Tag: pharmaceutical validation

Validating Water Circulation Systems for Extended Release Tablet Equipment

March 7, 2025 Admin

Validating Water Circulation Systems for Extended Release Tablet Equipment Validating Water Circulation Systems for Extended Release Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the quality and safety of extended release tablets is paramount. A critical aspect of this process is the validation of water circulation systems used in tablet manufacturing equipment. Water is a…

Solid Dosage form, Tablets

Problems with validating capsule weight variation for hard gelatin capsules.

March 7, 2025 Admin

Problems with validating capsule weight variation for hard gelatin capsules. Problems with validating capsule weight variation for hard gelatin capsules. Introduction: In the pharmaceutical industry, hard gelatin capsules are a prevalent form of solid oral dosage. Ensuring the consistency of capsule weight is crucial for maintaining dosage accuracy, therapeutic efficacy, and patient safety. Variations in…

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

Managing Challenges in Validating Spray Guns for Enteric-Coating Applications

March 6, 2025 Admin

Managing Challenges in Validating Spray Guns for Enteric-Coating Applications Managing Challenges in Validating Spray Guns for Enteric-Coating Applications Introduction: In the pharmaceutical industry, enteric coating is a critical process used to ensure that the active pharmaceutical ingredient (API) of a tablet survives the acidic environment of the stomach and is released in the intestine, where…

Solid Dosage form, Tablets

Challenges in validating capsule performance for pediatric formulations.

March 5, 2025 Admin

Challenges in validating capsule performance for pediatric formulations. Challenges in validating capsule performance for pediatric formulations. Introduction: In the realm of pharmaceutical development, pediatric formulations pose unique challenges that require careful consideration, particularly when it comes to solid oral dosage forms like capsules. Pediatric patients differ significantly from adults in terms of physiology, pharmacokinetics, and…

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

Problems with ensuring consistent gelatin spread during shell preparation validation.

March 5, 2025 Admin

Problems with ensuring consistent gelatin spread during shell preparation validation. Problems with Ensuring Consistent Gelatin Spread During Shell Preparation Validation Introduction: In the pharmaceutical industry, the production of capsules, both hard and soft gelatin, is a critical process that requires precision and consistency. One of the pivotal steps in this manufacturing process is ensuring a…

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

Validating Real-Time Process Monitoring Systems for Coating Applications

March 4, 2025 Admin

Validating Real-Time Process Monitoring Systems for Coating Applications Validating Real-Time Process Monitoring Systems for Coating Applications Introduction: The pharmaceutical industry is continually evolving, with advanced technologies enhancing precision, safety, and efficiency in drug manufacturing. One such advancement is the implementation of real-time process monitoring systems for coating applications in tablet production. These systems play a…

Solid Dosage form, Tablets

Inadequate validation protocols for new capsule formulations.

March 4, 2025 Admin

Inadequate validation protocols for new capsule formulations. Inadequate Validation Protocols for New Capsule Formulations Introduction: The pharmaceutical industry is continually evolving, with innovations leading to new and effective drug delivery systems. Among these, capsules remain a popular choice due to their ease of administration and ability to encapsulate a wide range of drug compounds. However,…

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

Problems with validating capsule printing for transparent capsules.

March 4, 2025 Admin

Problems with validating capsule printing for transparent capsules. Problems with validating capsule printing for transparent capsules. Introduction: In the pharmaceutical industry, capsules are a popular solid oral dosage form due to their versatility, ease of administration, and ability to encapsulate a variety of drug formulations. Among the different types of capsules, transparent capsules have gained…

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

Validating Water Circulation Systems for Fluid Bed Granulators

March 3, 2025 Admin

Validating Water Circulation Systems for Fluid Bed Granulators Validating Water Circulation Systems for Fluid Bed Granulators Introduction: The fluid bed granulator is a critical piece of equipment in pharmaceutical manufacturing, particularly in the production of solid dosage forms like tablets. Central to its operation is the water circulation system, which plays a crucial role in…

Solid Dosage form, Tablets

Inadequate systems for monitoring gelatin cross-linking during validation.

March 3, 2025 Admin

Inadequate systems for monitoring gelatin cross-linking during validation. Inadequate systems for monitoring gelatin cross-linking during validation. Introduction: Gelatin capsules, both hard and soft gelatin, are widely used in the pharmaceutical industry due to their versatility and patient compliance benefits. However, one of the key challenges faced during the formulation and manufacturing of gelatin capsules is…

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

Challenges in validating capsule sealing for capsules with modified-release coatings.

March 2, 2025 Admin

Challenges in validating capsule sealing for capsules with modified-release coatings. Challenges in validating capsule sealing for capsules with modified-release coatings Introduction: In the pharmaceutical industry, capsules remain a popular dosage form due to their versatility and patient compliance. Specifically, capsules with modified-release coatings offer the advantage of controlled drug release, enhancing therapeutic efficacy and minimizing…

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

Validating Residual Solvent Control Measures in Coated Tablets

March 2, 2025 Admin

Validating Residual Solvent Control Measures in Coated Tablets Validating Residual Solvent Control Measures in Coated Tablets Introduction: Residual solvents are volatile chemicals used or produced in the manufacture of pharmaceutical substances, excipients, or in the preparation of drug products. Their presence in pharmaceuticals is a critical quality and safety concern, especially in coated tablets where…

Solid Dosage form, Tablets