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Nevertheless, some aspects related to its ocular administration, such as sterilization and excipient's pharmacokinetics, remain unclear. So, in this study, we evaluated those two relevant aspects, related to chitosan administration in eye. We used chitosan\u2010based ocular inserts (CI) as formulation model. CI were produced by solvent\/casting method and sterilized by saturated steam. Sterilization was confirmed by direct inoculation of inserts in suitable microbiological growth media. Physicochemical characterization of inserts before and after sterilization was performed. Results suggested that, although steam sterilization changed the arrangement of the matrix, the heat and the humidity did not modify the structure of the main polymeric chain. Pharmacokinetics of CI radiolabeled with technetium\u201099m (<jats:sup>99m<\/jats:sup>Tc) was assessed by scintigraphic images and ex vivo biodistribution study, after ocular administration in male Wistar rats. Scintigraphic and images analysis and ex vivo biodistribution study showed that the insert remained mainly in the eye until 6\u2009hr after administration and its degradation products began to migrate to the abdominal cavity after 18\u2009hr. Together, these data represent an important step forward the manufacturing and the clinical application of CI in the ophthalmic field.<\/jats:p>","DOI":"10.1002\/jbm.b.34560","type":"journal-article","created":{"date-parts":[[2020,1,23]],"date-time":"2020-01-23T07:20:35Z","timestamp":1579764035000},"page":"2227-2237","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Use of chitosan as pharmaceutical excipient in ocular drug delivery systems: Sterilization and pharmacokinetics"],"prefix":"10.1002","volume":"108","author":[{"given":"Ju\u00e7ara R.","family":"Franca","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Products, Faculty of Pharmacy Federal University of Minas Gerais  Belo Horizonte Minas Gerais Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonardo L.","family":"Fuscaldi","sequence":"additional","affiliation":[{"name":"Department of Clinical and Toxicological Analysis, Faculty of Pharmacy Federal University of Minas Gerais  Belo Horizonte Minas Gerais Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana G.","family":"Ribeiro","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Products, Faculty of Pharmacy Federal University of Minas Gerais  Belo Horizonte Minas Gerais Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giselle","family":"Foureaux","sequence":"additional","affiliation":[{"name":"Department of Morphology, Institute of Biological Sciences Federal University of Minas Gerais  Belo Horizonte Minas Gerais Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aina L. 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