Profile Of Ingredients Research Articles

Two Erigeron species comparison based on their ingredient profile by UPLC-PDA-QTOF-MS/MS and discriminant analysis.

Erigeron breviscapus (EB) and Erigeron multiradiatus (EM) are the two species of the genus Erigeron (Asteraceae) with extremely close genetic relationships. They were used as the same "meiduoluomi" for the treatment of plague and epidemics in traditional Tibetan medicine. But in traditional Chinese medicine, only EB is used for treatment of cerebrovascular obstruction, hemiplegia due to stroke, coronary artery obstruction, chest congestion, and angina pectoris. These two Erigeron species show different effects in different traditional medicine systems. Therefore, analyzing the chemical compositions of two species will not only enhance comprehension of their medicinal properties but also foster the advancement and exploration of novel applications. However, to date, there has been no comprehensive and detailed investigation comparing the constituents of EB and EM. A methodology for rapid identification of chemical profiles from two Erigeron species was devised through the integration of ultra-high-performance liquid chromatography coupled with quadrupole time-of-flight tandem mass spectrometry (UHPLC-QTOF-MS/MS) and multivariate statistical analysis. Additionally, a UHPLC-photo-diode array (PDA) method was established to precisely quantify of 11 components. A total of 58 constituents comprising flavonoids, phenolic acids, saponin, and long chain fatty acids were elucidated. Thirteen compounds were identified as potential differentiators in chemical profiles among the two Erigeron species. For quantitative assessment, 11 bioactive compounds were simultaneously quantified across 49 batches of Erigeron species samples utilizing UHPLC-PDA with wavelengths of 325, 254, and 266 nm. The method demonstrated excellent precision, linearity, accuracy, repeatability, stability, and recovery. The findings from this study will serve as a reference for quality control, functional activity exploration, and improved clinical application based on the ingredient profiles of the two species. Furthermore, this inaugural investigation into the ingredient profiles of these two species will enhance the potential and optimal utilization of both EB and EM resources.

Bioactive composition and medicinal properties of Walnut kernels

The purpose of this review is to evaluate the biological compounds present in walnut kernels and also to assess potential human health benefits. Walnuts are one of the most important tree nuts, belonging to the Juglandaceae family. They are cultivated worldwide, primarily in temperate regions. Throughout history, walnut kernels have been utilized to treat various disorders such as diarrhea, diabetes mellitus, thyroid issues, cancer, anorexia, and infectious diseases, in addition to their dietary benefits. Presently, advanced techniques like UHPLC-MS/MS, HPLC-DAD chromatography, and GC–MS are employed to identify key compounds in walnuts. These include phenolic compounds, phenolic acids, tannins and related compounds, flavonoids, phytosterols, fatty acids, triglycerides, tocopherols, vitamins, and carotenoids. The review also demonstrates that walnut kernels possess numerous medicinal properties, including antioxidants, cardiovascular effects, anti-cancer effects, antidiabetic effects, hepatoprotective effects, and antimicrobial effects. The current review also gives details on plant origin, distribution, classification, cultivation, and consumption as food. The review also described the recent medicinal plant profile, identification, and screening of the active ingredients of walnut's kernels. Researchers around the world are taking an interest in the clinical evaluation of walnut's active ingredients. The current review also gives details of the most recent conducted clinical studies. Mostly the reviews of walnuts are focused on walnut cultivars and/or specific types of compounds, although our current review is mostly focused on the active ingredients of walnut kernels and their specified biological role. In conclusion, different varieties of walnuts are abundant in significant bioactive compounds that possess important medicinal properties.

Evaluation of the Safety of Cosmetic Ingredients and Their Skin Compatibility through In Silico and In Vivo Assessments of a Newly Developed Eye Serum.

