Cream Formulation Research Articles

Fractionation of Carlina acaulis L. Root Methanolic Extract as a Promising Path towards New Formulations against Bacillus cereus and Methicillin-Resistant Staphylococcus aureus.

The root of Carlina acaulis L. has been widely used in traditional medicine for its antimicrobial properties. In this study, the fractionation of methanol extract from the root was conducted. Four fractions (A, B, C, and D) were obtained and tested against a range of bacteria and fungi. The results showed promising antibacterial activity, especially against Bacillus cereus, where the minimal inhibitory concentration (MIC) was determined to be equal to 0.08 mg/mL and 0.16 mg/mL for heptane (fraction B) and ethyl acetate (fraction C), respectively. In the case of the methicillin-resistant Staphylococcus aureus (MRSA) ATCC 43300 strain, the same fractions yielded higher MIC values (2.5 and 5.0 mg/mL, respectively). This was accompanied by a lack of apparent cytotoxicity to normal human BJ foreskin fibroblasts, enterocytes derived from CaCo2 cells, and zebrafish embryos. Further analyses revealed the presence of bioactive chlorogenic acids in the fractionated extract, especially in the ethyl acetate fraction (C). These findings support the traditional use of the root from C. acaulis and pave the way for the development of new formulations for treating bacterial infections. This was further evaluated in a proof-of-concept experiment where fraction C was used in the ointment formulation, which maintained high antimicrobial activity against MRSA and displayed low toxicity towards cultured fibroblasts.

Expert opinion on the prescription practice of topical calamine lotion for chronic urticaria and other dermatologic conditions in Indian clinical settings

Background: Calamine is suggested as a potentially effective treatment for skin exudation, itching, and rashes. However, there aren't many thorough analyses of the drug prescription patterns for treating urticaria in the Indian literature. This study aimed to gather expert opinions on the prescription practice of topical calamine lotion for chronic urticaria and other dermatologic conditions in Indian clinical settings. Methods: The cross-sectional questionnaire-based survey, comprising 25 questions, gathered data regarding the prescription practice of topical calamine lotion for the management of chronic urticaria and other dermatological conditions. Results: Of the 467 participants, 62% indicated that they would prescribe topical calamine lotion for pruritus management. About 39% of the participants preferred the cream formulation of the calamine lotion for treating diaper dermatitis in 11-25% of patients. About 76% of the respondents stated that they would recommend an oral antihistamine along with topical calamine lotion to treat chronic urticaria. For the treatment of pruritus, 44% of the participants preferred menthol in addition to calamine. Sixty-eight per cent of the respondents stated that approximately 5% of those with chronic urticaria need to be treated with calamine and tetrahydrocurcumin. Most specialists (69.38%) preferred using calamine lotion on 5-10% of patients with itchy skin conditions during pregnancy. Conclusions: Experts recommend the topical calamine lotion for managing various skin conditions including pruritus and chronic urticaria. Specialists recommended it as a safe option for managing itchy skin conditions during pregnancy.

Histomorphometry of tissue repair after use of formulations based on extracts of Piptadenia gonoacantha (Mart.) J. F. Macbr.

Piptadenia gonoacantha is a tree species with several biological properties. The objective of this study was to evaluate the action of two pharmaceutical formulations, ointment and balm, containing Piptadenia gonoacantha extract, on the healing of wounds made in 45-day-old male mice. The animals were randomly grouped and 3 treatments with 6 repetitions were performed: an ointment containing the extract; balm containing the extract and silver sulfadiazine was used as the positive control. Tissue samples were collected on the 4th and 8th days. Treatment began immediately after the injury, and the treatments were applied once a day throughout the experiment. Treatment with the balm formulations on day 4 and the ointment on day 8 had better wound area regression rates compared to the control group, 45.4% and 81.6%, respectively. The balm and ointment treatments provided a reduction in vascularity indicating a reduction in the inflammatory process, initiating the proliferative phase in the scar tissue. These data were supported by the analysis of collagen synthesis. The results pointed out the efficacy of balm and ointment formulations concerning sulfadiazine. Therefore, the balm formulation is indicated for the beginning of the treatment, while the ointment formulation is indicated for continuation and end of treatment.

