Tag: GMP Practices

Addressing Challenges in Handling Enteric-Coated Tablets During Blister Packing

June 2, 2025 Admin

Addressing Challenges in Handling Enteric-Coated Tablets During Blister Packing Addressing Challenges in Handling Enteric-Coated Tablets During Blister Packing Introduction: Enteric-coated tablets are designed to withstand the acidic environment of the stomach and dissolve in the alkaline environment of the intestine. This specialized coating is crucial for the targeted delivery of certain medications, ensuring their efficacy…

Solid Dosage form, Tablets

Addressing Punch Wear Issues During Tablet Press Validation

May 25, 2025 Admin

Addressing Punch Wear Issues During Tablet Press Validation Addressing Punch Wear Issues During Tablet Press Validation Introduction: In the pharmaceutical manufacturing sector, ensuring the integrity and quality of tablet products is paramount. One critical aspect of this process is the validation of tablet presses, where punch wear can significantly impact product quality and efficiency. Punches,…

Solid Dosage form, Tablets

Troubleshooting Failures in Compression Force Validation for High-Speed Presses

May 22, 2025 Admin

Troubleshooting Failures in Compression Force Validation for High-Speed Presses Troubleshooting Failures in Compression Force Validation for High-Speed Presses Introduction: In the fast-paced world of pharmaceutical manufacturing, high-speed tablet presses are indispensable assets that enable large-scale production of solid dosage forms. These machines are designed to efficiently compress powders into tablets, making them crucial in meeting…

Solid Dosage form, Tablets

High variability in capsule weight due to poor powder flow properties.

April 25, 2025 Admin

High variability in capsule weight due to poor powder flow properties. High variability in capsule weight due to poor powder flow properties. Introduction: The pharmaceutical industry consistently strives to achieve high standards of quality and efficacy in its products. Solid oral dosage forms, such as capsules, play a critical role in this landscape. However, one…

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

Challenges in validating nitrogen purity levels for capsule drying processes.

April 25, 2025 Admin

Challenges in validating nitrogen purity levels for capsule drying processes. Challenges in Validating Nitrogen Purity Levels for Capsule Drying Processes Introduction: In the pharmaceutical industry, maintaining the quality and integrity of solid oral dosage forms, such as capsules, is paramount. The drying process of capsules, whether hard or soft gelatin, is a critical step that…

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

Ensuring Adequate Sealing in Multi-Chamber Blister Packs for Multi-Layer Tablets

April 22, 2025 Admin

Ensuring Adequate Sealing in Multi-Chamber Blister Packs for Multi-Layer Tablets Ensuring Adequate Sealing in Multi-Chamber Blister Packs for Multi-Layer Tablets Introduction: In the ever-evolving pharmaceutical industry, packaging plays a crucial role in ensuring drug efficacy, safety, and compliance. Multi-chamber blister packs are increasingly favored for their ability to segregate multi-layer tablets, offering enhanced protection and…

Solid Dosage form, Tablets

Difficulty in validating temperature control systems for capsule storage areas.

April 20, 2025 Admin

Difficulty in validating temperature control systems for capsule storage areas. Difficulty in Validating Temperature Control Systems for Capsule Storage Areas Introduction: Temperature control is a critical factor in the pharmaceutical industry, particularly for the storage of solid oral dosage forms like capsules. Both hard and soft gelatin capsules are susceptible to environmental conditions, which can…

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

Poor reproducibility in validation data for modified-release capsules.

April 17, 2025 Admin

Poor reproducibility in validation data for modified-release capsules. Poor reproducibility in validation data for modified-release capsules. Introduction: Modified-release capsules are pivotal in modern therapeutics, offering controlled drug delivery that improves patient compliance and therapeutic outcomes. However, ensuring the reproducibility of validation data for these formulations is crucial in maintaining their efficacy and safety. Inconsistent validation…

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

Poor reproducibility in weight variation measurements over extended storage.

April 13, 2025 Admin

Poor reproducibility in weight variation measurements over extended storage. Poor reproducibility in weight variation measurements over extended storage. Introduction: In the pharmaceutical industry, ensuring the consistency and quality of solid oral dosage forms is paramount. Capsules, both hard and soft gelatin, are popular due to their ease of administration and versatility. However, maintaining their weight…

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

Inadequate validation of capsule disintegration profiles for multi-particulate capsules.

April 13, 2025 Admin

Inadequate validation of capsule disintegration profiles for multi-particulate capsules. Inadequate validation of capsule disintegration profiles for multi-particulate capsules. Introduction: In the pharmaceutical industry, the validation of capsule disintegration profiles is a critical aspect of ensuring drug efficacy and patient safety. This is particularly important for multi-particulate capsules, which can offer benefits such as improved bioavailability…

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

Resolving Non-Homogeneity in API Distribution in Multi-API Tablets

April 6, 2025 Admin

Resolving Non-Homogeneity in API Distribution in Multi-API Tablets Resolving Non-Homogeneity in API Distribution in Multi-API Tablets Introduction: In the dynamic sphere of pharmaceutical manufacturing, ensuring the consistent distribution of Active Pharmaceutical Ingredients (APIs) within multi-API tablets is crucial. These tablets, designed to deliver multiple therapeutic effects, require precise formulation to ensure that each dose is…

Solid Dosage form, Tablets

Addressing Over-Lubrication in Powder Blends During Compression

March 25, 2025 Admin

Addressing Over-Lubrication in Powder Blends During Compression Addressing Over-Lubrication in Powder Blends During Compression Introduction: In the pharmaceutical industry, the production of high-quality tablets is pivotal. The tablet compression process is a critical phase where powder blends are transformed into solid dosage forms. However, one of the common challenges faced during this process is over-lubrication,…

Solid Dosage form, Tablets