Tag: pharmaceutical regulatory compliance

Troubleshooting Brittleness in High-Dose Tablets During Compression Validation

May 17, 2025 Admin

Troubleshooting Brittleness in High-Dose Tablets During Compression Validation Troubleshooting Brittleness in High-Dose Tablets During Compression Validation Introduction: In the pharmaceutical industry, tablet formulation and manufacturing represent critical processes that significantly impact the quality, efficacy, and safety of the final product. High-dose tablets are particularly challenging to develop due to the increased risks of brittleness, which…

Solid Dosage form, Tablets

Ensuring Adequate Process Controls for Hygroscopic Tablet Production

May 14, 2025 Admin

Ensuring Adequate Process Controls for Hygroscopic Tablet Production Ensuring Adequate Process Controls for Hygroscopic Tablet Production Introduction: Hygroscopic tablets, known for their ability to absorb moisture from the environment, pose unique challenges in pharmaceutical manufacturing. Ensuring adequate process controls during their production is crucial for maintaining product stability, efficacy, and quality. This comprehensive guide delves…

Solid Dosage form, Tablets

Difficulty in achieving consistent lubrication in encapsulation equipment.

April 20, 2025 Admin

Difficulty in achieving consistent lubrication in encapsulation equipment. Difficulty in achieving consistent lubrication in encapsulation equipment. Introduction: The encapsulation of pharmaceuticals, particularly in solid oral dosage forms like capsules, is a critical step in drug production. Achieving consistent lubrication in encapsulation equipment is pivotal for ensuring the smooth operation of machinery, maintaining product quality, and…

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

Difficulty in monitoring fill weight for semi-solid capsule formulations.

April 16, 2025 Admin

Difficulty in monitoring fill weight for semi-solid capsule formulations. Difficulty in Monitoring Fill Weight for Semi-Solid Capsule Formulations Introduction: The pharmaceutical industry is continuously evolving with advancements in drug delivery systems. Among these, semi-solid capsule formulations have gained significant attention due to their unique advantages over traditional solid and liquid dosage forms. However, one of…

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

Problems with detecting microscopic cracks in gelatin shells.

April 8, 2025 Admin

Problems with detecting microscopic cracks in gelatin shells. Problems with Detecting Microscopic Cracks in Gelatin Shells Introduction: Gelatin capsules, both hard and soft, are integral to the pharmaceutical industry due to their effectiveness in encapsulating drugs and providing controlled release. However, ensuring the integrity of these capsules is critical, as even microscopic cracks in the…

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

Poor reproducibility in monitoring capsule weight variation.

April 8, 2025 Admin

Poor reproducibility in monitoring capsule weight variation. Poor reproducibility in monitoring capsule weight variation. Introduction: Capsules, as solid oral dosage forms, play a critical role in the pharmaceutical industry due to their ease of administration, stability, and ability to encapsulate a variety of substances. However, ensuring consistent weight and content uniformity remains a significant challenge,…

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

Challenges in validating nitrogen flow rates for capsule drying systems.

April 6, 2025 Admin

Challenges in validating nitrogen flow rates for capsule drying systems. Challenges in Validating Nitrogen Flow Rates for Capsule Drying Systems Introduction: In the pharmaceutical industry, the production of hard and soft gelatin capsules is a critical process requiring stringent control measures to ensure product quality and efficacy. One of the essential steps in the capsule…

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

High rejection rates due to improper capsule sealing.

April 5, 2025 Admin

High rejection rates due to improper capsule sealing. High rejection rates due to improper capsule sealing. Introduction: In the pharmaceutical industry, capsules remain a popular choice for delivering medications due to their versatility, tamper-evidence, and patient compliance. However, high rejection rates due to improper capsule sealing can pose significant challenges, leading to increased production costs,…

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

Challenges in validating capsule filling for powders with poor flow properties.

April 3, 2025 Admin

Challenges in validating capsule filling for powders with poor flow properties. Challenges in Validating Capsule Filling for Powders with Poor Flow Properties Introduction: In the realm of solid oral dosage forms, capsules stand out for their versatility and patient compliance. However, ensuring consistent and accurate filling of capsules, especially when dealing with powders possessing poor…

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

Preventing Overfilling in Tablet Bottling Lines for Immediate Release Tablets

April 3, 2025 Admin

Preventing Overfilling in Tablet Bottling Lines for Immediate Release Tablets Preventing Overfilling in Tablet Bottling Lines for Immediate Release Tablets Introduction: In the pharmaceutical industry, precision in tablet bottling lines is critical, particularly for immediate release tablets. Ensuring that each bottle contains the correct number of tablets not only maintains dosage accuracy and therapeutic effectiveness…

Solid Dosage form, Tablets

Addressing Over-Drying in Sugar-Coated Tablets During Curing

March 27, 2025 Admin

Addressing Over-Drying in Sugar-Coated Tablets During Curing Addressing Over-Drying in Sugar-Coated Tablets During Curing Introduction: Sugar-coating is an essential phase in the production of tablets, offering not only aesthetic appeal but also protection from environmental factors. However, one of the prevalent challenges during the sugar-coating process is over-drying, which can compromise the integrity and effectiveness…

Solid Dosage form, Tablets

Challenges in measuring residual moisture in soft gelatin capsules.

March 15, 2025 Admin

Challenges in measuring residual moisture in soft gelatin capsules. Challenges in measuring residual moisture in soft gelatin capsules. Introduction: The pharmaceutical industry is constantly evolving, with a focus on precision, quality, and compliance. Soft gelatin capsules, widely used for their ease of consumption and ability to encapsulate both aqueous and oily solutions, are highly sensitive…

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