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Note: this service is for Research Use Only and Not intended for clinical use.
Particle characterization of drug substances, drug products and excipients is an important factor in R&D, production and quality control of pharmaceuticals. It is becoming increasingly important for compliance with requirements of FDA and European Health Authorities.[1] Particle characterization has significance in many industries. For the pharmaceutical industry, particle size and shape can influence a large variety of important physical properties, manufacturing processability and quality attributes, including:[2]
Dissolution rate and bioavailability of active pharmaceutical ingredients.
Drug release rate for sustained and controlled release formulations.
In vivo particle distribution and deposition, absorption rate and clearance time, especially for aerosols and different colloid systems designed for targeted drug delivery.
Content and dose uniformity and other properties related to the physicochemical stability.
Aerosolization behaviour and performance of respiratory formulations.
Flow and packing properties, mixing and segregation of powders, rheological characteristics of liquid and semisolid formulations.
"Grittiness" of solid particles in chewable tablets, dermal ointments, creams, and irritability of ophthalmic preparations.
In addition, the dissolution rate, which is proportional to surface area of drugs, is largely dependent on particle size distribution of drug particles.
As a global leading pharmaceutical analysis services company, Alfa Chemistry provides particle characterization and other preformulation analysis services. Alfa Chemistry is the perfect partner for getting expertise, flexibility, and reliability with your pharmaceutical formulation projects.
Particle Size Analysis
Surface Area Analysis by BET Technique
Bulk and Tapped Density
Density
Short Detection Cycle
Competitive Price
Years of Experience
Professional Equipment
Reliable Results
Compliance with Various Standards
BRÜMMER, H. (2008). Particle characterisation in excipients, drug products and drug substances. Life Science Technical Bulletin, 1(11), 1-6.
Shekunov, B. Y., Chattopadhyay, P., Tong, H. H., & Chow, A. H. (2007). Particle size analysis in pharmaceutics: principles, methods and applications. Pharmaceutical research, 24(2), 203-227.
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