POLYSORBATE 80

To determine the frequency of sensitization to polyethylene glycol and polysorbate in allergic patients with a complete vaccination schedule against COVID-19 who presented systemic adverse reactions. Cross-sectional, descriptive, observational and prolective study. Allergic patients between 18 and 60 years old, with complete vaccination schedule against COVID-19, with systemic adverse reactions were included. Skin tests were performed with polyethylene glycol 2000 and PS 80. The results were analyzed by calculating averages, percentages and frequencies. Fifty-five patients were included, 74.5% were women, average age was 31.4 (SD 11.6), the most prevalent allergologic diagnosis was allergic rhinitis, adverse reactions after vaccination were late in 54 patients, with myalgias being the most common. Sensitization was found in 40%, of these 32.7% were positive to polysorbate 80. The vaccines with the highest prevalence of sensitization were AstraZeneca and Sputnik. Adverse reactions during skin testing occurred in 5 patients and the most frequent adverse event was headache. A high frequency of sensitization to polyethylene glycol 2000 and polysorbate 80 was found. In sensitized patients, alternatives with vaccines that do not contain the excipients to which they were positive can be recommended to avoid the risk of subsequent adverse events. Determinar la frecuencia de sensibilización a polietilenglicol y/o polisorbato en pacientes alérgicos, con esquema de vacunación completo contra COVID-19, que manifestaron reacciones adversas sistémicas. Estudio transversal, descriptivo, observacional y prolectivo, llevado a cabo en pacientes alérgicos, de 18 a 60 años, con esquema de vacunación completo contra COVID-19, con reacciones adversas sistémicas. Se realizaron pruebas cutáneas con polietilenglicol 2000 y polisorbato 80. Los resultados se analizaron mediante el cálculo de promedios, porcentajes y frecuencias. Se registraron 55 pacientes (74.5% mujeres), con promedio de edad de 31.4 (DE 11.6). El diagnóstico alergológico más prevalente fue rinitis alérgica, las reacciones adversas fueron tardías en 54 pacientes, reportándose mialgias como la más común. Se encontró sensibilización en 40%, de estos 32.7% fueron positivos a polisorbato 80. Las vacunas con mayor prevalencia de sensibilización fueron AstraZeneca y Sputnik. Aparecieron reacciones adversas durante las pruebas cutáneas en 5 pacientes y el evento adverso más frecuente fue cefalea. Se encontró alta frecuencia de sensibilización a polietilenglicol 2000 y polisorbato 80. En los pacientes sensibilizados se pueden recomendar alternativas con vacunas que no contengan los excipientes a los que resultaron positivos con el fin de evitar el riesgo de eventos adversos posteriores.

The encapsulation of lipophilic compounds for use in the cosmetic, food, and detergency industries is an area of growing interest. However, most current strategies rely on non-biodegradable materials, often classified as microplastics, which pose significant environmental risks. To address these issues, alternative encapsulation methods using biodegradable materials are being developed. Despite their potential, these methods have yet to demonstrate efficacy or economic feasibility comparable to conventional encapsulation systems. To overcome these challenges, a novel strategy has been developed for the encapsulation of lipophilic compounds, such as fragrances, using sodium alginate (SA). This approach involves the formation of an oil-in-water nanoemulsion via the Phase Inversion Composition method, with polysorbate 80 serving as the surfactant. The process is followed by the internal gelation of SA and subsequent dispersion to generate the final microcapsules. The formulation was optimized by varying the ratios of surfactant, oil, and aqueous phases in the nanoemulsion. Characterization techniques, including Dynamic Light Scattering, Gas Chromatography-Mass Spectrometry, and Thermogravimetric Analysis, confirmed successful encapsulation (average of 81 %, up to 97 % for one fragrance). The formulations demonstrated prolonged release profiles, with the scent remaining detectable for up to 30 days. An organoleptic study further revealed that encapsulated fragrances retained higher perceived intensity over time compared to their non-encapsulated counterparts. Moreover, the microcapsules exhibited excellent long-term stability within a conditioner matrix, maintaining their fragrance load for four months. This work represents a significant advancement in the development of environmentally friendly encapsulation methods for lipophilic compounds, offering promising applications in the cosmetic industry.

