Test Product Research Articles

Characterization of Ad Libitum Use Behavior of On! Nicotine Pouches.

Objectives: Actual use of nicotine pouch products is not well studied. The objectives of this study were to characterize on ® nicotine pouch (Test Products (TP)) use behavior, including association with cigarette and smokeless tobacco (ST) product use. Methods: Adults who smoke cigarettes (AS) and/or adults who use ST (ASTU) (N=1147) that were not planning to quit and had expressed interest in trying and using TP after a 5-day trial were offered ad libitum use of TPs (7 flavors at 5 nicotine levels) for 6 weeks. Results: Participants used a median of ~5-6 pouches/day of a variety of flavors and nicotine levels. In the final week of the study, 27% of AS and 71% of ASTU reported no use of cigarettes or ST respectively, while reporting continued use of TPs. Additionally, 39% of AS and 14% of ASTU reduced consumption of cigarettes or ST products respectively by 50%-99%, compared to reported use at screening. We found a statistically significant inverse relationship between TP flavor varieties and number of cigarettes/ST. Conclusions: These data suggest that TPs can be potential substitutes for cigarettes/ST products, and complete switching may offer harm reduction potential for AS and ASTU not interested in quitting.

Drilling down the bioequivalence assessment of topical antifungal products: Microstructure and release

In recent years, the regulatory mechanisms for topical generic product bioequivalence (BE) assessment have been subjected to noteworthy changes, with the FDA issuing product specific guidances, and the EMA adopting a more universal approach with the quality and equivalence of topical products draft guideline. The agencies advise on a modular strategy for BE documentation. Nevertheless, their scope, data analysis and criteria are rather distinct.This study aims to tackle bioequivalence assessment issues of complex topical formulations starting by statistical implications of the EMA/FDA approaches concerning the documentation of qualitative (Q1), quantitative (Q2), microstructure (Q3) and performance requirements (Q4). As a model drug product, a bifonazole 10 mg/g cream formulation was selected. For this specific formulation, the commercially available Reference Product (RP) was compared with two comparator products, also commercially available, referred to as comparator product A (CPA) and comparator product B (CPB). The former displays Q1 sameness and Q2 differences, whilst CPB is categorically considered as Q1/Q2 different. Furthermore, intending to establish a regulatory rationale for the submission of a generic product according to the updated regulatory requirements, the RP was likewise compared with a Test Product (TP). This formulation was designed to display equal Q1/Q2 profile to that of the RP. Validated rheology and in vitro release test (IVRT) methods were used to infer on Q3/Q4 characteristics.During rheology studies, statistically significant RP batch to batch differences were observed. Therefore, in an attempt to surpass this heterogeneity, the initial pool of RP batches was expanded to include RP product batches at different lifecycle stages. Despite this effort, it was not possible to classify the RP/TP, RP/CPA or RP/CPB as rheologically equivalent products. Nevertheless, product performance results, retrieved from IVRT, were able to sustain equivalence between the RP and the formulations exhibiting Q1 sameness (TP and CPA). It should however be mentioned, that for some RP batch combinations, the IVRT results failed to demonstrate equivalence according to the EMA requirements. Enlarging the RP batch pool was then a critical step in further understanding an optimum statistical approach for establishing equivalence in product performance.This study highlights the need to that a ‘one-fits-all approach’ may not be an optimum path way for establishing the regulatory strategy and requirements to support generic product bioequivalence.

Addition of seaweed flour (Lithothamnium calcareum) combined with homeopathic feed for broiler chickens decreases the toxic effects caused by aflatoxin B1

The aim of this study was to determine whether a combination of seaweed flour (Lithothamnium calcareum) and a homeopathic added to broiler feed has a hepatoprotective effect capable of minimizing the negative impacts of aflatoxin B1 toxicosis. We used birds one day divided into four groups with six repetitions per group and 20 birds per repetition in a completely randomized design. The combination of seaweed flour + homeopathic product was identified as the test product (TP). The groups were identified as PC: intake of 300 µg/kg of AFB1 (positive control); PC+TP: intake of 300 µg/kg of AFB1 + 2 g/kg of TP; NC: birds that received control feed; and TP: supplemented with 2 g/kg TP. The birds in the PC+TP, NC and TP groups had the higher body weights on days 35 and 42 days than in the PC group. This same effect was also observed for daily weight gain and feed conversion for 1–42 days. A higher villus: crypt relationship was observed in PC + TP, NC and TP compared to PC. The seaweed flour combined with the TP minimizes the negative effects of AFB1 on the liver health of broilers and consequently avoids losses in zootechnical performance.

