PENGARUH KUALITAS PRODUK, HARGA DAN INFLUENCER MARKETING TERHADAP KEPUTUSAN PEMBELIAN SCARLETT BODY WHITENING

This research aimed to figure out the influence between product quality, price and marketing influencer with the purchasing decision of Scarlett Body Whitening in East Java. The research instrument employed questionnaire to collect data from Scarlett Body Whitening consumers in East Java. Since there was no valid data for number of the consumers, the research used Roscoe method to take the sample. Data analyzed using multiple linear regression test. Product quality and price have a positive and significant effect on purchasing decisions. Meanwhile, the marketing influencer had no significant effect on purchase decision for Scarlett Body Whitening. Need further research to ensure that marketing influencer had an effect on purchase decision. Keywords: Product quality, price, marketing influencer, buying decision

Conception and Clinical Efficacy of an Osmotic, Polymeric, Stable Nasal Filmogen Barrier for Preventive Treatment of Allergen and Pollution Induced Rhinitis and Respiratory Symptoms

Background: Pollution induced allergic rhinitis and respiratory symptoms is becoming a major health problem in the world for which still there is no safe and preventive treatment. Objectives: Conceive and evaluate the allergen preventive properties and clinical efficacy of an osmotic, polymeric, stable filmogen spray, called PCNS. Materials and Methods: Amb A 1 (ragweed), Der P 1 and 2 (dust mite), Bet v 1 (birch), Alt a 1 (Alternaria, fungus), and Fel d 1 (cat dander) allergens were exposed at a concentration of 5µg/ml (20 µl per tube) on the polymeric test product film (120 and 240µl layer) and the allergens crossing the barrier were quantified in the agar gel beneath the film. 0.40% HPMC and PBS solutions, tested identically, served as controls. Clinical efficacy of PCNS nasal spray was evaluated in patients suffering from allergic rhinitis and/or respiratory symptoms (29 in test product v/s 15 in saline controls) for 22 days. Nasal, ocular, respiratory symptoms and Rhino conjunctivitis Quality of Life Questionnaire (RQLQ) were measured. Statistical analyses: The normality of the populations was determined by the Shapiro-Wilk test, then statistical analysis was performed by two-tailed Student’s test for comparisons between two groups and the two-way ANOVA followed by the post hoc Bonferroni’s test for comparisons of multiple groups. p<0.05 was considered statistically significant. The analyses were performed with the software GraphPad Prism (version 8.4.2, La Jolla, USA). NS indicates not significant. Results: PCNS polymeric spray blocked the diffusion of all the allergens while 0.40% HPMC was able to prevent diffusion of only Alt a 1 and Fel d 1 allergens. Mean reflective total nasal symptom scores (rTNSS), reflective total ocular symptom score (rTOSS), and respiratory symptoms including effect on wheezing, cough, dyspnea, and chest tightness were moderately improved in the control saline group, but the improvements were nearly twice better in the PCNS group. RQLQ was improved by 23% in saline spray v/s 46% PCNS group. 4/15 patients in saline group v/s 1/29 in PCNS group required rescue medication during the study. PCNS was highly effective in reducing allergen and pollution induced respiratory symptoms. Conclusion: a polymeric, osmotic, and stable nasal barrier against pollutants and allergens represents an innovative approach against pollution induced respiratory symptoms.

Evaluation of skin irritation and skin sensitization potential of Venusia max lotion (paraben-free, alcohol-free, mineral oil-free, animal origin free) using human repeat insult patch test

