Tag: Stability testing

The Role of Excipients in Packaging Compatibility for Biopharmaceuticals Understanding the Role of Excipients in Packaging Compatibility for Biopharmaceuticals Introduction Excipients play a crucial role in the formulation of biopharmaceuticals, ensuring their stability, efficacy, and manufacturability. However, excipients can also interact with packaging materials, leading to potential stability issues or product degradation. As biopharmaceuticals are…

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Innovations in Blister Packaging for Long-Term Stability Studies Innovative Approaches in Blister Packaging for Long-Term Stability Studies Introduction Blister packaging has long been a popular choice in the pharmaceutical industry for its ability to protect individual doses of drugs from environmental factors such as moisture, oxygen, and light. Recent advancements in blister packaging have enhanced…

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How to Design Real-Time Stability Studies for Advanced Packaging Systems Designing Real-Time Stability Studies for Advanced Pharmaceutical Packaging Introduction Real-time stability studies are essential for evaluating the performance of advanced packaging systems in maintaining the quality, efficacy, and safety of pharmaceutical products. These studies simulate actual storage conditions over the product’s intended shelf life, providing…

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Addressing Humidity Sensitivity in Packaging Materials for Pharmaceuticals How to Address Humidity Sensitivity in Pharmaceutical Packaging Materials Introduction Humidity is one of the most critical environmental factors that can adversely affect the stability of pharmaceutical products. Many drugs, especially solid dosage forms, are hygroscopic and susceptible to degradation when exposed to moisture. Packaging materials play…

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Shelf Life Determination for Solid Dosage Forms in Advanced Packaging Determining Shelf Life for Solid Dosage Forms in Advanced Packaging Introduction Shelf life is a critical parameter in pharmaceutical development, ensuring that solid dosage forms like tablets and capsules maintain their efficacy, safety, and quality over time. Advanced packaging solutions play a pivotal role in…

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Regulatory Trends in Packaging Stability Testing for Biologics Emerging Regulatory Trends in Packaging Stability Testing for Biologics Introduction Biologics, including monoclonal antibodies, vaccines, and gene therapies, are among the most complex and sensitive pharmaceutical products. Ensuring their stability throughout the product lifecycle is critical, particularly as they are distributed globally under varying environmental conditions. Packaging…

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