title: Sub acute toxicity assessment of glipizide engineered polymeric nanoparticles.
abstract: To our knowledge, no such polymeric nanoparticle formulation toxicity study has been reported for oral use. The oral route of drug administration is generally preferred because of its versatility, safety and relative patient comfort. Hence, there is an outstanding need of research for polymeric nanoparticles to find whether they are stable for prolonged shelf life, and yet have no toxicity when administered orally. The main objective of this study is to assess the safety of Glipizide (GZ) loaded polymeric nanoparticle systematically and to observe the toxic effects of nanoparticles on the functions of various tissues and organs in rats. The rats were randomly divided into 7 groups (6 in each group); viz. one normal control group (received saline), two groups (1:2 and 1:5 ratio of GZ-Chitosan nanoparticle), two groups (1:2 and 1:5 ratio of GZ-Poly(methyl methacrylate) nanoparticle) and two groups (1:2 and 1:5 ratio of GZ-Ethyl Cellulose nanoparticle). After 30 days of nanoparticle administration, the blood haematology and biochemistry were investigated, along with the histopathological examination. The rats did not show any significant changes in all the parameters studied and the results clearly evidenced its safety. All formulations showed in vitro haemolytic activity less than 5%. Conclusion drawn from the present study is that the polymeric nanoparticles may be a suitable device for safe oral administration. A rigorous safety of these nanoparticles would enable their use in the field of diabetic therapy.
authors.affiliation: Bio Organic Chemistry Laboratory, Central Leather Research Institute, Council of Scientific and Industrial Research, Adyar Chennai 600020, India.
authors.forename: U M Dhana
authors.initials: UM
authors.lastname: Lekshmi
authors.forename: Narra
authors.initials: N
authors.lastname: Kishore
authors.forename: P Neelakanta
authors.initials: PN
authors.lastname: Reddy
mesh_terms: D000284:Administration, Oral; D000818:Animals; D002482:Cellulose / Q000031:analogs & derivatives / Q000737:chemistry; D048271:Chitosan / Q000737:chemistry; D005260:Female; D005913:Glipizide / Q000008:administration & dosage* / Q000633:toxicity*; D006461:Hemolysis / Q000187:drug effects; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000633:toxicity*; D008855:Microscopy, Electron, Scanning; D053769:Nanocapsules / Q000008:administration & dosage / Q000737:chemistry* / Q000648:ultrastructure; D036103:Nanotechnology; D010316:Particle Size; D019904:Polymethyl Methacrylate / Q000737:chemistry; D051381:Rats; D017208:Rats, Wistar
chemical_list: D007004:Hypoglycemic Agents; D053769:Nanocapsules; C013517:ethyl cellulose; D002482:Cellulose; D019904:Polymethyl Methacrylate; D048271:Chitosan; D005913:Glipizide