<p class="abstract"><strong>Background:</strong> Topical exposure to chemicals from cosmetics can lead to adverse skin effects or skin irritation. This study aimed to investigate the skin irritation and sensitizing potential of a moisturizer Venusia max lotion (paraben-free, alcohol-free, mineral oil-free, animal origin free (PAMA) free).</p><p class="abstract"><strong>Methods:</strong> In this single-center, non-randomized, observational study, skin irritation, and skin sensitization potential of a test product was assessed using the human repeat insult patch test (HRIPT) technique. Approximately 0.04 g of the test product and filter papers dipped in 0.9% isotonic saline solution (~0.04 ml of solution) were filled in different wells of patch chambers and applied occlusively, on the back of each participant. Scoring of the skin reactions in the induction phase and challenge phase was done using Draize and international contact dermatitis research group (ICDRG) scales respectively. Scores were compared to the baseline and the negative control (isotonic saline).<strong></strong></p><p class="abstract"><strong>Results:</strong> In total 234 participants (50 with sensitive skin), 224 and 221 participants completed the induction phase and challenge phase respectively. Scores for the induction phase for Venusia max lotion (PAMA free) and isotonic saline were 0.46 and 0.06 respectively. The mean cumulative score of erythema and oedema for Venusia max lotion (PAMA free) was below 2. For the challenge phase, none of the participants showed any positive reactions at any time point for test product and isotonic saline.</p><p class="abstract"><strong>Conclusions:</strong> Test product Venusia max lotion (PAMA free) found to be non-irritant and hypoallergenic. Thus, it can be used without fear of skin irritation or sensitization.</p>

A comparative pharmacokinetics study of Ashwagandha (Withania somnifera) Root Extract sustained-release capsules: an open-label, randomized, two treatment, two-sequence, two period, single-dose crossover clinical study

Background: In this open-label, randomized, balanced, two-treatment, two-sequence, two-period, crossover, single-dose oral comparative pharmacokinetics study, the pharmacokinetics, safety, and tolerability of test product ‘ashwagandha (Withania somnifera)’ root extract sustained release capsule 300 mg (Prolanza™), each containing 15 mg withanolides (administered dose: 2×15 mg) was compared with that of a reference product (organic KSM-66 ashwagandha extract [vegan] capsule, each containing 15 mg withanolides [administered dose: 2×15 mg]).Methods: Total 14 healthy men were randomized to receive either the test or the reference product as a single dose of 2 capsules in sequence, administered under fasting conditions. Plasma concentrations of total withanolides, withanolide A and 12-deoxywithastramonolide were measured using validated liquid chromatography–mass spectroscopy/mass spectroscopy.Results: The test product had higher relative absorption, better relative bioavailability, and longer elimination half-life indicating a sustained-release profile compared to reference. Specifically, the relative bioavailability of the test formulation was 12, 44, and 11 times higher for total withanolides, withanolide A and 12-deoxywithastramonolide, respectively. No adverse events were reported during the study.Conclusions: The sustained-release profile of the test product, compared to reference product, will provide more long-lasting therapeutic effects from a single daily dose (Retrospectively applied on Clinical Trials Registry - India [CTRI]. Application reference number: REF/2020/03/032408). The study reports the unique sustained release formulation of Withania somnifera (Ashwagandha) root extract. The pharmacokinetic study also reports for first time, the successful plasma estimation of withanolide A and 12-deoxywithastraamonolide, the major phytoactives of ashwagandha.

Jabuticaba juice improves postprandial glucagon-like peptide-1 and antioxidant status in healthy adults: a randomized crossover trial

Jabuticaba is a Brazilian berry rich in polyphenols, which may exert beneficial effects on metabolic diseases. This randomized crossover study aimed to determine the effects of jabuticaba juice (250 ml in a portion) on postprandial response. Sixteen healthy subjects (11 women; 5 men; 28.4 ± 3.8 years old; body mass index (BMI) 21.7 ± 2.3 kg m−2) consumed two test products after fasting overnight in a randomized controlled crossover design. Each test product portion had a similar composition of sugar components: 250 mL water with glucose, fructose, colored with artificial non-caloric food colorings (placebo); and 250 mL of jabuticaba juice. Beverages were administered immediately before a carbohydrate meal. Blood samples were collected at 0, 15, 30, 45, 60, 90, and 120 min after each test product to analyze the concentrations of glucose, insulin, C-peptide, antioxidant capacity, plasma glucagon-like peptide-1 (GLP-1), and appetite sensations. Compared to the placebo, the intake of jabuticaba juice resulted in a higher GLP-1 response as the area under the curve (AUC) and peaking at 60 min. Jabuticaba juice also resulted in higher antioxidant capacity. Postprandial glucose, insulin, C-peptide levels, and appetite sensations were not significantly different between tests. In conclusion, 250 mL of jabuticaba juice before a carbohydrate meal was able to improve the antioxidant status and GLP-1 concentrations in healthy subjects.

