Tag: USFDA guidelines

Troubleshooting Loss of Moisture Control in Hygroscopic Tablet Storage

March 14, 2025 Admin

Troubleshooting Loss of Moisture Control in Hygroscopic Tablet Storage Troubleshooting Loss of Moisture Control in Hygroscopic Tablet Storage Introduction: In the pharmaceutical industry, maintaining the integrity of solid dosage forms, particularly hygroscopic tablets, is crucial. Hygroscopic tablets are designed to absorb moisture from the environment, making them particularly vulnerable to degradation if not stored properly….

Solid Dosage form, Tablets

Difficulty in establishing validated cleaning cycles for capsule filling equipment.

March 14, 2025 Admin

Difficulty in establishing validated cleaning cycles for capsule filling equipment. Difficulty in establishing validated cleaning cycles for capsule filling equipment. Introduction: In the pharmaceutical industry, maintaining the integrity and safety of drug products is paramount. Solid oral dosage forms, particularly capsules, require stringent manufacturing processes to ensure they meet quality standards. A critical aspect of…

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

Ensuring Adequacy of Compressed Air Filters for Coating Machines

March 13, 2025 Admin

Ensuring Adequacy of Compressed Air Filters for Coating Machines Ensuring Adequacy of Compressed Air Filters for Coating Machines Introduction: In the pharmaceutical industry, ensuring the integrity and quality of tablet coatings is paramount. Compressed air systems play a pivotal role in the operation of coating machines, making the adequacy of compressed air filters crucial. These…

Solid Dosage form, Tablets

Validating Equipment Used for High-Speed Compression of Multi-API Tablets

March 13, 2025 Admin

Validating Equipment Used for High-Speed Compression of Multi-API Tablets Validating Equipment Used for High-Speed Compression of Multi-API Tablets Introduction: In today’s rapidly evolving pharmaceutical landscape, the demand for complex drug formulations, such as multi-API (Active Pharmaceutical Ingredient) tablets, is on the rise. These formulations offer several therapeutic benefits, including improved patient compliance and synergistic effects….

Solid Dosage form, Tablets

Controlling Dust Contamination in Coating Machines

March 13, 2025 Admin

Controlling Dust Contamination in Coating Machines Controlling Dust Contamination in Coating Machines Introduction: In the pharmaceutical industry, maintaining the quality and safety of drug products is paramount. One critical aspect of this is the control of dust contamination in coating machines used in the production of tablets. Dust contamination can lead to significant quality control…

Solid Dosage form, Tablets

Difficulty in achieving uniform distribution of capsules within packs.

March 13, 2025 Admin

Difficulty in achieving uniform distribution of capsules within packs. Difficulty in Achieving Uniform Distribution of Capsules within Packs Introduction: The pharmaceutical industry is continually evolving, driven by the need to ensure product efficacy, safety, and consumer satisfaction. Solid oral dosage forms, particularly capsules, are a staple in the industry due to their ease of administration…

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

Managing Failures in Content Uniformity Tests for Immediate Release Tablets

March 13, 2025 Admin

Managing Failures in Content Uniformity Tests for Immediate Release Tablets Managing Failures in Content Uniformity Tests for Immediate Release Tablets Introduction: In the world of pharmaceutical manufacturing, ensuring that each tablet contains the precise amount of active ingredient is crucial for both efficacy and safety. This is particularly true for immediate-release tablets, where rapid onset…

Solid Dosage form, Tablets

High variability in stability data for oil-filled capsules.

March 12, 2025 Admin

High variability in stability data for oil-filled capsules. High variability in stability data for oil-filled capsules. Introduction: In the pharmaceutical industry, maintaining the stability of medicinal products is crucial to ensure their safety, efficacy, and quality over their shelf life. Among various dosage forms, oil-filled capsules—encompassing both hard and soft gelatin variants—present unique challenges in…

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

Managing Failures in Stress Testing for Controlled Release Tablets

March 12, 2025 Admin

Managing Failures in Stress Testing for Controlled Release Tablets Managing Failures in Stress Testing for Controlled Release Tablets Introduction: In the pharmaceutical industry, controlled release tablets play a pivotal role in ensuring the precise delivery of active pharmaceutical ingredients (APIs) over an extended period. These tablets are designed to optimize therapeutic efficacy and improve patient…

Solid Dosage form, Tablets

Troubleshooting Spray Pattern Issues in Sugar-Coating Processes

March 12, 2025 Admin

Troubleshooting Spray Pattern Issues in Sugar-Coating Processes Troubleshooting Spray Pattern Issues in Sugar-Coating Processes Introduction: Sugar-coating is a critical process in pharmaceutical tablet manufacturing, providing not only aesthetic appeal but also functional benefits like taste masking and moisture protection. However, achieving a uniform sugar coat is often fraught with challenges, particularly when it comes to…

Solid Dosage form, Tablets

Preventing Tablet Breakage During Blister Sealing for High-Speed Machines

March 12, 2025 Admin

Preventing Tablet Breakage During Blister Sealing for High-Speed Machines Preventing Tablet Breakage During Blister Sealing for High-Speed Machines Introduction: The pharmaceutical industry constantly aims to enhance the efficiency and reliability of drug production, particularly in the area of solid dosage forms like tablets. One critical aspect is the packaging process, where blister sealing plays a…

Solid Dosage form, Tablets

Ensuring Consistency in API Release Profiles for Enteric-Coated Tablets

March 12, 2025 Admin

Ensuring Consistency in API Release Profiles for Enteric-Coated Tablets Ensuring Consistency in API Release Profiles for Enteric-Coated Tablets Introduction: Enteric-coated tablets are a crucial innovation in the pharmaceutical industry, designed to ensure that active pharmaceutical ingredients (APIs) are released in specific areas of the gastrointestinal tract. This targeted release is vital for enhancing the therapeutic…

Solid Dosage form, Tablets