Preliminary Evaluation of Stability Data for Dolutegravir-Containing Triple Active Formulations Intended for PEPFAR. Degradation of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide as the Limiting Factor.

FDA reviews applications that are filed under the PEPFAR program to ensure that these products are manufactured to FDA's stringent requirements. Dolutegravir is a comparatively recent molecular entity that represents an advance over previous products. The stability behaviors of tablets that contain dolutegravir, lamivudine, and tenofovir disoproxil fumarate and tablets that contain dolutegravir, emtricitabine and tenofovir alafenamide were surveyed and it was found that tenofovir-related degradants increase the most and are the parameters most likely to result in product failure. A desiccant is advantageous and this desiccant should remain in the bottle after it has been opened. In-use studies simulate consumer use. Bottles are stored at 30 °C/75% RH and opened for about 1 min a day. Water content increased significantly and the rate of degradation was faster than the degradation rate observed during long-term storage. The data predict that most formulations containing TDF will stay within specification over 4 years of long-term storage followed by dispensing one tablet per day. With the current data it appears that some TAF-containing formulations may fail under similar conditions. However, the data are limited and preliminary and it is possible that the situation may improve as more stability data are acquired.

The influence of hypothermia prevention by application of skin moisture absorbent on the value of body temperature, body weight and blood parameters in piglets / A influência da prevenção da hipotermia pela aplicação de absorvente de umidade da pele no valor da temperatura corporal, peso corporal e parâmetros sanguíneos em leitões

Reducing the mortality rate is of a great economic importance for pig farming. Therefore, it is necessary to define the conditions in the farrowing unit based on the performance of the piglets, and specific hematological and biochemical parameters. Therefore, the aim of this paper is to examine the importance of using skin moisture absorbent and its influence in preventing hypothermia, which causes great economic losses in pig production. The experiment was set up on a commercial farm in Serbia and included 92 pigs divided into the experimental and control group. Body temperature values, body weight and blood parameters were monitored. The obtained values indicate that there is a significantly positive correlation of body temperature change and body weight values, and body temperature showed a significantly higher increase in the experimental group compared to the control group. The results obtained from hematological and biochemical parameters provide a clearer picture of the metabolic processes in piglets in the farrowing unit and can be used to further improve pig production and as a complement to genetic enhancement.(AU)

A redução da taxa de mortalidade é de grande importância econômica para a suinocultura. Portanto, é necessário definir as condições na unidade de parto com base no desempenho dos leitões, para serem parâmetros hematológicos e bioquímicos específicos. Portanto, o objetivo deste trabalho é examinar a importância do uso de absorvente de umidade na pele e sua influência na prevenção da hipotermia, que causa grandes perdas econômicas na produção de suínos. A experiência foi montada em uma fazenda comercial na Sérvia, e incluiu 92 porcos divididos no grupo experimental e de controle. Os valores de temperatura corporal, pesos corporais e parâmetros sanguíneos foram monitorados. Os valores obtidos indicam que existe uma correlação significativamente positiva entre os valores da temperatura corporal e dos pesos corporais, e a temperatura corporal mostrou um aumento significativamente maior no grupo experimental em comparação com o grupo de controle. Os resultados obtidos a partir de parâmetros hematológicos e bioquímicos fornecem uma imagem mais clara dos processos metabólicos em leitões na unidade de parto e podem ser usados para melhorar ainda mais a produção de suínos e como um complemento ao melhoramento genético.(AU)

Contact Dermatitis from Hand Hygiene Practices in the COVID-19 Pandemic.