Probiotic icecream as a functional food - a review

PurposeGlobally, consumer’s inclination towards functional foods had noticed due to their greater health consciousness coupled with enhanced health-care cost. The fact that probiotics could promote a healthier gut microbiome led projection of probiotic foods as functional foods and had emerged as an important dietary strategy for improved human health. It had established that ice cream was a better carrier for probiotics than fermented milked due to greater stability of probiotics in ice cream matrix. Global demand for ice cream boomed and probiotic ice cream could have been one of the most demanded functional foods. The purpose of this paper was to review the technological aspects and factors affecting probiotic viability and to standardize methodology to produce functional probiotic ice cream.Design/methodology/approachAttempt was made to search the literature (review and researched papers) to identify diverse factors affecting the probiotic viability and major technological challenge faced during formulation of probiotic ice cream. Keywords used for data searched included dairy-based functional foods, ice cream variants, probiotic ice cream, factors affecting probiotic viability and health benefits of probiotic ice cream.FindingsRetention of probiotic viability at a level of >106 cfu/ml is a prerequisite for functional probiotic ice creams. Functional probiotic ice cream could have been produced with the modification of basic mix and modulating technological parameters during processing and freezing. Functionality can be further enhanced with the inclusion of certain nutraceutical components such as prebiotics, antioxidant, phenolic compounds and dietary fibres. Based upon reviewed literature, suggested method for the manufacture of functional probiotic ice cream involved freezing of a probiotic ice cream mix obtained by blending 10% probiotic fermented milk with 90% non-fermented plain ice cream mix for higher probiotic viability. Probiotic ice cream with functional features, comparable with traditional ice cream in terms of technological and sensory properties could be produced and can crop up as a novel functional food.Originality/valueProbiotic ice cream with functional features may attract food manufacturers to cater health-conscious consumers.

A composite gel formed by konjac glucomannan together with Nano-CF obtained by FeCl3-citric acid hydrolysis as a potential fat substitute

This study aims to fabricate composite gels using nano citrus fiber (Nano-CF) derived from the hydrolysis process of citric acid (CA) with FeCl3, with a simultaneous exploration of its potential as an substitute to fats. Investigation of varying FeCl3 concentrations (0.01 to 0.03 mmol/g of CA) revealed a significant enhancement in the water-holding and oil-retention capacity of the Nano-CF. The meticulous synthesis of the composite gels involved integrating nano citrus fibers with konjac glucomannan (KGM) through high-speed shearing, followed by a comprehensive evaluation of its microstructure and physicochemical attributes. Increasing the Nano-CF concentration within the gels led to a synergistic interaction with KGM, resulting in enhanced viscosity, improved thermal stability, and restricted water molecule mobility within the system. The gels initially displayed reduced firmness, resilience, and adhesive characteristics, followed by subsequent improvement. When the ratio of Nano-CF to KGM was 0.5:1, the composite gels exhibited texture parameters, viscosity, and viscoelastic stability comparable to whipped animal cream formulations. These findings provide a new idea for the application of Nano-CF/KGM composite gels in whipped cream.

Mathematical modeling of transdermal delivery of topical drug formulations in a dynamic microfluidic diffusion chamber in health and disease.

Mathematical models of epidermal and dermal transport are essential for optimization and development of products for percutaneous delivery both for local and systemic indication and for evaluation of dermal exposure to chemicals for assessing their toxicity. These models often help directly by providing information on the rate of drug penetration through the skin and thus on the dermal or systemic concentration of drugs which is the base of their pharmacological effect. The simulations are also helpful in analyzing experimental data, reducing the number of experiments and translating the in vitro investigations to an in-vivo setting. In this study skin penetration of topically administered caffeine cream was investigated in a skin-on-a-chip microfluidic diffusion chamber at room temperature and at 32°C. Also the transdermal penetration of caffeine in healthy and diseased conditions was compared in mouse skins from intact, psoriatic and allergic animals. In the last experimental setup dexamethasone, indomethacin, piroxicam and diclofenac were examined as a cream formulation for absorption across the dermal barrier. All the measured data were used for making mathematical simulation in a three-compartmental model. The calculated and measured results showed a good match, which findings indicate that our mathematical model might be applied for prediction of drug delivery through the skin under different circumstances and for various drugs in the novel, miniaturized diffusion chamber.

