Tag: pharmaceutical quality

Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions

April 27, 2025 Admin

Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions Introduction: Sugar-coated tablets have long been a staple in pharmaceutical formulations, offering benefits such as masking unpleasant tastes, improving tablet appearance, and protecting active pharmaceutical ingredients (APIs) from environmental factors. However, they also present unique challenges, particularly…

Solid Dosage form, Tablets

Challenges in assessing the stability of capsules containing biological APIs.

April 27, 2025 Admin

Challenges in assessing the stability of capsules containing biological APIs. Challenges in assessing the stability of capsules containing biological APIs. Introduction: The pharmaceutical industry is increasingly focusing on the development of capsules containing biological Active Pharmaceutical Ingredients (APIs) due to their potential in treating various complex diseases. However, ensuring the stability of these capsules poses…

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

Problems with establishing acceptance criteria for cleaning validation studies.

April 26, 2025 Admin

Problems with establishing acceptance criteria for cleaning validation studies. Problems with Establishing Acceptance Criteria for Cleaning Validation Studies Introduction: In the pharmaceutical industry, maintaining cleanliness and preventing cross-contamination are paramount to ensuring product safety and efficacy. Cleaning validation studies are critical components of Good Manufacturing Practice (GMP) compliance. They confirm that cleaning processes consistently produce…

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

Inadequate systems for monitoring capsule storage equipment performance.

April 25, 2025 Admin

Inadequate systems for monitoring capsule storage equipment performance. Inadequate systems for monitoring capsule storage equipment performance. Introduction: In the pharmaceutical industry, maintaining the integrity and efficacy of solid oral dosage forms, such as capsules, is paramount. Proper storage is essential to ensure that these products remain safe and effective until they reach the end-user. However,…

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

High variability in capsule weight due to poor powder flow properties.

April 25, 2025 Admin

High variability in capsule weight due to poor powder flow properties. High variability in capsule weight due to poor powder flow properties. Introduction: The pharmaceutical industry consistently strives to achieve high standards of quality and efficacy in its products. Solid oral dosage forms, such as capsules, play a critical role in this landscape. However, one…

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

Difficulty in evaluating stability of capsules with high oil content.

April 24, 2025 Admin

Difficulty in evaluating stability of capsules with high oil content. Difficulty in Evaluating Stability of Capsules with High Oil Content Introduction: In the pharmaceutical industry, capsules are a popular solid oral dosage form, prized for their ease of use and ability to encapsulate both solid and liquid forms. However, when it comes to capsules with…

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

Inadequate systems for validating capsule appearance inspection processes.

April 24, 2025 Admin

Inadequate systems for validating capsule appearance inspection processes. Inadequate systems for validating capsule appearance inspection processes. Introduction: The pharmaceutical industry is marked by stringent quality requirements, particularly when it comes to solid oral dosage forms like capsules. A critical aspect of manufacturing is ensuring the appearance of capsules meets predefined standards, as this directly impacts…

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

Inadequate systems for monitoring capsule weight loss due to evaporation.

April 23, 2025 Admin

Inadequate systems for monitoring capsule weight loss due to evaporation. Inadequate Systems for Monitoring Capsule Weight Loss Due to Evaporation Introduction: Capsules, both hard and soft gelatin, are among the most popular solid oral dosage forms in the pharmaceutical industry, renowned for their ease of administration and ability to encapsulate a wide range of formulations….

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

Inadequate systems for monitoring capsule printing accuracy.

April 23, 2025 Admin

Inadequate systems for monitoring capsule printing accuracy. Inadequate Systems for Monitoring Capsule Printing Accuracy Introduction: In the pharmaceutical industry, ensuring the accuracy of capsule printing is crucial for maintaining drug safety, efficacy, and compliance with regulatory standards. Capsule printing serves as a vital method for product identification, distinguishing between different medications, and providing necessary information…

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

Poor validation of capsule sealing temperature profiles.

April 23, 2025 Admin

Poor validation of capsule sealing temperature profiles. Poor validation of capsule sealing temperature profiles. Introduction: The pharmaceutical industry relies heavily on the precision and quality of its manufacturing processes. One critical aspect of ensuring the integrity and effectiveness of solid oral dosage forms, such as capsules, is the validation of capsule sealing temperature profiles. Proper…

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

Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing

April 21, 2025 Admin

Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing Introduction: Sugar-coated tablets are a popular dosage form in the pharmaceutical industry, valued for their aesthetic appeal and ability to mask unpleasant tastes. However, these advantages can be overshadowed by challenges encountered during stability testing, particularly disintegration…

Solid Dosage form, Tablets

Challenges in maintaining proper records for batch-specific quality deviations.

April 21, 2025 Admin

Challenges in maintaining proper records for batch-specific quality deviations. Challenges in maintaining proper records for batch-specific quality deviations Introduction: In the pharmaceutical industry, maintaining precise and thorough records of batch-specific quality deviations is vital for ensuring product safety and regulatory compliance. These records are essential for tracking the history of a product, identifying the root…

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