Tag: pharmaceutical guidelines

Managing Failures in Moisture Content Tests for Coated Tablets

March 13, 2025 Admin

Managing Failures in Moisture Content Tests for Coated Tablets Managing Failures in Moisture Content Tests for Coated Tablets Introduction: Moisture content tests are an essential part of ensuring the quality, safety, and efficacy of coated tablets in pharmaceutical manufacturing. Accurate moisture levels are crucial as they impact the physical and chemical stability of the tablet,…

Solid Dosage form, Tablets

Controlling Dust Contamination in Coating Machines

March 13, 2025 Admin

Controlling Dust Contamination in Coating Machines Controlling Dust Contamination in Coating Machines Introduction: In the pharmaceutical industry, maintaining the quality and safety of drug products is paramount. One critical aspect of this is the control of dust contamination in coating machines used in the production of tablets. Dust contamination can lead to significant quality control…

Solid Dosage form, Tablets

Identifying Causes of Friability Failures in Sugar-Coated Tablets

March 12, 2025 Admin

Identifying Causes of Friability Failures in Sugar-Coated Tablets Identifying Causes of Friability Failures in Sugar-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the quality and integrity of solid dosage forms is of paramount importance. Tablets, especially sugar-coated ones, are widely used due to their ease of administration and patient compliance. However, the friability of these…

Solid Dosage form, Tablets

Inadequate systems for monitoring capsule integrity during production.

March 11, 2025 Admin

Inadequate systems for monitoring capsule integrity during production. Inadequate systems for monitoring capsule integrity during production. Introduction: The pharmaceutical industry continuously strives to ensure the highest quality of its products, and capsule integrity plays a crucial role in this process. Capsules, whether hard or soft gelatin, are a popular solid oral dosage form, valued for…

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

Lack of robust methods for real-time moisture content monitoring in capsules.

March 11, 2025 Admin

Lack of robust methods for real-time moisture content monitoring in capsules. Lack of robust methods for real-time moisture content monitoring in capsules. Introduction: Moisture content within pharmaceutical capsules is a critical quality attribute that can significantly affect the product’s efficacy, stability, and shelf life. Both hard and soft gelatin capsules are particularly susceptible to moisture…

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

Inadequate systems for monitoring microbial levels in purified water.

March 11, 2025 Admin

Inadequate systems for monitoring microbial levels in purified water. Inadequate systems for monitoring microbial levels in purified water. Introduction: In the pharmaceutical industry, maintaining the purity of water used in manufacturing processes is critical. Purified water is an essential component in the production of solid oral dosage forms, such as capsules. However, without proper monitoring…

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

Preventing Crushing of Tablets During Carton Closing Operations

March 10, 2025 Admin

Preventing Crushing of Tablets During Carton Closing Operations Preventing Crushing of Tablets During Carton Closing Operations Introduction: In the pharmaceutical industry, ensuring the integrity of tablets from production to delivery is paramount. One critical stage where tablets are susceptible to damage is during carton closing operations. The crushing of tablets not only results in financial…

Solid Dosage form, Tablets

Validating Adequacy of Binder Concentration in Wet Granulation Processes

March 8, 2025 Admin

Validating Adequacy of Binder Concentration in Wet Granulation Processes Validating Adequacy of Binder Concentration in Wet Granulation Processes Introduction: In the realm of pharmaceutical manufacturing, the wet granulation process is a cornerstone for producing high-quality tablets. Ensuring the adequacy of binder concentration is critical in this process, as it directly influences the tablet’s integrity, dissolution…

Solid Dosage form, Tablets

Difficulty in validating capsule sealing for capsules with multi-layer fills.

March 8, 2025 Admin

Difficulty in validating capsule sealing for capsules with multi-layer fills. Difficulty in validating capsule sealing for capsules with multi-layer fills Introduction: Capsules have long been a preferred dosage form in the pharmaceutical industry due to their versatility and convenience. The advent of multi-layer fills in capsules has paved the way for innovative drug delivery systems….

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

Difficulty in testing for capsule tamper resistance.

March 7, 2025 Admin

Difficulty in testing for capsule tamper resistance. Difficulty in Testing for Capsule Tamper Resistance Introduction: In the pharmaceutical industry, ensuring the integrity and safety of drug products is paramount. Capsules, both hard and soft gelatin, are popular solid oral dosage forms due to their convenience and efficiency in delivering medication. However, they are vulnerable to…

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

Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets

March 6, 2025 Admin

Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of tablet formulations is paramount. Among various quality parameters, hardness testing plays a crucial role in assessing the mechanical integrity of coated tablets. The consistency of tablet…

Solid Dosage form, Tablets

Preventing Over-Drying in Coated Tablets During Curing Stages

March 6, 2025 Admin

Preventing Over-Drying in Coated Tablets During Curing Stages Preventing Over-Drying in Coated Tablets During Curing Stages Introduction: Coated tablets are a mainstay in the pharmaceutical industry, offering benefits such as controlled release, taste masking, and enhanced stability. However, one of the critical stages in the production of coated tablets is the curing process, which aims…

Solid Dosage form, Tablets