Citral and quercetin are, respectively, a monoterpene and a flavonoid of great interest for cosmetics. They have impaired water solubility, and the development of nanoemulsions is a suitable strategy to overcome this main issue. In this study, citral was used as the oily phase to nanoemulsify quercetin through a low-energy method. The nanoemulsions were prepared with deionized water or glycerol, and the best results were reached with polysorbate 80 and water, being observed a size diameter of around 20 nm and a relatively monodisperse distribution. Quercetin was capable of reducing droplet size when compared to citral, a mandatory component for classifying this colloid as a nanoemulsion. Up to 65ºC, there was no main difference in droplet size. Therefore, this study provides suitable prototypes of citral/quercetin nanoemulsion that can be further used in cosmetic applications through an eco-friendly method of preparation.

Cosmetic products, which typically contain multiple ingredients such as ethanol, glycerol and Tween 80 (polysorbate 80), may influence the homeostasis of the skin microbiome. However, the effect of common ingredients on the anaerobic members of human skin microbiome is poorly studied. In this study, we directly evaluated the effects of common cosmetic ingredients on a dominant human skin anaerobe Cutibacterium acnes using in vitro techniques. Five cosmetic ingredients were added to seven C. acnes strains, including type strains of the three subspecies (types I, II, and III), and their effects were evaluated by monitoring growth curves based on turbidity measurements. All strains exhibited growth inhibition in response to high concentrations (10 % v/v) of ethanol and glycerol, whereas low concentrations (3 % and/or 1 % v/v) of ethanol enhanced bacterial growth. The nonionic detergent Tween 80 significantly enhanced the growth of type I strains, with some strains also producing insoluble precipitates, which may relate to comedogenesis. In contrast, type III strains did not produce precipitates. The two polyamines, putrescine and spermidine, elicited a biphasic response, with growth inhibition observed at higher concentrations and growth promotion at lower concentrations. The response of C. acnes subspecies/strains to the cosmetic components varied with the different ingredient concentrations, often exhibiting opposite effects.

Vaccination has formed the mainstay for mitigation of the COVID-19 pandemic. Vaccine-induced allergic reactions, though rare, have made it difficult to ensure complete coverage of COVID-19 vaccination. Initial guideline issued by the Government of India contraindicated vaccination in those with food or drug allergies. Allergic reactions largely result from excipients such as polysorbate 80 (P-80) (present in COVISHIELD™) and polyethylene glycol (PEG) [present in the messenger ribonucleic acid (mRNA) vaccines]. The present study was carried out with the objective of allergy testing in those with a history of allergic diathesis to generate objective evidence to the extent of true allergies to COVID-19 vaccination. After approval from the Institutional Ethics Committee, written informed consent was obtained for this prospective, open-label study in 100 participants. Allergic response assessment in participants with a history of any allergies, yet unvaccinated to COVID-19, or have taken the first dose and were due for second dose, or had taken the second dose and were due for the precautionary dose, was done by skin prick test (SPT) followed by intradermal testing (IDT) injection with COVISHIELD™ vaccine, P-80, and PEG individually. Based on the result of the skin test (either positive or negative), participants were given advice regarding vaccination. Of the 100 enrolled participants, n = 75 had taken both doses of any COVID-19 vaccine, n = 15 had taken only the first dose of any COVID-19 vaccine, and n = 10 were yet unvaccinated. There was no [0/92 (0%) and 0/98 (0%)] positive test with PEG and P-80, respectively. Only 02/98 (2.04%) returned a positive test with full strength (1:1) COVISHIELD™ vaccine IDT but not with SPT. This study indicates a low risk of allergy to PEG, P-80, and COVISHIELD™. Where feasible, allergy testing and counseling can be offered to unvaccinated or partially vaccinated individuals with a history of allergic diathesis.

