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Excipient Screening vs Excipient Synthesis: Which Problem Are You Actually Solving?
13
Jul
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Excipient Screening vs Excipient Synthesis: Which Problem Are You Actually Solving?

Excipients play a fundamental role in pharmaceutical formulation development, influencing manufacturability, stability, drug release, bioavailability, patient acceptability, and overall product performance. Although many pharmaceutical products can be successfully developed using commercially available excipients, certain formulation challenges cannot always be resolved through conventional excipient selection alone. When formulation performance does not meet predefined development objectives, scientists […]
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Extractables, Leachables, and Nitrosamines: Where Pharmaceutical Packaging Risk Assessments Commonly Miss Risk
29
Jun
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Extractables, Leachables, and Nitrosamines: Where Pharmaceutical Packaging Risk Assessments Commonly Miss Risk

Pharmaceutical packaging systems are designed to protect products throughout manufacturing, storage, transportation, and patient use. As a result, packaging risk assessments have become a routine part of pharmaceutical development and quality management programs. However, one important challenge remains: not all packaging-related risks are immediately visible. While many packaging assessments focus on material compatibility, stability, and […]
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Elemental Impurity Risk Assessment vs Confirmatory ICP-MS Testing: When Do You Need Both?
23
Jun
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Elemental Impurity Risk Assessment vs Confirmatory ICP-MS Testing: When Do You Need Both?

Elemental impurities remain a critical consideration in pharmaceutical quality systems because trace metal contaminants can affect product safety, regulatory compliance, and overall product quality. To manage these risks, pharmaceutical manufacturers are expected to follow the principles outlined in ICH Q3D, which provides a risk-based framework for evaluating and controlling elemental impurities. However, one of the […]
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Nitrosamine Risk in Packaging and Storage: The Overlooked Source After Manufacturing
19
Jun
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Nitrosamine Risk in Packaging and Storage: The Overlooked Source After Manufacturing

Nitrosamine impurities have become one of the most closely scrutinized classes of pharmaceutical contaminants due to their potential carcinogenic risk and increasing regulatory attention. Following several high-profile product recalls, pharmaceutical manufacturers have implemented extensive risk assessment and testing programs to identify and control potential sources of nitrosamine formation. Most discussions surrounding nitrosamines focus on manufacturing […]
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How Membrane Selection Affects IVPT Outcomes in Topical Drug Development
17
Jun
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How Membrane Selection Affects IVPT Outcomes in Topical Drug Development

In Vitro Permeation Testing (IVPT) has become an essential tool in the development and evaluation of topical and transdermal drug products. By measuring the movement of an active pharmaceutical ingredient (API) across a membrane over time, IVPT helps scientists assess drug delivery performance, compare formulations, and support bioequivalence strategies. However, the reliability of IVPT data […]
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Pharmaceutical Polymer Synthesis for Controlled-Release Drug Delivery
26
May
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Pharmaceutical Polymer Synthesis for Controlled-Release Drug Delivery

In controlled drug delivery, product performance depends as much on polymer behaviour as on the active ingredient itself. A drug may have the right pharmacology, but if the surrounding material system is not designed properly, the formulation may still fail to achieve its intended release profile, stability target, or therapeutic performance. This is where pharmaceutical […]
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