The term "risk assessment" is often substituted with "safety assessment", to demonstrate the safe properties of cosmetic ingredients and formulations. With respect to the actual legislative framework, the proper use of in silico evaluation could offer a representative non-animal substitute for the toxicity evaluation of cosmetic ingredients. The in silico assessment needs to be integrated with other lines of proof (in vitro and/or in vivo data) in the form of a complex methodology in order to demonstrate the safety evaluation of cosmetic ingredients/products. The present study aimed to develop and characterize a new cosmetic formulation, designed for the skin care of the periorbital area. Quality control comprising stability, physicochemical, and microbiological evaluation was performed. Another objective of this study was to present a screening model for the safety evaluation of the cosmetic formulation by identifying individual ingredients, and to confirm the skin compatibility based on in vivo evaluation. The results demonstrated the in silico and in vivo safety profile of the cosmetic ingredients used in the present formulation. In silico evaluation, using a novel, specific software applicable for the risk evaluation of ingredients and formulations, showed that the incorporated ingredients were non-mutagenic and non-sensitizing, and considering the margin of safety (MoS), the cosmetic raw materials could be considered safe. Skin compatibility was confirmed by the patch test performed under dermatological control, evidencing the "non-irritating" potential of the developed cosmetic formulation.

Development of a Flavor Ingredient Wheel Linking E-Liquid Additives to the Labeled Flavor of Vaping Products

E-liquids contain combinations of chemicals, with many enhancing the sensory attractiveness of the product. Studies are needed to understand and characterize e-liquid ingredients, particularly flavorings, to inform future research and regulations of these products. We identified common flavor ingredients in a convenience sample of commercial e-liquids using gas chromatography–mass spectrometry. E-liquid flavors were categorized by flavor descriptors provided on the product packaging. A Flavor Ingredient Wheel was developed to link e-liquid flavor ingredients with flavor categories. An analysis of 109 samples identified 48 flavor ingredients. Consistency between the labeled flavor and ingredients used to produce such flavor was found. Our novel Flavor Ingredient Wheel organizes e-liquids by flavor and ingredients, enabling efficient analysis of the link between ingredients and their flavor profiles and allowing for quick assessment of an e-liquid ingredient’s flavor profile. Investigating ingredient profiles and identifying and classifying commonly used chemicals in e-liquids may assist with future studies and improve the ability to regulate these products.

The Use of an Antioxidant Enables Accurate Evaluation of the Interaction of Curcumin on Organic Anion-Transporting Polypeptides 4C1 by Preventing Auto-Oxidation.

Flavonoids have garnered attention because of their beneficial bioactivities. However, some flavonoids reportedly interact with drugs via transporters and may induce adverse drug reactions. This study investigated the effects of food ingredients on organic anion-transporting polypeptide (OATP) 4C1, which handles uremic toxins and some drugs, to understand the safety profile of food ingredients in renal drug excretion. Twenty-eight food ingredients, including flavonoids, were screened. We used ascorbic acid (AA) to prevent curcumin oxidative degradation in our method. Twelve compounds, including apigenin, daidzein, fisetin, genistein, isorhamnetin, kaempferol, luteolin, morin, quercetin, curcumin, resveratrol, and ellagic acid, altered OATP4C1-mediated transport. Kaempferol and curcumin strongly inhibited OATP4C1, and the Ki values of kaempferol (AA(-)), curcumin (AA(-)), and curcumin (AA(+)) were 25.1, 52.2, and 23.5 µM, respectively. The kinetic analysis revealed that these compounds affected OATP4C1 transport in a competitive manner. Antioxidant supplementation was determined to benefit transporter interaction studies investigating the effects of curcumin because the concentration-dependent curve evidently shifted in the presence of AA. In this study, we elucidated the food-drug interaction via OATP4C1 and indicated the utility of antioxidant usage. Our findings will provide essential information regarding food-drug interactions for both clinical practice and the commercial development of supplements.

Designing an effective dissolution test for bilayer tablets tailored for optimal melatonin release in sleep disorder management.

This project aims to investigate the release performance of bilayer tablet (BL-Tablet) designed with both fast and slow-release technology, targeting sleep disorders. The tablet incorporates Melatonin, extracts of Eschscholzia californica and Melissa officinalis. In order to validate the effectiveness of the extended-release profile, an advanced dissolution test was herein proposed. This new method utilizes biorelevant intestinal fluid media and incorporates a stomach-to-intestine fluid changing (SIFC) system. To demonstrate the advantages of employing this method for assessing the controlled release profile of active ingredients, the dissolution results were compared with those obtained using the conventional EU Pharmacopoeia approach. Furthermore, the comparative analysis was extended to include a monolayer tablet version (ML-Tablet) lacking the slow-release technology. Technological characterization and bioaccessibility studies, including intestinal permeability test, were conducted as well to assess the pharmacological performance and bioavailability of active ingredients. The dissolution data recovered revealed that the two dissolution methods did not exhibit any significant differences in the release of ML-Tablet's. However, the dissolution profile of the BL-Tablet exhibited notable differences between the two methods particularly when assessing the behavior of the slow-release layer. In this scenario, both methods initially exhibited a similar release pattern within the first approximately 0.5 h, driven by the fast-release layer of the tablet. Following this, distinct gradual and sustained releases were observed, spanning 2.5 h for the EU Pharmacopoeia method and 8 h for the new SIFC-biorelevant dissolution method, respectively. Overall, the novel method demonstrated a substantial improvement compared to conventional EU Pharmacopoeia test in evaluating the performance of a controlled slow-release technology. Remarkably, the prolonged release technology did not have an adverse impact on melatonin intestinal absorption, and, consequently, maintaining its potential bioavailability of around 78%. Concluding, this research provides valuable insights into how the innovative dissolution test can assist formulators in developing controlled release formulations.