The utility of bicontinuous microemulsions (BMEs) as carriers of the antimicrobial peptide (AMP) gramicidin D and antiseptic chlorhexidine was investigated for possible topical delivery to chronic wounds. The two water-insoluble solutes dissolved in pre-formed one-phase BMEs of Water/ Polysorbate 80/ Limonene/ Ethanol/ Glycerol and Water/ Aerosol-OT (AOT)/ Polysorbate 85/ Isopropyl Myristate and an AOT/ Polysorbate 85 Winsor-III system, achieving gramicidin and chlorhexidine concentrations of 1.0 (wt)% and 0.5% individually and 0.5% and 0.3% in mixtures at 22oC, respectively. Small-angle neutron scattering measurements demonstrated that both solutes decreased surfactant interfacial activity and increased interfacial fluidity for the Polysorbate 80 system. For the AOT/ Polysorbate systems, ellipsoidal aggregates consisting of gramicidin and likely adsorbed surfactant and oil formed, while chlorhexidine enhanced the surface activity of surfactants. According to bioassays performed on artificial skin, the incorporation of melittin, gramicidin, and chlorhexidine enhanced the bioactivity of BMEs for 24 h treatment against relevant antibiotic-resistant bacteria found on skin relative to controls. Yet, BME treatments were less effective than aqueous melittin control, in contrast to well diffusion bioassays performed previously. The results reflect the strong impact of AMPs and antiseptics on BME structure and dynamics and the complexity of formulating BMEs for optimal antimicrobial activity.

Fatty acid vesicles are natural biomaterials which possess unique bilayer structures and offer biomimetic advantages for drug and gene delivery. Nevertheless, the formation of fatty acid vesicles is limited to neutral alkaline circumstances and cannot adapt to the acidic environment of the living system. In this work, the non-ionic surfactant polysorbate 80 (TW80) was introduced, extending the pH window of vesicles formed by decanoic acid (DA) from 6.90-7.80 to 2.28-6.31. The DA/TW80 composite vesicles were used to encapsulate quercetin (QT), achieving an encapsulation efficiency of up to 75.6%. The formation of DA/TW80/QT composite vesicles was confirmed through Fourier transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffraction. Moreover, free QT was released rapidly, while QT encapsulated in the DA/TW80 composite vesicles demonstrated a slower release profile. Skin permeability studies revealed that the cumulative drug penetration within 24 h using the DA/TW80/QT composite vesicles reached approximately 904.7 μg·cm -2 , 1.81 times higher than that of a QT solution. Furthermore, the DA/TW80/QT composite vesicles demonstrated enhanced antioxidant activity and greater antibacterial efficacy compared to either the drug or the vesicles alone. The results provide a crucial foundation for the application of drug-loaded vesicles in cosmetics.

