Tag: USFDA guidelines

Preventing Overfilling in Tablet Bottling Lines for Immediate Release Tablets

April 3, 2025 Admin

Preventing Overfilling in Tablet Bottling Lines for Immediate Release Tablets Preventing Overfilling in Tablet Bottling Lines for Immediate Release Tablets Introduction: In the pharmaceutical industry, precision in tablet bottling lines is critical, particularly for immediate release tablets. Ensuring that each bottle contains the correct number of tablets not only maintains dosage accuracy and therapeutic effectiveness…

Solid Dosage form, Tablets

Addressing Seal Delamination Issues in Strip Packs for Hygroscopic Tablets

April 2, 2025 Admin

Addressing Seal Delamination Issues in Strip Packs for Hygroscopic Tablets Addressing Seal Delamination Issues in Strip Packs for Hygroscopic Tablets Introduction: In the pharmaceutical industry, the packaging of hygroscopic tablets presents unique challenges due to their sensitivity to moisture. Hygroscopic tablets are designed to absorb moisture from the environment, which can compromise the tablet’s integrity…

Solid Dosage form, Tablets

Addressing Challenges in Aluminum Blister Sealing for Extended Release Tablets

April 2, 2025 Admin

Addressing Challenges in Aluminum Blister Sealing for Extended Release Tablets Addressing Challenges in Aluminum Blister Sealing for Extended Release Tablets Introduction: In the pharmaceutical industry, the packaging of extended release tablets is crucial not only for maintaining the efficacy and safety of the product but also for ensuring patient compliance. Aluminum blister packs are commonly…

Solid Dosage form, Tablets

Challenges in validating the performance of capsule filling equipment.

April 1, 2025 Admin

Challenges in validating the performance of capsule filling equipment. Challenges in validating the performance of capsule filling equipment. Introduction: In the pharmaceutical industry, capsule filling equipment plays a crucial role in the production of solid oral dosage forms. These machines are responsible for accurately filling hard and soft gelatin capsules with the appropriate dosage of…

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

Poor reproducibility in steam quality validation for sterilization processes.

April 1, 2025 Admin

Poor reproducibility in steam quality validation for sterilization processes. Poor reproducibility in steam quality validation for sterilization processes. Introduction: In the pharmaceutical industry, sterilization processes are vital for ensuring the safety and efficacy of products, particularly those that are administered in sterile form, such as injectables and certain types of capsules. Steam sterilization, one of…

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

Problems with ensuring consistent capsule appearance during accelerated validation studies.

April 1, 2025 Admin

Problems with ensuring consistent capsule appearance during accelerated validation studies. Problems with ensuring consistent capsule appearance during accelerated validation studies. Introduction: In the pharmaceutical industry, ensuring the consistent appearance of capsules is crucial for maintaining product quality and consumer trust. During accelerated validation studies, which are designed to predict the long-term stability of a product…

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

Troubleshooting Poor Adhesion in Enteric-Coated Tablets During Production

April 1, 2025 Admin

Troubleshooting Poor Adhesion in Enteric-Coated Tablets During Production Troubleshooting Poor Adhesion in Enteric-Coated Tablets During Production Introduction: The production of enteric-coated tablets is a critical process in the pharmaceutical industry, ensuring the delivery of medication to the desired part of the gastrointestinal tract without degradation in the stomach. Enteric coatings protect the active pharmaceutical ingredient…

Solid Dosage form, Tablets

High variability in capsule weight due to uneven powder blending.

March 31, 2025 Admin

High variability in capsule weight due to uneven powder blending. High Variability in Capsule Weight Due to Uneven Powder Blending Introduction: In the pharmaceutical industry, ensuring consistent capsule weight is critical for maintaining drug efficacy and patient safety. High variability in capsule weight can lead to suboptimal therapeutic outcomes and regulatory non-compliance. Uneven powder blending…

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

Identifying Problems in Potency Testing for Extended Release Tablets

March 31, 2025 Admin

Identifying Problems in Potency Testing for Extended Release Tablets Identifying Problems in Potency Testing for Extended Release Tablets Introduction: Extended release tablets are a cornerstone of modern pharmaceutical therapy, providing patients with the convenience of reduced dosing frequency while maintaining therapeutic efficacy over an extended period. Potency testing of these formulations is critical to ensure…

Solid Dosage form, Tablets

Troubleshooting Variability in Thickness Testing for Film-Coated Tablets

March 31, 2025 Admin

Troubleshooting Variability in Thickness Testing for Film-Coated Tablets Troubleshooting Variability in Thickness Testing for Film-Coated Tablets Introduction: In the pharmaceutical industry, the production of film-coated tablets is a critical process that requires meticulous quality control. Thickness testing of these tablets is vital as it ensures uniformity, stability, and efficacy of the dosage form. Variability in…

Solid Dosage form, Tablets

Poor reproducibility in gelatin elasticity data under various storage conditions.

March 31, 2025 Admin

Poor reproducibility in gelatin elasticity data under various storage conditions. Poor reproducibility in gelatin elasticity data under various storage conditions. Introduction: Gelatin capsules, both hard and soft gelatin, are pivotal in the pharmaceutical industry as they offer a stable and effective medium for drug delivery. However, the elasticity of gelatin, a critical factor in capsule…

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

Inadequate systems for verifying capsule coating equipment calibration.

March 30, 2025 Admin

Inadequate systems for verifying capsule coating equipment calibration. Inadequate systems for verifying capsule coating equipment calibration. Introduction: In the pharmaceutical industry, the precision of capsule coating processes is critical for ensuring product quality and compliance with regulatory standards. Capsules, whether hard or soft gelatin, require exact coating specifications to achieve the desired therapeutic effect, stability,…

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