title: Effect of the moist-heat sterilization on fabricated nanoscale solid lipid particles containing rasagiline mesylate.
abstract: BACKGROUND
  Nanoscale solid lipid particles of rasagiline mesylate (RM) were fabricated by microemulsion technique. The nanoscale particle must be sterile for intravenous administration, and several approaches are available for sterilization. However, the selection of sterilization technique for the fabricated RM loaded nanoscale solid lipid particles mainly depends on the nature of the drug that needs to be encapsulated and release pattern of the polymer.
  
  
  METHODS
  We have preferred moist heat sterilization, as it is the most convenient and the composition of the carrier and incorporated drug should remain unchanged and the incorporated drug should not leak out of the drug carrier. The physical and chemical stability of RM loaded nanoscale solid lipid particles investigated during sterilization and to determine the average mean particle size, polydispersity index, zeta potential (ZP), transmission electron microscopy (TEM), entrapment efficiency (EE), and drug content after autoclaving.
  
  
  RESULTS
  There were no significant changes in the average mean particle size, polydispersity index, ZP, TEM, EE, and drug content of RM loaded nanoscale solid lipid particles after autoclaving (121°C for 20 min [15 lbs]).
  
  
  CONCLUSIONS
  These observations suggest that the moist heat sterilization by autoclaving is the most suitable method for nanoscale solid lipid formulations.
authors.affiliation: Department of Pharmacy, Faculty of Engineering and Technology, Annamalai University, Chidambaram, Tamil Nadu, India.
authors.forename: K
authors.initials: K
authors.lastname: Viveksarathi
authors.affiliation: Department of Pharmacy, Faculty of Engineering and Technology, Annamalai University, Chidambaram, Tamil Nadu, India.
authors.forename: K
authors.initials: K
authors.lastname: Kannan
keywords: Entrapment efficiency; photon correlation spectroscopy; selected area electron diffraction; transmission electron microscopy; zeta potential
references.citation: Asian Pac J Trop Biomed. 2012 Nov;2(11):841-8
references.pmid: 23569859
references.citation: J Adv Pharm Technol Res. 2014 Jul;5(3):115-21
references.pmid: 25126532
references.citation: Adv Drug Deliv Rev. 1998 Dec 1;34(2-3):171-189
references.pmid: 10837677
references.citation: Int J Pharm. 2011 Oct 31;419(1-2):271-80
references.pmid: 21807080
references.citation: Int J Pharm. 2005 Apr 11;293(1-2):261-70
references.pmid: 15778064
references.citation: Pharmacol Ther. 1984;24(2):207-33
references.pmid: 6379684
references.citation: Int J Pharm. 2000 Oct 10;207(1-2):99-108
references.pmid: 11036235
references.citation: J Control Release. 2001 Jan 29;70(1-2):1-20
references.pmid: 11166403
references.citation: Adv Drug Deliv Rev. 2004 May 7;56(9):1257-72
references.pmid: 15109768
references.citation: J Clin Oncol. 1986 May;4(5):789-97
references.pmid: 3701394
references.citation: Int J Nanomedicine. 2011;6:2393-401
references.pmid: 22114489
references.citation: Int J Pharm. 2005 Feb 16;290(1-2):137-44
references.pmid: 15664139
references.citation: J Microencapsul. 1998 Mar-Apr;15(2):173-84
references.pmid: 9532523
references.citation: AAPS PharmSciTech. 2009;10(3):985-92
references.pmid: 19641997