Harmful Substances in Cosmetics and Impact on Ocean

The article expresses the toxicological profile of micro plastics, heavy metals and active ingredients on cosmetics. The focus is on pollution hazards to the biosphere, humans and the environment. Animals easily absorb plastic particles, which not only spread throughout the food chain, but have also been shown to exist in humans. While the micro plastics in cosmetic bags themselves can leach toxins into the ocean, synergies between micro plastics and other pollutants can increase the toxicity of micro plastics to living things. Cosmetics are also harmful in the use of processing additives, polypropylene like absorb organic pollutants. In the future, in order to reduce the environmental pollution of cosmetics, we should use green cosmetics and reduce the use of packaging bags.

94 Sustainable Feeding Solutions Across the Animal Kingdom: Identifying and Implementing

Abstract To meet planetary limits, proactive sustainable solutions must be rapidly elevated across various sectors of the feed industry, with attention from production/selection of raw ingredients through diet manufacturing and formulation processes to precision nutrition programs targeting all animal species including livestock and poultry, pets, and managed wildlife. Responsible sourcing encompasses commitments for tracking environmental impact metrics of feeding systems, with various public calculation tools available. Sustainability data are starting to be incorporated into ingredient descriptions and formulation software for more widespread and standard use as marketing, economic and/or important conservation messaging. Ingredient strategies for sustainable food systems include regenerative agriculture practices, which are typically more holistic and address local needs, with resultant environmental benefits such as decreased water use or increased soil health, biodiversity, and resilience. Substitution of pulses (peas, beans) or other proteins for soybeans, multiple layers/species incorporated into cropping systems, low water use ingredients (i.e., hempseed or sorghum) can result in more intact ecosystems, better water balance, reduced greenhouse gas (GHG) emissions and increased carbon sequestration, with measurable impacts. Such options will become even more critical for global health with continuing climate change. Bio-circularity, which increases the use of residues, by- and co-products, or incorporates excess food streams to provide value-added sustainable feedstuffs serves to decrease GHG emissions from landfills/compost and can reduce the risk of commodity crop land conversion. Such ingredients, often niche or opportunistic, represent nearly 30% of global feed intake and may decrease food-feed competition as well as free up global arable land. Byproduct portions often contain quite suitable nutritional as well as sustainable feed ingredient profiles, and can be further enhanced through dehydration, fermentation, or upcycling as dietary substrates for insects, which are then incorporated into diets as alternative protein sources. Examples of common circular ingredients include processed and spent fermented grains, as well as bakery, fruit/vegetable, and retail excesses. Feeding Innovations that improve the carbon footprint through increased efficiency, productivity and/or health can reduce pressure on production (both animal and feed manufacturing) landscapes. Enzymes, pro- and pre-biotics, and additives fit under this broad category, as do the use of single cell proteins and fermentation products. While specific ingredients may directly or indirectly reduce GHG emissions (seaweeds, tannins, fats) through impacts on the rumen or hindgut microbiota, innovations are not limited to diets per se but rather encompass technologies, tools and entire feeding systems. The use of harvested natural plant sources (e.g., Miscanthus spp. grass, wood sawdust, local browses) as low-starch fiber ingredients in addition to (or in lieu of) cultivated forages represents sustainable value-add products, contributing to improved animal health with a focus on local producers/communities; environmental impacts should be monitored. Similarly, harvest and processing of edible invasive species for consumption as part of sustainable management/eradication programs must be considered. Logistically, policy barriers and scaling such efforts may prove the biggest challenges both regionally and globally; nonetheless, sustainability efforts are essential.

