Tag: pharmaceutical best practices

Difficulty in maintaining consistent capsule hardness over the stability period.

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Difficulty in maintaining consistent capsule hardness over the stability period. Difficulty in maintaining consistent capsule hardness over the stability period. Introduction: Capsules, both hard and soft gelatin, are a prevalent form of oral dosage in the pharmaceutical industry due to their versatility and patient compliance. However, maintaining consistent hardness throughout the stability period is a…

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

Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation

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Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation Introduction: The pharmaceutical industry is highly regulated, with stringent guidelines ensuring that products are safe and effective for consumers. Among the numerous challenges faced by manufacturers is the control of residual solvents in film-coated tablets. These solvents,…

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Solid Dosage form, Tablets

Inadequate validation of capsule performance under freezing conditions.

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Inadequate validation of capsule performance under freezing conditions. Inadequate validation of capsule performance under freezing conditions Introduction: In the pharmaceutical industry, solid oral dosage forms like capsules are a popular choice due to their convenience, stability, and patient compliance. However, the performance of capsules under various environmental conditions, especially freezing conditions, can be a significant…

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

Inadequate systems for monitoring color uniformity over the stability period.

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Inadequate systems for monitoring color uniformity over the stability period. Inadequate systems for monitoring color uniformity over the stability period. Introduction: In the pharmaceutical industry, ensuring the quality and consistency of solid oral dosage forms is paramount. Among the critical aspects of quality control is monitoring the color uniformity of capsules over the stability period….

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

Difficulty in distinguishing capsule defects due to environmental effects.

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Difficulty in distinguishing capsule defects due to environmental effects. Difficulty in Distinguishing Capsule Defects Due to Environmental Effects Introduction: Capsules, both hard and soft gelatin, are a prevalent form of solid oral dosage utilized in pharmaceutical products. They offer advantages such as ease of swallowing and the ability to mask unpleasant tastes. However, ensuring their…

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

Challenges in ensuring consistent capsule coating thickness during validation.

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Challenges in ensuring consistent capsule coating thickness during validation. Challenges in ensuring consistent capsule coating thickness during validation. Introduction: In the pharmaceutical industry, capsules are a prevalent solid oral dosage form due to their ease of administration and ability to deliver precise dosages. Both hard and soft gelatin capsules can be coated for various reasons…

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

Inadequate systems for monitoring the alignment of capsule parts during validation.

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Inadequate systems for monitoring the alignment of capsule parts during validation. Inadequate systems for monitoring the alignment of capsule parts during validation. Introduction: In the pharmaceutical industry, the integrity of solid oral dosage forms, such as capsules, is paramount to ensuring the efficacy and safety of medications. Among the critical steps in capsule manufacturing is…

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

Lack of validated protocols for capsule imaging and defect detection.

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Lack of validated protocols for capsule imaging and defect detection. Lack of validated protocols for capsule imaging and defect detection. Introduction: In the pharmaceutical industry, ensuring the quality and safety of products is paramount. Among the various dosage forms, capsules—both hard and soft gelatin—hold significant importance due to their widespread use. However, the absence of…

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

Poor reproducibility in API stability data for high-dose capsules.

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Poor reproducibility in API stability data for high-dose capsules. Poor reproducibility in API stability data for high-dose capsules Introduction: In the pharmaceutical industry, the stability of active pharmaceutical ingredients (APIs) is crucial for ensuring drug safety and efficacy. For high-dose capsules, achieving consistent and reproducible stability data is particularly challenging. Variability in stability data can…

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

Poor reproducibility in capsule weight variation validation data for soft gelatin capsules.

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Poor reproducibility in capsule weight variation validation data for soft gelatin capsules. Poor reproducibility in capsule weight variation validation data for soft gelatin capsules. Introduction: The pharmaceutical industry is dedicated to maintaining the highest quality standards for drug delivery systems. Among these, soft gelatin capsules are a popular dosage form due to their easy ingestion…

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

Problems with ensuring consistent fill weight for semi-solid formulations.

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Problems with ensuring consistent fill weight for semi-solid formulations. Problems with Ensuring Consistent Fill Weight for Semi-Solid Formulations Introduction: In the pharmaceutical industry, maintaining consistent fill weight in semi-solid formulations is crucial for ensuring product efficacy, safety, and regulatory compliance. Semi-solid formulations, often used in capsules, pose unique challenges due to their complex nature. Ensuring…

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

Inadequate systems for monitoring cleaning validation data across multiple equipment.

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Inadequate systems for monitoring cleaning validation data across multiple equipment. Inadequate Systems for Monitoring Cleaning Validation Data Across Multiple Equipment Introduction: In the pharmaceutical industry, maintaining impeccable hygiene and cleanliness is paramount, especially when dealing with solid oral dosage forms like capsules. The efficacy of drugs and patient safety hinge on the ability to prevent…

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