Tag: EMA guidelines

Ensuring Robustness in Layer Adhesion for Bilayer Tablet Equipment Validation

May 27, 2025 Admin

Ensuring Robustness in Layer Adhesion for Bilayer Tablet Equipment Validation Ensuring Robustness in Layer Adhesion for Bilayer Tablet Equipment Validation Introduction: In the realm of pharmaceutical manufacturing, bilayer tablets have emerged as a significant advancement, offering multiple benefits such as the ability to combine incompatible substances, controlled release profiles, and patient convenience. However, the manufacturing…

Solid Dosage form, Tablets

Investigating Solvent Evaporation Effects on Coated Tablets During Storage

May 13, 2025 Admin

Investigating Solvent Evaporation Effects on Coated Tablets During Storage Investigating Solvent Evaporation Effects on Coated Tablets During Storage Introduction: In the pharmaceutical industry, the stability and integrity of coated tablets during storage are paramount to ensuring their efficacy and safety. Solvent evaporation is a critical factor that can affect the coating’s performance, leading to potential…

Solid Dosage form, Tablets

Validating Cleaning Protocols for Sugar-Coating Pans

May 12, 2025 Admin

Validating Cleaning Protocols for Sugar-Coating Pans Validating Cleaning Protocols for Sugar-Coating Pans Introduction: In the pharmaceutical industry, the integrity of solid dosage forms, such as tablets, is paramount. A critical aspect of this process is ensuring that the equipment used, particularly sugar-coating pans, is thoroughly cleaned between batches. This not only prevents cross-contamination but also…

Solid Dosage form, Tablets

Challenges in predicting the impact of packaging material permeability on capsule stability.

April 28, 2025 Admin

Challenges in predicting the impact of packaging material permeability on capsule stability. Challenges in predicting the impact of packaging material permeability on capsule stability. Introduction: In the pharmaceutical industry, ensuring the stability of capsules—whether hard or soft gelatin—is a critical component of the drug development process. Packaging plays a pivotal role in preserving the integrity…

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

Challenges in assessing the stability of capsules containing biological APIs.

April 27, 2025 Admin

Challenges in assessing the stability of capsules containing biological APIs. Challenges in assessing the stability of capsules containing biological APIs. Introduction: The pharmaceutical industry is increasingly focusing on the development of capsules containing biological Active Pharmaceutical Ingredients (APIs) due to their potential in treating various complex diseases. However, ensuring the stability of these capsules poses…

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

Poor reproducibility in dissolution profiles for lipid-based capsules.

April 24, 2025 Admin

Poor reproducibility in dissolution profiles for lipid-based capsules. Poor reproducibility in dissolution profiles for lipid-based capsules. Introduction: Lipid-based capsules, encompassing both hard and soft gelatin varieties, are critical in the delivery of poorly water-soluble drugs. These formulations improve bioavailability, allowing for efficient drug release and absorption. However, achieving consistent dissolution profiles in lipid-based capsules poses…

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

Poor reproducibility in rinse sampling data for lipid-based formulations.

April 17, 2025 Admin

Poor reproducibility in rinse sampling data for lipid-based formulations. Poor reproducibility in rinse sampling data for lipid-based formulations. Introduction: Lipid-based formulations have gained significant attention in the pharmaceutical industry due to their ability to enhance the bioavailability of poorly water-soluble drugs. However, ensuring the cleanliness of manufacturing equipment used for these formulations poses unique challenges,…

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

Poor reproducibility in swab recovery rates for potent APIs.

April 15, 2025 Admin

Poor reproducibility in swab recovery rates for potent APIs. Poor reproducibility in swab recovery rates for potent APIs. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical, especially when dealing with potent active pharmaceutical ingredients (APIs). Swab recovery studies are essential for validating the cleaning processes that remove residues from surfaces….

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

Challenges in validating capsule filling equipment for pediatric formulations.

April 12, 2025 Admin

Challenges in validating capsule filling equipment for pediatric formulations. Challenges in validating capsule filling equipment for pediatric formulations. Introduction: Pediatric formulations, especially in the form of capsules, present unique challenges in pharmaceutical manufacturing. The demand for precise dosing, patient compliance, and safety in pediatric populations necessitates rigorous validation of capsule filling equipment. Validation ensures that…

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

Difficulty in validating cleaning procedures for non-aqueous formulations.

April 7, 2025 Admin

Difficulty in validating cleaning procedures for non-aqueous formulations. Difficulty in Validating Cleaning Procedures for Non-Aqueous Formulations Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to prevent cross-contamination and ensure product quality. This is especially critical when dealing with non-aqueous formulations, often used in the production of capsules, both hard and…

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

Challenges in validating cleaning processes for low-dose formulations.

April 4, 2025 Admin

Challenges in validating cleaning processes for low-dose formulations. Challenges in validating cleaning processes for low-dose formulations. Introduction: In the pharmaceutical industry, ensuring that equipment used in the manufacturing of drug products is free from contaminants is crucial. This is especially true for low-dose formulations, where even minimal residuals can affect product safety and efficacy. Cleaning…

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

Ensuring Consistency in Batch-to-Batch Content Uniformity for Tablets

March 30, 2025 Admin

Ensuring Consistency in Batch-to-Batch Content Uniformity for Tablets Ensuring Consistency in Batch-to-Batch Content Uniformity for Tablets Introduction: In the pharmaceutical industry, ensuring consistency in batch-to-batch content uniformity of tablets is paramount. Content uniformity is crucial for maintaining the safety and efficacy of medications. Variability in the active pharmaceutical ingredient (API) distribution can lead to suboptimal…

Solid Dosage form, Tablets