Tag: stability studies

Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing

April 21, 2025 Admin

Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing Resolving Disintegration Failures in Sugar-Coated Tablets During Stability Testing Introduction: Sugar-coated tablets are a popular dosage form in the pharmaceutical industry, valued for their aesthetic appeal and ability to mask unpleasant tastes. However, these advantages can be overshadowed by challenges encountered during stability testing, particularly disintegration…

Solid Dosage form, Tablets

Problems with ensuring compliance with regulatory guidelines for capsule packaging.

April 17, 2025 Admin

Problems with ensuring compliance with regulatory guidelines for capsule packaging. Problems with Ensuring Compliance with Regulatory Guidelines for Capsule Packaging Introduction: In the pharmaceutical industry, the packaging of solid oral dosage forms such as capsules plays a critical role in ensuring product safety, efficacy, and quality. Compliance with regulatory guidelines for capsule packaging is essential…

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

Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time

April 13, 2025 Admin

Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time Introduction: Sugar-coated tablets are a popular solid dosage form in the pharmaceutical industry due to their ability to mask unpleasant tastes and improve patient compliance. However, maintaining the potency of the Active Pharmaceutical Ingredient (API)…

Solid Dosage form, Tablets

Investigating Core Erosion in Extended Release Tablets During Stability Storage

April 13, 2025 Admin

Investigating Core Erosion in Extended Release Tablets During Stability Storage Investigating Core Erosion in Extended Release Tablets During Stability Storage Introduction: In the realm of pharmaceutical development, extended release (ER) tablets play a pivotal role in ensuring patient compliance and therapeutic efficacy. These tablets are designed to release active pharmaceutical ingredients (APIs) at a controlled…

Solid Dosage form, Tablets

Problems with maintaining consistent dissolution profiles over the product’s shelf life.

April 13, 2025 Admin

Problems with maintaining consistent dissolution profiles over the product’s shelf life. Problems with maintaining consistent dissolution profiles over the product’s shelf life. Introduction: The dissolution profile of a pharmaceutical product is a critical parameter that impacts its efficacy and safety. Consistency in dissolution profiles over the product’s shelf life ensures that the drug is released…

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 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

Poor reproducibility in API release profiles over the product’s shelf life.

April 4, 2025 Admin

Poor reproducibility in API release profiles over the product’s shelf life. Poor reproducibility in API release profiles over the product’s shelf life. Introduction: The reproducibility of Active Pharmaceutical Ingredient (API) release profiles is a critical component in the pharmaceutical industry, particularly for solid oral dosage forms such as capsules. Ensuring consistent drug release over a…

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

Poor reproducibility in gelatin cross-linking data under various storage conditions.

April 4, 2025 Admin

Poor reproducibility in gelatin cross-linking data under various storage conditions. Poor Reproducibility in Gelatin Cross-Linking Data Under Various Storage Conditions Introduction: In the pharmaceutical industry, the stability and integrity of solid oral dosage forms, particularly capsules, are paramount. Gelatin, a common excipient used in hard and soft capsules, undergoes a process known as cross-linking, which…

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

Troubleshooting Coating Cracks During Stability Testing

March 31, 2025 Admin

Troubleshooting Coating Cracks During Stability Testing Troubleshooting Coating Cracks During Stability Testing Introduction: In the pharmaceutical industry, the stability of solid dosage forms, particularly tablets, is critical for ensuring the efficacy and safety of medication over its shelf life. Coating cracks are a prevalent issue encountered during stability testing, which can compromise the protective function…

Solid Dosage form, Tablets