title: Development and Optimization of an Ex Vivo Colloidal Stability Model for Nanoformulations.
abstract: Nanotechnology is having a significant impact in the drug delivery systems and diagnostic devices. As most of the nanosystems are intended to be administered in vivo, there is a need for stability models, which could simulate the biological environment. Instability issues could lead to particle aggregation and in turn could affect the release of the drug from the nanosystems and even lead to clogging of the systemic blood circulation leading to life-threatening situation. We have developed an ex vivo colloidal stability model for testing the stability of nanosystems over a period of 48 h, which is the typical residence time of the nanoparticles in vivo. Tissue homogenates of rat spleen, brain, kidney, and liver were stabilized and optimized for the study; additionally, plasma and serum were used for the same. Poly (lactide-co-glycolic acid) nanoparticles were used as model nanosystem, and no significant change was found in the size and polydispersity index of the nanoparticles in the biological solutions. Moreover, no change in morphology was observed after 48 h as observed by TEM microscopy. Hence, the developed model could prevent the failure of the developed nanosystem during clinical and preclinical application by serving as an initial checkpoint to study their interaction with the complex milieu.
authors.affiliation: Department of Pharmacology and Toxicology, B. V. Patel Pharmaceutical Education and Research Development (PERD) Centre, S. G. Highway, Thaltej, Ahmedabad, 380054, Gujarat, India.|Faculty of Pharmacy, NIRMA University, Sarkhej-Gandhinagar Highway, Gota, Ahmedabad, Gujarat, 382481, India.
authors.forename: Muhammad Vaseem
authors.initials: MV
authors.lastname: Shaikh
authors.affiliation: Department of Pharmacology and Toxicology, B. V. Patel Pharmaceutical Education and Research Development (PERD) Centre, S. G. Highway, Thaltej, Ahmedabad, 380054, Gujarat, India.|Faculty of Pharmacy, NIRMA University, Sarkhej-Gandhinagar Highway, Gota, Ahmedabad, Gujarat, 382481, India.
authors.forename: Manika
authors.initials: M
authors.lastname: Kala
authors.affiliation: Department of Pharmacology and Toxicology, B. V. Patel Pharmaceutical Education and Research Development (PERD) Centre, S. G. Highway, Thaltej, Ahmedabad, 380054, Gujarat, India. manishnivsarkar@gmail.com.
authors.forename: Manish
authors.initials: M
authors.lastname: Nivsarkar
mesh_terms: D000818:Animals; D003102:Colloids; D004337:Drug Carriers / Q000737:chemistry*; D019344:Lactic Acid / Q000008:administration & dosage / Q000737:chemistry; D008297:Male; D053758:Nanoparticles / Q000737:chemistry* / Q000648:ultrastructure; D036103:Nanotechnology; D010316:Particle Size; D011100:Polyglycolic Acid / Q000008:administration & dosage / Q000737:chemistry; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D051381:Rats; D017207:Rats, Sprague-Dawley
chemical_list: D003102:Colloids; D004337:Drug Carriers; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid
keywords: PLGA; ex vivo colloidal stability; nanoparticle; nanosystem