PMID- 35522605
OWN - NLM
STAT- MEDLINE
DCOM- 20220614
LR  - 20220820
IS  - 2373-9878 (Electronic)
IS  - 2373-9878 (Linking)
VI  - 8
IP  - 6
DP  - 2022 Jun 13
TI  - Comprehensive Review on the Degradation Chemistry and Toxicity Studies of 
      Functional Materials.
PG  - 2161-2195
LID - 10.1021/acsbiomaterials.1c01304 [doi]
AB  - In recent decades there has been growing interest of material chemists in the 
      successful development of functional materials for drug delivery, tissue 
      engineering, imaging, diagnosis, theranostic, and other biomedical applications 
      with advanced nanotechnology tools. The efficacy and safety of functional 
      materials are determined by their pharmacological, toxicological, and immunogenic 
      effects. It is essential to consider all degradation pathways of functional 
      materials and to assess plausible intermediates and final products for quality 
      control. This review provides a brief insight into chemical degradation 
      mechanisms of functional materials like oxidation, photodegradation, and physical 
      and enzymatic degradation. The intermediates and products of degradation were 
      confirmed with analytical methods such as proton nuclear magnetic resonance ((1)H 
      NMR), gel permeation chromatography (GPC), UV-vis spectroscopy (UV-vis), infrared 
      spectroscopy (IR), differential scanning calorimetry (DSC), mass spectroscopy, 
      and other sophisticated analytical methods. These analytical methods are also 
      used for regulatory, quality control, and stability purposes in industry. The 
      assessment of degradation is important to predetermine the behavior of functional 
      materials in specific storage conditions and can be relevant to their behavior 
      during in vivo applications. Another important aspect is the evaluation of the 
      toxicity of functional materials. Toxicity can be accessed with various methods 
      using in vitro, in vivo, ex vivo, and in silico models. In vitro cell culture 
      methods are used to determine mitochondrial damage, reactive oxygen species, 
      stress responses, and cellular toxicity. In vitro cellular toxicity can be 
      measured by MTT assay, LDH leakage assay, and hemolysis. In vivo studies are 
      performed using various animal models involving zebrafish, rodents (mice and 
      rats), and nonhuman primates. Ex vivo studies are also used for efficacy and 
      toxicity determinations of functional materials like ex vivo potency assay and 
      precision-cut liver slice (PCLS) models. The in silico tools with computational 
      simulations like quantitative structure-activity relationships (QSAR), 
      pharmacokinetics (PK) and pharmacodynamics (PD), dose and time response, and 
      quantitative cationic-activity relationships ((Q)CARs) are used for prediction of 
      the toxicity of functional materials. In this review, we studied the principle 
      methods used for degradation studies, different degradation pathways, and 
      mechanisms of functional material degradation with prototype examples. We discuss 
      toxicity assessments with different toxicity approaches used for estimation of 
      the safety and efficacy of functional materials.
FAU - Pagar, Roshani R
AU  - Pagar RR
AD  - Department of Pharmaceutics, Dr. D.Y. Patil Institute of Pharmaceutical Sciences 
      and Research, Pimpri, Pune, Maharashtra 411018, India.
FAU - Musale, Shubham R
AU  - Musale SR
AD  - Department of Pharmaceutics, Dr. D.Y. Patil Institute of Pharmaceutical Sciences 
      and Research, Pimpri, Pune, Maharashtra 411018, India.
FAU - Pawar, Ganesh
AU  - Pawar G
AD  - Department of Pharmacology, Dr. D.Y. Patil Institute of Pharmaceutical Sciences 
      and Research, Pimpri, Pune, Maharashtra 411018, India.
FAU - Kulkarni, Deepak
AU  - Kulkarni D
AUID- ORCID: 0000-0001-5992-5903
AD  - Srinath College of Pharmacy, Bajajnagar, Aurangabad, Maharashtra 431136, India.
FAU - Giram, Prabhanjan S
AU  - Giram PS
AUID- ORCID: 0000-0003-0439-1347
AD  - Department of Pharmaceutics, Dr. D.Y. Patil Institute of Pharmaceutical Sciences 
      and Research, Pimpri, Pune, Maharashtra 411018, India.
AD  - Department of Pharmaceutical Sciences, University at Buffalo, State University of 
      New York, Buffalo, New York 14214, United States.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20220506
PL  - United States
TA  - ACS Biomater Sci Eng
JT  - ACS biomaterials science & engineering
JID - 101654670
SB  - IM
MH  - Animals
MH  - *Drug Delivery Systems
MH  - Mice
MH  - Models, Animal
MH  - Rats
MH  - *Zebrafish
OTO - NOTNLM
OT  - degradation chemistry
OT  - degradation pathways
OT  - functional materials
OT  - toxicity
OT  - toxicity assessments
EDAT- 2022/05/07 06:00
MHDA- 2022/06/15 06:00
CRDT- 2022/05/06 13:23
PHST- 2022/05/07 06:00 [pubmed]
PHST- 2022/06/15 06:00 [medline]
PHST- 2022/05/06 13:23 [entrez]
AID - 10.1021/acsbiomaterials.1c01304 [doi]
PST - ppublish
SO  - ACS Biomater Sci Eng. 2022 Jun 13;8(6):2161-2195. doi: 
      10.1021/acsbiomaterials.1c01304. Epub 2022 May 6.