Label Claim Research Articles

A Review of Meaningful Change Thresholds for EORTC QLQ-C30 and FACT-G Within Oncology

ObjectivesThis literature review provides an overview of meaningful change thresholds for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) and the Functional Assessment of Cancer Therapy – General (FACT-G) used across hematological cancers and solid tumors (melanoma, lung, bladder, and prostate). MethodsEmbase, MEDLINE, and PubMed were searched to identify relevant oncology publications from 2016 to 2021. Label claims from the US Food and Drug Administration and the European Medicines Agency for 7 recently approved drugs (pembrolizumab, atezolizumab, glasdegib, gilteritinib, tisagenlecleucel, axicabtagene ciloleucel, and daratumumab plus hyaluronidase-fihj) were reviewed. ResultsPublications providing guidance on meaningful change thresholds for the QLQ-C30 displayed a growing trend away from broad “legacy” thresholds of 10 points for all QLQ-C30 scales), toward deriving “contemporary” thresholds (eg, subscale specific, population specific). Contemporary publications generally provide guidance on selecting thresholds for specific scales that account for improved or worsening thresholds (eg, QLQ-C30 subscales). This trend was not clear for FACT-G, with less new guidance available. Most clinical trials used in regulatory label submissions have used thresholds of 10 points for the QLQ-C30 subscales and 3 to 7 points for the FACT-G total score. Despite the availability of more recent guidelines, contemporary meaningful change thresholds seem slow to emerge in the published literature and regulatory labels. ConclusionsTrialists should consider using contemporary thresholds, rather than legacy thresholds, for QLQ-C30 endpoints. Thresholds derived for a similar patient-population should be used where available. Further work is required to provide these across a broader range of cancer sites.

Characteristics of antimicrobial resistance in Escherichia coli isolated from retail meat products in North Carolina.

Escherichia coli is commonly used as an indicator for antimicrobial resistance (AMR) in food, animal, environment, and human surveillance systems. Our study aimed to characterize AMR in E. coli isolated from retail meat purchased from grocery stores in North Carolina, USA as part of the National Antimicrobial Resistance Monitoring System (NARMS). Retail chicken (breast, n = 96; giblets, n = 24), turkey (n = 96), and pork (n = 96) products were purchased monthly from different counties in North Carolina during 2022. Label claims on packages regarding antibiotic use were recorded at collection. E. coli was isolated from meat samples using culture-based methods and isolates were characterized for antimicrobial resistance using whole genome sequencing. Multi-locus sequence typing, phylogroups, and a single nucleotide polymorphism (SNP)-based maximum-likelihood phylogenic tree was generated. Data were analyzed statistically to determine differences between antibiotic use claims and meat type. Of 312 retail meat samples, 138 (44.2%) were positive for E. coli, with turkey (78/138; 56.5%) demonstrating the highest prevalence. Prevalence was lower in chicken (41/138; 29.7%) and pork (19/138;13.8%). Quality sequence data was available from 84.8% (117/138) of the E. coli isolates, which included 72 (61.5%) from turkey, 27 (23.1%) from chicken breast, and 18 (15.4%) from pork. Genes associated with AMR were detected in 77.8% (91/117) of the isolates and 35.9% (42/117) were defined as multidrug resistant (MDR: being resistant to ≥3 distinct classes of antimicrobials). Commonly observed AMR genes included tetB (35%), tetA (24.8%), aph(3'')-lb (24.8%), and blaTEM-1 (20.5%), the majority of which originated from turkey isolates. Antibiotics use claims had no statistical effect on MDR E. coli isolates from the different meat types (X2 = 2.21, p = 0.33). MDR was observed in isolates from meat products with labels indicating "no claims" (n = 29; 69%), "no antibiotics ever" (n = 9; 21.4%), and "organic" (n = 4; 9.5%). Thirty-four different replicon types were observed. AMR genes were carried on plasmids in 17 E. coli isolates, of which 15 (88.2%) were from turkey and two (11.8%) from chicken. Known sequence types (STs) were described for 81 E. coli isolates, with ST117 (8.5%), ST297 (5.1%), and ST58 (3.4%) being the most prevalent across retail meat types. The most prevalent phylogroups were B1 (29.1%) and A (28.2%). Five clonal patterns were detected among isolates. E. coli prevalence and the presence of AMR and MDR were highest in turkey retail meat. The lack of an association between MDR E. coli in retail meat and antibiotic use claim, including those with no indication of antimicrobial use, suggests that additional research is required to understand the origin of resistance. The presence of ST117, an emerging human pathogen, warrants further surveillance. The isolates were distinctly diverse suggesting an instability in population dynamics.