In-vitro Study and In-vivo Predictions of Valsartan and Amlodipine Capsules through Micro Tablets

Aim: The present research work was carried out to develop Valsartan and Amlodipine capsules using micro tablets and to evaluate the in-vitro drug release characteristics. The study was targeted to determine the systemic concentrations using in-vivo prediction. Study Design: The in vivo parameters along with the marketed Valsartan and Amlodipine product was predicted using WinNonlin® software external prediction method. Place and Duration of the Study: The present work was carried out at Pacific Academy of Higher Education and Research University, Udaipur between the duration of February-2019 to November-2019. Methodology: The dissolution studies were performed for test and reference products in 900ml Phosphate buffer (pH 6.8), and the USP Type II apparatus at 50 RPM with a sinker. The in vivo pharmacokinetic prediction was performed using WinNonlin® Software. A mechanistic oral absorption model was built in Phoenix® WinNonlin® 8.2 software (Certara, Princeton, NJ, 08540, USA). Results: The in-vitro dissolution studies were comparable between the test product and the reference product. The Similarity factor achieved was 61.7 and 84.8 for Amlodipine and Valsartan test product in comparison with the reference product. An average percent prediction error for Cmax and AUC for both Valsartan and Amlodipine achieved was less than 10% for all IVIVC models. Conclusion: The relatively low prediction errors for Cmax and AUC observed strongly suggest that the Valsartan and Amlodipine IVIVC models are valid. The average percent prediction error of less than 10% indicates that the correlation is predictive and allows the associated dissolution data to be used as a surrogate for bioavailability studies.

Buffering capacity and fecal pH in healthy horses submitted to experimental enteral nutrition

This study set out to determine the impacts of a commercial equine enteral nutrition product on fecal pH, buffering capacity (BC) and physical examination variables. Eight healthy horses were randomly allocated to one of two simultaneous experimental groups in a 4×4 Latin square design. Horses were submitted to 12 hours of solid fasting, then fed increasing doses of the test product via nasogastric tube, as follows: 0% (pure water), 50%, 75% and 100% of the daily recommended dose. Test product doses were diluted in water (1:3) and delivered by bolus feeding. Fecal samples were taken directly from the rectal ampulla prior to (T0) and within 3, 6, 12, 24, 36 and 48 hours of product administration (T3, T6, T12, T24, T36 and T48 respectively). Within 24 to 36 hours of product administration, fecal pH was near 6 (p = 0.01). However, dose variation had no effect on pH. Product dose and sample collection time had a significant impact (p = 0.00) on buffering capacity at pH 6. The more dramatic drop in pH occurred within 24 to 36 hours of product administration, except in horses receiving the 0% dose (water). At pH 5, buffering capacity was affected by dose but not by sample collection time. Soft fecal consistency, increased intestinal motility and fat droplets in fecal samples were noted in most horses. Fecal pH and buffering capacity assessment are indirect tests. Still, results obtained from these tests were deemed useful for detection of intestinal changes, particularly when combined with physical examination. The product had an impact on faecal pH, buffering capacity and intestinal motility, therefore, it is recommended that the formulation be revised.

