PMID- 16054683 OWN - NLM STAT- MEDLINE DCOM- 20060208 LR - 20061115 IS - 0142-9612 (Print) IS - 0142-9612 (Linking) VI - 27 IP - 4 DP - 2006 Feb TI - Number-concentration of nanoparticles in liposomal and polymeric multiparticulate preparations: empirical and calculation methods. PG - 651-9 AB - The actual number of particles in formulations of nanoparticles (NP) is of importance for quality assurance, comprehensive physicochemical characterization, and pharmacodynamics. Some calculation methods that have been previously employed are limited because they rely on several assumptions and are not applicable for certain preparations. Currently there are no validated experimental methods for determining the particle number-concentration (Nc) of liposomal and polymeric nanoparticulate preparations (<500 nm). This study examines a new empirical method for counting the number of particles in nanoparticulate formulations including drug-containing liposomes and polymeric NP. In the new method, suspended NP are nebulized to form aerosol droplets which are dried and counted using a scanning mobility particle sizer (SMPS). Experiments were conducted with three different preparations, empty liposomes (200 and 400 nm), drug-loaded liposomes (200 nm), and polymeric NP (150 nm). It was verified that no detrimental morphological or structural changes of the formulations have been induced by the SMPS technique, and that the obtained Nc values represent the original particles. It is concluded that nano-formulations with concentrations of up to 10(7) particles per 1 cm3 air, corresponding to approximately 10(12) particles per 1 ml solution, can be directly counted within the size range of 30-900 nm. The measured values are compared to newly developed theoretical calculations to assess the viability of these calculations. FAU - Epstein, Hila AU - Epstein H AD - School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Box 12065, Jerusalem 91120, Israel. FAU - Afergan, Eyal AU - Afergan E FAU - Moise, Tamar AU - Moise T FAU - Richter, Yoram AU - Richter Y FAU - Rudich, Yinon AU - Rudich Y FAU - Golomb, Gershon AU - Golomb G LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20050728 PL - Netherlands TA - Biomaterials JT - Biomaterials JID - 8100316 RN - 0 (Colloids) RN - 0 (Liposomes) RN - 0 (Polymers) SB - IM MH - Algorithms MH - Colloids/*analysis/chemistry MH - Liposomes/*analysis/chemistry MH - Microchemistry/*methods MH - Microfluidic Analytical Techniques/*methods MH - Molecular Weight MH - Nanotechnology/methods MH - Nanotubes/*analysis/chemistry MH - Particle Size MH - Polymers/*analysis/chemistry MH - Ultrafiltration/*methods EDAT- 2005/08/02 09:00 MHDA- 2006/02/09 09:00 CRDT- 2005/08/02 09:00 PHST- 2005/02/06 00:00 [received] PHST- 2005/06/20 00:00 [accepted] PHST- 2005/08/02 09:00 [pubmed] PHST- 2006/02/09 09:00 [medline] PHST- 2005/08/02 09:00 [entrez] AID - S0142-9612(05)00574-0 [pii] AID - 10.1016/j.biomaterials.2005.06.006 [doi] PST - ppublish SO - Biomaterials. 2006 Feb;27(4):651-9. doi: 10.1016/j.biomaterials.2005.06.006. Epub 2005 Jul 28.