Bovine mastitis is one of the most economically significant diseases affecting dairy cattle, leading to substantial losses due to decreased milk yield, higher treatment costs, and lower milk quality. Iodine-based teat disinfectants are commonly used to prevent mastitis but have several limitations, such as milk residue contamination, potential skin irritation, environmental persistence, and concerns about antimicrobial resistance. Plant-derived antimicrobials have thus gained interest as potential alternatives. Clove leaf oil from Syzygium aromaticum (L.) Merr. & L.M. Perry contains eugenol and other bioactive compounds with strong antimicrobial activity. However, its use is limited by poor water solubility and physicochemical instability. This study aimed to develop and optimize a clove leaf oil nanoemulsion (CLON) using a self-nanoemulsifying drug delivery system (SNEDDS) and to evaluate its physicochemical properties and in vitro antimicrobial activity against pathogens associated with bovine mastitis. This study followed a three-phase sequential workflow. Phase I involved screening and optimizing the formulation of CLON using SNEDDS technology. Nine ratios of clove leaf oil, Polysorbate 80 (Tween 80), and Polyethylene glycol 400 (PEG 400) were initially tested, followed by optimization with an I-optimal mixture design. Phase II included physicochemical characterization and assessing the thermodynamic stability of the optimized nanoemulsion, such as measurements of transmittance, pH, emulsification time, droplet size, polydispersity index, zeta potential, and transmission electron microscopy morphology. Phase III examined the in vitro antimicrobial activity of CLON against Staphylococcus aureus, Escherichia coli, and Candida albicans through agar diffusion assays, determination of minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), and killing-time kinetics. Inhibition zone data were analyzed using analysis of variance, followed by Duncan's multiple range test. The optimized CLON formulation contained 14.29% clove leaf oil, 68.56% Tween 80, and 17.15% PEG 400. The nanoemulsion showed high optical clarity (93.36 ± 0.25%), physiological pH (7.13 ± 0.01), rapid emulsification (35.46 ± 0.08 s), nanoscale droplet size (25.19 ± 2.31 nm), low polydispersity index (0.30 ± 0.04), and strong negative zeta potential (-45.07 ± 8.15 mV), indicating excellent stability. CLON demonstrated significant concentration-dependent antimicrobial activity (p < 0.01) against all tested microorganisms. The MIC and MBC values were 12.5% and 50% (v/v), respectively, indicating bactericidal activity. In the killing-time assay, 25% CLON achieved >3 log 10 colony-forming units/mL reduction within 60 min. The optimized CLON displayed favorable physicochemical properties, strong thermodynamic stability, and broad-spectrum in vitro antimicrobial activity against key bovine mastitis pathogens. These results indicate that CLON has potential as a plant-based alternative teat disinfectant to prevent mastitis. However, further in vivo studies and field trials are needed to verify its safety and practical use in dairy production systems.

Recent botulinum neurotoxin type A (BoNT/A) formulations have shifted towards the use of polysorbate 20 (PS20) and polysorbate 80 (PS80) as a non-human-derived excipient to enhance product stability. Polysorbates are a distinct class of synthetic non-ionic surfactants with high heterogeneity in chemical structure and properties. Accumulating mechanistic and clinical evidence suggests that they may trigger immunological reactions, including hypersensitivity and immunogenicity. Such risks are largely associated with their susceptibility to degradation via hydrolysis and oxidation, forming reactive byproducts that can interact with proteins and immune pathways. Despite these mechanistic insights, data on the association between polysorbate excipients and observed immune outcomes in practice is relatively sparse and excipient-related immunogenicity and hypersensitivity is often underrecognized in practice. This review provides a summary of polysorbate excipients in BoNT/A formulations, focusing on their chemical properties and degradation pathways, characterizing downstream immune effects and appraising available clinical data of polysorbate-containing BoNT/A formulations. Finally, we discuss potential risk mitigation strategies including process modifications that could prevent degradation, and consideration of alternative excipients, such as human serum albumin, that has been shown to be immunologically inert and has an established safety profile. By integrating chemical, mechanistic, and clinical perspectives, this review seeks to clarify the implications of polysorbate use in BoNT/A formulations and inform both clinical practice and future formulation strategies.

Dental caries is a prevalent oral health problem primarily driven by Streptococcus mutans. This study focused on the green synthesis of zinc oxide nanoparticles incorporated with Cymbopogon citratus essential oil (CEOZnONPs) and evaluated their anti-cariogenic efficacy against S. mutans. CEOZnONPs were prepared by dropwise addition of essential oil into zinc acetate solution at 100 °C, pH 7, and 800 rpm with polysorbate 80 as emulsifier. The nanoparticles were characterized by UV-Vis spectroscopy, HR-TEM, zeta potential, XRD, and FTIR. Antibacterial activity was assessed using MIC/MBC, adherence, biofilm inhibition, EPS production, and acidogenesis assays. An in vivo Wistar rat caries model and cytotoxicity assay on HeLa cell lines further validated efficacy and safety. Morphological analysis revealed that CEOZnONPs were predominantly spherical and rod-shaped with an average particle size of 49 nm. Its antibacterial activity demonstrated a MIC of 5 µg/mL and MBC of 10 µg/mL, inhibiting adherence to tooth surfaces (85%-97%), biofilm formation, and EPS production. The antioxidant activity showed DPPH and ABTS radical scavenging of 65.28% and 75.24%, respectively. Acid production by S. mutans was significantly reduced following treatment, with pH shifting from 4.5 to 6.2. These findings were corroborated by an in vivo study, which showed a substantial reduction in S. mutans colonies in Wistar rats over five weeks. Furthermore, the CEOZnONPs (90 µg/mL) were also non-cytotoxic to HeLa cell lines. This study is the first to report the antibacterial and anti-cariogenic efficacy of CEOZnONPs, which introduces a significant therapeutic approach. It is environmentally friendly and highly effective in combating S. mutans and preventing dental caries, opening novel avenues for future oral treatments. This nano-herbal formulation offers a promising, biocompatible alternative to conventional antimicrobials, with the potential to revolutionize caries prevention strategies in clinical dentistry.