An Instant, Safe, Antihistamine, Anti-Inflammatory and Decongestant Polymeric Nasal Barrier to Prevent and To Treat Allergic Rhinitis in Children

Introduction: Allergic rhinitis (AR) in children is a common chronic pathology with a strong impact on patient quality of life. The main physiopathology affects the nasal cavity as a multi-factorial disease involving nasal mucosa damage, nasal inflammation with high concentrations of histamine, pro-inflammatory cytokines such as histamine, TNF-α, IL-4, IL-5, IL-6, IL-10, IL-13, and IgE antibodies on the nasal mucosa. Systemic entry of these proteins through damaged nasal mucosa maintains continued inflammatory and allergen cascades. Therefore, an ideal treatment should be multitarget in order to stop allergen exposure, inflammation, and nasal mucosa barrier degradation, but such treatments are nearly impossible to conceive. We envisaged an osmotic and protective nasal barrier film, not only capable of protecting the nasal mucosa from allergen exposure but also of trapping and neutralizing selected cytokines and cleaning the nasal surface continuously without using any harmful substance for children. Materials and Methods: We associated highly osmotic glycerol solution with specific plant polymers to conceive an osmotic but stable film. As plant polymers (tannins) can bind with selective proteins, a range of glycerol binding non-cytotoxic polymers were screened using the sandwich ELISA method to select those having binding affinity for allergen induced nasal proinflammatory cytokines. After verifying cytotoxicity and irritant potential, a 15-day observational clinical study was performed with approval from the ethics committee on 30 children aged between 4-13, suffering from allergic rhinitis. The test product (TP) was supplied in 15-ml nasal sprays and applied 2-3 times per day for a period of 15 days. Saline solution served as control (CP). The scores of nasal and ocular symptoms, effect on quality of life, eosinophil count in nasal smears, and need for antihistamine treatment was evaluated at the start, at 30 minutes and on days 2, 3 and 15 of treatment. Results: A few specific polymers were able to bind with selected cytokines and histamine at adequate filmogen concentrations. The osmotic film was stable, non-irritant and was able to clean the nasal mucosa continuously for 4-6h after each application. Clinical observations of Total Nasal Symptom Score (TNSS) grouping the scores of nasal congestion, runny nose, sneezing, and itching, revealed a strong decrease right after the 1st treatment in both groups but the reduction was much stronger and faster with the TP. The mean TNSS score reduction was 44.74% in CP vs 83.53% in the TP group after 7 days of treatment (p<0.001). Total Ocular Symptom Score (TOSS) was decreased by 21.13% and 51.41% in CP v/s 35.12 and 99.59% in TP group on days 2 and 7, respectively. Nasal smear eosinophil count was equally strongly reduced in the TP v/s CP group. No treatment-related side effects were recorded in any of the groups. Conclusion: Protecting the nasal mucosa against allergens, neutralizing inflammatory cytokines, and keeping the nasal surface clean with an osmotic polymeric film, constitute a major breakthrough for the treatment of allergic rhinitis in children. This simple but scientific and logical approach should avoid exposing children to chemicals and to their long-term side effects.

Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.

IntroductionPatients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution—test product (TP)—compared with 5% minoxidil alcohol-based topical solutions—reference product 1 (RP1) and reference product 2 (RP2)—in Indian men with androgenetic alopecia.MethodsIn this randomized double-blind study, patients aged ≥ 18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp.ResultsAll screened patients (N = 100) were enrolled and randomized to TP (n = 33), RP1 (n = 33), or RP2 (n = 34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] (p-value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], (p-value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.ConclusionsTwice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations.Trial RegistrationClinical Trial Registry of India; CTRI/2018/11/016431.

A New Class of Polymeric Anti-Allergen Nasal Barrier Film Solution for the Treatment of Allergic Rhinitis

