Safety assessment of the pharmacological excipient, diethylene glycol monoethyl ether (DEGEE), using in vitro and in vivo systems

Published on Apr 18, 2019in Tehran University of Medical Sciences
· DOI :10.1007/S40199-019-00264-5
Sonal Srivastava7
Estimated H-index: 7
(Central Drug Research Institute),
Sakshi Mishra11
Estimated H-index: 11
(Central Drug Research Institute)
+ 7 AuthorsSrikanta Kumar Rath13
Estimated H-index: 13
(Central Drug Research Institute)
Background Diethylene glycol monoethyl ether (DEGEE) is widely used as a solubilizer in cosmetics as well as in oral, topical, transdermal and injectable pharmaceutical formulations. Due to the unavailability of detailed toxicological studies on DEGEE, the Scientific Committee on Consumer Products (SCCP) found its toxicological reports to be unsatisfactory, comprising only summaries. Also, a few reports have raised concern on the use of DEGEE as it might cause damage to the kidneys.
A heightened interest in (trans)dermal delivery is in part driven by the need to improve the existing skin therapies and also the demand for alternative routes of administration, notably for pharmaceutical actives with undesirable oral absorption characteristics. The premise of delivering difficult actives to the skin or via the skin however is weighed down by the barrier function properties of the stratum corneum. Short of disrupting the skin by physical means, scientists have resorted to formu...
48 CitationsSource
#1Rosa Pireddu (University of Cagliari)H-Index: 7
#2Chiara Sinico (University of Cagliari)H-Index: 36
Last. Francesco Lai (University of Cagliari)H-Index: 24
view all 9 authors...
Abstract The poor ability of many drugs to cross skin layers is the main limiting factor for the exploitation of the transdermal route for drug delivery. As a consequence, several approaches have been proposed to overcome the skin barrier, such as the inclusion of penetration enhancers in the topically applied drug solutions and emulsions. In this work, the penetration enhancer diethylene glycol monoethyl ether was included in novel diclofenac acid nanocrystal formulations, developed using the w...
11 CitationsSource
#1Jayant Dewangan (Central Drug Research Institute)H-Index: 9
#2Shweta Kaushik (Central Drug Research Institute)H-Index: 6
Last. Anil K. Balapure (Central Drug Research Institute)H-Index: 13
view all 4 authors...
Abstract Aims Angiogenesis is a recognized hallmark of cancer which promotes cancer cell progression and metastasis. Inhibition of angiogenesis to attenuate cancer growth is becoming desirable strategy for breast cancer management. The present study is aimed to investigate the antiangiogenic efficacy of a novel selective estrogen receptor modulator Centchroman (CC) on human breast cancer cells. Main methods Effect of CC on cell viability was evaluated using Sulforhodamine B assay. Endothelial ce...
18 CitationsSource
#1Jayant Dewangan (Central Drug Research Institute)H-Index: 9
#2Sonal Srivastava (Central Drug Research Institute)H-Index: 7
Last. Srikanta Kumar Rath (Central Drug Research Institute)H-Index: 13
view all 6 authors...
Abstract Human triple-negative breast cancer (TNBC) is poorly diagnosed and unresponsive to conventional hormone therapy. Chetomin (CHET), a fungal metabolite synthesized by Chaetomium cochliodes, has been reported as a promising anticancer and antiangiogenic agent but the complete molecular mechanism of its anticancer potential remains to be elucidated. In our study, we explored the anti-neoplastic action of CHET on TNBC cells. Cytotoxicity studies were performed in human TNBC cells viz. MDA-MB...
11 CitationsSource
#1Sonal Srivastava (Central Drug Research Institute)H-Index: 7
#2Sakshi Mishra (Central Drug Research Institute)H-Index: 11
Last. Srikanta Kumar Rath (Central Drug Research Institute)H-Index: 13
view all 6 authors...
Abstract In vitro assays for toxicological studies is the refinement and replacement of animal testing in order to minimize the use of traditional animal-based toxicology studies. In the recent decades, in vitro methods have been routinely used as these can be correlated with the in vivo studies and can help in understanding a specific in vivo response in any given species. Optimization of cell culture is the major primary step to in vitro studies as it includes handling of cells and tissues out...
6 CitationsSource
#1Jayant Dewangan (Central Drug Research Institute)H-Index: 9
#2Divya Tandon (Central Drug Research Institute)H-Index: 2
Last. Srikanta Kumar Rath (Central Drug Research Institute)H-Index: 13
view all 6 authors...
Resveratrol (RES) is a natural polyphenol having anti-proliferative activity against breast cancer cells. RES in combination with other chemo modulatory agents, minimizes toxicity and increases efficacy of the treatment. Salinomycin (SAL), a monocarboxylic polyether ionophore is known for selectively targeting breast cancer stem cells. Purpose of the present study was to investigate whether RES in combination with SAL exerts synergistic anti-proliferative activity on breast cancer cells. We furt...
