Dermatological Products Research Articles

Zinc in Dermatology: Exploring Its Emerging Role in Enhancing Botulinum Toxin Formulations and Clinical Efficacy

This literature review provides a novel exploration of zinc’s multifaceted roles in dermatology, with a particular focus on its potential integration into botulinum toxin formulations—an area that remains relatively underexplored in clinical practice. Zinc is widely recognized for its critical functions in skin health, including morphogenesis, regeneration, and protection, and its use in aesthetic medicine offers a unique opportunity for innovation. Specifically, incorporating zinc into botulinum toxin formulations could enhance the efficacy and stability of these treatments. Although zinc has historically been used in topical dermatological products and systemic health interventions, its potential in cosmetic preparations, such as anti-aging therapies or non-invasive aesthetic treatments, remains under-researched. Emerging patents suggest promising formulations combining zinc with botulinum toxin that may improve product stability and extend therapeutic effects. While current studies on oral zinc supplementation present mixed results concerning its ability to prolong botulinum toxin effects, this underscores the need for more rigorous investigation in the realm of aesthetic medicine. Zinc’s well-established role in stabilizing dermatological products, such as sunscreens, and its applications in wound healing and skin regeneration, further highlights its potential for broader therapeutic uses beyond cosmetic applications. This review identifies a critical gap in the literature and calls for future research to optimize zinc concentrations and delivery methods specifically for aesthetic medical procedures, offering new insights into improving dermatological treatments beyond the scope of traditional cosmetic preparations.

Future challenges of direct-to-consumer genetic testing for sustainable safety in the Republic of Korea's skin care market: a systematic review.

Social distancing due to the pandemic is accelerating the fragmentation of Korean society in the megatrend of continuous individualization after industrialization. In this context, consumers are turning to direct-to-consumer (DTC) genetic testing for tailored skin healthcare strategies. However, there are still concerns about the safety of personal information in DTC genetic testing. The purpose of this review article is to examine the sustainable safety of DTC genetic testing for customized dermatology products, focusing on skin healthcare market after coronavirus disease 2019 (COVID-19). A systematic review approach was used in this study. Using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) flow chart, a total of 920 references were selected from PubMed, Medline, and Scopus. The composition of a total of 59 references from professional papers was finally reviewed. To this end, the most relevant recent literature was added, and the reference period was limited to 2018 to 2023 based on a 6-year period. With the practice of mask wearing since COVID-19, various methods are being used to strengthen the skin's immune system, and maintain and promote skin health. There is a need to have a method to increase the safety of DTC genetic testing for sustainable skin healthcare market. It is concluded that there is a need to continue to develop more sustainable and safer security applications (apps) in the field of customized dermatology cosmetics to address the privacy issues and improve the accuracy of DTC genetic testing.

Opportunities of topical drug products in a changing dermatological landscape

Despite the prevalence and the impact on quality of life of dermatological indications, drug products to treat such conditions have rarely been blockbusters. The prevailing perception of a limited commercial potential of dermatological drug products has restricted innovation and encouraged a more conservative development approach. For example, the focus was on repurposing/reformulation of existing active pharmaceutical ingredients (APIs) specifically for the topical delivery route.However, the situation is quite different today catalyzed in part by the blockbuster success of Dupixent (dupilumab), the first monoclonal antibody treatment for atopic dermatitis which has been approved by the US Food and Drug Administration (US FDA) in 2017. Dupixent's success not only encouraged the development of other biologics but also inspired the (re-)development of new dermal drug products that can reap the many benefits of topical administration.We have also witnessed a shift toward outsourcing development efforts (and associated risks) towards small- to mid-size pharmaceutical companies which often require support of contract research and development/manufacturing organizations (CRO and CDMO). Such trends also emphasize the need of greater expertise in topical formulation design, as well as associated commercial and regulatory considerations.Today, we believe that topical drug products remain not only an essential but also commercially viable class of dermatological therapeutics. In this opinion article, we will address the challenges as well as opportunities of coherent development strategies in the current market environment, formulation innovations of topical drug products and technological advances to facilitate rational topical drug formulation development.