Prevalence of adulteration in dietary supplements and recommendations for safe supplement practices in sport.

The prevalence of dietary supplement use among athletes continues to rise with 60-80% of athletes often reporting current or previous use of dietary supplements. While select dietary ingredients have been shown to improve acute performance and enhance training adaptations over time, it is important to still consider the risk vs. reward for athletes before opting to consume a dietary supplement. Previous work has indicated that certain dietary supplements may pose risks for inadvertent doping, may be susceptible to mislabelling, could be banned by certain governing bodies of sport, or pose health risks for certain populations. The purpose of the current narrative review is to summarize the prevalence of adulteration in dietary sport supplement products, outline the risks of inadvertent doping for athletes, and highlight best practices regarding safe supplementation strategies. Analytical studies have found anywhere from 14 to 50% of samples analyzed from dietary supplement products have tested positive for anabolic agents or other prohibited substances. It is important for the consumer to adhere to safe supplementation strategies, which include following serving size recommendations, cross-referencing ingredient profiles with the list of prohibited substances, choosing quality products that have been verified by a third-party certification program, and being cognizant of consuming multiple dietary supplement products with overlapping ingredient profiles. Once these practices have been considered, it is reasonable for an athlete to utilize dietary supplements as a strategy to optimize performance and health, with a low risk of failing a drug test (adverse analytical finding) and experiencing adverse events.

Novel Gastroprotective and Thermostable Cocrystal of Dimethyl Fumarate: Its Preparation, Characterization, and In Vitro and In Vivo Evaluation.

Crystallization has revolutionized the field of solid-state formulations by modulating the physiochemical and release profile of active pharmaceutical ingredients (APIs). Dimethyl fumarate (DF), an FDA-approved first-line drug for relapsing-remitting multiple sclerosis, has a sublimation problem, leading to loss of the drug during its processing. To tackle this problem, DF cocrystal has been prepared by using solvent evaporation technique using nicotinamide as a coformer, which has been chosen based on in silico predictions and their ability to participate in hydrogen bonding. Fourier transform infrared (FT-IR), powder X-ray diffraction (PXRD), thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), and sublimation analysis have characterized the cocrystal and its thermostability. Comparative analysis of the release profile has been done by the dissolution and pharmacokinetic study of DF and its cocrystal. Formulated cocrystal is noncytotoxic, antioxidant and inhibits interleukin-6 and tissue necrosis factor-α in peripheral blood mononuclear cells induced by lipopolysaccharide. We have obtained a thermostable cocrystal of DF with a similar physicochemical and release profile to that of DF. The formulated cocrystal also provides a gastroprotective effect which helps counterbalance the adverse effects of DF by reducing lipid peroxidation and total nitrite levels.