27 CitationsSource
#1Sebastian Björklund (Malmö University)H-Index: 11
#2Quoc Dat Pham (Lund University)H-Index: 11
Last. Emma Sparr (Lund University)H-Index: 31
view all 9 authors...
In the development of transdermal and topical products it is important to understand how formulation ingredients interact with the molecular components of the upper layer of the skin, the stratum corneum (SC), and thereby influence its macroscopic barrier properties. The aim here was to investigate the effect of two commonly used excipients, transcutol and dexpanthenol, on the molecular as well as the macroscopic properties of the skin membrane. Polarization transfer solid-state NMR methods were...
32 CitationsSource
#1Soodabeh SaeidniaH-Index: 26
#2Azadeh ManayiH-Index: 20
Last. Mohammad Abdollahi (Tehran University of Medical Sciences)H-Index: 101
view all 3 authors...
Biomedical investigators use different methods including experimental animals, tissue, and cell cultures as well as computational simulations and clinical studies finding the ways to treat human diseases and disorders. All the mentioned procedures have their own advantages and disadvantages. For instance although animal models provide some drawbacks like difference in biokinetics parameters or extrapolation of results to human, they are more reliable than in vitro tests. The disadvantage of the ...
66 CitationsSource
#1Dexter W. SullivanH-Index: 5
#2Shayne C. GadH-Index: 25
Last. Marjorie JulienH-Index: 1
view all 3 authors...
Transcutol® (Diethylene glycol monoethyl ether, DEGEE), CAS # 111-90-0, is commonly used as a vehicle in the formulation or manufacturing process of pharmaceuticals, cosmetics, and food additives. This paper presents unpublished nonclinical safety data using a form of DEGEE which includes a significantly decreased level of impurities, specifically ethylene glycol and diethylene glycol. It also reviews the history of use, regulatory status, and previously published toxicity data for DEGEE. The re...
66 CitationsSource
#1Dmitry B. Zorov (NIH: National Institutes of Health)H-Index: 49
#2Magdalena Juhaszova (NIH: National Institutes of Health)H-Index: 34
Last. Steven J. Sollott (NIH: National Institutes of Health)H-Index: 36
view all 3 authors...
Byproducts of normal mitochondrial metabolism and homeostasis include the buildup of potentially damaging levels of reactive oxygen species (ROS), Ca2+, etc., which must be normalized. Evidence suggests that brief mitochondrial permeability transition pore (mPTP) openings play an important physiological role maintaining healthy mitochondria homeostasis. Adaptive and maladaptive responses to redox stress may involve mitochondrial channels such as mPTP and inner membrane anion channel (IMAC). Thei...
1,500 CitationsSource
Cited By4
Cassia occidentalis Linn (CO) is an annual/perennial plant having traditional uses in the treatments of ringworm, gastrointestinal ailments and piles, bone fracture, and wound healing. Previously, we confirmed the medicinal use of the stem extract (ethanolic) of CO (henceforth CSE) in fracture healing at 250 mg/kg dose in rats and described an osteogenic mode of action of four phytochemicals present in CSE. Here we studied CSE's preclinical safety and toxicity. CSE prepared as per regulations of...
#1Rubén R. López (École de technologie supérieure)H-Index: 2
#2Paula G. Font de Rubinat (UPC: Polytechnic University of Catalonia)H-Index: 1
Last. Vahé Nerguizian (École de technologie supérieure)H-Index: 9
view all 10 authors...
Liposomes are versatile particles used in the biomedical field as drug delivery systems (DDS). Liposome production using micromixers have shown to yield nanoparticles for DDS in a single step with a controllable size by changing flow conditions. Nonetheless, other factors such as the organic solvent, play a crucial role in the liposome formation process. Furthermore, drug solubility and toxicity are pivotal when deciding which organic solvent to choose. In this work, liposomes were produced in a...
2 CitationsSource
#1Sonal SrivastavaH-Index: 7
#2Jayant DewanganH-Index: 9
Last. Srikanta Kumar RathH-Index: 13
view all 8 authors...
Abstract Background: Celecoxib (CXB), a selective COX-2 inhibitor NSAID, has exhibited prominent anti-proliferative potential against numerous cancers. However, its low bioavailability and long term exposure related cardiovascular side effects, limit its clinical application. In order to overcome these limitations, natural bioactive compounds with lower toxicity profile are used in combination with therapeutic drugs. Therfore, in this study Piperine (PIP), a natural chemo-preventive agent posses...
1 CitationsSource
#1Liza Józsa (University of Debrecen)
#2Zoltán Ujhelyi (University of Debrecen)H-Index: 11
Last. Pálma Fehér (University of Debrecen)H-Index: 14
view all 13 authors...
Natural products used in the treatment of acne vulgaris may be promising alternative therapies with fewer side effects and without antibiotic resistance. The objective of this study was to formulate creams containing Spirulina (Arthrospira) platensis to be used in acne therapy. Spirulina platensis belongs to the group of micro algae and contains valuable active ingredients. The aim was to select the appropriate nonionic surfactants for the formulations in order to enhance the diffusion of the ac...