Real-time PCR methods for identification and stability monitoring of Bifidobacterium longum subsp. longum UABl-14 during shelf life.

Bifidobacterium longum subsp. longum UABl-14™ is an important probiotic strain that was found to support digestive health. Here we present the development and validation of real-time PCR methods for strain-specific identification and enumeration of this important strain. The identification method was evaluated for specificity using 22 target samples and 30 non-target samples. All target samples successfully amplified, while no amplification was observed from any non-target samples including other B. longum strains. The identification method was evaluated for sensitivity using three DNA dilution series and the limit of detection was 2 pg. of DNA. Coupled with a viability dye, the method was further validated for quantitative use to enumerate viable cells of UABl-14. The viability dye treatment (PMAxx) was optimized, and a final concentration of 50 μM was found as an effective concentration to inactivate DNA in dead cells from reacting in PCR. The reaction efficiency, linear dynamic range, repeatability, and reproducibility were also evaluated. The reaction efficiency was determined to be 97.2, 95.2, and 95.0% with R2 values of 99%, in three replicates. The linear dynamic range was 1.3 × 102 to 1.3 × 105 genomes. The relative standard deviation (RSD%) for repeatability ranged from 0.03 to 2.80, and for reproducibility ranged from 0.04 to 2.18. The ability of the validated enumeration method to monitor cell counts during shelf life was evaluated by determining the viable counts and total counts of strain UABl-14 in 18 multi-strain finished products. The viable counts were lower than label claims in seven products tested post-expiration and were higher than label claims in products tested pre-expiration, with a slight decrease in viable counts below label claim in three samples that were tested 2-3 months pre-expiration. Interestingly, the total counts of strain UABl-14 were consistently higher than label claims in all 18 products. Thus, the method enables strain-specific stability monitoring in finished products during shelf life, which can be difficult or impossible to achieve using the standard plate count method. The validated methods allow for simultaneous and cost-effective identification and enumeration of strain UABl-14 and represent an advancement in the quality control and quality assurance of probiotics.

Human in vivo assessment of the survival and germination of Heyndrickxia coagulans SNZ1969 spores delivered via gummy candies

Confectionary products hold promise as unconventional food carriers for probiotic microorganisms. This study explored the delivery of Heyndrickxia coagulans SNZ1969, a spore-forming probiotic, using gummy candies. In this study, we prepared gummy candies containing bacterial spores with a viable count that remained stable during a 24-month shelf-life period, meeting the label claim of at least one billion CFUs per serving (24 g). Then, we carried out an intervention trial involving 24 healthy adults who consumed one serving per day for two weeks followed by an additional two weeks of follow-up. Fecal samples were collected and analyzed with a protocol that allowed the viable counts of SNZ1969, both in spore and vegetative forms. The obtained results revealed that bacterial spores germinated in all volunteers. SNZ1969 persistence in the gut was monitored for two weeks after the end of gummy candy consumption, indicating its potential for prolonged colonization. These findings highlight the potential of unconventional food carriers for probiotic delivery and suggest that spore-forming probiotics can be metabolically active in the human intestine. These findings provide information for the development of food products containing spore-forming probiotics and their potential benefits in promoting gastrointestinal health.

Antibiotic quality and use practices amongst dairy farmers and drug retailers in central Kenyan highlands

