Some IV Drugs Require Filtration, What Type of Filters Do They Require?
Does your IV drug require filtration?
December 20, 2021
A recent article published in Hospital Pharmacy showed that 93 Intravenous (IV) drugs approved by the FDA between December 2011 and April 2019 require filtration with a syringe or in-line filter 1. Filtration of parenteral formulations (IV drugs) may be required either during preparation of the drug and/or during administration to the patient to remove particulate matter and other contamination.
Why parenteral formulations (IV drugs) require in-line filtration prior to administration?
Although parenteral formulations (IV drugs) are sterile preparations intended for direct administration into the systemic circulation they can be supplied as solutions, suspensions, emulsions or powders for injection or infusion. There are many reasons why the manufacturer may include a requirement for filtration in their instructions for use, it is essential the requirements are followed to provide the necessary protection to the patient.
Worldwide regulations for parenteral products require them to be essentially free from particulates or free from readily detectable foreign matter. Parenteral drugs can be provided in many formats including concentrated and ready to use solutions and freeze-dried formulations which need reconstituting and diluting prior to use. These may then be provided in various packaging types including plastic, glass with rubber stoppers or glass ampules. All these variants give the opportunity for particles to form/ be introduced. Infusion of particulates has been shown to be involved in clinical complications such as phlebitis, granuloma, arterial embolism, modulation of immune response and inflammatory reaction, microcirculation deterioration and even death2 because of organ failure 3.
What does the recent article published by Hospital Pharmacy indicate?
The recently updated chart of IV drugs to be used with a syringe or in-line filter, published in Hospital Pharmacy1 includes an extensive list of drug formulations of different categories including monoclonal antibody (mAb) formulations, antimicrobial drugs, cancer drugs and more. Figures 1 – 3 graphically summarize the distribution of number of drugs requiring filtration by pore size, requirement, and drug category as listed in the article. The detailed list of drugs is available in the paper1.
Monoclonal antibody formulations constitute over ¼ of the list and may require filtration during preparation and/or administration with a 0.2/ 0.22 µm filter the common requirements for these are low-protein binding and/or polyethersulfone (PES) membrane. The list of drugs requiring filtration increases all the time, the paper by Ipema only includes drugs approved by the FDA to 2019. In addition to these, many of the recently approved mAb formulation for COVID-19 treatment for example bamlanivimab and etesevimab, casirivimab and imdevimab (administered together) and sotrovimab also recommend the use of 0.2 / 0.22 µm polyethersulfone (PES) membrane in-line filter during administration4-6.
Ultimately, the selection of an appropriate IV in-line filter for administration or syringe filter for preparation is not a trivial undertaking even if the drug manufacturer includes information, such as pore size, membrane type and intended use (preparation and/or administration) of the appropriate filter there are many options.
What are the points to consider while selecting an in-line or syringe filter for IV drug administration?
When selecting an appropriate syringe filter for preparation or in-line filter for IV drug administration there are many considerations such as
- Performance claims of the filter – Are they indicated for this use
- Target population (adult or pediatric) -Different size filters will have different hold up volumes and allow different flow rates if used under gravity.
- Length of use – will the formulation be administered for 24 hours or longer and if so are the filters indicated for this use
- Manufacturer’s instructions – even the same drug type from different manufacturers may have different requirements for filtration
- Does the filter manufacturer have any data on drug binding to the filter?
Our Scientific Lab Services” (SLS) and our Clinical Specialists are here to help you and offer advice on filter selection of the optimal intravenous filtration selection. We have previously carried out testing on different formulation with our filters and can perform similar testing as required.
Figure 1. Distribution of number of IV drugs requiring filtration by different pore size.
Figure 2. Distribution of number of IV drugs requiring filtration for (a) preparation, (b) in-line administration.
Figure 3. Distribution of number of IV drugs requiring filtration by drug category.
Note: Category “Other” includes drugs like Immunosuppressant, vasodilator, diuretic, neurology treatment, antithrombotic etc.
- Ipema.J.H, et al., Hospital Pharmacy, 2021 56(2) 81-87.
- Jack, T., et al., Intensive Care Medicine, 2012 38(6), 1008-1016.
- Schmitt, E., et al., Critical Care (2019) 23, 373.
- Eli Lilly and Company (September 16th, 2021). Fact Sheet for Health Care Providers Emergency Use Authorization (Eua). Retrieved from https://www.fda.gov/media/145802/download
- Regeneron Pharmaceuticals, Inc. (September 2021). Fact Sheet for Health Care Providers Emergency Use Authorization (Eua) Of Regen-Covtm (Casirivimab And Imdevimab). Retrieved from https://www.regeneron.com/downloads/treatment-covid19-eua-fact-sheet-for-hcp.pdf
- GlaxoSmithKline LLC. (2021). Fact Sheet for Healthcare Providers Emergency Use Authorization (Eua) Of Sotrovimab. Retrieved from https://www.fda.gov/media/149534/download
Thank you for your interest. We will be in touch soon.
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IV Filtration in:
Dr. Smruti Ragunath, PhD - Senior Application Specialist
Dr. Sam Spiers, PhD - Senior Technical Specialist
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