28 Effect of Dietary Hempseed Meal on Growth Performance and Dry Matter Intake in Yearling Rough-Stock Bulls

Abstract The Association of American Feed Control Officials (AAFCO) is gathering information about the safety and efficacy of hemp and its derivatives as potential animal feedstuffs. Yearling rough-stock bulls (n = 38) were used in a randomized complete block design to evaluate the effects of hempseed meal (HSM) as a concentrate ingredient on growth, dry matter intake (DMI), and efficiency. Bulls were blocked by body weight (BW), grouped into 10 pens (n = 3 or 4 bulls/pen), and randomly assigned to hempseed meal (HSM) or a control supplement treatment (CON; 72.5% cottonseed meal, 14.5% soy hulls, and 13% fat). Ingredients for CON were used because they were common commercial commodities and were formulated to match the macronutrients of HSM. Treatments were top-dressed at 10% of the diet, while 90% was fed as a mixed ration [50% bermudagrass hay, 40% textured commercial feed (10% CP)]. Feed delivery, treatment delivery, and orts were recorded daily. Diet samples were dried and used to calculate dry matter intake (DMI). Blood for urea-N (SUN; VetScan Chemistry Analyzer) and BW were obtained on days 0, 21, 42, and 63. Efficiency was evaluated for each period using DMI and average daily gain (ADG). Data were analyzed using the GLIMMIX procedure in SAS 9.4. Results were considered significant at P < 0.05, and tendencies were discussed at 0.05 > P > 0.10. No treatment×time interaction occurred for BW (P = 0.999), ADG (P = 0.563), interim DMI (P = 0.672), feed efficiency (P = 0.254), or SUN (P = 0.170). Treatment did not affect BW (320.4 and 324.69 ± 121.57 kg for CON and HSM, respectively, P = 0.996), but BW increased over time (261.13 ± 74.71 and 322.5 ± 121.57 kg, initial and final BW, respectively, P = 0.001). No treatment effect on ADG occurred (0.73 and 0.84 ± 0.13 kg for CON and HSM, respectively, P = 0.680). However, ADG decreased over time (1.0 ± 0.29, 1.19 ± 0.21 and 0.79 ± 0.13 kg, d0-21, d21-42, and d42-63, respectively, P = 0.005). Daily DMI resulted in a treatment×time interaction, where HSM often consumed more DM than CON (P < 0.01). Interim DMI increased over time (7.44 ± 1.25, 7.84 ± 0.98, and 8.18 ± 0.82 kg, d0-21, d21-42, and d42-63, respectively, P = 0.0073), but when combined with ADG to determine feed efficiency, the main effects were not different (P ≥ 0.17). Over time, SUN increased (4.91, 10.52, 11.66 and 12.72 ± 0.35 mg/dL for days 0, 21, 42 and 63, respectively, P < 0.001), and HSM had greater SUN than CON (10.46 and 9.45 ± 0.30 mg/dL for HSM and CON, respectively, P = 0.0426). These data suggest that bulls fed HSM at 10% diet DM perform similarly to bulls fed the same nutrient profile of standard commercial feed ingredients, indicating comparable nutrient availability between the treatments. Conversely, increased DMI and SUN in the HSM bulls suggest a difference in nitrogen metabolism between the treatments that warrants further investigation.

70 Ahiflower (Buglosoides Arvensis) oil supplementation alters whole blood and muscle fatty acid profile in mature horses

The omega-3 (n-3) profile of common plant-based ingredients are derived from α-linolenic acid (ALA). Previous research has indicated that horses lack the ability to convert ALA or other short-chain polyunsaturated fatty acids (SC-PUFA) into the biologically relevant docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Ahiflower (Buglossoides Arvensis) oil is a novel plant-based source of omega-3 fatty acids derived from n-3 stearidonic acid (SDA), and gamma-linolenic acid (GLA), an omega-6 fatty acid (see Table 1 for fatty acid profile). The objective of this trial was to evaluate how supplementation of Ahiflower oil to horses would alter whole blood and muscle fatty acid composition. Mature Quarter Horses (n = 20) were balanced by age, BW, and BCS and assigned to one of 4 treatment groups. LOW (n = 5; BW = 507.12 ± 2.3kg; BCS = 5.4 ± 0.3) was offered 30mL/day of Ahiflower oil. HIGH (n = 5; BW = 517.45 ± 4.5kg; BCS = 5.7 ± 0.1) was offered 60mL/day of Ahiflower oil. FLAX (n = 5; BW = 497.25 ± 3.5kg; BCS = 6.1 ± 0.7) was offered a flaxseed pellet (CP = 15.42%, Total omega-3 = 3.75%) formulated to provide the same amount of total omega-3′s as LOW was offered. PAST (n = 5; BW = 508.14 ± 3.6kg; BCS = 5.2 ± 0.6) was allowed free-choice access to mixed grass pasture (CP = 16.0%, Total omega-3 = 0.79%). All horses were offered 1.81kg/d of Purina® Strategy GX® (CP = 14.24%, Total omega-3 = 0.44%) daily. LOW, HIGH, and FLAX were housed in drylots by treatment group and were offered 2.0% BW as Timothy grass hay (CP = 10.10%, Total omega-3 = 0.35%). On d 0, 30, and 60 blood samples were collected along with a mid-gluteal muscle sample (∼1g). Samples were analyzed for fatty acid profile via LC-HPLC (UF ATCL).Data were analyzed via ANOVA (SAS 9.4). Horses in the LOW group had a 12.5% increase in total omega-3, while horses in HIGH had a 40.1% increase. Similar differences were observed for EPA (LOW = 19.2%; HIGH = 40.1%), and GLA (LOW = 60.1%; HIGH = 167%). Horses in HIGH had a greater increase from baseline in muscle EPA + DHA compared with all other groups (250%). All differences were significant at P < 0.05. Taken together these data indicate that horses had the ability to convert the PUFA's in Ahiflower oil into EPA. Increased EPA in whole blood and muscle tissue potentially allows for increased production of anti-inflammatory eicosanoids and prostaglandins. Further research is necessary to elucidate the mechanism by which this conversion occurs.

