Tag: pharmaceutical compliance

Difficulty in testing gelatin-free capsules for uniformity.

March 7, 2025 Admin

Difficulty in testing gelatin-free capsules for uniformity. Difficulty in Testing Gelatin-Free Capsules for Uniformity Introduction: In the evolving landscape of pharmaceutical formulations, gelatin-free capsules have emerged as a significant advancement, especially for those seeking vegetarian or vegan alternatives. These capsules not only cater to dietary preferences but also overcome some of the limitations associated with…

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

Addressing Cross-Contamination Risks in Utility Systems for Hygroscopic Tablets

March 7, 2025 Admin

Addressing Cross-Contamination Risks in Utility Systems for Hygroscopic Tablets Addressing Cross-Contamination Risks in Utility Systems for Hygroscopic Tablets Introduction: In the pharmaceutical industry, ensuring the integrity and safety of drug products is paramount. Hygroscopic tablets, which readily absorb moisture from the environment, pose unique challenges during manufacturing. Cross-contamination in utility systems can compromise the quality…

Solid Dosage form, Tablets

Resolving Non-Compliance in Dissolution Testing for Extended Release Tablets

March 7, 2025 Admin

Resolving Non-Compliance in Dissolution Testing for Extended Release Tablets Resolving Non-Compliance in Dissolution Testing for Extended Release Tablets Introduction: In the pharmaceutical industry, dissolution testing is a critical quality control measure, especially for extended release tablets. This testing ensures that the drug releases its active ingredients at the desired rate and duration, which is essential…

Solid Dosage form, Tablets

Challenges in ensuring proper alignment of capsule packs in cartons.

March 7, 2025 Admin

Challenges in ensuring proper alignment of capsule packs in cartons. Challenges in ensuring proper alignment of capsule packs in cartons. Introduction: Proper alignment of capsule packs in cartons is a critical component in pharmaceutical manufacturing and packaging. This process is crucial to ensure product integrity, safety, and compliance with stringent industry regulations. Ensuring that capsule…

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

Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing

March 7, 2025 Admin

Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing Introduction: Coated tablets are a prevalent form of medication delivery in the pharmaceutical industry, designed to improve the stability, appearance, and release characteristics of the active pharmaceutical ingredient (API). The disintegration of these tablets is a critical quality attribute…

Solid Dosage form, Tablets

Poor reproducibility in monitoring capsule disintegration profiles.

March 6, 2025 Admin

Poor reproducibility in monitoring capsule disintegration profiles. Poor reproducibility in monitoring capsule disintegration profiles. Introduction: The disintegration profile of capsules is a critical quality attribute that significantly impacts the bioavailability and therapeutic efficacy of the drug product. Ensuring consistent and reproducible disintegration times is essential for achieving regulatory compliance and maintaining product quality. Despite its…

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

Ensuring Uniform Blending of APIs in Powder Mixtures

March 6, 2025 Admin

Ensuring Uniform Blending of APIs in Powder Mixtures Ensuring Uniform Blending of APIs in Powder Mixtures Introduction: In pharmaceutical manufacturing, particularly in the production of solid dosage forms like tablets, the uniform blending of Active Pharmaceutical Ingredients (APIs) in powder mixtures is critical. This process ensures that each tablet contains the intended dosage and achieves…

Solid Dosage form, Tablets

Managing Failures in Steam Quality Validation for Multi-Layer Tablet Equipment

March 6, 2025 Admin

Managing Failures in Steam Quality Validation for Multi-Layer Tablet Equipment Managing Failures in Steam Quality Validation for Multi-Layer Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the high quality of steam used in the manufacturing of multi-layer tablets is crucial. Steam quality validation is an essential process that guarantees the steam used is free of…

Solid Dosage form, Tablets

Inadequate methods for monitoring capsule brittleness under low humidity conditions.

March 6, 2025 Admin

Inadequate methods for monitoring capsule brittleness under low humidity conditions. Inadequate Methods for Monitoring Capsule Brittleness Under Low Humidity Conditions Introduction: Capsules, both hard and soft gelatin, are a prevalent form of solid oral dosage forms in the pharmaceutical industry. Ensuring their integrity and efficacy is crucial for therapeutic effectiveness. One of the significant challenges…

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

Validating Clean Steam Systems for Sustained Release Tablet Coating Machines

March 5, 2025 Admin

Validating Clean Steam Systems for Sustained Release Tablet Coating Machines Validating Clean Steam Systems for Sustained Release Tablet Coating Machines Introduction: In the pharmaceutical industry, the precision and reliability of equipment are crucial to ensuring product efficacy and safety. Among these, sustained release tablet coating machines play a pivotal role in controlling the release profile…

Solid Dosage form, Tablets

Preventing Non-Homogeneity in Blends for Controlled Release Tablets

March 5, 2025 Admin

Preventing Non-Homogeneity in Blends for Controlled Release Tablets Preventing Non-Homogeneity in Blends for Controlled Release Tablets Introduction: Controlled release tablets are at the forefront of modern pharmaceutical development due to their ability to deliver therapeutic agents at a regulated pace, enhancing patient compliance and therapeutic efficacy. However, achieving uniform distribution of active pharmaceutical ingredients (APIs)…

Solid Dosage form, Tablets

Challenges in preventing capsule breakage during bulk packing.

March 5, 2025 Admin

Challenges in preventing capsule breakage during bulk packing. Challenges in preventing capsule breakage during bulk packing. Introduction: In the pharmaceutical industry, the integrity of capsules during bulk packing is paramount. Capsules, whether hard or soft gelatin, are a popular dosage form due to their ease of use and ability to encapsulate various types of formulations….

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