Tag: USFDA guidelines

Managing Failures in Cleaning Validation for High-Speed Coating Lines

Posted on By 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…

Read More “Managing Failures in Cleaning Validation for High-Speed Coating Lines” »

Solid Dosage form, Tablets

Managing Brittleness in Hygroscopic Tablets Stored Under Dry Conditions

Posted on By 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…

Read More “Managing Brittleness in Hygroscopic Tablets Stored Under Dry Conditions” »

Solid Dosage form, Tablets

Ensuring Robustness in Steam Quality Tests for Coating Equipment

Posted on By Admin

Ensuring Robustness in Steam Quality Tests for Coating Equipment Ensuring Robustness in Steam Quality Tests for Coating Equipment Introduction: In the pharmaceutical industry, maintaining high standards of quality and compliance is critical, especially during the production of solid dosage forms such as tablets. One crucial aspect in the manufacturing process is the coating of tablets,…

Read More “Ensuring Robustness in Steam Quality Tests for Coating Equipment” »

Solid Dosage form, Tablets

Investigating Solvent Evaporation Effects on Coated Tablets During Storage

Posted on By Admin

Investigating Solvent Evaporation Effects on Coated Tablets During Storage Investigating Solvent Evaporation Effects on Coated Tablets During Storage Introduction: In the pharmaceutical industry, the stability and integrity of coated tablets during storage are paramount to ensuring their efficacy and safety. Solvent evaporation is a critical factor that can affect the coating’s performance, leading to potential…

Read More “Investigating Solvent Evaporation Effects on Coated Tablets During Storage” »

Solid Dosage form, Tablets

Managing Layer Delamination Issues in Multi-Layer Tablets During Validation

Posted on By Admin

Managing Layer Delamination Issues in Multi-Layer Tablets During Validation Managing Layer Delamination Issues in Multi-Layer Tablets During Validation Introduction: In the pharmaceutical industry, multi-layer tablets are a popular dosage form due to their ability to deliver multiple drugs or distinct release profiles in a single tablet. However, manufacturing such tablets comes with its own set…

Read More “Managing Layer Delamination Issues in Multi-Layer Tablets During Validation” »

Solid Dosage form, Tablets

Ensuring Consistency in Hardness Testing During Validation of Compression Lines

Posted on By Admin

Ensuring Consistency in Hardness Testing During Validation of Compression Lines Ensuring Consistency in Hardness Testing During Validation of Compression Lines Introduction: The pharmaceutical industry places a significant emphasis on the quality and consistency of solid dosage forms, particularly tablets. Tablet hardness is a critical quality attribute that influences not only the tablet’s mechanical strength but…

Read More “Ensuring Consistency in Hardness Testing During Validation of Compression Lines” »

Solid Dosage form, Tablets

Managing Brittleness in High-Dose Tablets Under Stability Conditions

Posted on By Admin

Managing Brittleness in High-Dose Tablets Under Stability Conditions Managing Brittleness in High-Dose Tablets Under Stability Conditions Introduction: In the pharmaceutical industry, the development of high-dose tablets presents several challenges, particularly concerning their brittleness under stability conditions. Brittleness can compromise the efficacy, safety, and quality of the medication, which is crucial for patient health. Understanding and…

Read More “Managing Brittleness in High-Dose Tablets Under Stability Conditions” »

Solid Dosage form, Tablets

Troubleshooting Calibration Failures in Dissolution Testing Equipment

Posted on By Admin

Troubleshooting Calibration Failures in Dissolution Testing Equipment Troubleshooting Calibration Failures in Dissolution Testing Equipment Introduction: Dissolution testing is a critical process in the pharmaceutical industry, serving as a quality control measure to ensure the efficacy and safety of tablets and other solid dosage forms. Calibration of dissolution testing equipment is essential for accurate and reliable…

Read More “Troubleshooting Calibration Failures in Dissolution Testing Equipment” »

Solid Dosage form, Tablets

Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity

Posted on By Admin

Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity Introduction: Extended release tablets are a cornerstone of modern pharmaceutical formulations, offering controlled release of active pharmaceutical ingredients (APIs) over time to improve patient compliance and therapeutic efficacy. However, when these tablets are…

Read More “Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity” »

Solid Dosage form, Tablets

Validating Cleaning Effectiveness for Wet Granulation Equipment

Posted on By Admin

Validating Cleaning Effectiveness for Wet Granulation Equipment Validating Cleaning Effectiveness for Wet Granulation Equipment Introduction: In the pharmaceutical industry, maintaining the cleanliness and functionality of equipment is paramount to ensuring product quality and patient safety. Wet granulation, a critical step in tablet production, involves the agglomeration of powder particles using a liquid binder. This process,…

Read More “Validating Cleaning Effectiveness for Wet Granulation Equipment” »

Solid Dosage form, Tablets

Troubleshooting Poor Coating Adhesion in Extended Release Tablets Over Time

Posted on By Admin

Troubleshooting Poor Coating Adhesion in Extended Release Tablets Over Time Troubleshooting Poor Coating Adhesion in Extended Release Tablets Over Time Introduction: Extended release tablets are a crucial aspect of modern pharmaceutical delivery systems, offering consistent therapeutic effects over extended periods. However, the integrity of their coating is paramount to ensure proper drug release and efficacy….

Read More “Troubleshooting Poor Coating Adhesion in Extended Release Tablets Over Time” »

Solid Dosage form, Tablets

Ensuring Consistency in Disintegration Time During Long-Term Stability Studies

Posted on By Admin

Ensuring Consistency in Disintegration Time During Long-Term Stability Studies Ensuring Consistency in Disintegration Time During Long-Term Stability Studies Introduction: In the realm of pharmaceuticals, ensuring consistency in the disintegration time of tablets during long-term stability studies is pivotal for guaranteeing a drug’s efficacy, safety, and patient compliance. Disintegration time is a critical quality attribute that…

Read More “Ensuring Consistency in Disintegration Time During Long-Term Stability Studies” »

Solid Dosage form, Tablets