Tag: API Stability

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

Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity

May 6, 2025 Admin

Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity Introduction: Extended release tablets are a cornerstone of modern pharmaceutical formulations, offering controlled release of active pharmaceutical ingredients (APIs) over time to improve patient compliance and therapeutic efficacy. However, when these tablets are…

Solid Dosage form, Tablets

Ensuring Robustness of Coating Adhesion in Multi-API Tablets Over Time

May 4, 2025 Admin

Ensuring Robustness of Coating Adhesion in Multi-API Tablets Over Time Ensuring Robustness of Coating Adhesion in Multi-API Tablets Over Time Introduction: In the dynamic landscape of pharmaceutical manufacturing, ensuring the robustness of coating adhesion in multi-API (Active Pharmaceutical Ingredient) tablets is crucial. The coating plays a pivotal role in protecting the drug, controlling its release,…

Solid Dosage form, Tablets

Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets

April 19, 2025 Admin

Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets Introduction: Active Pharmaceutical Ingredients (APIs) are the heart of any medication, providing the therapeutic effect intended for the patient. In the realm of solid dosage forms, particularly tablets, preserving the stability of APIs is crucial. Temperature-sensitive tablets,…

Solid Dosage form, Tablets

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

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 Heat Damage in API Granules During Drying Validation

April 3, 2025 Admin

Troubleshooting Heat Damage in API Granules During Drying Validation Troubleshooting Heat Damage in API Granules During Drying Validation Introduction: In the pharmaceutical industry, the drying process of Active Pharmaceutical Ingredient (API) granules is a critical step in the production of solid dosage forms such as tablets. Ensuring the stability and integrity of APIs during drying…

Solid Dosage form, Tablets

Difficulty in validating capsule drying processes for thermosensitive APIs.

April 1, 2025 Admin

Difficulty in validating capsule drying processes for thermosensitive APIs. Difficulty in validating capsule drying processes for thermosensitive APIs Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability and efficacy of Active Pharmaceutical Ingredients (APIs) is paramount. Thermosensitive APIs, which are prone to degradation at elevated temperatures, pose unique challenges. As capsules, especially hard and…

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

Ensuring Consistency in API Release Profiles for Controlled Release Tablets

March 26, 2025 Admin

Ensuring Consistency in API Release Profiles for Controlled Release Tablets Ensuring Consistency in API Release Profiles for Controlled Release Tablets Introduction: In the world of pharmaceuticals, controlled release tablets play a pivotal role in ensuring the therapeutic efficacy of drugs. These formulations are designed to release active pharmaceutical ingredients (APIs) at a predetermined rate, maintaining…

Solid Dosage form, Tablets

Addressing API Variability Issues During Quality Assurance Audits

March 16, 2025 Admin

Addressing API Variability Issues During Quality Assurance Audits Addressing API Variability Issues During Quality Assurance Audits Introduction: In the pharmaceutical industry, ensuring the consistency and reliability of Active Pharmaceutical Ingredients (APIs) is crucial, especially during quality assurance audits. API variability can significantly impact the safety, efficacy, and quality of the final product, making it a…

Solid Dosage form, Tablets

Ensuring Robustness of API Potency in Sustained Release Tablets Over Time

March 14, 2025 Admin

Ensuring Robustness of API Potency in Sustained Release Tablets Over Time Ensuring Robustness of API Potency in Sustained Release Tablets Over Time Introduction: The development of sustained release tablets represents a significant advancement in pharmaceutical technology, aiming to provide consistent therapeutic effects over extended periods. These formulations are essential for enhancing patient compliance, minimizing dosing…

Solid Dosage form, Tablets