Objective: Allergic rhinitis (AR) is oversensitivity of nasal mucosa to allergen exposure leading to IgE-mediated nasal mucosal inflammation and cellular destruction. Applying any chemical drug over the nasal mucosa may provide symptomatic relief but at the same time the presence of chemicals, such as cortisones and antihistaminic, hampers mucosa repair and, in consequence, cellular defense functions. Therefore, cleaning, avoiding allergen exposure, and protecting nasal mucosa from contact with allergens with a cell-friendly mechanical device, could be an effective remedy to treat allergic rhinitis. Methods: A double blind, randomized, placebo controlled, multicenter clinical trial was conducted in patients suffering from severe AR. 15 patients were treated with saline as comparator product (CP) versus 31 treated with the test product (TP). The test product contained a natural gum-glycerol solution (VB-Gy) which was rendered filmogen using inert natural polymers (Allercyanidin-H) and termed as VB-Gy-Allercyanidin-H formula. The products (15 ml sprays) were applied topically over the nasal mucosa, 3-4 times a day over a period of 3 weeks. Total, reflective and instantaneous nasal symptom scores for rhinorrhea, nasal discharge, sneezing, and itching, as well as ocular scores (itching, tearing, redness) and rescue medicine use scores were evaluated daily during weeks -1 to +3 employing a 0 (no symptoms) to 3 (severe symptoms) scoring scale. Rhino-conjunctivitis quality of life (RQLQ) questionnaires were completed at the start and at the end of the study. Saline solution (CP) was used identically to the TP. Mean weekly results in CP and TP groups were compared with the scores at the start of treatment (baseline) and between the two groups. Results: CP was found to reduce only slightly the symptomatic manifestation of allergic rhinitis. The mean reduction compared to baseline at the end of weeks 1, 2, and 3 was respectively 11.7%, 13.6% and 15.1% for total nasal symptom scores (rTNSS); 9.9%, 14.5%, and 15.8% for total ocular symptom scores (rTOSS); and 4.97%, 8.45%, and 10.94% for pre-dose instantaneous total ocular symptom scores (am-iTOSS, p: Not Significant: NS). During the same period, compared to CP scores, the reduction in TP group was higher by 37.7%, 58.4%, and 73.5% for rTNSS; 38.3%, 54.6%, and 64.1% for rTOSS and 29.84%, 48.91%, and 59.77% for am-iTOSS (p<0.05 for all parameters vs. CP at the same time points). The rhinoconjunctivitis quality of life questionnaire (RQLQ), measured using standard established questionnaire, was improved by 50.28% in TP group compared to 22.85% in CP group. During the study period, at least one rescue medicine was used by 80% patients in CP group compared to only 29% in TP group. Both products were well tolerated and induced no undesired effects. Conclusion: In the absence of any cell-friendly, safe, and multi-target treatment for allergic rhinitis, using a mechanically acting, filmogen barrier solution capable of blocking new allergen contact and minimizing the concentration of immune cells on the nasal surface represents a simple but highly effective approach for the treatment of common allergic rhinitis.

A randomized, double-blind, controlled study to evaluate clinical efficacy and safety of novel filmogen osmotic treatment for pharyngitis

Background: Pharyngitis is caused principally by primary viral infection: virus growth causes lysis of throat mucosa cells, leading to inflammation, secondary bacterial infection, accumulation of contaminants on the throat, and clinical signs of sore throat infection. Currently available drugs only provide partial therapeutic action or relief. Since pharyngitis is a multifactorial condition, a multi target treatment should be more effective. We tested a novel hypertonic, highly osmotic, filmogen liquid bandage which can mechanically clean the throat surface to quickly alleviate the symptoms while also eliminating their causing pathogens. A clinical trial was conducted to evaluate its efficacy and safety. Methods and findings: A 14-day, randomized, placebo controlled, double blind, efficacy and safety study was conducted in 36 treated with Test Product (TP) v/s 18 treated with Comparator Product (CP, containing saline solution) patients suffering from sore throat infection. Products were applied as spray, every 20 to 30 min. during the first 2-3 hours then 3-4 times daily, for a maximum 14 days, and primary and secondary sore throat infection-related parameters were evaluated on days 1, 2, 3, 4, 7, and 14. Saline solution showed some beneficial effects on sore throat, but the TP proved significantly more effective, producing not only very rapid but also durable effects on all clinical signs of pharyngitis. The statistically significant effectiveness and rapidity of results obtained with the test product, led to faster recovery and reduced need for antibiotics compared to the CP group. No treatmentrelated undesirable or adverse effect was observed. Conclusions: This novel hypertonic, highly osmotic, filmogen liquid bandage is a safe and effective treatment for pharyngitis.

DESLOCANDO O GENE: O DNA ENTRE OUTRAS TECNOLOGIAS DE IDENTIFICAÇÃO FAMILIAR

Resumo Neste artigo, inspirado nos estudos de ciência e tecnologia, revisitamos a hipótese de uma possível "genetização" da vida social causada pelo uso do teste de DNA em investigações judiciais de paternidade. Consideramos a produção e os efeitos do teste no contexto, primeiro, da evolução de provas científicas de paternidade, segundo, do aprimoramento de práticas de governo que facilitam a "legibilidade" da população e, finalmente, do quadro afetivo e material de algumas famílias contemporâneas. Esse percurso analítico nos leva a questionar as perspectivas que opõem o genético ao social e a valorizar as sutilezas contextuais dos mundos "locais". O mergulho nos detalhes etnográficos sugere que são em grande medida os elementos mundanos da experiência cotidiana que medeiam o impacto das tecnologias globalizadas.

