Tag: USFDA guidelines

Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation

May 24, 2025 Admin

Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation Introduction: In the pharmaceutical industry, ensuring the consistent production of high-quality tablets is paramount. The tablet press feed system plays a crucial role in this process by delivering a uniform and precise amount…

Solid Dosage form, Tablets

Ensuring Consistency in Packaging Material Thickness for Stability

May 23, 2025 Admin

Ensuring Consistency in Packaging Material Thickness for Stability Ensuring Consistency in Packaging Material Thickness for Stability Introduction: In the pharmaceutical industry, maintaining the stability of solid dosage forms like tablets is crucial. Packaging plays a vital role in ensuring product stability by protecting the contents from environmental factors such as moisture, oxygen, and light. Consistency…

Solid Dosage form, Tablets

Troubleshooting Failures in Compression Force Validation for High-Speed Presses

May 22, 2025 Admin

Troubleshooting Failures in Compression Force Validation for High-Speed Presses Troubleshooting Failures in Compression Force Validation for High-Speed Presses Introduction: In the fast-paced world of pharmaceutical manufacturing, high-speed tablet presses are indispensable assets that enable large-scale production of solid dosage forms. These machines are designed to efficiently compress powders into tablets, making them crucial in meeting…

Solid Dosage form, Tablets

Addressing Double Seal Lines in Heat-Sealed Strip Packaging

May 20, 2025 Admin

Addressing Double Seal Lines in Heat-Sealed Strip Packaging Addressing Double Seal Lines in Heat-Sealed Strip Packaging Introduction: In the pharmaceutical industry, ensuring the integrity and quality of product packaging is paramount. Heat-sealed strip packaging is a popular method used to package solid dosage forms such as tablets, providing a barrier against environmental factors and maintaining…

Solid Dosage form, Tablets

Resolving Layer Delamination in Multi-Layer Tablets Under Stress Testing

May 19, 2025 Admin

Resolving Layer Delamination in Multi-Layer Tablets Under Stress Testing Resolving Layer Delamination in Multi-Layer Tablets Under Stress Testing Introduction: In the pharmaceutical industry, multi-layer tablets have become a sophisticated option for delivering multiple active pharmaceutical ingredients (APIs) with distinct release profiles. These tablets offer numerous advantages, including improved patient compliance and efficient dosing schedules. However,…

Solid Dosage form, Tablets

Managing Layer Separation in Bilayer Tablets Under Accelerated Conditions

May 18, 2025 Admin

Managing Layer Separation in Bilayer Tablets Under Accelerated Conditions Managing Layer Separation in Bilayer Tablets Under Accelerated Conditions Introduction: Bilayer tablets are increasingly utilized in the pharmaceutical industry to deliver multiple drugs or different release profiles in a single dosage form. This innovative approach not only enhances patient compliance but also offers significant benefits in…

Solid Dosage form, Tablets

Managing Material Compatibility Issues in Packaging for Coated Tablets

May 17, 2025 Admin

Managing Material Compatibility Issues in Packaging for Coated Tablets Managing Material Compatibility Issues in Packaging for Coated Tablets Introduction: In the pharmaceutical industry, the packaging of coated tablets is a critical process that ensures the safety, efficacy, and longevity of the product. Coated tablets, designed to enhance stability, control release, and improve patient compliance, require…

Solid Dosage form, Tablets

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

Addressing Problems in Tamper-Evident Sealing for Enteric-Coated Tablets

May 17, 2025 Admin

Addressing Problems in Tamper-Evident Sealing for Enteric-Coated Tablets Addressing Problems in Tamper-Evident Sealing for Enteric-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the safety and integrity of drug products is paramount. Enteric-coated tablets are designed to withstand the acidic environment of the stomach and dissolve in the more neutral pH of the intestine, providing targeted…

Solid Dosage form, Tablets

Addressing Non-Compliance in QA Tests for Multi-Layer Tablets

May 16, 2025 Admin

Addressing Non-Compliance in QA Tests for Multi-Layer Tablets Addressing Non-Compliance in QA Tests for Multi-Layer Tablets Introduction: In the pharmaceutical industry, multi-layer tablets have emerged as a preferred solid dosage form due to their ability to deliver multiple active pharmaceutical ingredients (APIs) in a single dose and to provide controlled release of medications. However, ensuring…

Solid Dosage form, Tablets

Managing Failures in Cleaning Validation for High-Speed Coating Lines

May 14, 2025 Admin

Managing Failures in Cleaning Validation for High-Speed Coating Lines Managing Failures in Cleaning Validation for High-Speed Coating Lines Introduction: In the pharmaceutical industry, maintaining stringent hygiene and cleanliness standards is paramount, especially in the production of solid dosage forms like tablets. High-speed coating lines, which apply protective or functional coatings to tablets, play a critical…

Solid Dosage form, Tablets

Managing Brittleness in Hygroscopic Tablets Stored Under Dry Conditions

May 14, 2025 Admin

Managing Brittleness in Hygroscopic Tablets Stored Under Dry Conditions Managing Brittleness in Hygroscopic Tablets Stored Under Dry Conditions Introduction: In the pharmaceutical industry, maintaining the integrity of solid dosage forms is crucial for ensuring efficacy and safety. Among these forms, hygroscopic tablets present unique challenges due to their affinity for moisture, which can significantly affect…

Solid Dosage form, Tablets