Developement and Stability Evaluation of Natural Topical Formulations Containing Pinus sibirica Essential Oil

Abstract Pinus sibirica (P. sibirica) is used in folk medicine for centuries in treatment of various diseases due to its anti-inflammatory, antioxidant, and antimicrobial activity. The present study was focused on formulating semi-solid topical cream and gel preparations with P. sibirica essential oil (EOPS) and on evaluation of their stability during three months of storage. After preparation of semi-solid formulations (cream and gel), we followed parameters such as organoleptic characteristics, pH values, electrical conductivity, phase separation, washability, swelling index and microbiological contamination. Tests for physical and microbiological stability were performed considering different storage conditions at temperature (4±2° C, 25±2°C and 40±2°C) for 12 weeks. All test were performed at sampling time points of 7th, 30th, 60th, 90th day after storage. Cream with EOPS was white colour, it is homogenous with pleasant odor characteristic to used EOPS while gel with EOPS was transparent, it is homogenous with specific odor. After application to skin, EOPS cream was leaving non-greasy film while gel with EOPS was leaving sticky film and cooling effect. In all tested samples, we observed no phase separation and pH values were optimal for skin application. During three months of storage at different conditions, all tested formulations were stable and addition of EOPS did not cause any changes in followed parameters. Both cream and gel formulation remained stable since we did not notice any significant changes in all followed parameters during storage at different temperatures. Addition of 0.5% of EOPS did not change visual, sensory and microbial properties of formulations.

Evaluation of the effectiveness and safety of interferon alpha-2b ointment and gel for prevention of acute respiratory infections in organized groups

Relevance: the annual incidence of acute respiratory infections (ARI) is in the lead in the structure of infectious pathology in the Russian Federation. One of the main issues is the development of optimal strategies for prevention of these diseases in high-risk groups.Aim: to evaluate the preventive and clinical efficacy as well as safety of various dosage forms of interferon alpha-2b in relation to ARI in young adults from organized groups.Materials and methods: our study included 300 volunteers aged 18 to 20 years, 100 of them were prescribed interferon alpha-2b in the form of a gel in addition to non-specific methods for the prevention of ARVI, 100 participants received interferon alpha-2b in the form of an ointment, 100 participants did not receive antiviral drugs.Results: the use of interferon alpha-2b ointment for prevention of ARI in organized groups significantly reduced the number of people who had ARVI and cases of ARI during the observation period. Among those who used interferon alpha2b no pneumonias occurred, the duration of hospitalization was statistically significantly reduced compared to the group of volunteers who used only non-specific prophylaxis methods. Participants who received interferon alpha-2b ointment had ARVI mainly in a mild form. No adverse events that could be associated with the use of the study drug were recorded during the observation period.Conclusion: the use of interferon alpha-2b in the form of ointment showed preventive and clinical efficacy against ARI in young adults from organized groups.

In vitro and split-faced placebo-controlled in vivo study on the skin rejuvenating effects of cream loaded with bioactive extract of Indigofera argentea Burm.f.

The bioactive extracts of traditional medicinal plants are rich in polyphenols and help to rejuvenate skin. The study was designed to assess the skin rejuvenating effects of a stable cream enriched with 4% I. argentea (IaMe) extract. The quantity of polyphenols by spectrophotometric methods was TPC, 101.55 ± 0.03mg GAE/g and total flavonoid content; 77.14 ± 0.13mg QE/g, while HPLC-PDA revealed gallic acid; 4.91, chlorogenic acid 48.12, p-coumaric acid 0.43, and rutin 14.23μg/g. The significant results of biological activities were observed as DPPH; 81.81% ± 0.05%, tyrosinase; 72% ± 0.23% compared to ascorbic acid (92.43% ± 0.03%), and kojic acid (78.80% ± 0.19%) respectively. Moreover, the promising sun protection effects Sun protection factor of extract (20.53) and formulation (10.59) were observed. The active cream formulation (w/o emulsion) was developed with liquid paraffin, beeswax, IaMe extract, and ABIL EM 90, which was stable for 90 days as shown by various stability parameters. The rheological results demonstrated the active formulation's non-Newtonian and pseudo-plastic characteristics and nearly spherical globules by SEM. The IaMe loaded cream was further investigated on human trial subjects for skin rejuvenating effects and visualized in 3D skin images. Herein, the results were significant compared to placebo. IaMe formulation causes a substantial drop in skin melanin from -1.70% (2 weeks) to -10.8% (12 weeks). Furthermore, it showed a significant increase in skin moisture and elasticity index from 7.7% to 39.15% and 2%-30%, respectively. According to the findings, Indigofera argentea extract has promising bioactivities and skin rejuvenating properties, rationalizing the traditional use and encouraging its exploitation for effective and economical cosmeceuticals.

