Tag: ICH guidelines

Managing API Degradation in Sugar-Coated Tablets During Stability Studies

June 4, 2025 Admin

Managing API Degradation in Sugar-Coated Tablets During Stability Studies Managing API Degradation in Sugar-Coated Tablets During Stability Studies Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of a drug product throughout its shelf life is of paramount importance. Sugar-coated tablets, a popular dosage form due to their aesthetic appeal and ease of ingestion,…

Solid Dosage form, Tablets

Ensuring Consistent Release Profiles in Multi-API Tablets Over Time

May 27, 2025 Admin

Ensuring Consistent Release Profiles in Multi-API Tablets Over Time Ensuring Consistent Release Profiles in Multi-API Tablets Over Time Introduction: In the pharmaceutical industry, the formulation and manufacturing of multi-API (Active Pharmaceutical Ingredient) tablets present a complex challenge. Ensuring consistent drug release profiles over time is crucial for therapeutic efficacy and patient safety. A consistent release…

Solid Dosage form, Tablets

Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation

May 25, 2025 Admin

Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation Introduction: The sugar-coating process in pharmaceutical manufacturing plays a crucial role in enhancing the aesthetic appeal, taste masking, and stability of tablets. However, managing residual solvent build-up during this process, particularly in the coating pans, is a…

Solid Dosage form, Tablets

Evaluating Interaction Between Packaging and Tablets in Stability Testing

May 21, 2025 Admin

Evaluating Interaction Between Packaging and Tablets in Stability Testing Evaluating Interaction Between Packaging and Tablets in Stability Testing Introduction: In the pharmaceutical industry, the stability of a drug product is a critical factor that determines its safety, efficacy, and shelf life. Solid dosage forms, like tablets, are particularly sensitive to environmental factors such as humidity,…

Solid Dosage form, Tablets

Challenges in predicting the impact of high humidity on capsule disintegration times.

April 30, 2025 Admin

Challenges in predicting the impact of high humidity on capsule disintegration times. Challenges in predicting the impact of high humidity on capsule disintegration times. Introduction: In the realm of pharmaceutical manufacturing, ensuring the efficacy and stability of solid oral dosage forms such as capsules is paramount. Capsules, both hard and soft gelatin, are a prevalent…

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

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

Difficulty in validating capsule integrity for long-term storage conditions.

April 23, 2025 Admin

Difficulty in validating capsule integrity for long-term storage conditions. Difficulty in validating capsule integrity for long-term storage conditions. Introduction: In the pharmaceutical industry, ensuring the integrity of capsules over their shelf life is paramount. Capsules, whether hard or soft gelatin, are a preferred dosage form due to their ease of administration and ability to encapsulate…

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

Poor correlation between laboratory and field stability data for capsules.

April 20, 2025 Admin

Poor correlation between laboratory and field stability data for capsules. Poor correlation between laboratory and field stability data for capsules. Introduction: In the pharmaceutical industry, stability testing is a critical component that ensures the safety, efficacy, and quality of drug products throughout their shelf life. Capsules, both hard and soft gelatin, are popular solid oral…

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

Managing Temperature Fluctuations in Stability Testing Chambers

April 19, 2025 Admin

Managing Temperature Fluctuations in Stability Testing Chambers Managing Temperature Fluctuations in Stability Testing Chambers Introduction: Stability testing is a critical component of the pharmaceutical development process, ensuring that drug products maintain their intended quality, safety, and efficacy throughout their shelf life. Central to this process are stability testing chambers, which simulate various environmental conditions to…

Solid Dosage form, Tablets

Challenges in assessing stability of capsules with non-aqueous fills.

April 18, 2025 Admin

Challenges in assessing stability of capsules with non-aqueous fills. Challenges in assessing stability of capsules with non-aqueous fills. Introduction: In the pharmaceutical industry, ensuring the stability of drug products is crucial for maintaining efficacy and safety. Capsules, both hard and soft gelatin, are popular solid oral dosage forms. However, when these capsules are filled with…

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

Difficulty in evaluating the impact of excipient changes on capsule stability.

April 12, 2025 Admin

Difficulty in evaluating the impact of excipient changes on capsule stability. Difficulty in Evaluating the Impact of Excipient Changes on Capsule Stability Introduction: In the pharmaceutical industry, the stability of a drug product is a critical factor that influences its safety, efficacy, and shelf-life. Capsules, both hard and soft gelatin, are popular solid oral dosage…

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

Inadequate protocols for evaluating shell-to-fill interaction effects.

April 5, 2025 Admin

Inadequate protocols for evaluating shell-to-fill interaction effects. Inadequate Protocols for Evaluating Shell-to-Fill Interaction Effects in Capsules Introduction: In the pharmaceutical industry, solid oral dosage forms such as capsules are a staple due to their ease of administration and versatility. Capsules, which can be either hard or soft gelatin, serve as a vehicle to deliver active…

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