Understanding antibiotic use in dairy systems is critical to guide antimicrobial stewardship programs. We investigated antibiotic use practices in small-holder dairy farms, antibiotic quality, and antimicrobial resistance (AMR) awareness among veterinary drug retailers in a mixed farming community in the central Kenyan highlands. Data were collected from 248 dairy farms and 72 veterinary drug stores between February 2020 and October 2021. A scale was developed to measure knowledge about AMR and antibiotic use using item response theory, and regression models were used to evaluate factors associated with antibiotic use and AMR knowledge. The active pharmaceutical ingredient (API) content of 27 antibiotic samples was determined using high-performance liquid chromatography (HPLC). The presence and levels of 11 antibiotic residues in 108 milk samples collected from the study farms were also investigated using liquid chromatography tandem mass spectrometry (LC–MS/MS). Almost all farms (98.8%, n = 244) reported using antibiotics at least once in the last year, mostly for therapeutic reasons (35.5%). The most used antibiotics were tetracycline (30.6%), penicillin (16.7%), and sulfonamide (9.4%), either individually or in combination, and predominantly in the injectable form. Larger farm size (OR = 1.02, p < 0.001) and history of vaccination use (OR = 1.17, p < 0.001) were significantly associated with a higher frequency of antibiotic use. Drug retailers who advised on animal treatments had a significantly higher mean knowledge scores than those who only sold drugs. We found that 44.4% (12/27) of the tested antibiotics did not meet the United States Pharmacopeial test specifications (percentage of label claim). We detected nine antibiotics in milk, including oxytetracycline, sulfamethoxazole, and trimethoprim. However, only three samples exceeded the maximum residue limits set by the Codex Alimentarius Commission. Our findings indicate that antibiotics of poor quality are accessible and used in small-holder dairy systems, which can be found in milk. These results will aid future investigations on how to promote sustainable antibiotic use practices in dairy systems.

Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19.

The FDA initiated a cross-sectional, statistically based sampling and testing study to characterize the quality of marketed alcohol-based hand sanitizer (ABHS) by evaluating the alcohol content and impurities present in ABHS products manufactured by establishments that registered with the FDA during March-April 2020. A stratified sampling design divided the population of manufacturers into independent groups based on each establishment's level of experience with FDA oversight and its geographic location. ABHS products were collected and analyzed by spatially offset Raman spectroscopy and gas chromatography with mass spectrometry (GC-MS). The GC-MS results for 310 products, from 196 newly registered domestic manufacturers, showed that 71.6% (± 5.7%) of these manufacturers had violative products. In 104 (33.5%) cases, the alcohol content did not meet label claim assay specifications but still fell within CDC efficacy ranges. Ethanol ABHS products failed more often overall (assay and impurities) (84.3%) and for impurities (84.3%), than isopropanol ABHS products (11.2% and 6.2%, respectively). Differences in test results across active ingredients were statistically significant. Ethanol ABHS products often (63.5% of cases) failed due to the presence of acetal or acetaldehyde, particularly in products with pH ≤ 6. Other impurities were also detected in several ABHS products, suggesting the use of low-grade alcohol in the manufacture of these products. Evidence was insufficient to conclude that having experience manufacturing FDA-regulated products, or lack thereof, influenced product-level violative results. This study highlights the importance of sourcing and testing active pharmaceutical ingredients to produce quality drug products.

Scarcity and consumption priorities

This paper focuses on whether economic scarcity tend to change consumption priorities as measured by the share of spending on necessity goods relative to luxury goods in a large national supermarket chain in Israel for the years 2011–2018. Based on detailed weekly revenue data from that supermarket chain, we found that in weeks of economic scarcity (i.e., weeks without payments of social security allowances or salary), the spending on necessity goods, which are regulated products, is down by 4.8%, but the cut in spending on luxury goods is even more pronounced at 8%, and the difference between these two types of goods is up significantly by 3.2%. Within the luxury category, we observe a 10% or more decline in feast-related goods, indicating a “feast and famine” consumption strategy. Nevertheless, spending on food with label claims such as gluten-free and omega-3 eggs, is smaller (6%) than the overall spending on luxury goods in scarcity week but more than the overall spending on necessities.

First foods in a packaged world: Results from the COMMIT consortium to protect young child diets in Southeast Asia

