Tag: USFDA guidelines

Investigating Stability of Coating Polymers Under UV Exposure

April 6, 2025 Admin

Investigating Stability of Coating Polymers Under UV Exposure Investigating Stability of Coating Polymers Under UV Exposure Introduction: The stability of coating polymers under ultraviolet (UV) exposure is a crucial aspect of pharmaceutical development, particularly for solid dosage forms like tablets. Coating polymers serve multiple functions: they protect the active pharmaceutical ingredient (API), control the release…

Solid Dosage form, Tablets

Difficulty in testing capsules with multi-phase drug release profiles.

April 5, 2025 Admin

Difficulty in testing capsules with multi-phase drug release profiles. Difficulty in testing capsules with multi-phase drug release profiles. Introduction: In the ever-evolving landscape of pharmaceutical development, capsules with multi-phase drug release profiles have emerged as a sophisticated solution to optimize therapeutic outcomes. These formulations are designed to release active ingredients at different intervals, ensuring prolonged…

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

Inadequate systems for monitoring the performance of capsule inspection machines.

April 4, 2025 Admin

Inadequate systems for monitoring the performance of capsule inspection machines. Inadequate systems for monitoring the performance of capsule inspection machines. Introduction: In the pharmaceutical industry, ensuring the quality and safety of products is of paramount importance. Among the various solid oral dosage forms, capsules, particularly hard and soft gelatin capsules, require meticulous inspection to ensure…

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

Troubleshooting Overwrapping Problems in Sustained Release Tablets

April 4, 2025 Admin

Troubleshooting Overwrapping Problems in Sustained Release Tablets Troubleshooting Overwrapping Problems in Sustained Release Tablets Introduction: In the pharmaceutical industry, the packaging of sustained release tablets is a critical component that ensures product efficacy, stability, and safety. Overwrapping, a common packaging method, plays a vital role in protecting these tablets from environmental factors, preserving their intended…

Solid Dosage form, Tablets

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

Problems with maintaining consistent capsule hardness.

April 4, 2025 Admin

Problems with maintaining consistent capsule hardness. Problems with Maintaining Consistent Capsule Hardness Introduction: Capsules, whether hard or soft gelatin, are among the most prevalent forms of solid oral dosage forms in the pharmaceutical industry. Ensuring consistent capsule hardness is crucial as it affects the product’s stability, dissolution rate, and bioavailability. Variability in capsule hardness can…

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 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 cleaning cycles for gelatin drying trays.

April 3, 2025 Admin

Difficulty in validating cleaning cycles for gelatin drying trays. Difficulty in Validating Cleaning Cycles for Gelatin Drying Trays Introduction: In the pharmaceutical industry, ensuring the cleanliness of equipment is paramount to maintaining product integrity and patient safety. Gelatin drying trays, used extensively in the production of hard and soft gelatin capsules, present unique challenges in…

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

Lack of real-time monitoring systems for capsule sealing uniformity.

April 3, 2025 Admin

Lack of real-time monitoring systems for capsule sealing uniformity. Lack of real-time monitoring systems for capsule sealing uniformity. Introduction: In the pharmaceutical industry, ensuring the quality and integrity of solid oral dosage forms, particularly capsules, is paramount. Capsules, both hard and soft gelatin types, are a preferred delivery system for many medications due to their…

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

Problems with validating capsule sealing for capsules with delayed-release profiles.

April 3, 2025 Admin

Problems with validating capsule sealing for capsules with delayed-release profiles. Problems with Validating Capsule Sealing for Capsules with Delayed-Release Profiles Introduction: In the pharmaceutical industry, the demand for delayed-release capsules has been on the rise due to their ability to deliver active ingredients at specific sites within the gastrointestinal tract. These capsules are crucial for…

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