Tag: stability challenges

Ensuring Adequate pH Stability in Enteric-Coated Tablets During Testing

March 22, 2025 Admin

Ensuring Adequate pH Stability in Enteric-Coated Tablets During Testing Ensuring Adequate pH Stability in Enteric-Coated Tablets During Testing Introduction: In the pharmaceutical industry, enteric-coated tablets play a crucial role in ensuring that active pharmaceutical ingredients (APIs) are delivered to the intestine, bypassing the acidic environment of the stomach. This not only protects the drug from…

Solid Dosage form, Tablets

Addressing Brittleness in Sugar-Coated Tablets Under Freeze-Thaw Cycles

March 15, 2025 Admin

Addressing Brittleness in Sugar-Coated Tablets Under Freeze-Thaw Cycles Addressing Brittleness in Sugar-Coated Tablets Under Freeze-Thaw Cycles Introduction: Sugar-coated tablets are a popular solid dosage form in the pharmaceutical industry due to their aesthetic appeal and ability to mask the taste of active pharmaceutical ingredients (APIs). However, the stability of these tablets can be significantly challenged…

Solid Dosage form, Tablets

Troubleshooting Variability in Dissolution Profiles During Stability Studies

March 14, 2025 Admin

Troubleshooting Variability in Dissolution Profiles During Stability Studies Troubleshooting Variability in Dissolution Profiles During Stability Studies Introduction: Dissolution testing is a critical aspect of pharmaceutical development, acting as a quality control measure to ensure that tablets release their active ingredients at the intended rate and extent. During stability studies, the variability in dissolution profiles can…

Solid Dosage form, Tablets

High variability in stability data for oil-filled capsules.

March 12, 2025 Admin

High variability in stability data for oil-filled capsules. High variability in stability data for oil-filled capsules. Introduction: In the pharmaceutical industry, maintaining the stability of medicinal products is crucial to ensure their safety, efficacy, and quality over their shelf life. Among various dosage forms, oil-filled capsules—encompassing both hard and soft gelatin variants—present unique challenges in…

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

Poor correlation between accelerated and real-time stability results.

March 12, 2025 Admin

Poor correlation between accelerated and real-time stability results. Poor correlation between accelerated and real-time stability results. Introduction: Stability testing is an essential component of the pharmaceutical development process. It ensures that a drug product maintains its intended physical, chemical, microbiological, and therapeutic properties throughout its shelf life. Accelerated stability testing and real-time stability testing are…

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

Problems with ensuring consistent drug release profiles during stability studies.

March 11, 2025 Admin

Problems with ensuring consistent drug release profiles during stability studies. Problems with ensuring consistent drug release profiles during stability studies. Introduction: In the pharmaceutical industry, stability studies are essential for ensuring that a drug maintains its intended efficacy, safety, and quality over time. These studies are particularly critical for solid oral dosage forms, such as…

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

High rejection rates due to brittleness in capsule shells after stability testing.

March 10, 2025 Admin

High rejection rates due to brittleness in capsule shells after stability testing. High rejection rates due to brittleness in capsule shells after stability testing. Introduction: The pharmaceutical industry is ever-evolving, with a constant push towards enhancing the quality and efficacy of drug delivery systems. Capsules, both hard and soft gelatin, play a pivotal role in…

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

Addressing Coating Peel-Off During Stability Studies

March 8, 2025 Admin

Addressing Coating Peel-Off During Stability Studies Addressing Coating Peel-Off During Stability Studies Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability and integrity of tablet coatings is paramount. Coatings play a crucial role in protecting the active pharmaceutical ingredient (API), controlling release profiles, improving patient compliance, and enhancing the aesthetic appeal of the product….

Solid Dosage form, Tablets

Resolving Failures in Stability Testing Due to Packaging Interaction

March 3, 2025 Admin

Resolving Failures in Stability Testing Due to Packaging Interaction Resolving Failures in Stability Testing Due to Packaging Interaction Introduction: In the pharmaceutical industry, stability testing is crucial to ensure that a drug product maintains its intended quality, safety, and efficacy throughout its shelf life. Stability testing evaluates how environmental factors such as temperature, humidity, and…

Solid Dosage form, Tablets