Formulation Development of Haritaki Cream by Using 2 (square ) Factorial Design

Creams, in general, are versatile skincare formulations that provide a balance of water and oil to deliver hydration and nutrients to the skin. Eye creams are a category of skincare products specifically designed for the sensitive and delicate skin around the eyes. The skin in this area is thinner and more prone to issues such as fine lines, wrinkles, puffiness, and dark circles. Eye creams are formulated to be lightweight and easily absorbed, and they typically contain ingredients tailored to address these specific concerns. Common ingredients in eye creams include hydrating agents, anti-aging compounds, brightening ingredients, and sometimes caffeine or other ingredients to reduce puffiness. From the developed formulation of haritaki cream we concluded that it can be used for dark circle. It contains various other excipients like potato starch, alovera, methyl and propyl paraben etc. it does not only reduce dark circles but also glows skin and reduces skin damage. As it causes no irritation it is better than allopathic cream. As it had passed all the evaluation parameters like pH, washability, phase separation, irritations, edema, spread ability etc.

Deferoxamine topical cream superior to patch in rescuing radiation-induced fibrosis of unwounded and wounded skin.

Topical patch delivery of deferoxamine (DFO) has been studied as a treatment for this fibrotic transformation in irradiated tissue. Efficacy of a novel cream formulation of DFO was studied as a RIF therapeutic in unwounded and excisionally wounded irradiated skin. C57BL/6J mice underwent 30 Gy of radiation to the dorsum followed by 4 weeks of recovery. In a first experiment, mice were separated into six conditions: DFO 50 mg cream (D50), DFO 100 mg cream (D100), soluble DFO injections (DI), DFO 1 mg patch (DP), control cream (Vehicle), and irradiated untreated skin (IR). In a second experiment, excisional wounds were created on the irradiated dorsum of mice and then divided into four treatment groups: DFO 100 mg Cream (W-D100), DFO 1 mg patch (W-DP), control cream (W-Vehicle), and irradiated untreated wounds (W-IR). Laser Doppler perfusion scans, biomechanical testing, and histological analysis were performed. In irradiated skin, D100 improved perfusion compared to D50 or DP. Both D100 and DP enhanced dermal characteristics, including thickness, collagen density and 8-isoprostane staining compared to untreated irradiated skin. D100 outperformed DP in CD31 staining, indicating higher vascular density. Extracellular matrix features of D100 and DP resembled normal skin more closely than DI or control. In radiated excisional wounds, D100 facilitated faster wound healing and increased perfusion compared to DP. The 100 mg DFO cream formulation rescued RIF of unwounded irradiated skin and improved excisional wound healing in murine skin relative to patch delivery of DFO.

Prospects of quercetin’s using as an active ingredient of soft medicinal forms for the treatment of burns wound (literature review)