Evaluation of different blackcurrant seed ingredients in meatballs by using conventional quality assessment and untargeted metabolomics

Blackcurrants are sources of phenolic compounds, such as anthocyanins, possessing strong antioxidant, antimicrobial and antifungal activity. Therefore, the addition of different blackcurrant pomace ingredients may affect the overall meat quality. The actual chemical profile and bioactivities of blackcurrant pomace ingredients may strongly depend on its preparation; for instance, in our study the highest values of the in vitro antioxidant capacity were determined for blackcurrant seeds after supercritical CO2 extraction. Starting from these background conditions, in this work, we evaluated the ability of three different concentrations (namely 1, 3, and 5% w/w) of blackcurrant (BC) seeds following EtOH/water extraction (BC-AE), before supercritical fluid CO2 extraction (BC-RS), and after supercritical fluid CO2 extraction (BC-ASC) to affect different quality parameters of pork meatballs. These latter were stored considering three different time-points, namely 1, 3 and 6 days at 4 °C packed under modified atmosphere (i.e., 70% N2 and 30% CO2). Untargeted metabolomics allowed to identify several lipid and protein-related oxidation products involved in redox reactions, such as 13-L-hydroperoxylinoleic acid, (12S,13S)-epoxylinolenic acid, 9,10-epoxyoctadecenoic acid, glutathione, glutathione disulfide, L-carnosine, l-ascorbic acid, and tocotrienols. Besides, multivariate statistics applied on the metabolomics dataset confirmed that the chemical profile of meatballs was an exclusive combination of both BC inclusion levels and type of BC-ingredients considered. Our findings showed that the higher the concentration of BC seed ingredients in meatballs, the lower the cooking loss and the higher the fibre content. Also, all the ingredients significantly affected the colour parameters.

Networking to reduce microbial risk in foods

Networking to reduce microbial risk in foods

Home-cooked diets cost more than commercially prepared dry kibble diets for dogs with chronic enteropathies

Nutrition plays a fundamental role in the management of canine chronic enteropathies (CCEs). Dog owners may elect to feed home-cooked diets (HCDs) rather than veterinary commercially prepared diets (CPDs) because of perceived lower costs. There is a paucity of data comparing costs of these options. We hypothesize there will be differences in costs between complete and balanced HCDs and nutritionally comparable CPDs. 6 Home-cooked diets. Six HCD recipes (2 highly digestible, 2 limited antigen, 2 low-fat) were formulated by 2 board-certified veterinary nutritionists to mimic the nutritional and ingredient profiles of veterinary CPDs for management of CCEs. The cost (in US$ on a per 100 kilocalorie [kcal] basis) of each recipe was determined via collection of ingredient prices from 3 grocery stores combined with supplement prices from online retailers. Prices of CPDs were obtained from a national online retailer. Maintenance energy requirements of 1.6 X (70 X BWkg0.75), where BWkg represents body weight in kilograms, were calculated for 3 dog sizes (5, 20, and 40 kg), and costs of feeding maintenance energy requirements with HCDs versus dry and canned CPDs were compared with a Kruskal-Wallis test and post hoc testing. The median costs of all dry and canned CPDs and HCDs were $0.29 (range, $0.18 to $0.46), $1.01 (range, $0.77 to $1.20), and $0.55 (range, $0.35 to $1.14), respectively. Feeding complete and balanced HCDs cost more than feeding dry CPDs (P < .001), but not canned CPDs (P > .99). Dry CPDs cost the least for nutritional management of CCEs. There is a wide range of costs for both CPDs and HCDs.