Bacterial folliculitis, commonly associated with  Staphylococcus aureus , often stems from trauma to hair follicles, such as during waxing, and can be exacerbated by improper aftercare that triggers inflammation and skin damage. This report describes a 23-year-old man with widespread folliculitis, mainly concentrated in the lower back, with involvement of the arms and entire back, post-waxing, aggravated by alcohol and soap use. He initially experienced high fever, trouble sleeping, discomfort when lying down, and strong itching, with the fever subsiding after a couple of days. He self-medicated with ibuprofen and diphenhydramine for five days without relief, followed by ineffective prescribed treatments with mupirocin and hydrocortisone. Adding oral azithromycin and Tend Skin® solution (isopropyl alcohol, water, propylene glycol, acetylsalicylic acid, cyclomethicone, glycerin, polysorbate 80) brought significant symptom relief, reduced pustule size, and less exudate within days. This case highlights the efficacy of combined systemic and topical therapies for refractory folliculitis and underscores the importance of proper post-waxing care to curb inflammation and skin damage.

The COVID-19 pandemic significantly increased the demand for allergy consultations to evaluate the risk of hypersensitivity reactions in patients either before receiving their first dose of an anti-SARS-CoV-2 vaccine (Group 1) or following suspected allergic reactions after vaccination (Group 2). We conducted a retrospective analysis of patients referred to the Immunology and Allergy Unit of the Azienda Ospedaliera Ordine Mauriziano in Turin, Italy, between December 2020 and December 2022. Risk assessment was performed according to Italian and European guidelines, and allergy skin tests were administered when necessary. Patient data were cross-referenced with the SIRVA platform (Regional Vaccination Management Information System) to assess vaccine eligibility, administration, and outcomes. A total of 1222 patients were evaluated (mean age: 52 years; female-to-male ratio 4:1). In Group 1 (n = 914), 137 patients (15%) underwent skin testing, of whom 15 (1.6%) tested positive. Vaccination was recommended for 899 patients (98%), though 184 (20%) did not proceed. Among those vaccinated, 679 (74%) received additional doses, with 48% receiving a third and 11% a fourth dose. In Group 2 (n = 308), 104 patients (33%) underwent skin testing, with 9 (8%) testing positive. Vaccination without restrictions was recommended for 299 patients (97%), but 45 patients (15%) did not proceed. Among the remaining, 262 (85%) received a second dose, 183 (59%) a third, and 29 (9%) a fourth dose. Overall, 1198 patients (98%) had no specific contraindications to vaccination. Only 5 patients (0.4%) were completely exempted from vaccination due to confirmed sensitivity to both polyethylene glycol (PEG) and polysorbate 80 (PS80). An alternative vaccine was recommended for 19 patients; 16 of them proceeded with vaccination and tolerated it without adverse effects. Our findings demonstrate that the majority of high-risk allergic patients can safely receive anti-SARS-CoV-2 vaccines following allergological evaluation. The rate of confirmed excipient allergy was very low, and vaccine adherence was comparable to the general population. This is, to our knowledge, the first study to longitudinally assess the number and types of vaccine doses administered to high-risk allergic individuals.