Evaluation of comedogenic potential of a paraben-free plant-based butter moisturizing cream: A double-blind, comparative study

Objectives: Comedogenicity is a critical factor in making of cosmetics and skin care products. The term “acne cosmetica” was coined to link the relationship between female acne to the use of cosmetic formulations, stating that the ingredients used in the cosmetic formulations have the potential to evoke a comedogenic response or produce comedones. Therefore, it is important that a skin care product is non-comedogenic and efficacious at the same time. The main objective of this study is to evaluate the comedogenic potential of the test product (Venusia Max Cream – paraben free) when applied topically under occluded patch to the skin. Material and Methods: This was a randomized, double-blinded, comparative study conducted in 24 healthy female participants, with prominent follicular orifices on the upper back region. Comedogenic potential of the test product (Venusia Max Cream – paraben free) was evaluated in comparison to positive (coconut oil) and negative (glycerin) controls in women. Each participant received topical application of test and control products under occluded patch to the skin on the upper aspect of the back, 3 times weekly for 4 weeks. Cyanoacrylate biopsies were performed before and after treatment to determine the microcomedones histologically. Microcomedones were graded using light microscopy and results were analyzed based on scale rating (0–3). Results: The mean comedone grading was assessed between positive versus negative control, and positive control versus test product. The mean comedone grades were significantly less in test product 0.41 ± 0.50 and negative control 0.82 ± 0.73 in comparison to positive control 2.09 ± 0.68. The test product was least comedogenic in this study. Furthermore, no adverse events were reported during the study period. Conclusion: Based on the histological evidence, Venusia Max Cream (paraben free) is a non-comedogenic, plant-based intense moisturizing cream and its use in regular skin care routine can be beneficial, particularly for acne prone and dry skin as it improves the skin hydration levels.

Nitrogen Balance after the Administration of a Prolonged-Release Protein Substitute for Phenylketonuria as a Single Dose in Healthy Volunteers

Nitrogen balance is the difference between nitrogen excreted as urea and nitrogen ingested, mainly in proteins. Increased circulating concentrations of amino acids (AA) in the bloodstream are usually associated with proportional increases in the production and excretion of urea. Previously, we reported results from a randomized, controlled, single-dose, crossover trial in healthy adult volunteers (n = 30) (Trial Registration: ISRCTN11016729), in which a Test product (prolonged-release AA mixture formulated with Physiomimic Technology™ (PT™)) significantly slowed down the release and reduced the peak plasma concentrations of essential AAs compared with a free AA mixture (Reference product) while maintaining essential AA bioavailability. Here, we report an assessment of the nitrogen balance from the same study. The amount of nitrogen contained in plasma AAs, levels of blood urea nitrogen (BUN) (p < 0.0001) and changes in BUN (p < 0.0001) were smaller after the Test product compared with the Reference product. These findings suggest that the production of urea in proportion to systemic AA availability was significantly smaller after the administration of the Test product compared with the Reference product and that the test product conferred the increased utilization of AAs for protein synthesis and reduced their oxidation and conversion to urea. In the clinical setting, it is possible that the effects of PT™ observed on the disposition of free AAs in this study may translate to health benefits in terms of physiological body composition and growth if used for the treatment of subjects with phenylketonuria (PKU). Further investigation in patients with PKU is warranted.

Effects of Venusia Max Lotion on skin hydration and skin barrier in patients with dry skin

Objectives: The objectives of the study were to evaluate skin hydration and transepidermal water loss (TEWL), after the application of the test product (Venusia Max Lotion [Paraben, Alcohol, Mineral Oil, and Animal Origin (PAMA)] free). Material and Methods: The study was a single-center, non-randomized, observational study. Test product was compared to control sites after application on volar forearms of women with dry skin. Hydration and TEWL measurements at baseline, after 12 hours, 24 hours and 36 hours of product application were done under the occluded and unoccluded condition. Results: The study was completed with 30 female subjects. Increase in the mean MMSC values was significantly greater on test product site as compared to control site, at all-time points. For TEWL readings over 36 h, when kept occluded and unoccluded, respectively, there were no significant differences in TEWL readings between the test product site and control site at any time points. Conclusion: The test product, Venusia Max Lotion (PAMA free), can be useful in maintaining the skin barrier properties and significantly improving skin hydration in individuals with dry skin or dry skin-related conditions.