Related Experiment Video
Updated: Apr 27, 2026
04:46
The Quantification of Injectability by Mechanical Testing
Published on: May 13, 2020
9.3K
Extractables and leachables considerations for prefilled syringes.
1Baxter Healthcare Corporation, Technology Resources Division , 25212 W. Illinois Route 120, Round Lake, IL 60073 , USA +1 224 270 5821 ; +1 224 270 5897 ; dennis_jenke@baxter.com.
Expert Opinion on Drug Delivery
|June 24, 2014
Summary
Pre-filled syringes require rigorous compatibility testing beyond traditional extractables and leachables analysis. New research is needed to understand drug-leachable interactions for safer, more effective drug delivery systems.
Area of Science:
- Pharmaceutical packaging and drug delivery systems
- Materials science and compatibility testing
- Drug product quality and stability
Background:
- Pre-filled syringes (PFS) are increasingly used for pharmaceutical packaging and drug delivery.
- PFS must meet quality and suitability requirements, including compatibility with drug products.
- Incompatibilities can arise from syringe-based leachables affecting drug safety, efficacy, and stability.
Purpose of the Study:
- To discuss suitability considerations for pre-filled syringes.
- To highlight extractables and leachables issues in PFS.
- To examine the toxicological impact and potential for altered drug efficacy.
Main Methods:
- Review of suitability considerations for pre-filled syringes.
- Citation of specific examples of suitability-for-use issues.
- Focus on extractables and leachables derived from PFS.
Main Results:
- Traditional safety risks from leachables are minimized by modern PFS materials and use conditions.
- Drug products in PFS are susceptible to non-traditional interactions, like protein conformation disruption.
- These interactions can lead to potential issues with efficacy, safety, and quality.
Conclusions:
- Traditional extractables and leachables measurement must be supplemented with rigorous compatibility testing for PFS qualification.
- Further research is essential to understand the fundamental relationship between leachables and drug substances.
- This research will enable a more time- and cost-efficient 'measure and infer' approach for PFS assessment.
Related Concept Videos
01:19Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
241
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
241
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
830
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
830
01:28Parenteral Drug Delivery Systems: Injectables, Implants, and Infusion Devices
204
Parenteral drug delivery systems play a crucial role in modern therapeutics by enabling the direct administration of drugs into the systemic circulation, bypassing the gastrointestinal tract. These systems are particularly valuable for poorly absorbed oral medications that are unstable in the digestive environment or require rapid onset or sustained therapeutic levels. Delivery is achieved through intravenous, intramuscular, or subcutaneous routes, each selected based on the drug's properties...
204
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
541
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
541
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
226
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
226
01:20Modified-Release Drug Delivery Systems: Influencing Factors
200
Modified-release drug delivery systems are designed to optimize the therapeutic effect of drugs by minimizing side effects, reducing the dosage required, and controlling drug release to align with pharmacokinetic and pharmacodynamic needs. The system depends on two key factors: the drug's release from the formulation and its movement through the body to the target site. Unlike conventional dosage forms, where absorption is the limiting step, the rate of drug release is the key determinant in...
200