Tag: USFDA guidelines

Inadequate systems for monitoring capsule release profiles.

April 17, 2025 Admin

Inadequate systems for monitoring capsule release profiles. Inadequate systems for monitoring capsule release profiles. Introduction: The pharmaceutical industry is a cornerstone of modern healthcare, where ensuring the efficacy and safety of medications is paramount. Solid oral dosage forms, particularly capsules, play a significant role due to their convenience and patient compliance. However, the inadequacy of…

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

Challenges in ensuring proper serialization for track-and-trace requirements.

April 16, 2025 Admin

Challenges in ensuring proper serialization for track-and-trace requirements. Challenges in ensuring proper serialization for track-and-trace requirements. Introduction: Serialization in the pharmaceutical industry is a crucial process that involves assigning a unique identifier to each saleable unit of a drug, ensuring traceability throughout the supply chain. This process is essential for preventing counterfeit drugs, enhancing patient…

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

Challenges in testing soft gelatin capsules with high oil content.

April 16, 2025 Admin

Challenges in testing soft gelatin capsules with high oil content. Challenges in testing soft gelatin capsules with high oil content Introduction: Soft gelatin capsules are a popular dosage form in the pharmaceutical industry, offering unique advantages such as improved bioavailability and patient compliance. However, when these capsules contain high oil content, they present significant challenges…

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

Inadequate validation of capsule performance under freezing conditions.

April 16, 2025 Admin

Inadequate validation of capsule performance under freezing conditions. Inadequate validation of capsule performance under freezing conditions Introduction: In the pharmaceutical industry, solid oral dosage forms like capsules are a popular choice due to their convenience, stability, and patient compliance. However, the performance of capsules under various environmental conditions, especially freezing conditions, can be a significant…

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

Difficulty in distinguishing capsule defects due to environmental effects.

April 16, 2025 Admin

Difficulty in distinguishing capsule defects due to environmental effects. Difficulty in Distinguishing Capsule Defects Due to Environmental Effects Introduction: Capsules, both hard and soft gelatin, are a prevalent form of solid oral dosage utilized in pharmaceutical products. They offer advantages such as ease of swallowing and the ability to mask unpleasant tastes. However, ensuring their…

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

Problems with detecting changes in gelatin plasticizer levels during stability testing.

April 16, 2025 Admin

Problems with detecting changes in gelatin plasticizer levels during stability testing. Problems with Detecting Changes in Gelatin Plasticizer Levels During Stability Testing Introduction: In the pharmaceutical industry, solid oral dosage forms, particularly gelatin capsules, are prevalent due to their ease of use and patient compliance. However, maintaining the stability of these dosage forms is critical…

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

Ensuring Consistent Strip Sealing Quality for Multi-API Tablets

April 15, 2025 Admin

Ensuring Consistent Strip Sealing Quality for Multi-API Tablets Ensuring Consistent Strip Sealing Quality for Multi-API Tablets Introduction: In the pharmaceutical industry, ensuring the integrity and quality of tablet packaging is paramount, especially for multi-active pharmaceutical ingredient (multi-API) tablets. These complex formulations require precise handling and packaging to maintain efficacy and safety. Strip sealing is a…

Solid Dosage form, Tablets

Poor reproducibility in API stability data for high-dose capsules.

April 15, 2025 Admin

Poor reproducibility in API stability data for high-dose capsules. Poor reproducibility in API stability data for high-dose capsules Introduction: In the pharmaceutical industry, the stability of active pharmaceutical ingredients (APIs) is crucial for ensuring drug safety and efficacy. For high-dose capsules, achieving consistent and reproducible stability data is particularly challenging. Variability in stability data can…

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

Difficulty in implementing real-time data monitoring systems for quality checks.

April 15, 2025 Admin

Difficulty in implementing real-time data monitoring systems for quality checks. Difficulty in implementing real-time data monitoring systems for quality checks. Introduction: In the rapidly advancing pharmaceutical industry, quality assurance remains a cornerstone of successful manufacturing processes, particularly for solid oral dosage forms like capsules. As the demand for higher quality and more consistent pharmaceutical products…

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

Problems with ensuring consistent fill weight for semi-solid formulations.

April 14, 2025 Admin

Problems with ensuring consistent fill weight for semi-solid formulations. Problems with Ensuring Consistent Fill Weight for Semi-Solid Formulations Introduction: In the pharmaceutical industry, maintaining consistent fill weight in semi-solid formulations is crucial for ensuring product efficacy, safety, and regulatory compliance. Semi-solid formulations, often used in capsules, pose unique challenges due to their complex nature. Ensuring…

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

Addressing Color Changes in Film-Coated Tablets During Stability Studies

April 14, 2025 Admin

Addressing Color Changes in Film-Coated Tablets During Stability Studies Addressing Color Changes in Film-Coated Tablets During Stability Studies Introduction: In the pharmaceutical industry, maintaining the integrity and appearance of film-coated tablets throughout their shelf life is crucial. Stability studies play a significant role in ensuring that these products meet quality standards over time. One common…

Solid Dosage form, Tablets

High variability in the thickness of blister foil materials.

April 14, 2025 Admin

High variability in the thickness of blister foil materials. High Variability in the Thickness of Blister Foil Materials Introduction: Blister packaging is a critical component in the pharmaceutical industry, offering protection and extended shelf life for solid oral dosage forms like capsules and tablets. However, variability in the thickness of blister foil materials can pose…

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