets

Inadequate systems for monitoring capsule integrity during validation.

March 9, 2025 Admin

Inadequate systems for monitoring capsule integrity during validation. Inadequate Systems for Monitoring Capsule Integrity During Validation Introduction: In the pharmaceutical industry, the integrity of capsules, whether hard or soft gelatin, is crucial for ensuring the efficacy and safety of the medication contained within. Monitoring capsule integrity during validation is an essential part of the manufacturing…

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

Preventing Core Breakage in Multi-Layer Tablets During Compression

March 8, 2025 Admin

Preventing Core Breakage in Multi-Layer Tablets During Compression Preventing Core Breakage in Multi-Layer Tablets During Compression Introduction: In the pharmaceutical industry, the development of multi-layer tablets offers a strategic approach to deliver multiple active pharmaceutical ingredients (APIs) or to control the release profiles of medications. However, the manufacturing of these complex dosage forms presents unique…

Solid Dosage form, Tablets

Managing Residual Solvent Contamination in Utility Lines for Coated Tablets

March 8, 2025 Admin

Managing Residual Solvent Contamination in Utility Lines for Coated Tablets Managing Residual Solvent Contamination in Utility Lines for Coated Tablets Introduction: Residual solvent contamination in utility lines presents a significant challenge in the production of coated tablets. These solvents, often used in pharmaceutical manufacturing processes, must be carefully managed to ensure product safety, efficacy, and…

Solid Dosage form, Tablets

Difficulty in validating capsule sealing for capsules with multi-layer fills.

March 8, 2025 Admin

Difficulty in validating capsule sealing for capsules with multi-layer fills. Difficulty in validating capsule sealing for capsules with multi-layer fills Introduction: Capsules have long been a preferred dosage form in the pharmaceutical industry due to their versatility and convenience. The advent of multi-layer fills in capsules has paved the way for innovative drug delivery systems….

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

Addressing Layer Delamination Issues During Disintegration Testing

March 8, 2025 Admin

Addressing Layer Delamination Issues During Disintegration Testing Addressing Layer Delamination Issues During Disintegration Testing Introduction: In the world of pharmaceuticals, ensuring the integrity of solid dosage forms like tablets is of utmost importance. Layer delamination, a challenge often encountered during disintegration testing, can compromise the efficacy and safety of a pharmaceutical product. This phenomenon occurs…

Solid Dosage form, Tablets

Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets

March 8, 2025 Admin

Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets Introduction: Weight uniformity testing is a critical quality control measure in the pharmaceutical industry, particularly for immediate release tablets. Ensuring consistency in tablet weight is essential not only for compliance with regulatory standards but also…

Solid Dosage form, Tablets

Difficulty in ensuring consistent gelatin solution cooling rates.

March 7, 2025 Admin

Difficulty in ensuring consistent gelatin solution cooling rates. Difficulty in ensuring consistent gelatin solution cooling rates. Introduction: Gelatin capsules, both hard and soft, are a vital part of the pharmaceutical landscape. Their popularity stems from their ability to encapsulate a wide range of formulations, offering precise dosage and bioavailability. However, one of the critical aspects…

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

Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity

March 7, 2025 Admin

Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity Introduction: In the pharmaceutical industry, maintaining the stability and efficacy of drug products is paramount. Coated tablets, a common solid dosage form, are often designed with specific moisture content to ensure their integrity and therapeutic…

Solid Dosage form, Tablets