In vitro and in vivo safety evaluation of low molecular weight chitosans prepared by hydrolyzing crab shell chitosans with bamboo shoots chitosanase

Chang, Ya-Min; Lee, Yu-Jing; Liao, Jiunn‐Wang; Jhan, Jyun‐Kai; Chang, Chung‐Ju; Chung, Yun‐Chin

doi:10.1016/j.fct.2014.05.016

Cited by 10 publications

(4 citation statements)

References 25 publications

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“…Moreover, chitosan based NPs lack of oral toxicity was also reported for single dose administrations (Mukhopadhyay et al, 2015; Leng et al, 2018). Therefore, considering these reports, we may hypothesize that chitosan NPs (as well as bulk chitosan Chang et al, 2014) do not present oral toxicity. On the other hand, although only 2 reports were found testing chitosan NPs toxicity through the injectable route (Yuan et al, 2015; Shan et al, 2017), a dose dependent toxicity was found, even though chitosan and chitosan NPs appear to be hemocompatible in some hemolysis assays (Fernandes et al, 2010; Lü et al, 2011; Wang et al, 2014; Kumar et al, 2017; Leng et al, 2018).…”

Section: Hazard Characterization Of Polymeric Nanomaterials—literaturmentioning

confidence: 89%

Hazard Assessment of Polymeric Nanobiomaterials for Drug Delivery: What Can We Learn From Literature So Far

Jesus

Schmutz

Som

et al. 2019

Front. Bioeng. Biotechnol.

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The physicochemical properties of nanobiomaterials, such as their small size and high surface area ratio, make them attractive, novel drug-carriers, with increased cellular interaction and increased permeation through several biological barriers. However, these same properties hinder any extrapolation of knowledge from the toxicity of their raw material. Though, as suggested by the Safe-by-Design (SbD) concept, the hazard assessment should be the starting point for the formulation development. This may enable us to select the most promising candidates of polymeric nanobiomaterials for safe drug-delivery in an early phase of innovation. Nowadays the majority of reports on polymeric nanomaterials are focused in optimizing the nanocarrier features, such as size, physical stability and drug loading efficacy, and in performing preliminary cytocompatibility testing and proving effectiveness of the drug loaded formulation, using the most diverse cell lines. Toxicological studies exploring the biological effects of the polymeric nanomaterials, particularly regarding immune system interaction are often disregarded. The objective of this review is to illustrate what is known about the biological effects of polymeric nanomaterials and to see if trends in toxicity and general links between physicochemical properties of nanobiomaterials and their effects may be derived. For that, data on chitosan, polylactic acid (PLA), polyhydroxyalkanoate (PHA), poly(lactic-co-glycolic acid) (PLGA) and policaprolactone (PCL) nanomaterials will be evaluated regarding acute and repeated dose toxicity, inflammation, oxidative stress, genotoxicity, toxicity on reproduction and hemocompatibility. We further intend to identify the analytical and biological tests described in the literature used to assess polymeric nanomaterials toxicity, to evaluate and interpret the available results and to expose the obstacles and challenges related to the nanomaterial testing. At the present time, considering all the information collected, the hazard assessment and thus also the SbD of polymeric nanomaterials is still dependent on a case-by-case evaluation. The identified obstacles prevent the identification of toxicity trends and the generation of an assertive toxicity database. In the future, in vitro and in vivo harmonized toxicity studies using unloaded polymeric nanomaterials, extensively characterized regarding their intrinsic and extrinsic properties should allow to generate such database. Such a database would enable us to apply the SbD approach more efficiently.

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Section: Hazard Characterization Of Polymeric Nanomaterials—literaturmentioning

confidence: 89%

Hazard Assessment of Polymeric Nanobiomaterials for Drug Delivery: What Can We Learn From Literature So Far

Jesus

Schmutz

Som

et al. 2019

Front. Bioeng. Biotechnol.