Towards the Use of Lichens as a Source of Bioactive Substances for Topical Applications.

The increasing incidence of dermatological diseases prompts the search for new natural methods of treatments, and lichens, with their special symbiotic structure, are a little-known and promising source of biologically active substances. Seven lichen species, Cladonia unicialis (L.) Weber ex F.H. Wigg. (Cladoniaceae), Evernia prunastri (L.) Ach. (Parmeliaceae), Hypogymnia physodes (L.) Nyl. (Parmaliaceae), Parmelia sulcata (Taylor) (Parmeliaceae), Physcia adscendens (Fr.) H. Olivier (Physciaceae), Pseudoevernia furfuracea (L.) Zopf (Parmeliaceae), and Xanthoria parietina (L.) Th. Fr. (Teloschistaceae), were used in our experiment. We identified different metabolites in the acetone extracts of all the lichen species. Based on the high-performance liquid chromatography analysis, the content of lichen substances in the extracts was evaluated. The impact of the individual lichen-specific reference substances, compared to the lichen extracts, on the viability of keratinocytes (HaCaT cell line) and fibroblasts (BJ cell line) and on the activity of selected skin-related enzymes was investigated. Our results revealed that only emodin anthrone at a concentration of 200 mg/L was cytotoxic to keratinocytes and fibroblasts in both cell viability assays. In turn, the C. uncialis extract was only cytotoxic to keratinocytes when used at the same concentration. The other tested treatments showed a positive effect on cell viability and no cytotoxicity or indeterminate cytotoxicity (shown in only one of the tests). Elastase and collagenase activities were inhibited by most of the lichen extracts. In turn, the individual lichen compounds (with the exception of evernic acid) generally had an undesirable stimulatory effect on hyaluronidase and collagenase activity. In addition, almost all the tested compounds and extracts showed anti-inflammatory activity. This suggests that some lichen compounds hold promise as potential ingredients in dermatological and skincare products, but their safety and efficacy require further study. The high cytotoxicity of emodin anthrone highlights its potential use in the treatment of hyperproliferative skin diseases such as psoriasis.

54694 Analysis of FDA Warning Letters within dermatologic care products

54694 Analysis of FDA Warning Letters within dermatologic care products

Greenhouse gas equivalents and water consumption of product sample packaging in dermatology

Sampling refers to the free supply of small product samples. In this process, the packaging can be disproportionate to the contents leading to raw material consumption and, in the case of poor recyclability, environmental pollution. In this article, calculations regarding the ratio between packaging and product weight for commonly used types of packaging (sachet, tube, jar) of dermatological product samples are presented. The usefulness of sampling is discussed considering environmental and economic criteria. A total of 43 dermatological product samples from different manufacturers were manually weighed and classified. Packaging was disassembled into its structural components. The proportional weights or the weight of the bottle/tube body were calculated with database values for the respective material in terms of greenhouse gas equivalents (CO2eq) and freshwater consumption. Subsequently, atotal sum for the impact of each packaging was formed. Only the material and manufacturing process were considered because there were no valid data available for transport, utilization, and end of life (EoL) impacts. The smallest and lightest product sample (1.24 g) generated ca. 15 g CO2eq and approximately 700 ml of freshwater consumption. The largest and heaviest product sample (37 g) generated 53 g CO2eq and 5.78 l of freshwater consumption. Assuming an annual distribution of 10 million units of the 43product samples examined here, ca. 8000 t of CO2eq are produced by the packaging alone. Additionally, 880,000,000 l of water are used and approximately 2300 t of packaging waste are generated. Sampling shows an unfavorable ratio between CO2eq/water consumption and utility, especially in comparison to larger units of packaging. Millions of product samples are distributed annually in doctor's practices, hospitals and pharmacies, particularly in dermatology. The practice of sampling should be questioned both ecologically and economically.

Comparative Analyses of Bioequivalence Assessment Methods for In Vitro Permeation Test Data.

