Discover the latest innovations in pharmaceutical characterization using advanced light scattering techniques from experts.
Can you explain why particle size is critical in drug formulation and how it impacts drug efficacy?
Dr. John F. Miller: Particle size is important because it determines a drug’s dissolution rate, bioavailability, and stability. For poorly soluble medications, smaller particles increase surface area, accelerating dissolution. This, in turn, increases the drug’s bioavailability, which means more of it is available in the bloodstream to have the desired therapeutic effect.
It also promotes uniformity across dosage forms—whether you are producing tablets or capsules, constant particle size ensures that each dose has the appropriate amount of active medicinal components.
The ICH Q6A guideline emphasizes these features of particle size, making them critical for regulatory compliance. Controlling particle size throughout the drug’s lifespan enhances manufacturing efficiency, product quality, and patient outcomes.
What is zeta potential, and why is it important for ensuring the stability of pharmaceutical suspensions?
Dr. John F. Miller: Zeta potential measures the electrical charge on the surface of particles in a colloidal system. It is important in predicting the stability of pharmacological suspensions.
A high zeta potential, whether positive or negative, typically suggests that the particles will reject each other, avoiding aggregation and maintaining the suspension stable over time. This is especially relevant for nanoscale drug delivery systems, where stability is critical to ensure the drug reaches its intended target while being efficacious.
Zeta potential is also useful in studying drug-carrier interactions, which is critical for optimizing drug delivery systems. Several ICH guidelines mention this characteristic because it impacts the stability and efficacy of pharmaceuticals.
How do dynamic light scattering (DLS) and electrophoretic light scattering (ELS) contribute to pharmaceutical development, particularly in nanoparticle-based formulations?
Dr. John F. Miller: DLS and ELS are critical for evaluating nanoparticle-based compositions. DLS detects Brownian motion in particles, allowing us to assess their size and distribution. It is especially useful for investigating the stability of nanoparticles over time and under different environments.
ELS contrastingly measures the zeta potential, which provides information about the particles’ surface charge and stability. Together, these techniques provide a full perspective of nanoparticles’ physical dimensions and electrostatic properties, making them helpful for optimizing therapeutic formulations, particularly when dealing with complicated systems such as lipid nanoparticles.
Could you describe the role of the BeNano system in measuring particle size and zeta potential and how this data impacts the drug development process?
Zhibin Guo: The BeNano system is intended to offer precise measurements of particle size and zeta potential, which are critical characteristics for understanding the behavior of nanoparticles in therapeutic formulations.
The system employs DLS for size measurement and ELS for zeta potential determination. This data aids researchers in determining drug stability, optimizing formulation methods, and ensuring product quality.
The BeNano system is important in ensuring that pharmaceutical goods satisfy regulatory standards and work efficiently throughout their lifecycle because it provides precise information regarding particle behavior under various settings.
Image Credit: Bettersize Instruments
What challenges do you face when measuring highly polydispersed or complex formulations, and how does the BeNano system address these issues?
Dr. John F. Miller: One of the main issues with extremely polydispersed formulations is that DLS struggles to discriminate between particles of varying sizes. Larger particles dominate the scattering signal, making tiny particles difficult to detect.
The BeNano system tackles this by allowing for measurements at various angles, which aids in separating signals from big and small particles.
Another problem is interpreting autocorrelation functions, which is particularly difficult when dealing with material mixes. If you build a strong procedure employing the BeNano and precisely describe your sample preparation, the system can still deliver valuable insights, even for exceedingly complicated formulations.
How does the BeNano system help ensure compliance with regulatory guidelines such as ICH, USP, and ISO?
Zhibin Guo: The BeNano system complies with regulatory criteria, including those from ICH, USP, and ISO. It meets USP and ISO requirements for particle size and zeta potential measurements and 21 CFR Part 11 regulations for electronic records, which are required for regulatory submission.
This means that the data provided by BeNano can readily be used to meet the high quality and safety criteria of foreign markets, allowing pharmaceutical makers to streamline their development process while retaining complete regulatory compliance.
