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Transplantation and Cellular Therapy May 2022Autologous hematopoietic cell transplantation (AHCT) remains a standard therapeutic option for patients with multiple myeloma (MM). Outcomes have improved for this... (Review)
Review
Autologous hematopoietic cell transplantation (AHCT) remains a standard therapeutic option for patients with multiple myeloma (MM). Outcomes have improved for this patient group after first AHCT, with the use of novel agents in induction, as well as post-transplantation maintenance. High-dose melphalan remains the gold standard as the conditioning regimen for MM. Traditional melphalan is a lyophilized formulation that after reconstitution has insufficient chemical stability and water solubility, thus requiring the addition of propylene glycol to act as a cosolvent to improve these characteristics. After the reconstitution of melphalan with propylene glycol-containing solution, impurities can develop within 30 minutes, and if further dilution occurs, the potency of melphalan diminishes. Propylene glycol is associated with a spectrum of toxicities that can be dose limiting. Evomela is a propylene glycol-free melphalan (PGF-Mel) that at a high dose of 200 mg/ (100 mg/m/d for 2 days) is approved for conditioning before AHCT in MM patients. Once reconstituted by directly dissolving in saline solution, PGF-Mel solution can be stored in the vial for up to 1 hour at room temperature or for up to 24 hours at refrigerated temperature (2° to 8°C) with no significant degradation. The demonstrated stability, up to 24 hours at room temperature, results in reduced handling requirements and increased convenience and flexibility of administration. Since its approval, Evomela has been the subject of several retrospective and investigator-initiated studies. This review summarizes the prospective and real-world evidence on practical aspects of PGF-Mel and critically appraises the available data and its clinical implications.
Topics: Humans; Amyloidosis; Hematopoietic Stem Cell Transplantation; Melphalan; Multiple Myeloma; Propylene Glycol; Prospective Studies; Retrospective Studies
PubMed: 35196581
DOI: 10.1016/j.jtct.2022.02.014 -
Giornale Italiano Di Dermatologia E... Jun 2020A new propylene glycol (PG)-free 5% minoxidil (Mnx) lotion has been recently commercialized. Aim of this study was to evaluate the acceptability/tolerability and... (Clinical Trial)
Clinical Trial Comparative Study
BACKGROUND
A new propylene glycol (PG)-free 5% minoxidil (Mnx) lotion has been recently commercialized. Aim of this study was to evaluate the acceptability/tolerability and clinical efficacy of 3-month application of this new PG-free Mnx lotion and the penetration of the active compound in a reconstructed human epidermis (RHE/Episkin) model in comparison with a PG Mnx 5% lotion.
METHODS
Thirty subjects of both sex with a diagnosis of AGA were enrolled in the trial. Cosmetic acceptability and clinical efficacy were evaluated after 4, 8 and 12 weeks of treatment. Global tolerability was evaluated at week 12. Cosmetic acceptability evaluation was assessed using a 7-item questionnaire using a 10-point scale score. Global Tolerability was evaluated with a 4-grade scale. Clinical efficacy was evaluated with a 5-grade scale. Skin absorption of PG-free Mnx was evaluated and compared with a PG Mnx solution using the Episkin model.
RESULTS
All subjects concluded the study. The 7-item questionnaire mean values were always <2 at each time-point evaluation, demonstrating high cosmetic acceptability/tolerability. No subjects reported burning, itching or redness sensations. Global Tolerability score mean±SD value was 1.7±0.4. Clinical efficacy scores were 0.4, 0.6 and 1.2 at week 4, 8 and 12, respectively. PG-free Mnx showed similar amount of absorbed dose in comparison with PG Mnx.
CONCLUSIONS
This new PG-free lotion shows a very good cosmetic acceptability/tolerability profile. Clinical efficacy was also documented. The skin penetration of this formulation is comparable to the PG Mnx lotion, supporting the bioequivalence of the two products.
Topics: Administration, Topical; Alopecia; Female; Humans; Male; Middle Aged; Minoxidil; Propylene Glycol; Prospective Studies; Single-Blind Method; Skin Absorption; Skin Cream; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vasodilator Agents
PubMed: 32635707
DOI: 10.23736/S0392-0488.20.06554-2 -
Regulatory Toxicology and Pharmacology... Feb 2023Propylene glycol (PG) has widespread use in pharmaceuticals, cosmetics, fragrances and personal care products. PG is not classified as hazardous under the Globally... (Review)
Review
Propylene glycol (PG) has widespread use in pharmaceuticals, cosmetics, fragrances and personal care products. PG is not classified as hazardous under the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) but poses an intriguing scientific and regulatory conundrum with respect to allergic contact dermatitis (ACD), the uncertainty being whether and to what extent PG has the potential to induce skin sensitisation. In this article we review the results of predictive tests for skin sensitisation with PG, and clinical evidence for ACD. Patch testing in humans points to PG having the potential to be a weak allergen under certain conditions, and an uncommon cause of ACD in subjects without underlying/pre-disposing skin conditions. In clear contrast PG is negative in predictive toxicology tests for skin sensitisation, including guinea pig and mouse models (e.g. local lymph node assay), validated in vitro test methods that measure various key events in the pathway leading to skin sensitisation, and predictive methods in humans (Human Repeat Insult Patch and Human Maximisation Tests). We here explore the possible scientific basis for this intriguing inconsistency, recognising there are arguably no known contact allergens that are universally negative in, in vitro, animal and human predictive tests methods.
