Tag: capsule integrity

Poor oversight of third-party vendors supplying capsule shells.

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Poor oversight of third-party vendors supplying capsule shells. Poor Oversight of Third-Party Vendors Supplying Capsule Shells Introduction: In the pharmaceutical industry, ensuring the quality and safety of solid oral dosage forms, such as capsules, is paramount. Capsules, whether hard or soft gelatin, serve as vital delivery vehicles for medications. However, the integrity of these capsules…

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

Challenges in assessing stability of capsules with non-aqueous fills.

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Challenges in assessing stability of capsules with non-aqueous fills. Challenges in assessing stability of capsules with non-aqueous fills. Introduction: In the pharmaceutical industry, ensuring the stability of drug products is crucial for maintaining efficacy and safety. Capsules, both hard and soft gelatin, are popular solid oral dosage forms. However, when these capsules are filled with…

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

Challenges in detecting cross-linking of gelatin in hard capsules.

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Challenges in detecting cross-linking of gelatin in hard capsules. Challenges in detecting cross-linking of gelatin in hard capsules. Introduction: Gelatin capsules, especially hard gelatin capsules, are a cornerstone in the pharmaceutical industry, prized for their versatility and efficiency in delivering medications. However, one significant challenge that can impact their performance is gelatin cross-linking. This chemical…

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

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

Inadequate systems for verifying tamper-evident features on packaging.

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Inadequate systems for verifying tamper-evident features on packaging. Inadequate Systems for Verifying Tamper-Evident Features on Packaging Introduction: In the pharmaceutical industry, ensuring the integrity and security of drug packaging is paramount. Tamper-evident features on packaging are critical in safeguarding against unauthorized access and contamination, thereby protecting consumers and maintaining trust in pharmaceutical products. However, inadequate…

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

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

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

Problems with detecting changes in gelatin plasticizer levels during stability testing.

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Problems with detecting changes in gelatin plasticizer levels during stability testing. Problems with Detecting Changes in Gelatin Plasticizer Levels During Stability Testing Introduction: In the pharmaceutical industry, solid oral dosage forms, particularly gelatin capsules, are prevalent due to their ease of use and patient compliance. However, maintaining the stability of these dosage forms is critical…

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

Difficulty in evaluating the impact of excipient changes on capsule stability.

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Difficulty in evaluating the impact of excipient changes on capsule stability. Difficulty in Evaluating the Impact of Excipient Changes on Capsule Stability Introduction: In the pharmaceutical industry, the stability of a drug product is a critical factor that influences its safety, efficacy, and shelf-life. Capsules, both hard and soft gelatin, are popular solid oral dosage…

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

Poor validation of capsule disintegration profiles for capsules stored under stressed conditions.

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Poor validation of capsule disintegration profiles for capsules stored under stressed conditions. Poor validation of capsule disintegration profiles for capsules stored under stressed conditions. Introduction: In the pharmaceutical industry, ensuring the effective disintegration of capsules is crucial for the drug’s efficacy and safety. Disintegration testing is an essential quality control measure that determines whether capsules…

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

Inadequate systems for verifying capsule alignment in high-speed operations.

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Inadequate systems for verifying capsule alignment in high-speed operations. Inadequate Systems for Verifying Capsule Alignment in High-Speed Operations Introduction: In the pharmaceutical manufacturing industry, ensuring the proper alignment of capsules in high-speed operations is crucial for maintaining product quality and compliance with regulatory standards. Misalignment can lead to significant production inefficiencies, increased waste, and potential…

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

High rejection rates due to improperly filled capsule packs.

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High rejection rates due to improperly filled capsule packs. High Rejection Rates Due to Improperly Filled Capsule Packs Introduction: In the pharmaceutical industry, solid oral dosage forms such as capsules are a cornerstone due to their convenience and efficacy in delivering medication. However, the integrity of capsule packs is paramount to ensure patient safety and…

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