For topical, dermatological drug products, an in vitro option to determine bioequivalence (BE) between test and reference products is recommended. In particular, in vitro permeation test (IVPT) data analysis uses a reference-scaled approach for two primary endpoints, cumulative penetration amount (AMT) and maximum flux (Jmax), which takes the within donor variability into consideration. In 2022, the Food and Drug Administration (FDA) published a draft IVPT guidance that includes statistical analysis methods for both balanced and unbalanced cases of IVPT study data. This work presents a comprehensive evaluation of various methodologies used to estimate critical parameters essential in assessing BE. Specifically, we investigate the performance of the FDA draft IVPT guidance approach alongside alternative empirical and model-based methods utilizing mixed-effects models. Our analyses include both simulated scenarios and real-world studies. In simulated scenarios, empirical formulas consistently demonstrate robustness in approximating the true model, particularly in effectively addressing treatment-donor interactions. Conversely, the effectiveness of model-based approaches heavily relies on precise model selection, which significantly influences their results. The research emphasizes the importance of accurate model selection in model-based BE assessment methodologies. It sheds light on the advantages of empirical formulas, highlighting their reliability compared to model-based approaches and offers valuable implications for BE assessments. Our findings underscore the significance of robust methodologies and provide essential insights to advance their understanding and application in the assessment of BE, employed in IVPT data analysis.

Role of skin circadian rhythm and the effect of day and night cream: a survey on Indian dermatologists’ and cosmetologists’ views and patient experiences

Background: The skin plays different functions during the day and night to adapt to the changing environments. Various specialized creams are available to meet these skincare needs. The present study was conducted to explore the perspective of Indian dermatologists and cosmetologists on skin’s circadian rhythm and assess the effectiveness of a particular day and night cream formulation. Methods: A non-interventional, questionnaire-based study was conducted as part of a survey series on multiple dermatology products across India. Every month, a product-specific survey link was released to these registered doctors, and each doctor could take up to 10 surveys for a maximum of two products. A total of 379 healthcare professionals (HCPs) took the survey on the day and night cream and reported experiences of 2085 patients regarding the use of these products. Results: The doctors believed that for majority of the patients (1997, 97%), required day and night cream to maintain their skin’s circadian rhythm. Most patients (1440, 70%) were compliant with day and night care cream regimens. Most patients (966, 47%) were highly satisfied with the use of day and night cream, with majority of the patients (1028, 49.4%) experiencing considerable reduction in dark spots and uneven skin tone. Most patients (971, 47%) felt that the application of day and night cream left their skin moisturized and rejuvenated. Conclusions: The use of day and night cream improved skin condition and hydration, addressing circadian rhythm imbalance. Indian HCPs understand the impact of skin circadian rhythm imbalance and promote a comprehensive skincare regimen to patients.

Niacinamide and sea daffodils-based bright healthy radiance product range for dark spots: a survey of Indian dermatologists' views and patient insights

Background: Niacinamide has demonstrated its ability to treat dark spots in various studies. The present study evaluated the perspectives and experiences of healthcare professionals (HCPs) and patients with the niacinamide and sea daffodils-based bright healthy radiance product range for dark spots. Methods: This study was part of a survey series focusing on various dermatology products across India. The study involved over 1000 registered HCPs including dermatologists, pediatricians, and cosmetologists nationwide. A total of 203 HCPs participated in the survey on the niacinamide and sea daffodils-based product range. A well-structured questionnaire with 15 questions was used to collect the data and the responses were recorded by the HCPs. Results: Out of the total of 1086 individuals who participated in the survey, majority were females (774, 71.2%). Most HCPs reported that nearly 15-30% of their patients present with dark spots. A vast majority of individuals reported extreme satisfaction with the use of niacinamide and sea daffodils-based bright healthy radiance product range (493, 45.5%) and rated its effectiveness as excellent (511, 47.2%). HCPs reported that most patients showed major improvement in skin brightness (529, 48.7%), while the rest of them (418, 38.4%; 137, 12.6%) experienced good and satisfactory improvement respectively. Importantly, an even skin tone was achieved in most of the patients (492, 45.8%) after the application of the product range. Conclusions: A personalized approach of using niacinamide and sea daffodil-based products according to the patient's skin types and skin conditions is essential to remove blemishes and dark spots and improve skin brightness.

