Tag: Capsule formulation

Challenges in validating capsule coating processes.

March 14, 2025 Admin

Challenges in validating capsule coating processes. Challenges in Validating Capsule Coating Processes Introduction: In the pharmaceutical industry, the coating of capsules—both hard and soft gelatin—is a critical step in ensuring product stability, controlled release, and patient compliance. Validating these coating processes is essential for maintaining product efficacy and safety. This article explores the challenges of…

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

Difficulty in monitoring fill weight uniformity during high-speed production.

March 13, 2025 Admin

Difficulty in monitoring fill weight uniformity during high-speed production. Difficulty in monitoring fill weight uniformity during high-speed production. Introduction: In the pharmaceutical industry, ensuring the uniformity of fill weight in capsule production is crucial for maintaining product quality and efficacy. This becomes increasingly complex during high-speed manufacturing, where rapid production rates can introduce variability. This…

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

Difficulty in validating water quality for multi-product capsule facilities.

March 13, 2025 Admin

Difficulty in validating water quality for multi-product capsule facilities. Difficulty in Validating Water Quality for Multi-Product Capsule Facilities Introduction: In the pharmaceutical industry, water quality is a critical component of manufacturing processes, especially in facilities that produce solid oral dosage forms like capsules. Both hard and soft gelatin capsules require water of a specific quality…

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

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

Lack of robust methods for real-time moisture content monitoring in capsules.

March 11, 2025 Admin

Lack of robust methods for real-time moisture content monitoring in capsules. Lack of robust methods for real-time moisture content monitoring in capsules. Introduction: Moisture content within pharmaceutical capsules is a critical quality attribute that can significantly affect the product’s efficacy, stability, and shelf life. Both hard and soft gelatin capsules are particularly susceptible to moisture…

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

Challenges in validating cleaning methods for multi-layer capsule formulations.

March 11, 2025 Admin

Challenges in validating cleaning methods for multi-layer capsule formulations. Challenges in validating cleaning methods for multi-layer capsule formulations. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical to producing safe and effective medications. This is particularly true for multi-layer capsule formulations, which involve complex manufacturing processes. The validation of cleaning methods…

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

Problems with achieving uniform capsule appearance in transparent packs.

March 9, 2025 Admin

Problems with achieving uniform capsule appearance in transparent packs. Problems with achieving uniform capsule appearance in transparent packs. Introduction: The pharmaceutical industry continually strives for excellence in manufacturing practices, with capsule appearance being a critical quality attribute. Uniformity in capsule appearance is not only essential for aesthetic appeal but also for ensuring consumer confidence in…

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

Inadequate methods for monitoring oil leakage in soft gelatin capsules.

March 9, 2025 Admin

Inadequate methods for monitoring oil leakage in soft gelatin capsules. Inadequate methods for monitoring oil leakage in soft gelatin capsules. Introduction: Soft gelatin capsules, commonly known as softgels, are a popular dosage form in the pharmaceutical industry due to their ability to encapsulate oils and active ingredients that are sensitive to light or oxidation. However,…

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

Poor reproducibility in stability data across multiple batches.

March 8, 2025 Admin

Poor reproducibility in stability data across multiple batches. Poor Reproducibility in Stability Data Across Multiple Batches Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability of products is paramount. Stability data are crucial for determining the shelf life and storage conditions of pharmaceutical products, ensuring they remain safe and effective for patients throughout their…

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