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The level of particles in parenteral pharmaceutical formulations is a critical quality attribute. This is no surprise; the clinical consequence of their presence can be very severe, including fatality. In the major pharmacopeia, from the US, Europe, and Japan, there is a specified limit for particles in the final parenteral formulation. Moreover, these pharmacopeia specify two methods for measurement – light obscuration (LO) and microscopic particle count (MPC).For the analysis of drug product, LO is the primary method and, MPC should be used only if LO is not adequate or not possible. However, for the analysis of components, both MCP and LO are recommended. MCP is more effective at detecting particles >25µm in diameter. Additionally, MCP allows for the use of surfactant in the extraction, which improves the ability to rinse particles from the component surface. However, LO can be used effectively for the analysis of sub-visible particulate on components, if used appropriately. The principle behind LO is simple. The sample solution is drawn into an illuminated flow cell path; particles in the sample solution obscure light. The degree of obscuration is dependent upon the size of the particles. Data are compared to that for standard polystyrene beads; an equivalent spherical diameter of particles is calculated. With today’s technology, it is more efficient and requires less labor.But – are the results from LO accurate and reflective of the actual quality of the samples tested? To ensure the answer is yes, the following conditions are necessary:
a) robust pre-rinse protocol – to avoid any effects of disturbance
b) appropriate dilution – a solution too concentrated may cause coincidence of particles
c) test solution free of bubbles
d) particle-free test environment
e) sufficient difference in refractive index difference between particles and test solution
Take an in-depth look at the science behind containment & delivery ofinjectable medicines in the West Knowledge Center.
The development of a drug product is an arduous and intricate process. Besides ensuring the sterility and effectiveness of the final product, it should also be as free of particles as possible. In protein-based pharmaceuticals, aggregates may form over time and are mostly detrimental to product quality, as they can affect the efficacy, potency, clinical safety, and immunogenicity of the product.<sup>1-3</sup> Protein aggregates are considered a type of particulate matter (PM), and it is important to minimize their occurrence, as well as to quantify the PM for ensuring the quality and safety of the drug products.
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the <em>FDA Recalls, Market Withdrawals, & Safety Alerts</em> database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination<sup>1</sup>.
The presence of particulate matter (PM) in parenteral drug products is a well-known challenge for pharmaceutical companies due to the potential quality and safety risks involved. In biotherapeutics, critical attributes related to efficacy, potency, clinical safety, and immunogenicity can be affected by PM.<sup>1-3 </sup><br />PM is defined as extraneous mobile undissolved particles (excluding gas bubbles) that are unintentionally present in solutions.<sup>4</sup><br />Several USP chapters describe the measurement of PM, namely:
A parenteral drug product contaminated by particles is a potential health threat. In the bloodstream, particles can cause serious issues, such as capillary occlusion and immunogenic responses. In most cases, the observation of particles in a drug product leads to a recall.
Particles in parenteral drug products are a serious concern; they can cause issues such as product recalls, or worse, immunogenic responses. Sources of particles are varied; they can be from aggregates of biologic API’s, excipient contaminants, components, or silicone oil used to promote syringe function. With emphasis on safe and efficient delivery of drug products, West is focused on strategies to both measure particles, and mitigate their presence.