Tag: USFDA guidelines

Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets

March 21, 2025 Admin

Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets Introduction: Enteric tablets are specially designed to withstand the acidic environment of the stomach and dissolve in the more neutral pH of the intestines. This targeted dissolution is critical for drugs that are sensitive to stomach acid…

Solid Dosage form, Tablets

Addressing Brittleness in High-Compression Tablets During Stability Studies

March 21, 2025 Admin

Addressing Brittleness in High-Compression Tablets During Stability Studies Addressing Brittleness in High-Compression Tablets During Stability Studies Introduction: In the pharmaceutical industry, the development and production of solid dosage forms, particularly tablets, is a critical aspect of delivering effective therapies to patients. High-compression tablets are increasingly popular due to their compact size and ease of production….

Solid Dosage form, Tablets

Addressing Non-Compliance in Stability Studies for Film-Coated Tablets

March 20, 2025 Admin

Addressing Non-Compliance in Stability Studies for Film-Coated Tablets Addressing Non-Compliance in Stability Studies for Film-Coated Tablets Introduction: In the pharmaceutical industry, stability studies play a crucial role in ensuring the efficacy, safety, and quality of drug products. For film-coated tablets, stability studies are essential to evaluate how the product maintains its intended physical, chemical, microbiological,…

Solid Dosage form, Tablets

Troubleshooting Failures in Cleaning Validation for Coating Equipment

March 20, 2025 Admin

Troubleshooting Failures in Cleaning Validation for Coating Equipment Troubleshooting Failures in Cleaning Validation for Coating Equipment Introduction: In the pharmaceutical industry, maintaining the integrity of cleaning validation processes is crucial, especially for coating equipment in the production of tablets. Cleaning validation ensures that the equipment is free from contaminants and residues that could affect product…

Solid Dosage form, Tablets

Ensuring Consistency in Coating Thickness Measurements During QA Testing

March 20, 2025 Admin

Ensuring Consistency in Coating Thickness Measurements During QA Testing Ensuring Consistency in Coating Thickness Measurements During QA Testing Introduction: In the realm of pharmaceutical manufacturing, ensuring the consistency and quality of tablet coatings is crucial. Coating not only enhances the aesthetic appeal but also plays a significant role in controlling the release of active ingredients,…

Solid Dosage form, Tablets

Managing Hardness Variability in High-Speed Compression Tablets

March 20, 2025 Admin

Managing Hardness Variability in High-Speed Compression Tablets Managing Hardness Variability in High-Speed Compression Tablets Introduction: In the pharmaceutical industry, tablets are a widely used solid dosage form, offering convenience in administration and precise dosing. However, ensuring the consistency of tablet hardness, especially during high-speed compression, is a critical quality attribute that directly impacts the dissolution…

Solid Dosage form, Tablets

Preventing Brittleness in Coated Tablets During High-Speed Compression

March 20, 2025 Admin

Preventing Brittleness in Coated Tablets During High-Speed Compression Preventing Brittleness in Coated Tablets During High-Speed Compression Introduction: In the pharmaceutical industry, the production of coated tablets is a complex process that requires meticulous attention to detail. Coated tablets are favored for their ability to mask unpleasant tastes, protect the drug from the stomach environment, and…

Solid Dosage form, Tablets

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

Troubleshooting Failures in Coating Integrity Testing for Enteric Tablets

March 19, 2025 Admin

Troubleshooting Failures in Coating Integrity Testing for Enteric Tablets Troubleshooting Failures in Coating Integrity Testing for Enteric Tablets Introduction: Enteric tablets are designed to withstand the acidic environment of the stomach, dissolving only in the more neutral pH of the intestine. This protective mechanism is achieved through a specialized coating that ensures the active ingredients…

Solid Dosage form, Tablets

Challenges in maintaining uniform mixing of multi-component powder blends.

March 19, 2025 Admin

Challenges in maintaining uniform mixing of multi-component powder blends. Challenges in maintaining uniform mixing of multi-component powder blends. Introduction: In the pharmaceutical industry, ensuring the uniform mixing of multi-component powder blends is crucial for the efficacy and safety of solid oral dosage forms, such as capsules. Uniformity in blending impacts the quality and consistency of…

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

Real-Time Detection of Defects in Coated Tablet Layers

March 19, 2025 Admin

Real-Time Detection of Defects in Coated Tablet Layers Real-Time Detection of Defects in Coated Tablet Layers Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of tablets is of paramount importance. Coated tablets are widely used not only for aesthetic purposes but also to enhance stability, control release profiles, and mask unpleasant tastes. However,…

Solid Dosage form, Tablets

Poor standardization of capsule quality specifications.

March 18, 2025 Admin

Poor standardization of capsule quality specifications. Poor standardization of capsule quality specifications. Introduction: In the pharmaceutical industry, capsules represent one of the most common solid oral dosage forms, offering a convenient and effective means of delivering medications. However, the standardization of capsule quality specifications remains a significant challenge for manufacturers. With a vast array of…

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