Related Experiment Video
Updated: May 10, 2026
04:59
Disposable Dosators Intended for Dry Powder Delivery to Mice
Published on: August 18, 2023
Particulate matter in injectable drug products
1Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave, Bldg. 51, Rm. 4158 Silver Spring, MD 20993.
PDA Journal of Pharmaceutical Science and Technology
|June 12, 2013
Summary
Particulate matter contamination is present in all injectable drugs, posing potential risks to patients. Continuous efforts are needed to minimize these particles in parenteral products, especially for high-risk individuals.
Area of Science:
- Pharmaceutical Science
- Drug Manufacturing
- Patient Safety
Background:
- Particulate matter contamination in injectable drugs has been a long-standing clinical concern.
- All parenteral products contain particulate matter, including fibers, dust, rubber, and silicone, primarily introduced during manufacturing.
- Injected particulate matter has the potential to cause patient harm.
Purpose of the Study:
- To understand the types and sources of particulate matter in injectable drug products.
- To evaluate the potential effects of injected particulate matter on patients.
- To review current regulations and standards for particulate matter in injectable drug products.
Main Methods:
- Review of existing literature and regulatory standards.
- Analysis of common sources of particulate contamination in parenteral products.
- Assessment of potential patient sequelae from particulate matter exposure.
Main Results:
- Injectable drug products invariably contain particulate matter from manufacturing processes.
- The impact of particulate matter on patients varies, necessitating risk assessment.
- Existing manufacturing standards and regulations have improved quality but require ongoing enhancement.
Conclusions:
- Minimizing particulate matter contamination in injectable drugs is critical due to widespread use and potential harm.
- Continued collaboration among manufacturers, regulators, and standards-setting organizations is essential.
- Focus should be on reducing risks, particularly for high-risk patients, without imposing undue manufacturing burdens.
Related Concept Videos
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...
01:23Inhaled Medications
Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
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...
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...
01:29Drug Delivery: Parenteral Route
The parenteral route is a critical method of drug administration. It delivers compounds directly into the systemic circulation and bypasses the gastrointestinal tract. This approach is particularly advantageous for drugs that exhibit poor absorption or instability when administered orally.
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...
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...