Topics: Mice; Humans; Animals; Guinea Pigs; Dermatitis, Allergic Contact; Skin; Allergens; Skin Tests; Patch Tests; Propylene Glycol; Cosmetics
PubMed: 36702195
DOI: 10.1016/j.yrtph.2023.105341 -
Annual Review of Analytical Chemistry... Jun 2019The study of e-cigarette aerosol properties can inform public health while longer-term epidemiological investigations are ongoing. The determination of aerosol levels of... (Review)
Review
The study of e-cigarette aerosol properties can inform public health while longer-term epidemiological investigations are ongoing. The determination of aerosol levels of known toxins, as well as of molecules with unknown inhalation toxicity profiles, affords specific information for estimating the risks of e-cigarettes and for uncovering areas that should be prioritized for further investigation.
Topics: Aerosols; Chemistry Techniques, Analytical; Electronic Nicotine Delivery Systems; Flavoring Agents; Glycerol; Humans; Nicotine; Propylene Glycol; Public Health
PubMed: 30848928
DOI: 10.1146/annurev-anchem-061318-115329 -
Medycyna Pracy 2015Both ethylene and propylene glycol alkyl ethers (EGAEs and PGAEs, respectively) are widely used, mainly as solvents, in industrial and household products. Some EGAEs... (Review)
Review
Both ethylene and propylene glycol alkyl ethers (EGAEs and PGAEs, respectively) are widely used, mainly as solvents, in industrial and household products. Some EGAEs demonstrate gonadotoxic, embriotoxic, fetotoxic and teratogenic effects in both humans and experimental animals. Due to the noxious impact of these ethers on reproduction and development of organisms EGAEs are replaced for considerably less toxic PGAEs. The data on the mechanisms of testicular, embriotoxic, fetotoxic and teratogenic effects of EGAEs are presented in this paper. Our particular attention was focused on the metabolism of some EGAEs and their organ-specific toxicities, apoptosis of spermatocytes associated with changes in the expression of various genes that code for oxidative stress factors, protein kinases and nuclear hormone receptors.
Topics: Ethers; Ethylene Glycol; Human Development; Humans; Propylene Glycol; Reproductive Physiological Phenomena; Solvents
PubMed: 26647990
DOI: 10.13075/mp.5893.00219 -
Chemical & Pharmaceutical Bulletin 2023Propan-1,3-diol (PD) and propan-1,2-diol (propylene glycol, PG) are very similar compounds because their structures, safety data, and anti-microbial activities are...
Propan-1,3-diol (PD) and propan-1,2-diol (propylene glycol, PG) are very similar compounds because their structures, safety data, and anti-microbial activities are almost the same. Actually, both compounds are made up of three carbon atoms and two hydroxyl groups. Regarding their safety, they do not have serious hazard data for animals, and LD values (in rats) of both are similar. As for the anti-microbial activity, minimum inhibitory concentration (MIC) values of both PD and PG are approximately 10% (v/v). In this study, we used the preservatives-effectiveness test (PET) to evaluate the anti-microbial activities of PD and PG, because both compounds are used in cosmetics as preservatives. The results indicated that PD was more effective as an anti-microbial agent compared with PG, and the effect of PD was marked against Escherichia coli and Pseudomonas aeruginosa. Scanning electron microscopy (SEM) images showed that the membrane of Escherichia coli was injured by PD and PG, but the damage by PD was more marked. The damage of the cell membrane may be the cause of high anti-microbial activity of PD in PET. These results suggest that PD has greater potential as a preservative, and PD should be recommended as an additive for food and medicine.
Topics: Animals; Rats; Anti-Infective Agents; Escherichia coli; Microbial Sensitivity Tests; Phenylpropanolamine; Preservatives, Pharmaceutical; Propylene Glycol
PubMed: 36596515
DOI: 10.1248/cpb.c22-00625 -
Respiration; International Review of... 2013Marketed since 2004 as an alternative to nicotine delivery and advertised as a valid means to smoking cessation, the electronic (e)-cigarette has been the subject of... (Review)
Review
Marketed since 2004 as an alternative to nicotine delivery and advertised as a valid means to smoking cessation, the electronic (e)-cigarette has been the subject of much controversy but very little experimental study. This review provides a brief summary of the current knowledge of this product. Propylene glycol and glycerol, the main ingredients of the fluid that is vaporized, have proved to be harmless in the fog machines of the entertainment industry. However, in the case of the e-cigarette fluid, the composition is not properly labeled: additives like nicotine and flavors vary between and within brands and contamination with various chemicals has been detected. The short-term toxicity seems low, but the long-term toxicity is unknown. The usefulness of the e-cigarette in smoking cessation has still to be clinically established.
