Tag: Gelatin capsules

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

Inadequate systems for validating capsule shell properties under high-humidity conditions.

April 2, 2025 Admin

Inadequate systems for validating capsule shell properties under high-humidity conditions. Inadequate systems for validating capsule shell properties under high-humidity conditions. Introduction: Capsule shell properties are critical to the performance and stability of solid oral dosage forms. In particular, the validation of these properties under high-humidity conditions is of paramount importance. High humidity can drastically affect…

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

Lack of validated protocols for testing highly hydrophobic APIs.

April 2, 2025 Admin

Lack of validated protocols for testing highly hydrophobic APIs. Lack of validated protocols for testing highly hydrophobic APIs. Introduction: In the pharmaceutical industry, the development and testing of Active Pharmaceutical Ingredients (APIs) are crucial for ensuring drug efficacy and safety. However, one significant challenge that researchers and formulators face is dealing with highly hydrophobic APIs,…

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

Difficulty in ensuring consistent pump calibration for liquid-filled capsules.

April 2, 2025 Admin

Difficulty in ensuring consistent pump calibration for liquid-filled capsules. Difficulty in ensuring consistent pump calibration for liquid-filled capsules Introduction: The pharmaceutical industry is intricately dependent on precision and accuracy, especially in the production of solid oral dosage forms like liquid-filled capsules. These capsules, whether hard or soft gelatin, are essential for delivering precise doses of…

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

Difficulty in validating capsule drying processes for dual-layer capsules.

April 2, 2025 Admin

Difficulty in validating capsule drying processes for dual-layer capsules. Difficulty in validating capsule drying processes for dual-layer capsules Introduction: The pharmaceutical industry is constantly evolving, with innovations aimed at improving drug delivery systems and enhancing patient compliance. One such innovation is the development of dual-layer capsules. These capsules offer the advantage of delivering multiple drugs…

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

Difficulty in conducting root cause analysis for capsule quality failures.

April 2, 2025 Admin

Difficulty in conducting root cause analysis for capsule quality failures. Difficulty in conducting root cause analysis for capsule quality failures. Introduction: The pharmaceutical industry is tasked with the critical responsibility of ensuring that all medicinal products are safe, effective, and of the highest quality. Capsules, both hard and soft gelatin, are among the most common…

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

Inadequate methods for detecting trace levels of insoluble residues.

April 1, 2025 Admin

Inadequate methods for detecting trace levels of insoluble residues. Inadequate Methods for Detecting Trace Levels of Insoluble Residues Introduction: In the pharmaceutical industry, the integrity and purity of drug products are paramount. Particularly with solid oral dosage forms, such as capsules, ensuring that no insoluble residues remain is critical for both efficacy and patient safety….

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

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

Problems with ensuring consistent capsule appearance during accelerated validation studies.

April 1, 2025 Admin

Problems with ensuring consistent capsule appearance during accelerated validation studies. Problems with ensuring consistent capsule appearance during accelerated validation studies. Introduction: In the pharmaceutical industry, ensuring the consistent appearance of capsules is crucial for maintaining product quality and consumer trust. During accelerated validation studies, which are designed to predict the long-term stability of a product…

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

Problems with maintaining consistent pack quality during high-speed operations.

April 1, 2025 Admin

Problems with maintaining consistent pack quality during high-speed operations. Problems with Maintaining Consistent Pack Quality During High-Speed Operations Introduction: In the fast-paced world of pharmaceutical manufacturing, efficiency and quality often go hand in hand. High-speed operations, particularly in the packaging of solid oral dosage forms like capsules, are essential for meeting market demand and maintaining…

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

Poor reproducibility in gelatin elasticity data under various storage conditions.

March 31, 2025 Admin

Poor reproducibility in gelatin elasticity data under various storage conditions. Poor reproducibility in gelatin elasticity data under various storage conditions. Introduction: Gelatin capsules, both hard and soft gelatin, are pivotal in the pharmaceutical industry as they offer a stable and effective medium for drug delivery. However, the elasticity of gelatin, a critical factor in capsule…

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

Inadequate systems for verifying capsule coating equipment calibration.

March 30, 2025 Admin

Inadequate systems for verifying capsule coating equipment calibration. Inadequate systems for verifying capsule coating equipment calibration. Introduction: In the pharmaceutical industry, the precision of capsule coating processes is critical for ensuring product quality and compliance with regulatory standards. Capsules, whether hard or soft gelatin, require exact coating specifications to achieve the desired therapeutic effect, stability,…

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