AbstractAlthough commercially produced complementary foods (CPCFs) are increasingly sold throughout Southeast Asia, concerns have been raised about CPCFs nutritional quality, labelling practices and the strength and scope of national CPCF regulations. The Consortium for Improving Complementary Foods in Southeast Asia (COMMIT), composed of UN agencies and civil society organizations, was formed to assess the nutrient gap in the diets of young children and the consumer, product and policy landscapes for CPCFs in seven Southeast Asian countries. Results from a nutrient gap assessment indicate that the diets of children aged 6–23 months are suboptimal and deficient in micronutrients. A consumer survey revealed that caretakers commonly use CPCFs, are conscious of the importance of nutrition and are influenced by label claims. Results from a CPCF benchmarking showed that many products sold in Southeast Asia contained added sugar or sweeteners, had a high total sugar and/or high sodium content and that no CPCF product adhered to all recommended labelling practices. Further, a legal review of national binding legal measures relevant to CPCFs showed minimal alignment with available global guidance. Urgent actions are necessary to strengthen national regulations related to CPCF nutrient composition and labelling practices. To speed progress, COMMIT developed a compendium of existing standards and global guidance to help countries align their national regulations with CPCF composition, labelling and production recommendations. Advocacy to garner public support for new or improved CPCF regulations, as well as strong government monitoring and enforcement of regulations, is crucial to support efforts to safeguard and improve the diets of older infants and young children in Southeast Asia.

CO73 Overview of COA Measures in SLE Clinical Trials and Label Claims

CO73 Overview of COA Measures in SLE Clinical Trials and Label Claims

Exploring consumer beliefs about novel fortified foods: A focus group study with UK-based older and younger adult consumers

Consuming ‘nutritionally-enhanced’ food products (including those that are fortified or enriched to deliver nutritional and functional properties) may help to improve overall diet quality and combat risks associated with malnutrition. However, fortification can negatively impact consumer acceptance, particularly where expected sensory properties of ‘delivery’ foods are affected by target ingredients. Here, we explored factors influencing consumer acceptability for six novel food products that had been fortified, including both savoury and sweet meal components (e.g., high protein dumplings, probiotic yoghurt drink). In person focus groups (25 consumers aged between 22 and 76 years old) were conducted with two stages; firstly, participants completed a blind taste test of products without awareness of fortification. Secondly, participants discussed products with awareness of additional ingredients and food properties. Reflexive thematic analysis showed that liking of sensory properties differed between foods, but informing participants about the fortification of products highlighted potential trade-offs between taste, health, price, and familiarity. Though taste and texture were generally prioritised by participants, positive perceptions of health benefits increased consumer willingness to buy, whilst both cost and uncertainty about product use were potential barriers. Trust of information was a key concern for labelling and product claims. These results highlight product features that may be optimised to support the success of fortified foods. Greater transparency when building product brands and improving consumer knowledge of fortification may also be important for longer-term consumer acceptance.

HPR12 Assessing COA Label Claims Based on Single-Arm Trials in Rare Diseases: A Review of US FDA Labels

HPR12 Assessing COA Label Claims Based on Single-Arm Trials in Rare Diseases: A Review of US FDA Labels

Cure-All cannabidiol? The cannabidiol content of commercial products

BackgroundThe recent easing of regulations around the world regarding Cannabis sativa and its main active compounds, such as cannabidiol (CBD), led to an explosion in the number of over-the-counter consumer products. The number of product types is surpassed by the vast quantity of products of each type, but even this is exceeded by the associated health claims which range from the benign, such as ‘fighting inflammation’, to the completely asinine such as ‘fighting the tyranny of the urgent’ or ‘shedding light on your inner darkness’. Any health claim should in the first instance be supported by the product containing the correct actives at the correct dosage. PurposeThe purpose of this study was to test a diverse range of commercially available product types including soft drinks, honey, coffee, oils, gummy bears, chocolate, etc. that claim to contain CBD and compare the results to their label claims. Study designForty commercially available products were extracted and quantitatively analyzed. MethodsExtraction efficiency for all product types was conducted over a 1 h period using acetonitrile and ultrasonication. Samples were taken every five min and analyzed using a validated HPLC method. All products were then extracted in triplicate using the applicable extraction time and quantitatively analyzed. ResultsFifteen min of sonication was found to be adequate for the oils and drinks samples. The honey, chocolate and gummies samples required initial dissolution in water followed by extraction with acetonitrile. The remaining products required sonication of 45 min. It was found that only three products (7.5 %) contained CBD levels within 90–110 % of their label claim. Two products had trace amounts of delta-9-tetrahydrocannabinol and some of the products were completely devoid of CBD. ConclusionMislabeling is of serious concern and this study shows that the problem not only includes problems with the content of CBD, but also regarding the chemical properties such as containing “water-soluble CBD” while it is insoluble in water, and the diverse number of health claims that in some cases have no foundation in reality. This highlights not only the lax attitude of producers but also of the regulatory authorities in ensuring the consistent quality of these products.

