Formulation and characterization of a plasma sterilized, pharmaceutical grade chitosan powder.
Chitosan has great potential as a pharmaceutical excipient. In this study, chitosan flake was micronized using cryo-ball and cryo-jet milling and subsequently sterilized with nitrogen plasma. Micronized chitosan was characterized by laser diffraction, scanning electron microscopy (SEM), conductometric titration, viscometry, loss on drying, FTIR, and limulus amebocyte lysate (LAL) assays. Cryo-jet milling produced mean particle size of 16.05μm, 44% smaller than cryo-ball milling. Cryomilled chitosan demonstrated increased hygroscopicity, but reduced molecular weight and degree of deacetylation (DD). SEM imaging showed highly irregular shapes. FTIR showed changes consistent with reduced DD and an unexplained shift at 1100cm(-1). Plasma treated chitosan was sterile with <2.5EU/g after low-pressure plasma and <1.3EU/g after atmospheric pressure plasma treatment. Plasma treatment decreased the reduced viscosity of chitosan flake and powder, with a greater effect on powder. In conclusion, pharmaceutical grade, sterile chitosan powder was produced with cryo-jet milling and plasma sterilization.
Department of Anatomy, School of Medicine, Loma Linda University, 11234 Anderson St., Medical Center A537, Loma Linda, CA 92350, United States; Neurosurgery Center for Research, Training, and Education, School of Medicine, Loma Linda University, 11234 Anderson St., Medical Center A537, Loma Linda, CA 92350, United States. Electronic address: acrofton@llu.edu.
Andrew R
AR
Crofton
College of Textiles, North Carolina State University, 2401 Research Dr., Raleigh, NC 27695, United States. Electronic address: shudson@ncsu.edu.
Samuel M
SM
Hudson
Neurosurgery Center for Research, Training, and Education, School of Medicine, Loma Linda University, 11234 Anderson St., Medical Center A537, Loma Linda, CA 92350, United States. Electronic address: khoward@llu.edu.
Kristy
K
Howard
Neurosurgery Center for Research, Training, and Education, School of Medicine, Loma Linda University, 11234 Anderson St., Medical Center A537, Loma Linda, CA 92350, United States. Electronic address: tpender@llu.edu.
Tyler
T
Pender
College of Textiles, North Carolina State University, 2401 Research Dr., Raleigh, NC 27695, United States. Electronic address: aabdelg@ncsu.edu.
Abdelrahman
A
Abdelgawad
College of Textiles, North Carolina State University, 2401 Research Dr., Raleigh, NC 27695, United States. Electronic address: dwolski@ncsu.edu.
Daniel
D
Wolski
Division of Biochemistry, School of Medicine, Loma Linda University, 11234 Anderson St., Medical Center A537, Loma Linda, CA 92350, United States; Neurosurgery Center for Research, Training, and Education, School of Medicine, Loma Linda University, 11234 Anderson St., Medical Center A537, Loma Linda, CA 92350, United States. Electronic address: wkirsch@llu.edu.
Wolff M
WM
Kirsch
D002626:Chemistry, Pharmaceutical; D048271:Chitosan / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry*; D008970:Molecular Weight; D010316:Particle Size; D011208:Powders; D014783:Viscosity; D017155:Wettability
D005079:Excipients; D011208:Powders; D048271:Chitosan
Ball milling; Chitosan; Cryo-ball milling; Cryo-jet milling; Cryomilling; Jet milling; Plasma sterilization