Physicochemical characterization of the metamorphosis of film-forming formulations of betamethasone-17-valerate

Following topical application of a dermatological product, the loss (by evaporation and/or absorption through the skin) of volatile excipients will alter the composition of the formulation remaining on the tissue. This so-called metamorphosis impacts the concentration of the drug in the residual vehicle, (potentially) its physical form therein and, as a result, its uptake into and subsequent permeation through the skin. This research aimed to characterise – using primarily confocal Raman microspectroscopy – the metamorphosis of film-forming formulations of betamethasone-17-valerate (at different loadings) comprised of hydroxypropyl cellulose (film-forming agent), triethyl citrate (plasticizer) and ethanol (solvent). Dissolved and crystalline drug in the films were identified separately by their different characteristic Raman frequencies (1666 cm−1 and 1659 cm−1, respectively). These Raman measurements, as well as optical imaging, confirmed corticosteroid crystallisation in the residual films left after ethanol evaporation when drug concentration exceeded the saturation limit. In vitro release tests of either sprayed or pipette-deposited films into either aqueous or ethanolic receptor solutions revealed drug release kinetics dominated by the residual film post-metamorphosis. In particular, the rate and extent of drug release depends on the concentration of dissolved drug in the residual film, which is limited by drug saturation unless supersaturation occurs. For the simple films examined here, supersaturation was not detected and the solubility limit of drug in the films was sufficient to sustain drug release at a constant flux from the saturated films through a thin silicone elastomer membrane into an aqueous receptor solution for 30 h. Flux values were ∼ 1 μg cm–2h−1 from saturated residual films independent of the amount of crystallized drug present. Flux from subsaturated films was reduced by an amount that was consistent with the lower degree of saturation.

Enhancing productivity through comprehensive evaluation and contextual analysis: A model for continuous improvement

The main objective of the case study is to measure the productivity of a laboratory dedicated to the development of dermatological products from coconut oil and other natural ingredients, as well as to analyze the influence of the external context on it in order to propose an improvement model that will allow it to improve its competitiveness in the market, strengthen its organizational structure and increase its profitability. This will be done through the application of the PESTEL analysis and the Integral Productivity Evaluation Technique in order to identify areas for improvement. It should be noted that the study is descriptive, with a mixed approach (qualitative and quantitative).

A squalene analog 4,4′-diapophytofluene from coconut leaves having antioxidant and anti-senescence potentialities toward human fibroblasts and keratinocytes

Coconut (Cocos nucifera) leaves, an unutilized resource, enriched with valuable bioactive compounds. Spectral analysis of purified pentane fraction of coconut leaves revealed the presence of a squalene analog named 4,4′-diapophytofluene or in short 4,4′-DPE (C30H46). Pure squalene standard (PSQ) showed cytotoxicity after 8 µg/ml concentration whereas 4,4′-DPE exhibited no cytotoxic effects up to 16 µg/ml concentration. On senescence-induced WI38 cells, 4,4′-DPE displayed better percentage of cell viability (164.5% at 24 h, 159.4% at 48 h and 148% at 72 h) compared to PSQ and BSQ (bio-source squalene) with same time duration. Similar trend of result was found in HaCaT cells. SA-β-gal assay showed that number of β-galactosidase positive cells were significantly decreased in senescent cells (WI38 and HaCaT) after treated with 4,4′-DPE than PSQ, BSQ. Percentage of ROS was increased to 60% in WI38 cells after olaparib treatment. When PSQ, BSQ and 4,4′-DPE were applied separately on these oxidative-stress-induced cells for 48 h, the overall percentage of ROS was decreased to 39.3%, 45.6% and 19.3% respectively. This 4,4′-DPE was found to be more effective in inhibiting senescence by removing ROS as compared to squalene. Therefore, this 4,4′-DPE would be new potent senotherapeutic agent for pharmaceuticals and dermatological products.