Coronavirus disease 2019 (COVID-19) pandemic continues to spread globally at a staggering speed. At present, there is no effective treatment or vaccine for COVID-19. Hand disinfection is a cost-effective way to prevent its transmission. According to the Centres for Disease Control and Prevention (CDC) guidelines, we should wash our hands with soap and water for at least 20 seconds. If soap and water are not readily available, alcohol-based hand rubs (ABHRs) with at least 60% alcohol are the alternative. With diligent hand disinfection reinforced during COVID-19, there is an increased prevalence of contact dermatitis. This commentary highlights the fact that contact dermatitis is a readily treatable condition and should not cause any deviation of proper hand hygiene. In irritant contact dermatitis (ICD), the management strategies are selection of less irritating hand hygiene products, frequent use of moisturisers to rebuild the skin barrier, and education on proper hand hygiene practices. In allergic contact dermatitis (ACD), the identification and avoidance of the contact allergen is the key to treatment. However, ACD is less common and only accounts for 20% of the cases. The identified allergens in hand cleansers are predominantly preservative excipients and ACD attributable to ABHR are very uncommon. Alcohol-free hand rubs are widely available on the market but it is not a recommended alternative to ABHRs by the CDC.

A cream containing omega-3-fatty acids, humectants and emollients as an aid in the treatment of equine Culicoides hypersensitivity.

BACKGROUND: Topical application of polyunsaturated fatty acids (PUFAs) has shown satisfactory results in dogs and humans with allergic skin diseases. Urea and glycolic acid act as keratolytics and moisturizers. Culicoides hypersensitivity is the most common equine hypersensitivity disorder and only limited treatment options exist. OBJECTIVES: To evaluate the effect of a cream containing topical PUFAs, humectants and emollients on clinical signs of equine Culicoides hypersensitivity. ANIMALS: Privately owned horses (n = 28) with clinical signs of Culicoides hypersensitivity. METHODS AND MATERIALS: For a period of four weeks, one half of the horse's body (left or right) was treated with a cream containing concentrated fish oil and several moisturizing and emollient ingredients in a randomized, single-blinded fashion to evaluate the influence of the treatment on skin lesions. In the subsequent four weeks, the lesional areas of the entire body were treated to assess the treatment effect on pruritus. Additionally, the quality of the hair coat, an overall assessment and adverse effects were recorded. RESULTS: Twenty-one horses completed the study. Skin lesions on the treated side improved significantly between days 0 and 28 (P < 0.0001) in comparison to the untreated side. Neither pruritus scores nor coat quality improved significantly between days 0 and 56. Overall condition improved during the study. Five horses showed adverse effects. CONCLUSIONS AND CLINICAL IMPORTANCE: The cream improved Culicoides-induced skin lesions in affected horses, but anti-pruritic effects were less prominent.

The effects of a desiccant agent in the treatment of chronic periodontitis: a randomized, controlled clinical trial.

OBJECTIVE: Chemotherapeutic agents have been widely used as adjuncts for the treatment of chronic periodontitis (CP). This study investigated and compared a desiccant agent as an adjunct to scaling and root planing (SRP) versus SRP alone for the treatment of CP. MATERIALS AND METHODS: Thirty-six patients with CP were studied. Using a split-mouth design, the maxillary right and left quadrants were randomly assigned to SRP plus desiccant (Hybenx® EPIEN Medical, Inc. St. Paul, MN, USA) or SRP alone. Patients were examined on a regular basis for clinical, microbiological, and inflammatory mediator changes over a 1-year period. Clinical attachment level (CAL) was the primary outcome variable. In addition, the red complex bacteria and gingival crevicular fluid (GCF) inflammatory mediators were monitored. RESULTS: Compared to baseline, both treatments demonstrated an improvement in periodontal parameters. Compared to SRP alone, SRP plus desiccant yielded a significant improvement in probing depth (PD) (SRP: 2.23 ± 0.31 mm vs. desiccant: 3.25 ± 0.57 mm, p < 0.05), CAL (SRP: 3.16 ± 0.29 mm vs. desiccant: 4.21 ± 0.34 mm, p < 0.05 mm) and bleeding on probing (BOP) (SRP: 4.56 ± 1.5% vs. desiccant: 34.23 ± 4.2%, p < 0.001) at 12 months. Similarly, in the SRP plus desiccant group, the bacteria of the red complex were significantly reduced (p < 0.05); and the level of inflammatory mediators was significantly reduced (p < 0.003) compared to SRP alone. CONCLUSIONS: SRP plus the desiccant resulted in a greater reduction in clinical, microbial and inflammatory mediators compared to SRP alone. CLINICAL RELEVANCE: Desiccant, when combined to SRP, was demonstrated as a significant approach to control the levels of certain periodontal pathogens, inflammatory mediators in patients with CP.