Application of Quality-by-Design Approach to Justify the Composition and Technology of Two-component Suppositories

Introduction. One of the modern remedies used to treat vaginal infections are suppositories "Depantol", which have an antiseptic, regenerating effect due to the combination of chlorhexidine and dexpanthenol. The initial stage in the life cycle of any medicinal product (MP) is pharmaceutical development, a systematic approach to which implies the principle of Quality-by-Design (QbD), which is based on obtaining reliable scientific data and risk management for quality. With this approach, pharmaceutical development begins with a preliminary determination of significant factors in the creation of a drug.Aim. Aim of study was to design Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes – the initial data necessary for the development of composition and technology of a generic drug in accordance with the QbD methodology of ICH Guidance Q8 "Pharmaceutical Development".Materials and methods. Objects of study: chlorhexidine bigluconate, dexpanthenol, PEG-400 and PEG-1500, pharmaceutical development documents. Methods of study: content analysis, system analysis; FMECA method (Failure Modes, Effects and Criticality Analysis).Results and discussion. In order to implement the QbD for the production of a drug of good quality, initial data for the development of the composition and technology of two-component suppositories were obtained. Quality Target Product Profile (QTPP) was compiled taking into account the data of the original drug was used as reference. Based on the compiled QTPP, Critical Quality Attributes (CQAs) were identified. The determination of CQAs from QTPP parameters was based on the strength of the potential harm to the product. Due to the fact that we developed a well-known dosage form, quality indicators were chosen that are standard for hydrophilic suppositories. In order to determine the parameters of the drug components that affect the Critical Quality Attributes, for each of the active pharmaceutical ingredients (APIs) suppositories contain, the Critical Material Attributes (CMAs) were determined. For example, for liquid ingredients, according to the specification of the substance manufacturer, these are pH, viscosity, impurities, identification, assay, refraction index. For the initial risk assessment, risk assessment matrices of the influence of the Сritical Material Attributes of the components on the Critical Quality Attributes were compiled. When evaluating the effect of chlorhexidine bigluconate on the critical characteristics of the final product, attention was paid to all parameters from the manufacturer's specification, since any deviations in pH, density, presence of related substances and extraneous impurities, assay and identification of the substance may signal the chemical unsuitability of the component. The weight uniformity of suppositories is affected only by the parameters of the technological process. The influence of CMAs of dexpanthenol on the Critical Quality Attributes of the finished product is generally similar to the influence of the parameters of chlorhexidine bigluconate. The difference in the influence of pH and water content on the microbial limits: unlike chlorhexidine bigluconate, which has antiseptic properties, dexpanthenol is more susceptible to microbial contamination. The effect of base CMAs on identification, content uniformity, and assay is not critical. Whereas the pH, assay and identification of PEG-400 and PEG-1500 have a significant impact on the dissolution profile of the active ingredients from the finished dosage form.Conclusion. The data required for the pharmaceutical development of a generic drug, two-component suppositories, was obtained: Quality Target Product Profile, Critical Quality Attributes, Critical Material Parameters. The impact of the critical characteristics of the raw materials on the critical quality attributes of the developed suppositories was assessed.

Pharmacognostic, physicochemical, and TLC Characterisation of Brhatyadi Kwatha used in Kerala

Brihatyadi Kwatha (BK) a popular Ayurvedic polyherbal decoction for urinary problems is a formulation of five roots - Salaparni, Prisniparni, Brihati, Kan-takari and Gokshura. Sahasrayoga, adopting Ashtanga Hrdaya describes the drug ratio as 1:1:1:1:2 respectively, but some formularies consider ratio of the last drug as 4 and 8. The source of Prisniparni is Desmodium gangeticum (L.) DC in Kerala where as it is Uraria picta (Jacq.)DC in north. This diversity in source plants and proportion of ingredients can create variability in product standards. Currently there is no specific standard prescribed for BK in Ayurve-da Formulary of India. Hence, this study is taken up as step towards standard-isation of Brihatyadi Kwatha. The study aims to determine characteristic Pharmacognostic and Physicochemical parameters and TLC profile of ingredi-ents as well as the end product - two variants of Brihatyadi Kwatha, to set standards. Ingredient drugs of BK were subjected to macroscopic, microscop-ic, physicochemical analysis. Ingredients and products were subjected to Thin Layer ChromatographyCharacteristic features of the analyses were recorded. Rf values in the TLC profile demonstrated presence of all ingredients of BK. The findings may be useful as standards for quality control of Brihatyadi Kwatha.

Two Species Origins Comparison of Herba Patriniae Based on Their Ingredients Profile by UPLC-QTOF/MS/MS and Orthogonal Partial Least Squares Discriminant Analysis.