A review of the efficacy of popular eye cream ingredients.

Due to the periorbital region's high susceptibility to damage from external factors, along with its tendency to demonstrate early signs of aging, periorbital skin is a common target for antiaging therapy. This review aims to evaluate the efficacy of active ingredients commonly found in eye creams, particularly focusing on their impact on periorbital skin concerns. A comprehensive review of the literature on active ingredients in eye creams, including retinoids, vitamins C and E, peptides, ceramides, hyaluronic acid, caffeine, and niacinamide, was conducted. Clinical studies assessing the efficacy of these ingredients in addressing periorbital concerns were examined. Studies demonstrate the potential of these ingredients to improve various aspects of periorbital skin, including hydration, elasticity, collagen synthesis, and reduction of inflammatory mediators. Ingredients such as retinoids, vitamin C, and caffeine show promise in addressing wrinkles and hyperpigmentation, while peptides and hyaluronic acid aid in collagen production and hydration. Niacinamide and ceramides offer benefits in reducing wrinkles and enhancing the skin barrier function. The lack of clinical trials specifically targeting eye cream formulations and periorbital skin is a notable limitation. Furthermore, the variability in study designs, sample sizes, and concentrations of active ingredients across studies complicates direct comparisons. The reviewed studies highlight the potential of active ingredients in eye creams to address various periorbital concerns. Further research, particularly large-scale clinical trials focusing on eye cream formulations and their efficacy on periorbital skin, is warranted to establish their significance and comparability with other dermatologic products.

Unveiling the mechanisms for the development of rosehip-based dermatological products: an updated review.

Rosa spp., commonly known as rosehips, are wild plants that have traditionally been employed as herbal remedies for the treatment of a wide range of disorders. Rosehip is a storehouse of vitamins, including A, B complex, C, and E. Among phytonutrients, vitamin C is found in the highest amount. As rosehips contain significant levels of vitamin C, they are perfect candidates for the development of skincare formulations that can be effectively used in the treatment of different skin disorders (i.e., scarring, anti-aging, hyperpigmentation, wrinkles, melasma, and atopic dermatitis). This research focuses on the vitamin C content of several Rosa sp. by their botanical and geographic origins, which according to research studies are in the following order: R. rugosa > R. montana > R. canina > R. dumalis, with lower levels in R. villosa and R. arvensis, respectively. Among rosehip species, R. canina is the most extensively studied species which also displays significant amounts of bioactive compounds, but also antioxidant, and antimicrobial activities (e.g., against Propionibacterium acnes, Staphylococcus aureus, S, epidermis, and S. haemolyticus). The investigation also highlights the use of rosehip extracts and oils to minimise the harmful effects of acne, which primarily affects teenagers in terms of their physical appearance (e.g., scarring, hyperpigmentation, imperfections), as well as their moral character (e.g., low self-confidence, bullying). Additionally, for higher vitamin C content from various rosehip species, the traditional (i.e., infusion, maceration, Soxhlet extraction) and contemporary extraction methods (i.e., supercritical fluid extraction, microwave-assisted, ultrasonic-assisted, and enzyme-assisted extractions) are highlighted, finally choosing the best extraction method for increased bioactive compounds, with emphasis on vitamin C content. Consequently, the current research focuses on assessing the potential of rosehip extracts as medicinal agents against various skin conditions, and the use of rosehip concentrations in skincare formulations (such as toner, serum, lotion, and sunscreen). Up-to-date studies have revealed that rosehip extracts are perfect candidates as topical application products in the form of nanoemulsions. Extensive in vivo studies have revealed that rosehip extracts also exhibit specific activities against multiple skin disorders (i.e., wound healing, collagen synthesis, atopic dermatitis, melasma, and anti-aging effects). Overall, with multiple dermatological actions and efficacies, rosehip extracts and oils are promising agents that require a thorough investigation of their functioning processes to enable their safe use in the skincare industry.

