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.
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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-960 Laser Diffraction Particle Size Analyzer offers unique advantages including:
- Dynamic range from 10 nanometers – 5,000 microns
- Automatic control of powder flow rate with the PowderJet accessory leads to repeatable dry measurements
- Built-in USP 429 calculations
Learn how the LA-960 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)
Laser Diffraction Application: Biopolymer Nanoparticles used for Drug Delivery
Biodegradable polymers such as polylactic acid (PLA) are frequently studied as potential carriers for controlled release formulations of active pharmaceutical. Since PLA nanoparticles are often in the range of 50 – 500 nm using both laser diffraction and dynamic light scattering (DLS) could be used for size analysis, but laser diffraction has the advantage of also being able to detect aggregates above 1 micron. The unique ability measure particles down to 30 nanometers and up to 5,000 microns makes the LA-960 uniquely qualified to measure the entire range of biopolymer nanoparticles used for drug delivery.
Download Application Note 196: Particle Size Analysis of Biopolymer Nanoparticles using Laser Diffraction (You need to be logged in).
Laser Diffraction Case Studies: Excipients
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-960 data shown below indicates the high degree of precision possible when following a structured approach to method development.