Tag: stability protocols

Managing API Migration in Multi-API Tablets During Stability Testing

May 11, 2025 Admin

Managing API Migration in Multi-API Tablets During Stability Testing Managing API Migration in Multi-API Tablets During Stability Testing Introduction: In the ever-evolving world of pharmaceuticals, the development of multi-active pharmaceutical ingredient (API) tablets has gained significant momentum. These formulations offer the advantage of delivering multiple therapeutic effects in a single dose, enhancing patient compliance and…

Solid Dosage form, Tablets

Addressing Deviations in Stability Studies for Bilayer Tablets

April 27, 2025 Admin

Addressing Deviations in Stability Studies for Bilayer Tablets Addressing Deviations in Stability Studies for Bilayer Tablets Introduction: Bilayer tablets have emerged as a versatile drug delivery system, offering the advantage of combining two different drugs or formulations with varied release profiles in a single dosage form. This innovation not only improves patient compliance but also…

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

Poor correlation between in vitro dissolution and stability data.

April 24, 2025 Admin

Poor correlation between in vitro dissolution and stability data. Poor correlation between in vitro dissolution and stability data. Introduction: In the pharmaceutical industry, the correlation between in vitro dissolution and stability data is pivotal for ensuring the efficacy and safety of solid oral dosage forms, particularly capsules. Dissolution testing is a key quality control measure…

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

Difficulty in assessing the stability of capsules containing low-dose APIs.

April 21, 2025 Admin

Difficulty in assessing the stability of capsules containing low-dose APIs. Difficulty in assessing the stability of capsules containing low-dose APIs. Introduction: In the pharmaceutical industry, ensuring the stability of drug products is paramount, particularly when dealing with capsules containing low-dose Active Pharmaceutical Ingredients (APIs). Stability refers to the ability of a drug product to maintain…

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

Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies.

April 9, 2025 Admin

Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies. Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies. Introduction: In the realm of pharmaceuticals, the dissolution testing of capsules is a critical parameter in ensuring the efficacy and safety of drug products. Evaluating capsule dissolution in biorelevant media during…

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

Problems with predicting the stability of capsules containing sensitive APIs.

April 6, 2025 Admin

Problems with predicting the stability of capsules containing sensitive APIs. Problems with Predicting the Stability of Capsules Containing Sensitive APIs Introduction: In the pharmaceutical industry, ensuring the stability of drug products is paramount to maintaining efficacy and safety throughout their shelf life. Capsules, both hard and soft gelatin, are popular dosage forms due to their…

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

Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies

April 3, 2025 Admin

Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies Introduction: Stability studies are a crucial component of the pharmaceutical development process, ensuring that drug products maintain their intended quality, safety, and efficacy throughout their shelf life. Non-adherence to stability protocols can lead to significant issues, including…

Solid Dosage form, Tablets

Managing Root Cause Analysis for Failures in Stability Studies

March 22, 2025 Admin

Managing Root Cause Analysis for Failures in Stability Studies Managing Root Cause Analysis for Failures in Stability Studies Introduction: In the pharmaceutical industry, stability studies are crucial to ensuring that a drug product maintains its intended quality, safety, and efficacy throughout its shelf life. Failures in stability studies can lead to significant setbacks in drug…

Solid Dosage form, Tablets