Topics: Aerosols; Electrical Equipment and Supplies; Humans; Nebulizers and Vaporizers; Nicotine; Nicotinic Agonists; Propylene Glycol; Smoking; Smoking Cessation
PubMed: 24080743
DOI: 10.1159/000353253 -
Molecules (Basel, Switzerland) May 2023Refill liquids for electronic cigarettes are an important area of research due to the health safety and quality control of such products. A method was developed for the...
Refill liquids for electronic cigarettes are an important area of research due to the health safety and quality control of such products. A method was developed for the determination of glycerol, propylene glycol, and nicotine in refill liquids using liquid chromatography, coupled with tandem mass spectrometry (LC-MS/MS) in multiple reaction monitoring (MRM) mode with electrospray ionisation (ESI). Sample preparation was based on a simple dilute-and-shoot approach, with recoveries ranging from 96 to 112% with coefficients of variation < 6.4%. Linearity, limits of detection and quantification (LOD, LOQ), repeatability, and accuracy were determined for the proposed method. The proposed sample preparation and the developed chromatographic method using hydrophilic interaction liquid chromatography (HILIC) were successfully applied for the determination of glycerol, propylene glycol, and nicotine in refill liquid samples. For the first time, the developed method using HILIC-MS/MS has been applied for the determination of the main components of refill liquids in a single analysis. The proposed procedure is rapid and straightforward and is suitable for quick determination of glycerol, propylene glycol, and nicotine. The nicotine concentrations corresponded to the labelling of samples (it varied from
propylene glycol to glycerol were also determined. Topics: Nicotine; Glycerol; Chromatography, Liquid; Electronic Nicotine Delivery Systems; Tandem Mass Spectrometry; Propylene Glycol
PubMed: 37298901
DOI: 10.3390/molecules28114425 -
Journal of Primary Care & Community... Apr 2017Electronic cigarettes (e-cigarettes) are often advertised as a healthier product when compared with traditional cigarettes. Currently, there are limited data to support...
Electronic cigarettes (e-cigarettes) are often advertised as a healthier product when compared with traditional cigarettes. Currently, there are limited data to support this and only a threat of federal regulation from the US Food and Drug Administration. Calls to poison control centers about e-cigarette toxicity, especially in children, and case reports of toxic exposures have increased over the past 3 years. This research letter reports the frequency of hazardous exposures to e-cigarettes and characterizes the reported adverse health effects associated with e-cigarette toxicity.
Topics: Adolescent; Adult; Child; Child, Preschool; Electronic Nicotine Delivery Systems; Environmental Exposure; Humans; Infant; Infant, Newborn; Nausea; Nicotine; Poison Control Centers; Propylene Glycol; Smoking; Suicide; United States; Vomiting; Young Adult
PubMed: 27650036
DOI: 10.1177/2150131916668645 -
Journal of Dairy Science Mar 2020This experiment aimed to evaluate the suitability of glycerol and propylene glycol to reduce microbial count and preserve immune properties in heat-treated goat...
This experiment aimed to evaluate the suitability of glycerol and propylene glycol to reduce microbial count and preserve immune properties in heat-treated goat colostrum. Colostrum samples from 11 goats were each divided into 9 aliquots. Different concentrations (2, 6, 10, and 14%; vol/vol) of either glycerol or propylene glycol were added to the aliquots. Phosphate buffer solution was added to one aliquot, which was set as the control (CG). After the respective additions, all colostrum samples were heat treated at 56°C for 1 h. After cooling, aerobic mesophilic bacteria were cultured. The samples were frozen until free fatty acid, IgG, IgA, and IgM concentrations and chitotriosidase activity were measured. No differences were found in aerobic mesophilic bacteria counts between either 10 or 14% glycerol and propylene glycol additives. These additions reduced bacterial count to a greater extent than CG, and 2 or 6% additions. Colostrum IgG concentration was not affected by either of the additives or their concentrations. The propylene glycol additive reduced IgA and IgM concentrations and chitotriosidase activity, compared with CG. Conversely, glycerol did not affect any of the studied immune variables. In conclusion, glycerol addition to goat colostrum before heat treatment is suitable to enhance bacterial reduction, whereas colostrum immune properties were not affected.
Topics: Animals; Bacteria; Bacterial Load; Colostrum; Female; Glycerol; Goats; Hexosaminidases; Hot Temperature; Immunoglobulin A; Immunoglobulin G; Immunoglobulin M; Pasteurization; Pregnancy; Propylene Glycol
PubMed: 31882214
DOI: 10.3168/jds.2019-17535