The problem of treatment of burn wounds in Ukraine and in the world was shown. Every year in Ukraine more than 20,000 adults and 10,000 children need inpatient treatment for burn wounds. The frequency of burn injuries in the developed countries of the world reaches one per 1 thousand population. In the USA about 200,000 people get burns every year, half of them require hospitalization. In Great Britain, about 250,000 people receive care every year, of which 175,000 people sought emergency inpatient care. One of the means of conservative treatment of burn wounds is soft medicinal forms in the form of ointments, creams, gels, balms, etc. with wound-healing, antiseptic and/or antimicrobial properties. Analysis of the nomenclature of soft medicinal forms for the treatment of burn wounds, which are using in Ukraine, shows that none of them contain quercetin. Significant interest of researchers in the study of the local wound-healing effect of quercetin and its mechanisms has been demonstrated. Demonstrated the flavonoid quercetin is found in many plants and has proven broad pharmacodynamics due to the peculiarities of the molecular structure. The quercetin molecule contains a phenolic group and double bonds that bind free radicals, transition metal ions, which affects the processes of oxidation and phosphorylation. Thanks to this, quercetin exhibits powerful antioxidant, membrane stabilizing and cytoprotective effects, which play a significant role in the mechanism of antioxidant, anti-inflammatory, antiallergic, antimicrobial and reparative action. This provides a significant wound-healing activity of quercetin in the local treatment of the wound process due to atopic dermatitis, eczema, cold and thermal burns. The conducted analysis and generalization substantiate the relevance, expediency and timeliness of the search and creation of new soft forms of medicines containing quercetin for the treatment of burn wounds. Keywords: flavonoid quercetin, ointments and gels, wound-healing effect, antioxidant and cytoprotective activity.

Formulation and Antibacterial Activity Test of Cream containing Cassia alata Leaves Extract against Propionibacterium acnes and Staphylococcus epidermidis

Formulation and Antibacterial Activity Test of Cream containing Cassia alata Leaves Extract against Propionibacterium acnes and Staphylococcus epidermidis

The Quality by design Approach for Analytical Method Development and Validation of the RP-HPLC Method for Estimation of Quercetin in Pure, Marketed, and Cream Formulation

ABSTRACT: A simple, precise reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the flavonoid quercetin, isolated from Tridax procumbens L. The method was validated by using Phenomenex C18 (250 x 4.6mm i.d) Column. A simple, cost effective mobile phase consisting of (ACN and 10 m/moL Phosphate buffer as mobile phase in proportion of 50:50 v/v ) pH 3, 1.0 ml/min Flow rate at 370nm by using UV Visible detector. The retention time of Quercetin was found to be 3.392 minutes. The Quercetin linearity range was found to be 05 to 25 μg/mL. The accuracy and precision of commercially available preparations and in-house cream formulations were investigated using a one-way ANNOVA test. The Percentage recovery of both formulations was found to be 99.83%, 99.88%, 99.82% and 98.92%, 98.18%, 98.86%. Robustness of analytical method was studied by using 2/3 full factorial design by using Design expert software. The Percentage assay and % RSD of marketed capsule and in house cream was found to be 98.38 %, 97.40% and 0.05273, 0.02053 respectively. The Limit of Quantitation and Limit of detection were found to be 0.9053μg/mL and 2.5435μg/mL respectively. The development method of quercetin is simple, accurate, precise, sensitive, and robust

Determination of consistency in pH of some commercial herbal formulations in Ghana

IntroductionThere are no strict pH standards for herbal formulations; however, pH can affect the characteristics of drugs and herbal formulations. In this study, the pHs of different herbal formulations produced in the past two batch years at the Centre for Plant Medicine Research (Mampong-Akuapem, Ghana) were analysed. We aimed to evaluate pH consistency among the formulations and suggest suitable pH ranges for the different product classes. MethodsThe formulations analysed were 17 decoctions, three ointments, and nine powders. Suitable ointment and powder samples were prepared before pH was measured, whereas decoctions were analysed directly. ResultsWe found that 93.1% of the preparations had average pH < 7 over the two years. The pH values for the decoctions, ointments, and powders were 3.507−6.755, 5.153−5.700, and 5.413−10.719, respectively. Differences in pH over the two production years were not statistically significant for all the powder and ointment formulations as well as for majority of the decoctions (82.4%). This indicates pH consistency for approximately 90% of the products, possibly pointing to consistencies in plant material compositions, formulation conditions, and process parameters. ConclusionsFrom our data and reported literature, we recommend that the labels of oral herbal preparations with pH < 5.5 should include an instruction to dilute the product before intake, or to drink water or rinse the mouth after intake to prevent enamel erosion. Decoctions may also be taken after food. Additionally, pH ranges of 4.6−7.0 and 4.0−6.0 may be suitable for rectal and topical herbal formulations, respectively.

