Tag: stability challenges

Managing API Degradation in Sugar-Coated Tablets During Stability Studies

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Managing API Degradation in Sugar-Coated Tablets During Stability Studies Managing API Degradation in Sugar-Coated Tablets During Stability Studies Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of a drug product throughout its shelf life is of paramount importance. Sugar-coated tablets, a popular dosage form due to their aesthetic appeal and ease of ingestion,…

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Solid Dosage form, Tablets

Managing Brittleness in High-Dose Tablets Under Stability Conditions

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Managing Brittleness in High-Dose Tablets Under Stability Conditions Managing Brittleness in High-Dose Tablets Under Stability Conditions Introduction: In the pharmaceutical industry, the development of high-dose tablets presents several challenges, particularly concerning their brittleness under stability conditions. Brittleness can compromise the efficacy, safety, and quality of the medication, which is crucial for patient health. Understanding and…

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Solid Dosage form, Tablets

Managing API Migration in Multi-API Tablets During Stability Testing

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Managing API Migration in Multi-API Tablets During Stability Testing Managing API Migration in Multi-API Tablets During Stability Testing Introduction: In the ever-evolving world of pharmaceuticals, the development of multi-active pharmaceutical ingredient (API) tablets has gained significant momentum. These formulations offer the advantage of delivering multiple therapeutic effects in a single dose, enhancing patient compliance and…

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Solid Dosage form, Tablets

Ensuring Packaging Compatibility for Tablets with Extended Stability Requirements

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Ensuring Packaging Compatibility for Tablets with Extended Stability Requirements Ensuring Packaging Compatibility for Tablets with Extended Stability Requirements Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of tablets throughout their shelf life is paramount. This is particularly critical for tablets with extended stability requirements. The compatibility between the packaging and the tablet formulation…

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Solid Dosage form, Tablets

Ensuring Consistency in Disintegration Time During Long-Term Stability Studies

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Ensuring Consistency in Disintegration Time During Long-Term Stability Studies Ensuring Consistency in Disintegration Time During Long-Term Stability Studies Introduction: In the realm of pharmaceuticals, ensuring consistency in the disintegration time of tablets during long-term stability studies is pivotal for guaranteeing a drug’s efficacy, safety, and patient compliance. Disintegration time is a critical quality attribute that…

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Solid Dosage form, Tablets

Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions

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Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions Introduction: Sugar-coated tablets have long been a staple in pharmaceutical formulations, offering benefits such as masking unpleasant tastes, improving tablet appearance, and protecting active pharmaceutical ingredients (APIs) from environmental factors. However, they also present unique challenges, particularly…

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Solid Dosage form, Tablets

Poor correlation between laboratory and field stability data for capsules.

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Poor correlation between laboratory and field stability data for capsules. Poor correlation between laboratory and field stability data for capsules. Introduction: In the pharmaceutical industry, stability testing is a critical component that ensures the safety, efficacy, and quality of drug products throughout their shelf life. Capsules, both hard and soft gelatin, are popular solid oral…

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

Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets

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Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets Introduction: Active Pharmaceutical Ingredients (APIs) are the heart of any medication, providing the therapeutic effect intended for the patient. In the realm of solid dosage forms, particularly tablets, preserving the stability of APIs is crucial. Temperature-sensitive tablets,…

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Solid Dosage form, Tablets

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

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

Problems with predicting the stability of capsules containing sensitive APIs.

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Problems with predicting the stability of capsules containing sensitive APIs. Problems with Predicting the Stability of Capsules Containing Sensitive APIs Introduction: In the pharmaceutical industry, ensuring the stability of drug products is paramount to maintaining efficacy and safety throughout their shelf life. Capsules, both hard and soft gelatin, are popular dosage forms due to their…

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

Investigating Stability of Coating Polymers Under UV Exposure

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Investigating Stability of Coating Polymers Under UV Exposure Investigating Stability of Coating Polymers Under UV Exposure Introduction: The stability of coating polymers under ultraviolet (UV) exposure is a crucial aspect of pharmaceutical development, particularly for solid dosage forms like tablets. Coating polymers serve multiple functions: they protect the active pharmaceutical ingredient (API), control the release…

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Solid Dosage form, Tablets