The Role of Moisturizers in Addressing Various Kinds of Dermatitis: A Review.

Moisturizer is a major component of basic daily skin care, particularly in presence of epidermal barrier alteration and reduced epidermal water content. It is an important part of a dermatologist's strategy to maintain skin health as well as treating various dermatoses which co-exist with skin dryness and are linked to impaired skin barrier function, such as in atopic disorders as well as other types of dermatitis. Mastering the knowledge regarding mechanism of action, application, dosage, adverse effects as well as specific clinical usage of moisturizers is a must for a dermatologist in order to support their use, particularly for evidence-based, therapeutic purposes. This review discusses the use of moisturizer both for skin health maintenance as well as a definitive or adjuvant therapy for many kinds of dermatitis.

Clinical impact in the real life of guidelines recommendations for atopic dermatitis in a tropical population (TECCEMA cohort).

BACKGROUND: Real-life impact of guidelines for the management of atopic dermatitis has been poorly studied. OBJECTIVE: To assess atopic dermatitis clinical control in residents of a tropical area managed according to international consensuses. METHODS: Prospective study with a 24-month follow-up. Clinical response was assessed with SCORAD, DLQI and a subjective scale (SS) on severity perception by the patient. RESULTS: Two-hundred and thirty-three patients were stratified according to SCORAD: 53 had mild severity (22%), 116 moderate (49%) and 64 severe (27%). Baseline SCORAD mean was 33 (15-41), for DLQI, it was 14 (11-20), and for the subjective scale, 85% (67-99). At 6 months, there was significant reduction (p < 0.5): SCORAD 29 (14-41), DLQI 12 (8-16) and subjective scale 62% (45-80). At 2 years, SCORAD was 21 (9-34), DLQI 7 (4-10) and subjective scale 41% (27-56); only 33% achieved complete control (SCORAD < 15%, DLQI < 5, subjective scale < 20%). CONCLUSIONS: Following international guidelines' recommendations reduces eczema severity and improves quality of life, although only 33% achieved complete control after 2 years.

Antecedentes: Se ha estudiado poco el impacto en la vida real de las guías de manejo de la dermatitis atópica. Objetivo: Evaluar el control clínico de la dermatitis atópica en residentes de un área tropical manejados conforme a los consensos internacionales. Métodos: Estudio prospectivo con seguimiento por 24 meses. La respuesta clínica fue evaluada mediante SCORAD, DLQI y una escala subjetiva (SS) de la percepción de severidad del paciente. Resultados: 233 pacientes fueron estratificados conforme el SCORAD: gravedad leve 53 (22 %), moderada 116 (49 %) y severa 64 (27 %). La media inicial del SCORAD fue de 33 (15-41), del DLQI de 14 (11-20) y de la escala subjetiva de 85 % (67-99). A los 6 meses existió reducción significativa (p < 0.5): SCORAD 29 (14-41), DLQI 12 (8-16) y escala subjetiva 62 % (45-80). A los 2 años, SCORAD (21, 9-34), DLQI (7, 4-10) y escala subjetiva (41 %, 27-56); solo 33 % consiguió control completo (SCORAD < 15 %, DLQI < 5, escala subjetiva < 20 %). Conclusiones: El apego a las guías internacionales reduce la gravedad del eccema y mejora de forma importante la calidad de vida de los pacientes con dermatitis. Sin embargo, solo 33 % de los pacientes alcanza un control completo a los 2 años de seguir las recomendaciones.

Assessment of a Comprehensive Anti-Aging Neck Cream.