Sustainable Alternatives to Petroleum-Derived Excipients in Pharmaceutical Oil-in-Water Creams.

Recently, vast efforts towards sustainability have been made in the pharmaceutical industry. In conventional oil-in-water (O/W) cream formulations, various petroleum-based excipients, namely mineral oil and petrolatum, are commonly used. Natural or synthetic excipients, derived from vegetable sources, were explored as alternatives to petroleum-based excipients in prototype topical creams, with 1% (w/w) lidocaine. A conventional cream comprised of petroleum-derived excipients was compared to creams containing sustainable excipients in terms of key quality and performance attributes, physicochemical properties, and formulation performance. The petrolatum-based control formulation had the highest viscosity of 248.0 Pa·s, a melting point of 42.7°C, a low separation index at 25°C of 0.031, and an IVRT flux of 52.9 µg/cm2/h. Formulation SUS-4 was the least viscous formulation at 86.9 Pa·s, hadthe lowest melting point of 33.6°C, the highest separation index of 0.120, and the highest IVRT flux of 139.4 µg/cm2/h. Alternatively, SUS-5 had a higher viscosity of 131.3 Pa·s, a melting point of 43.6°C, a low separation index of 0.046, and the lowest IVRT flux of 25.2 µg/cm2/h. The cumulative drug permeation after 12 h from SUS-4, SUS-5, and the control were 126.2 µg/cm2, 113.8 µg/cm2, and 108.1 µg/cm2, respectively. The composition of the oil-in-water creams had influence on physicochemical properties and drug release; however, skin permeation was not impacted. Sustainable natural or synthetic excipients in topical cream formulations were found to be suitable alternatives to petroleum-based excipients with comparable key quality attributes and performance attributes and should be considered during formulation development.

In vitro studies into establishing therapeutic bioequivalence of complex topical products: Weight of evidence

Over the past decade, topically applied drug products have experienced extraordinary price increases, due to the shortage of multisource generic drug products. This occurrence is mainly related to the underlying challenges evolved in topical bioequivalence documentation. Although there has been continuing regulatory efforts to present surrogate in vitro methods to clinical endpoint studies, there is still a continued need for cost- and time-efficient alternatives that account for product specificities. Hence, this work intended to expose bioequivalence assessment issues for complex topical formulations, and more specifically those related with product efficacy guidance. As a model drug and product, a bifonazole 10 mg/g cream formulation was selected and two different batches of the commercially available Reference Product (RP) were used: RP1 that displayed lower viscosity and RP4 which presented high, but not the highest, viscosity. In vitro human skin permeation testing (IVPT) was carried out and the results were evaluated by means of the traditional bioequivalence assessment approach proposed by the EMA, as well as by the Scaled Average Bioequivalence assessment approach proposed by the FDA. Based on previous experience, there was an expectation of a high level of variability in the results, thus alternative methods to evaluate local drug skin availability were developed. More specifically, an infected skin disease model, where ex vivo human skin was infected and ATP levels were used as a biological marker for monitoring antifungal activity after product application. The results showed that permeation equivalence could not be supported between the different RP batches. In contrast, this statistical difference between the formulation batches was not indicated in the disease model. Nevertheless, in pivotal IVPT studies, the lowest permeant formulation (RP4) evidenced a higher antifungal in vitro activity as reported by the lower levels of ATP. A critical appraisal of the results is likewise presented, focusing on an outlook of the real applicability of the regulatory guidances on this subject.

Formulation, physical characterization, and antibacterial activity of modifications of Bawang Dayak Eleutherine bulbosa (Mill.) Urb. anti-acne cream