Can you share examples of how the BeNano system has enhanced the stability and effectiveness of drug delivery systems like lipid nanoparticles?
Zhibin Guo: Lipid nanoparticles (LNPs) are an excellent example of how the BeNano excels. The technique enables quick analysis of LNPs, providing vital information on size, polydispersity, and zeta potential, all of which are required to ensure their stability and efficacy.
For example, in gene therapy or vaccine research, where LNPs are important in delivering the payload, the BeNano monitors aggregation to ensure the particles remain stable and retain their therapeutic function. Its capacity to provide extensive insights into particle behavior under varied settings makes it invaluable in optimizing formulations.
What is the significance of detecting aggregates in pharmaceutical formulations, and how does this impact the safety and efficacy of drugs?
Zhibin Guo: Detecting aggregates is important since they can jeopardize a drug’s safety and efficacy. Aggregates can elicit immunogenic reactions in patients, resulting in negative side effects. Aggregates frequently indicate that the medicine formulation is unstable, potentially decreasing effectiveness.
BeNano’s sophisticated backscattering technique enables highly sensitive detection of even minute aggregates, assisting manufacturers in guaranteeing that their goods meet safety and stability criteria.
How do temperature and time affect particle size, and how does continuous monitoring help improve drug formulation?
Zhibin Guo: Temperature and time can significantly impact particle size, especially in formulations containing proteins or other sensitive biomolecules. Monitoring these changes is critical for determining the formulation’s long-term stability.
The BeNano system measures time and temperature trends, allowing researchers to see how particles respond under various storage settings. This information is critical for optimizing formulations and ensuring they remain stable during their shelf life.
Can you explain how light scattering technology, specifically the innovations in the BeNano system, improves the characterization of nanoparticle-based drug delivery systems?
Dr. John F. Miller: The BeNano system combines DLS with ELS, allowing for a more detailed and subtle characterization of nanoparticles than standard approaches.
For example, the phase analysis light scattering (PALS) technique improves the sensitivity of zeta potential measurements, especially in high-ionic-strength liquids or with weakly charged particles.
These improvements enable precise control over particle behavior, critical when creating sophisticated drug delivery systems such as lipid nanoparticles or polymeric carriers.
In what ways do the findings from particle size and zeta potential measurements support global health initiatives, such as the Clinton Health Access Initiative?
Dr. John F. Miller: My major aim at the Clinton Health Access Initiative is to ensure access to high-quality, affordable medicines. Particle size and zeta potential measurements are critical for assuring drug stability and efficacy, particularly in locations with inefficient supply chains and storage conditions.
By providing trustworthy data on medication stability, the BeNano system promotes the development of formulations that can withstand these obstacles, increasing access to vital medicines in low- and middle-income nations.
What advancements do you see in the future of light-scattering technologies, and how might they further revolutionize pharmaceutical development?
Dr. John F. Miller: The future of light scattering technology lies in increased precision and automation. We are already seeing breakthroughs in PALS, which improves the precision of zeta potential measurements.
In the future, I expect we will see more advanced systems capable of measuring numerous parameters simultaneously under real-world settings, possibly with the integration of artificial intelligence for real-time data processing. These innovations will streamline medication development, making it faster, more efficient, and more exact.
About Dr. John F. Miller and Zhibin Guo
Dr. John F. Miller, PhD is the inventor of Phase Analysis Light Scattering (PALS). He received his PhD in Colloid/Physical Chemistry from the University of Bristol. With three decades of experience as a formulation scientist in the pharmaceutical industry, Dr. Miller has been working on colloid science and light scattering techniques.
Zhibin Guo, MS is a Senior Application Scientist at Bettersize Instruments. He received his master's degree in pharmaceutical synthesis from Seoul National University. Since joining Bettersize, he has focused on application research in nanoparticle analysis and the synthesis and characterization of drug delivery systems using light scattering techniques.
This information has been sourced, reviewed, and adapted from materials provided by Bettersize Instruments Ltd.
For more information on this source, please visit Bettersize Instruments Ltd.
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