INTRODUCTION: With many effective anti-aging solutions for the face, consumer focus is now turning to other parts of the body including the delicate skin on the neck. This study investigates the effect of a new neck cream on the appearance of texture, fine lines and wrinkles, laxity, and hydration. METHODS: 85 adult females ages 35-65 with Fitzpatrick skin types I through IV applied the test neck cream twice daily for a 3-month study period. Screening was conducted at Baseline, 2, 30, 60, and 90 days via a virtual trial. Subjects rated satisfaction in each of 4 anti-aging categories including hydration, texture, appearance of wrinkles, and appearance of laxity as well as three product attributes including application, feel, and smell. RESULTS: Improvement was statistically significant for all measured categories (hydration, texture, appearance of wrinkles, and appearance of laxity) with 94% of study subjects noting improvement in one or more of the measured categories. Further, the quantity of "Satisfied" and "Highly Satisfied" assessments increased 8-fold from baseline with a 94x increase in the quantity of "Highly Satisfied" assessments. DISCUSSION: The results demonstrate the product's rapid and continuing ability to improve the self-perceived signs of aging in the neck area including improvement in skin texture on the neck and a reduction in the appearance of wrinkles and laxity along the jawline. Future studies are recommended to determine the primary action mechanisms and to assess the degree of improvement by blinded physician assessment.

[Toothpastes: ingredients, brands, categories and their utilization].

Toothpaste is one of the most widely used dental products, with the largest sales. Its use is one of the most popular oral hygiene behaviors in developed countries. In the last 30 years there has been a large variety of changes in toothpaste composition. One of the main changes is utilizing the toothpaste as a delivery system for therapeutic agents to the oral cavity. A large variety of toothpastes can be found on the market, for different purposes: caries prevention, gingivitis prevention, anti calculus formation, dentine hypersensitivity prevention and for teeth whitening. Toothpastes have a wide range of ingredients: abrasives, humectants, preservatives, thickening or binding agents, detergents, flavoring agents and therapeutic agents. This review provides details on the ingredients of dentifrices, the evidence about the different brands and categories, and questions about their utilization.

Desenvolvimento de formulações cosméticas hidratantes e avaliação da eficácia por métodos biofísicos / Development of cosmetic moisturizer formulations and evaluation of hydrating eficcacy by biophysical methods

Introdução: A comprovação da eficiência de formulações hidratantes deve ser criteriosa e analisada por com métodos adequados. Objetivo: O objetivo principal do trabalho foi avaliar in vivo a eficácia hidratante de formulações contendo diferentes componentes ativos por capacitância elétrica e perda de água transepidérmica. Compararam-se os desempenhos entre Corneometer® e Moisturemeter® e entre o Vapometer® e Tewlmeter®. Verificou-se o comportamento in vitro das alterações causadas pelas substâncias hidratantes, em modelo de estrato córneo alternativo. Material e Métodos: Os compostos ativos selecionados (4% p/p) para incorporação nos géis a base de carbômero foram: uréia, extrato vegetal de Imperata cylindrica; complexo contendo fatores de hidratação natural; e os derivados do açúcar, sacarídeo isomerato e a mistura de xilitilglicosídeo e anidroxilitilglicosídeo. A avaliação in vivo da eficácia hidratante, teve o delineamento experimental baseado no projeto fatorial ANOVA three way. Os tempos estudados foram: após a aplicação e 30,60, 120; 240 e 360 minutos. O estudo de estabilidade acelerada das formulações envolveu condições drásticas de armazenamento (temperatura, umidade e luminosidade) durante 90 dias. Na avaliação in vitro do comportamento das substâncias hidratantes utilizou-se a espectroscopia Raman com transformada de Fourier (FT-Raman) e Calorimetria exploratória diferencial (DSC)...

El valor de la urea en el cuidado y tratamiento de la piel / The urea in the treatment and care of skin

La urea es uno de los humectantes naturales más efectivos y su disminución da lugar a alteraciones de la piel en algunas afecciones dermatológicas. Se revisa brevemente sus propiedades farmacológicas así como sus indicaciones principales.

Urea is one of more effective moisturizer of skin and its disminution is the cause of some dermatologic diseases. Its pharmacologic properties as well its indications are briefly revised.