Particle Characterization in
the Pharmaceutical Industry

The particle size distribution of active ingredients and excipients is an important physical characteristic of the materials used to create pharmaceutical products. The size, distribution and shape of the particles can affect bulk properties, product performance, processability, stability and appearance of the end product.

The link between particle size and product performance is well documented with regards to dissolution, absorption rates and content uniformity. Reducing particle size can aid the formulation of NCE’s with poor water solubility. Proper matching of active ingredient and excipient particle size is important for several process steps. Particle size analysis is an integral component of the effort to formulate and manufacture many pharmaceutical dosage forms. HORIBA Instruments can provide both the analytical tools and technical support required to help pharmaceutical companies characterize their particulate systems with confidence.

Laser Diffraction

This is the most popular particle size analysis technique used in the pharmaceutical industry. This technology is fast, easy to use, flexible, and repeatable. The LA-950 Partica laser diffraction analyzer offer unique advantages including:

Dynamic range from 0.01 – 3000 µm
Automatic control of the dry powder feed rate
Built-in USP <429> calculations

Learn how the LA-950 could be used in your pharmaceutical lab by downloading these applications notes.

Wet Method Development (You need to be logged in)
Dry method Development (You need to be logged in)
Utilizing USP <429> (You need to be logged in)

Pharmaceutical Excipients – Case Study

An excipient is an inactive substance used as a carrier for the active ingredients of a medication. In addition excipients can be used to aid the process by which a product is manufactured. Two common excipients – magnesium stearate and microcrystalline cellulose – were used as the samples for the wet and dry method development application notes. The LA-950 data shown below indicates the high degree of precision possible when following a structured approach to method development.

Magnesium Stearate - Dry

Microcrystalline Cellulose - Wet

Dynamic Image Analysis

This processing is becoming more common in the pharmaceutical industry for applications where particle shape, high resolution and images of the particles are important. The CAMSIZER provides high-resolution size and shape data for pharmaceutical powders such granules and globules, and has been used successfully in coating thickness applications.

: Roundness Comparison for Two Globule Samples

Download the application note on determination of the roundness of globules in the pharmaceutical industry (You need to be logged in).

Static Image Analysis

: Large particle detection from an actuated dry powder inhaler (DPI).

Static Image Analysis provides accurate particle size and shape distribution information from 0.5 to 1000 µm. Leading pharmaceutical companies now use this technique for a variety of application including characterization of pharmaceutical actives, screening excipients, supporting method validation, and inspecting MDI's and DPI's. The PSA300 static image analysis sytem and Disperser Unit provides a complete turn key system that can be installed and validated in just a few days.

Download the application note on Particle Characterization of MDIs (You need to be logged in).

Download the application note on Particle Characterization of DPIs (You need to be logged in).

Dynamic Light Scattering

(DLS) is the preferred technique for submicron particle size analysis. The HORIBA LB-550 measures particles size from 1 nm – 6 µm using the Fourier-Transform/Iterative Deconvolution technique, making it the fastest DLS measurement possible. Temperature control, a wide concentration range (1 ppm – 40 wt %,) and an optional built in viscometer facilitate submicron analysis of suspensions and emulsions. This is the preferred technique for nano-sized particles used in the pharmaceutical industry.

Protein Aggregation - Case Study

The study of protein aggregation encompasses a broad range of interactions and mechanisms. Many studies into this subject area investigate the aggregation of mis-folded proteins, which is thought to be responsible for many degenerative diseases. Since aggregation typically leads to a physical change in protein size, particle size analysis has proven to be a useful experimental technique in this field. Dynamic light scattering (DLS) is now widely used to study protein aggregation as described in the application note referenced below.

Download the application note on Monitoring Protein Aggregation Using Dynamic Light Scattering (You need to be logged in).

Liposomes - Case Study

Liposomes are bilayer vesicles made of phospholipids derived from natural or man-made materials. They are mainly used in the pharmaceutical field for treatment of cancers as carriers of chemotherapeutic drugs to the tumor area. The amount of drug loaded into the liposomes and the size of the liposomes play pivotal roles in the pharmacokinetic and pharmacodynamic parameters of the drug. Hence accurate and rapid measurement of the size of liposomes is essential for novel and effective drug delivery systems.

The LB-550 data shown below shows the particle size distribution of liposomes after five passes through a 100 µm filter.

Download the application note on Particle Size Analysis of Liposomes (You need to be logged in).

Acoustic and ElectroAcoustic Spectroscopy

This is an advanced particle characterization technique for suspensions at high concentration without dilution. The Dispersion Technology DT-1201 has solved difficult application challenges in many pharmaceutical applications including emulsions and particle systems that destabilize with dilution.

Download the application note on acoustic characterization of emulsions(You need to be logged in).

Raman Mapping

The ARAMIS from the HORIBA Jobin Yvon Raman Division provides information on particle properties including size, shape and chemical identification within final products such as tablets. This data is useful for investigating content uniformity, polymorphism, coating thicknesses, component mapping, and differentiation between amorphous and crystalline phases.

Now with the just released fast Raman mapping options SWIFT™ and DuoScan™ whole tablets like the 12.5mm diameter tablet shown above can be mapped in 10 minutes or less.

Visit the Raman Spectroscopy home page.

Visit the Pharmaceutical Applications Note page.

Questions? Call a Particle Specialist about your application at 1-888-903-5001

Member login

Please enter your e-mail address and password in order to login on to www.horiba.com. We may ask you later to answer additional questions if you are the first time to this area.

Forgot Password?

Having trouble login in? Please click here and we will send a new password. If you are still having trouble, contact us at web_member@horiba.com.

Not a member yet?

Register and receive access to advanced information, including Application Data Sheets, Application Notes, Brochures, Links to External Articles, Manuals, Software Downloads, Software Updates. When you register you will also receive periodic updates by e-mail. Create a new account.