View full text Add to dashboard Cite

show abstract

“…The positively charged chitosan also facilitates adhesion to the mucous membrane. Chitosan is also known to be biocompatible, biodegradable, nontoxic, and nonallergenic in nature [ 20 21 22 23 ]. Poloxamer biodegrades easily in the body and is excreted through the urinary system, which is an important feature when considering safety or the prevention of foreign-body reactions [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial

et al. 2021

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Purpose Restricted shoulder motion is a major morbidity associated with a lower quality of life and disability after axillary lymph node dissection (ALND) in patients with breast cancer. This study sought to evaluate the antiadhesive effect of a poloxamer-based thermosensitive sol-gel (PTAS) agent after ALND. Methods We designed a double-blind, multicenter randomized controlled study to evaluate the clinical efficacy and safety of PTAS in reducing upper-limb dysfunction after ALND. The primary outcome was the change in the range of motion (ROM) of the shoulder before surgery and 4 weeks after ALND (early postoperative period). Secondary outcomes were shoulder ROM at six months, axillary web syndrome, and lymphedema (late postoperative period). Results A total of 170 patients with planned ALND were randomly assigned to one of 2 groups (poloxamer and control) and 15 patients were excluded. In the poloxamer group (n = 76), PTAS was applied to the surface of the operative field after ALND. ALND was performed without the use of poloxamer in the control group (n = 79). Relative to the control group, the poloxamer group had significantly lower early postoperative restrictions in total shoulder ROM at four weeks (−30.04 ± 27.76 vs. −42.59 ± 36.79; p = 0.0236). In particular, the poloxamer group showed greater reductions in horizontal abduction at four weeks (−3.92 ± 9.80 vs. −10.25 ± 15.42; p = 0.0050). The ROM of the shoulder at 24 weeks, axillary web syndrome, and lymphedema were not significantly different between the two groups. No adverse effects were observed in either group. Conclusion We suggest that poloxamer might improve the early postoperative shoulder ROM in patients with breast cancer who have undergone ALND. Trial Registration ClinicalTrials.gov Identifier: NCT02967146

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“…Chitosan and gelatin are also known to be biocompatible, biodegradable, non-toxic, and non-allergenic. 17,36–38 Owing to such properties, these components also play an important role as physical or biological barrier of membrane to cope with bleeding (anti-coagulant) and prevent invasion of bacteria (anti-bacterial). 39 Several in vivo studies have shown promising results of TAP hydrogel after spine surgery.…”

Section: Discussionmentioning

confidence: 99%

Temperature-sensitive anti-adhesive poloxamer hydrogel decreases fascial adhesion in total knee arthroplasty: A prospective randomized controlled study

et al. 2019

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A temperature sensitive anti-adhesive poloxamer (TAP) hydrogel has been developed to reduce post-operative adhesion. The purpose of this study was to evaluate the efficacy and safety of TAP hydrogel on fascial adhesion and clinical outcomes including range of motion, pain, and patient satisfaction after total knee arthroplasty. Sixty patients who underwent unilateral primary total knee arthroplasty for knee osteoarthritis were included and randomized to either TAP group or control group. After capsular closure, TAP hydrogel was applied on the fascial layer in 30 patients of the TAP hydrogel group, while normal saline was applied to 30 patients of the control group. The primary variable was range of motion at postoperative seven days, three months, and one year. As secondary outcomes, degree of skin fold, fascial thickness measured with ultra-sonography, postoperative pain visual analogue scale, total cumulative analgesics consumption, clinical scores, and degree of satisfaction were evaluated. There were no significant differences in range of motion after surgery between the two groups. However, the degree of suprapatellar skin folding in the TAP hydrogel group was less than that of the control group at six weeks after surgery (p = 0.041). There were no significant differences in postoperative fascial thickness, pain visual analogue scale, analgesics consumption, clinical scores, or degree of satisfaction. No surgical site complication was observed. The use of TAP hydrogel failed to enhance range of motion. However, application of TAP hydrogel on the fascial layer after capsular closure in total knee arthroplasty may decrease early postoperative fascial adhesion without any complications.

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In vitro and in vivo safety evaluation of low molecular weight chitosans prepared by hydrolyzing crab shell chitosans with bamboo shoots chitosanase

Cited by 10 publications

References 25 publications

Hazard Assessment of Polymeric Nanobiomaterials for Drug Delivery: What Can We Learn From Literature So Far

Hazard Assessment of Polymeric Nanobiomaterials for Drug Delivery: What Can We Learn From Literature So Far

Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial

Temperature-sensitive anti-adhesive poloxamer hydrogel decreases fascial adhesion in total knee arthroplasty: A prospective randomized controlled study

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