Herba Patriniae (HP) is widely used as a medicinal and edible material in China. Besides food value, HP attracts more attention due to its medicinal potential. Patrinia villosa Juss. (PV) and Patrinia scabiosaefolia Fisch. (PS) are the two species origins of HP. These two of HP show different effects on cell proliferation, migration, angiogenesis and anti-diabetic. As we have previously reported, PV and PS show significant differences on their anti-inflammatory ability in the same experimental model. Comparing the ingredient profiles of two different sources will not only facilitate the understanding of their medicinal effects, but also help the development and research of new activities. However, still now, there is no systematic and detailed study to compare the components of PV and PS. In present study, ultra-high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry was employed to achieve a high-throughput qualitative and thorough analysis of the chemical composition spectrum of HP. A total of 164 compounds were identified, among these compounds, 127 compounds were identified from PV, and 107 compounds were identified from PS. Most of the chemical components was discovered for the first time. Flavonoids, saponins, terpenoids and organic acids, as the main ingredients in PV and PS were 45.45 %vs 28.46 %, 12.61 % vs. 32.09 %, 14.33 % vs. 22.38 % and 14.58 % vs. 6.79 %, respectively. Flavonoids are the main components of PV, while PS is rich in saponins. PV and PS were classified into two groups by principal component analysis (PCA) and screened out the main molecular differences responsible by orthogonal partial least squares discriminant analysis (OPLS-DA). All the results will be a guide for the quality control, functional activity research, or better clinic use based on the ingredients profile between these two species. Besides, this first study on ingredients profile of two species origins will be beneficial for potential and best resources utilization of both PV and PS.

Application of Af4-Multidetection to Liraglutide in Its Formulation: Preserving and Representing Native Aggregation.

Aggregation is among the most critical parameters affecting the pharmacological and safety profile of peptide Active Pharmaceutical Ingredients (APIs). For this reason, it is of utmost importance to define the exact aggregation state of peptide drugs, particularly when the API is marketed as a ready-to-use solution. Consequently, appropriate non-destructive techniques able to replicate the peptide environment must be employed. In our work, we exploited Asymmetrical Flow Field-Flow Fractionation (AF4), connected to UV, dRI, fluorescence, and MALS detectors, to fully characterize the aggregation state of Liraglutide, a peptide API used for the treatment of diabetes type 2 and chronic obesity. In previous studies, Liraglutide was hypothesized to assemble into hexa-octamers in phosphate buffer, but no information on its behavior in the formulation medium was provided up to now. The method used allowed researchers to work using formulation as the mobile phase with excellent recoveries and LoQ/LoD, discerning between stable and degraded samples, and detecting, when present, aggregates up to 108 Da. The native state of Liraglutide was assessed and found to be an association into pentamers, with a non-spherical conformation. Combined to benchmark analyses, the sameness study was complete and descriptive, also giving insight on the aggregation process and covalent/non-covalent aggregate types.

Comprehensive study for the development of rectal suppositories with diosmin and hesperidin

The aim. To conduct a comprehensive study of biphasic-type suppositories that contain diosmin and hesperidin.&#x0D; Materials and methods. Samples of biphasic-type suppositories with a mass of 4.0 were objects of the study. Pharmacological, technological and analytical research methods were used to directly or indirectly analyze the strength and completeness of the drug activity. Thus, in this work we combined the study of the specificity of the pharmacological action of the drug, experimental verification of the quantitative content of API, analysis of the structural properties of suppositories and study of the profile of the release of active pharmaceutical ingredients.&#x0D; Results. Therefore, based on the obtained data, the most effective dose was 75 mg / kg (in terms of a human dose of 300 mg per suppository). The drug in the selected dose showed a significant therapeutic effect, which significantly exceeded that of the test sample at a lower dose and the reference agent. According to the results of technological studies, it was determined that all samples of suppositories had satisfactory structural and mechanical properties. Studies of the histological structure of the mucous membrane of rats proved that there is a positive effect of treatment with suppositories with diosmin and hesperidin due to the improvement of the normal condition of the mucous membrane, the absence of edema and ulcerative defect. Research of the release profile of active pharmaceutical ingredients showed that the best percentage of release is characteristic of sample 2 (99.8 %)&#x0D; Conclusions. Therefore, suppositories with diosmin and hesperidin in therapeutically dose of 75 mg/kg of animal weight can be used for further research and will be of interest in the treatment of hemorrhoids of both acute and chronic forms