Related Experiment Video
Updated: Aug 9, 2026
09:39
Injectable Supramolecular Polymer-Nanoparticle Hydrogels for Cell and Drug Delivery Applications
Published on: February 7, 2021
Risk-Based Extraction and Leaching Studies for Injectable Drug Products: Addressing Process Impurities, Nitrosamine
1Novavax pranjan@novavax.com.
PDA Journal of Pharmaceutical Science and Technology
|August 7, 2026
Summary
Ensuring injectable drug safety requires a holistic risk-based approach to container closure systems. This involves managing extractables and leachables (E&L), nitrosamines, and siliconization for product quality and patient safety.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
- Materials Science
Background:
- Injectable drug product safety and quality depend on formulation, manufacturing, and container closure systems (CCS).
- Extractables and leachables (E&L) from CCS components can compromise drug safety, efficacy, and regulatory compliance.
- Emerging risks include nitrosamine formation and siliconization-related issues in prefilled syringes, necessitating updated risk management strategies.
Purpose of the Study:
- To discuss strategies for a holistic, risk-based extractables and leachables (E&L) framework for injectable drug products.
- To address emerging challenges such as nitrosamine formation and prefilled syringe siliconization.
- To align E&L evaluations with current regulatory guidance (USP <1663>, <1664>, ICH, EMA).
Main Methods:
- Characterization and monitoring of E&L under stability conditions.
- Evaluation of nitrosamine formation and syringe siliconization risks.
- Application of robust analytical, mechanical, and toxicological testing methodologies.
Main Results:
- A holistic E&L framework strengthens product quality, patient safety, and regulatory confidence.
- Risk-based strategies mitigate potential safety and efficacy issues from CCS.
- Integration of chemical, mechanical, and toxicological data supports lifecycle and regulatory strategies.
Conclusions:
- Holistic E&L evaluations are crucial for ensuring the safety and quality of injectable drug products.
- Addressing emerging risks like nitrosamines and siliconization is vital for regulatory compliance.
- A comprehensive approach supports innovation in injectable drug delivery systems.
Related Concept Videos
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
01:19Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
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...
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
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,...
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
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 pharmacologically...
01:28Parenteral Drug Delivery Systems: Injectables, Implants, and Infusion Devices
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...