In Indonesia, drug evaluation usually takes between 100 and 300 working days to be completed by the Badan Pengawas Obat dan Makanan (BPOM), the national agency for food and drug controls.

The agency abides by the U.S Food and Drug Administration’s standard measurement and guidance, which cover the mandatory specific tests and criteria for drugs’ particle size. The acceptance criteria include a number of rate of total particles in a drug’s given size range, which means the upper and/or lower particle size limits should be clearly defined.

For businesses, it is critical to be sure that all drugs submitted for certification are following the national regulation and that all supporting documentation are available for health authorities to refer to and proceed to register the product. This can also greatly shorten your lead time to market.

Besides fulfilling the compliance requirements, particle size and size distribution have a direct influence on a finished product such as reaction rate, dissolution rate, packing density, appearance and texture. For solids, the size distribution of the particle is critical in determining the rate of a chemical reaction as well as the dissolution rate.

Particle size can affect a substance’s dissolve rate. Smaller particles have a smaller surface area, therefore making dissolution occur more quickly. Water-soluble drugs also dissolve at a faster rate if they have a smaller particle size.

Particles above a certain size are filtered out of the respiratory system to avoid any potential damage to the lungs. Nanoparticle Tracking Analysis (NTA) helps characterize nanoparticles from 0.01 - 1 µm in solution. This methodology produces high resolution results for nanoparticle size distribution and concentration, while visual validation provides users with additional confidence in their data. NTA can be used to develop targeted drug delivery systems.

As particle analyzers use many different techniques to arrive at measurements, manufacturers considering buying or upgrading their particle size analyzer equipment will need to ask themselves what technique will work best for their intended application.

The key factors to take into consideration when choosing the right solution include:

• What exactly do you want to measure and why?
• What is the size range to be measured?
• In what “state” should the measurements be made?
• What are the instruments needed to achieve the finished product quality?
• Do they meet international standards and are they in compliance with local regulations?
• Are you trying to characterize different particle types in a single sample?
• Is measuring the count or concentration of the particles along with size/shape important?
• How easy is it to generate reliable data?

You may also want to consider the after-sales service engineering offered by your business partner, as well as their assured response time in possible production downtime.