Surfactin as an ingredient in cosmetic industry: Benefits and trends.

Surfactin is a natural surfactant almost exclusively produced by Bacillus species with excellent physical-chemical, and biological properties. Among innovative applications, surfactin has been recently used as an ingredient in formulations. The antibacterial and anti-acne activities, as well as the anti-wrinkle, moisturizing, and cleansing features, are some of the reasons this lipopeptide is used in cosmetics. Considering the importance of biosurfactants in the world economy and sustainability, their potential properties for cosmetic and dermatological products, and the importance of patents for technological advancement in a circular bioeconomy system, the present study aims to review all patents involving surfactin as an ingredient in cosmetic formulas. This review was conducted through Espacenet, wherein patents containing the terms "cosmetic" and "surfactin" in their titles, abstracts, or claims were examined. Those patents that detailed a specific surfactin dosage within their formulations were selected for analysis. All patents, irrespective of their publication date, from October 1989 to December 2022, were considered. Additionally, a comprehensive search was performed in the MEDLINE and EMBASE databases, spanning from their inception until the year 2023. This complementary search aimed to enrich the understanding derived from patents, with a specific emphasis on surfactin, encompassing its associated advantages, efficacy, mechanisms of action on the skin, as well as aspects related to sustainability and its merits in cosmetic formulations. From the 105 patents analysed, 75% belong to Japan (54), China (14), and Korea (9). Most of them were submitted by Asian companies such as Showa Denko (15), Kaneka (11) and Kao Corporation (5). The formulations described are mainly emulsions, skincare, cleansing, and haircare, and the surfactin dose does not exceed 5%. Surfactin appears in different types of formulas worldwide and has a high tendency to be used. Surfactin and other biosurfactants are a promising alternative to chemical ingredients in cosmetic formulations, guaranteeing skin health benefits and minimizing the impact on the environment.

Sustainability of Pharmaceutical and Cosmeceutical Products within Dermatology

The extent of packaging materials used in topical dermatological products and the sustainability of these are not well known. It is a known fact, however, that individual dermatology departments prescribe or recommend these dermatological products to patients. This study aims to evaluate current practice in terms of how many dermatological products distributed to patients are recyclable, by assessing whether the topical treatments available within a dermatology department display a Mobius loop or equivalent – thus indicating that a product and its packaging may be recycled. Our results show that a low proportion of the assessed items displays any indication of their recycling potential, therefore adding to unnecessary waste. Raising awareness, promoting sustainability from grassroots levels within dermatology departments and empowering patients to adopt recycling practices enable dermatology as a specialty to encourage pharmaceutical and cosmeceutical companies supplying these products to support ethical recycling values in all medical fields.

Justification of the composition of the base of the emulsion ointment for the fungal diseases skin treatment

The relevance and socio-economic significance of the problem is determined by the prevalence of fungal diseases, which are affected by every fifth inhabitant of the planet (according to the World Health Organization). Among fungal diseases, dermatomycoses, which are complicated by infection and keratization of the skin, are of particular importance.
 In the treatment of dermatomycoses, a significant place belongs to external therapy (soft and liquid medicinal products). Dermatological medicinal products in Ukraine are mainly represented by drugs of foreign production – 58.2%.The range of multicomponent drugs affecting all links of the pathological process is 21%. Therefore, the development of a scientifically based composition and technology of a multicomponent soft medicine for the treatment of dermatomycoses is an urgent problem of our time.
 The goal of our research was to develop the optimal composition of the emulsion ointment base for the treatment of fungal skin diseases.
 The objects of the study were combinations in different ratios of surface-active substances, hydrophilic non-aqueous substances and emulsifiers. The osmotic properties of the experimental bases were studied using dialysis through a semipermeable membrane. The study of the rheological properties of the samples was carried out on a rotary viscometer Reotest-2 (USA) with a water circulation heater. Determination of colloidal stability (for emulsion systems) was carried out according to DSTU 4765:2007 «Cosmetic creams. General technical conditions». Determination of thermal stability was carried out according to DSTU 4765:2007 «Cosmetic creams. General technical conditions».
 Based on the conducted experimental studies, the composition of the base of the emulsion ointment was substantiated. Rheological studies have established the optimal concentration of surface-active substances in emulsions. The study of the osmotic activity of model emulsions made it possible to establish the optimal ratio of hydrophilic-non-aqueous solvents in the composition of model samples.
 On the basis of the conducted structural-mechanical and pharmacological studies, the composition of the emulsion base of the o/w type emulsion ointment was substantiated for treatment of fungal skin lesions: petroleum jelly (20.0 g), emulsifier No. 1 (5.0 g), PEO-400 (5.0 g), glycerin (5.0 g), Na-KMC (1.0 g), purified water up to 100.0 g.