IntroductionSeveral studies have reported the ability of Bawang Dayak cream to inhibit Cutibacterium acnes, but the lack of specific formulations has led to its ineffectiveness. This is indicated by a smaller inhibition zone and the predominant scent of the plant. Therefore, this study aims to assess the physical characteristics and antibacterial activity of two modified formulations of Bawang Dayak anti-acne cream. MethodsTwo modified formulations of Bawang Dayak anti-acne cream were prepared, namely M1 (containing peppermint water) and M2 (comprising peppermint water, cinnamon extract, and honey). Each formulation had four concentrations: 5% (F1), 10% (F2), 15% (F3), and 20% (F4). The physical characteristics were then examined. The antibacterial activity test was carried out using the disc-diffusion method against acne-causing bacteria. ResultsThe addition of peppermint water to the cream formula masked the odour of Bawang Dayak. All the formulas examined met the requirements of the homogeneity, pH, and spreadability tests. However, the adhesion test showed that only F2 and F4 of M2 met the requirement. The results also showed that M1 had better antibacterial activity compared to M2. ConclusionsThis study found that all the formulas observed passed the homogeneity, pH, and spreadability tests. Only F2 and F4 of M2 met the requirements of the adhesion tests. M1 exhibited superior antibacterial activity compared to the M2. F1 of M1 showed the highest antibacterial activity against Staphylococcus epidermidis. Further investigation was needed to evaluate the effectiveness of M2 against S. epidermidis and Staphylococcus aureus, as well as assess the stability.

Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation.

Medical devices (MDs) have a long history of use, and come with regulatory frameworks to ensure user safety. Although topically applied MDs in the form of gels and creams might be used on damaged skin, their composition is often similar to that of cosmetic products applicable to intact skin, especially in terms of preservatives and fragrances. However, unlike cosmetics, these products are not subject to compound-specific restrictions when used in MDs. This study aimed to identify and quantify preservatives and fragrances in topically applied MDs and assess their safety towards the Cosmetic Regulation (EC) 1223/2009. Sixty-nine MDs available on the EU market were subjected to previously validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) methods to identify and quantify occurring preservatives and fragrances. Findings revealed that 32% of the examined MDs did not provide comprehensive ingredient lists, leaving users uninformed about potential risks associated with product use. Furthermore, 30% of these MDs would not meet safety standards for cosmetic products and, most significantly, 13% of the analysed samples contained ingredients that are prohibited in leave-on cosmetics. Results highlight the pressing demand for more stringent requirements regarding the labelling and composition of MDs to enhance patient safety. Improved regulation and transparency can mitigate potential risks associated with the use of topically applied MDs.

Zeofilters for potentially innovative sunscreen products: formulation, stability and spectroscopic studies

Exposure to both UVA and UVB radiation from the sun stands as the primary cause of skin cancers, contributing to the escalating yearly count of diagnosed cases. Sunscreen products, (i.e. organic and inorganic UV filters) have become ubiquitous in personal-care products, packaging, plastics, dyes, and many other sectors. Ideal UV filters should be photostable and dissipate the absorbed energy efficiently. However, most organic UV filters are photolabile upon protracted UV exposure, leading to the formation of photoproducts of unknown toxicity for human health and environment. The chemical environment surrounding UV filters may strongly affect their behaviour: the interaction with other components of sunscreen formulations may enhance their degradation. Particularly, the interaction between photochemically incompatible ingredients must be avoided. Therefore, much effort has been invested in developing more effective and safe sunscreens.Our team recently focused on the preparation and characterization of hybrid UVfs obtained by the encapsulation of organic UV filters into various zeolites differing for topology. The zeolite most efficient for the encapsulation of organic UV filters, in term of stability and efficiency in radiation filtration, resulted to be LTL zeolite. Here, hybrid materials realized after the encapsulation of octinoxate (OMC) and avobenzone (AVO) in LTL zeolite were tested in terms of skin permeation profiles, cytotoxicity and photostability once the materials are dispersed in cream formulations, so to mimicking the real condition of use.The results show that the hybrids were successfully incorporated into oil-in-water emulsions and the skin permeation tests displayed a very low UV filter permeation through pig skin and no UV filter accumulation in dermis layer.The photostability of the hybrid-based emulsions were compared with that of emulsions containing a mixture of bare OMC and AVO, highlighting a reduced decrease in UV screening efficiency upon irradiation for the samples containing the hybrid materials with respect to the free filters. This evidence confirms that the encapsulation in the zeolite frameworks prevents some of the photodegradation reactions. The result of this paper highlights that zeolite encapsulation is increasingly establishing as a viable way to stabilize UV filters and other photoactive molecules.