Children's Acceptance, Nutritional, and Instrumental Evaluations of Whole Grain and Soluble Fiber Enriched Foods

The Dietary Guidelines for Americans 2005 report recommends 3 or more daily ounce-equivalents of whole grains (WG), and the FDA suggests consumption of 25 g of total dietary fiber (TDF) and 6 g of soluble fiber (SF) for a 2000-calorie diet. Efforts to increase the consumption of WG and SF among elementary school-aged children are needed. The objectives of this study were to examine the consumption of WG- and SF-enriched burritos and cookies among elementary school-aged children and to perform a quality evaluation of all products. Children in grades K to 6 from a local elementary school consumed control (CTR) products made with refined flour along with the test products (TRT) over a 13-wk period. TRT burritos and cookies contained 51% and 100% WG, respectively. CTR and TRT products were served on 3 and 4 different Fridays, respectively. Children's consumption was determined via plate waste. Quality parameters such as texture, color, water activity, weight, and product dimensions were also measured. No significant differences in consumption between CTR and TRT burritos and cookies were found (36% and 90%, respectively). Texture (area) was higher for CTR burritos compared with TRT burritos (1.31 and 0.66 kg-s, respectively). CTR burritos were lighter than TRT burritos with L* values of 80.04 and 64.61, respectively. CTR cookies required a higher breaking force (3.14 compared with 0.58 kg), were lighter than TRT cookies (63.18 compared with 50.27), and had lower water activity (0.5 compared with 0.71).

Effect of hand hygiene regimens on skin condition in health care workers

Frequent, repetitive exposure to hand cleansers can negatively impact the skin, particularly the protective stratum corneum (SC). We investigated the effects of synergistic test products (TP) and current products (CP) among health care workers (HCWs) during spring and winter. TP and CP were significantly different in quantitative measures of skin condition. TP resulted in improved condition versus CP at times during both trials. Compared with non-HCW control subjects, HCW hand skin was appreciably compromised. The skin was damaged at the start of a work cycle, suggesting that the SC damage did not recover during time off. In general, the skin was in poorer condition (higher grades) for CP at the end of a cycle than the start during both trials. The dryness scores were often lower for TP at the end of the cycle, suggesting an improvement in skin condition. During some winter cycles, the skin remained unchanged for TP and worsened for CP. For others, the skin improved with TP and was unchanged with CP. Dryness tended to decrease (improve) and erythema increased for TP. Overall, the use of TP consistently resulted in higher skin hydration compared with CP, indicating that product composition can significantly influence HCW skin condition. Regimens that minimize skin damage can improve condition while achieving skin disinfection. The findings emphasize the importance of providing hand hygiene products to minimize irritant dermatitis and maintain an effective skin barrier. Use of such products is expected to substantially impact and increase hand hygiene compliance.

Hand Hygiene: Antimicrobial Activity Comparison of Three Alcoholic Products – Gel and Liquid – in the Hands with Organic Material

BACKGROUND/OBJECTIVES: Alcohol is the preferred agent for hand hygiene (HH) and is indicated to be used when hands are not visibly dirty with proteinaceous material but an inadvertent hand's contact with blood and organic matter can occur during routine patient care. OBJECTIVE: to compare the antimicrobial activity of three alcoholic products, commonly used in Brazil, in the hands with organic material (OM). METHODS: Fourteen healthy volunteers were randomized in 3 groups, using modified European Standard EN 1500 and cross-over design. The test-products (TP) were ethanol: A – gel 62%, B – gel 70% and C – liquid 70% with glycerol 2% and the reference-product (RP): D – alcohol isopropanolol 60% and they were used on artificially contaminated hands with S.marcescens ATCC 14756 and sheep blood as OM to simulate contamination. For each TP and RP the following sequence was carried through: hands were washed with soft soap, 1,2 ml of sterile sheep blood defibrinated was dispensed by sterile syringe into the hands, air-dried and immersed in the contamination fluid up to the mid-metacarpals. Bacterial samples were recovered for the inicial count by rubbing the fingertips of each hand for 1 min in the Petri dish containing tryptone soya broth (TSB). The hands were rubbed thoroughly over their entire surface (30 to 60 seconds) with 2–3 ml of the test products. The reference product was used twice (total of 6 ml) and rubbed for 60 seconds. Both hands were rinsed in running water and excess water was drained off. Final bacterial count was obtained rubbing the fingertips of each hand for 1 min in the Petri dish containing TSB. For both reference and test products, the mean log10 reduction factors (RF) were calculated (difference between the pre-value and post-value) and for testing the RF of the test products against that of reference product the Wilcoxon teste was used (level of significance was set at P = 0,1, one sided). RESULTS: The mean log10 RF for products A, B and C were: 3.29; 3.36 and 3.56 respectively and for D: 3.66. Wilcoxon test indicated: product A did not meet standard criteria (P = 0,074) and the products B (P = 0,198) and C (P = 0,826) met EN 1500 requirement. CONCLUSIONS: All the TP used in hands with OM, significantly reduced transient flora, more than 3 log10 (99,9% reduction). These results emphasize the advantage of alcohol use in the hand hygiene.