Cutaneous Pharmacokinetics of Topically Applied Novel Dermatological Formulations.

Novel formulations are developed for dermatological applications to address a wide range of patient needs and therapeutic challenges. By pushing the limits of pharmaceutical technology, these formulations strive to provide safer, more effective, and patient-friendly solutions for dermatological concerns, ultimately improving the overall quality of dermatological care. The article explores the different types of novel dermatological formulations, including nanocarriers, transdermal patches, microsponges, and microneedles, and the techniques involved in the cutaneous pharmacokinetics of these innovative formulations. Furthermore, the significance of knowing cutaneous pharmacokinetics and the difficulties faced during pharmacokinetic assessment have been emphasized. The article examines all the methods employed for the pharmacokinetic evaluation of novel dermatological formulations. In addition to a concise overview of earlier techniques, discussions on novel methodologies, including tape stripping, in vitro permeation testing, cutaneous microdialysis, confocal Raman microscopy, and matrix-assisted laser desorption/ionization mass spectrometry have been conducted. Emerging technologies like the use of microfluidic devices for skin absorption studies and computational models for predicting drug pharmacokinetics have also been discussed. This article serves as a valuable resource for researchers, scientists, and pharmaceutical professionals determined to enhance the development and understanding of novel dermatological drug products and the complex dynamics of cutaneous pharmacokinetics.

Update on the advances and challenges in bioequivalence testing methods for complex topical generic products.

Most of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence. The evaluation of bioequivalence for complex topical dermatological formulations is a challenging task that requires careful consideration of several factors. Although comparative clinical studies are still considered the gold standard approach for establishing bioequivalence in most formulations, these studies can be costly and insensitive to detect formulation differences. Therefore, significant efforts have been made to develop and validate alternative approaches that demonstrate bioequivalence and expedite the availability of high-quality generic topical dermatological products. This article reviews the current methods for determining the bioequivalence of topical formulations in humans, with particular emphasis on recent advances in these methodologies. Most of the alternative methods are sensitive and reproducible, with the capability to ease the financial burden of comparative clinical studies within a short delivery time. The limitations associated with each technique are reviewed in detail.

Review on Nanotechnology in Cosmetics and Dermatology

Nanotechnology is a cutting-edge technology that involves the manipulation of atoms and molecules on a microscopic scale. The cosmetic industry was the first to embrace this technology in their product development, and it has since become one of the most widely-used and capable technologies of the 21st century. It is a safe and effective method for creating innovative drug delivery systems. Nanomaterials, which contain active substances, carriers, and aids, are used in the development of haircare, oral care, and dermatological products that aim to enhance the user’s appearance. The cosmetic industry uses various types of nanomaterials, such as nanosomes, fullerenes, liposomes, ectosomes, and solid lipid nanoparticles. Due to the superior qualities of atoms at the nanoscale level, nanotechnology is increasingly being utilized in the fields of cosmetics and dermatology. Overall, nanotechnology is an excellent option for improving the quality of cosmetic products. Its effectiveness and safety have been proven, making it an indispensable tool in modern product development.