title: Hydrogel Based Drug Delivery Systems: A Review with Special Emphasis on Challenges Associated with Decontamination of Hydrogels and Biomaterials.
abstract: BACKGROUND
  Many researches involving the development of new techniques and biomaterials to formulate a suitable drug delivery system and tissue engineering have been conducted. The majority of published literature from these researches emphasizes the production and materials characterization. The safety aspect of hydrogels and biomaterials is a major constraint in their biological applications.
  
  
  OBJECTIVE
  The present review article aimed to summarize various literatures that encompass the difficulties encountered with decontamination and sterilization methods in the preparations of biomaterials and especially hydrogels for biological applications.
  
  
  METHODS
  We searched for original and review articles from various indexed journals reporting applications of hydrogels and biomaterials in drug delivery systems and the importance of decontamination process for hydrogel containing preparations based on various patents evidences.
  
  
  RESULTS
  Despite the vast literature available, limited information regarding the decontamination and sterilization processes related to hydrogels and biomaterials is reported. Sterilization processes to hydrogels are not yet fully explored. Researchers working on hydrogel based systems can consider decontamination of such biomaterial as an important tool to allow for commercialization within the chemical, herbal or pharmaceutical industries.
  
  
  CONCLUSIONS
  Unfortunately, till date, limited papers are available which reported the challenges associated with decontamination methods to prepare hydrogels and biomaterials for biological applications. In conclusion, each case of biomaterial requires individual consideration to decontamination and/or sterilization. This must be submitted to a specific method, but more than one technique can be involved. Physicochemical and biological alterations must be avoided and evaluated by the appropriate assays method. Furthermore, it is also important to consider that each method must be validated depending upon the process variables.
authors.affiliation: Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Av. Prof. Lineu Prestes, 580, CEP 05508-900, Sao Paulo, SP. Brazil.
authors.forename: Irene Satiko
authors.initials: IS
authors.lastname: Kikuchi
authors.affiliation: Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Av. Prof. Lineu Prestes, 580, CEP 05508-900, Sao Paulo, SP. Brazil.
authors.forename: Raquel Sofia
authors.initials: RS
authors.lastname: Cardoso Galante
authors.affiliation: School of Pharmacy and Biomedical Sciences, The University of Newcastle, Newcastle, Callaghan NSW 2308. Australia.
authors.forename: Kamal
authors.initials: K
authors.lastname: Dua
authors.affiliation: Amity Institute of Pharmacy, Amity University, Lucknow, Uttar Pradesh. India.
authors.forename: Venkata Ramana
authors.initials: VR
authors.lastname: Malipeddi
authors.affiliation: Department of Pharmaceutics, Laureate Institute of Pharmacy, Jawalamukhi, Kangra, Himachal Pradesh. India.
authors.forename: Rajendra
authors.initials: R
authors.lastname: Awasthi
authors.affiliation: Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Av. Prof. Lineu Prestes, 580, CEP 05508-900, Sao Paulo, SP. Brazil.
authors.forename: Daniela Dal Molim
authors.initials: DDM
authors.lastname: Ghisleni
authors.affiliation: Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Av. Prof. Lineu Prestes, 580, CEP 05508-900, Sao Paulo, SP. Brazil.
authors.forename: Terezinha
authors.initials: T
authors.lastname: de Jesus Andreoli Pinto
mesh_terms: D000818:Animals; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D001672:Biocompatible Materials; D003666:Decontamination / Q000379:methods*; D016503:Drug Delivery Systems; D020100:Hydrogels / Q000008:administration & dosage*
chemical_list: D000890:Anti-Infective Agents; D001672:Biocompatible Materials; D020100:Hydrogels
keywords: Biomaterials; decontamination; drug delivery; hydrogels; stability; sterilization