Factors influencing consumer motivations for protein choice.

This study evaluated the factors that motivate US consumers (18-65 years) to choose protein products derived from specific protein sources. An online survey was conducted. Participants who purchased protein products (n=673) were shown agree/disagree questions, along with maximum difference (MaxDiff), constant sum, and Kano questions on factors surrounding protein choice. Last, follow-up qualitative interviews were conducted with 51 survey participants to further investigate consumer motivations behind protein choice. Survey participants conceptually desired a protein product or protein-fortified food that was a good source of protein, tasted great, and was healthy. Three clusters of consumers with distinct motivations for protein purchases were identified. Cluster 1 (C1) consumers (n=176) desired plant-based, environmentally friendly products and valued sustainability label claims more than flavor/taste. Cluster 2 (C2) consumers (n=271) were nutritionally conscious and desired high-protein healthy products that were also high in vitamins/minerals. Cluster 3 (C3) consumers (n=226) showed the most loyalty to the products they currently purchased and were also most willing to try new products based on the recommendations. Cluster 1 consumers placed importance on protein sources, while C2 valued price most and C3 gave the highest value to flavor. In side-by-side protein comparisons, plant-based proteins were considered superior to dairy proteins in sustainability, health, ethics, and digestibility, while both protein types were at parity for naturalness, satiety, and taste across all consumers, but differences were documented among consumer clusters. Results from this study demonstrate that there are many different motivations for consumers to purchase protein products. These motivations can be applied to consumer education as well as the strategic positioning of protein products. Practical Application: This study investigated consumer perception of different protein types and the drivers of choice for protein types among distinct consumer groups. Further application of findings from this study may help guide the development and formulation of new products with a diverse range of protein sources.

A Stable Formulation of a Non-Steroidal Anti-inflammatory Drug, Ibuprofen and an Antihistamine drug, Famotidine for a Combination Therapy

Purpose: The present research study was focused on developing an oral dosage form with two highly incompatible drugs, a non-steroidal anti-inflammatory drug, Ibuprofen and an antihistamine drug, Famotidine to be administered as a combination therapy in a single dose and further asses the stability of the finished product. Methods: A novel drug formulation was designed by employing mini tablets technology to manufacture Famotidine core tablets and the core tablets are further film coated with Opadry II coating solution to inhibit Famotidine contact with Ibuprofen matrix. Film coated Famotidine 30 mg mini-tablets were then encapsulated in Ibuprofen blend to improve the compatibility and stability of the drug product [1,2]. Each mini-tablet of Famotidine contain 5 mg dose of Famotidine and 6 such mini-tablets were encapsulated in each size “00” hard gelatin capsule containing Ibuprofen blend equivalent to 800 mg claim. The stability of the finished product was evaluated in accelerated stability conditions to ensure the impurities are well within the Pharmacopeia (USP) assigned limits. Results: The dissolution release of Ibuprofen and Famotidine is higher than 85 % in 15 minutes and is compared against the only available product in the combination therapy, DUEXIS® (Ibuprofen and Famotidine Tablets 800 mg and 26.6 mg). The stability of the final formulation is evaluated by placing the samples in 40°C/75 % RH storage condition for six months and the results of the pharmacopeia (USP) listed specified and unspecified impurities are well not more than 0.5 % w/w of the label claim. Famotidine and Ibuprofen are two highly in-compatible drugs for a combination therapy, and has been a challenge in the field to formulate for a combination therapy to improve patient compliance. The two drugs tend to form impurities at significate levels in direct physical contact during any stage of the manufacturing process.

Multi-wavelength fusion spectral extraction-assisted HPLC for simultaneous quantification of multiple secondary metabolites in herbal matrices

AbstractThe existing HPLC methods for the assaying of multiple markers in standardized herbal extracts use a single wavelength for quantification, which usually leads to lower assay than actual claims. It was because screening multiple phytochemical standards irrespective to their absorption maxima which drive decrease in peak are response which ultimately impact the assay. To overcome this issue, we have applied a methodology, called Mixed Standard Multi-Signal (MSMS) simultaneous detection, where multiple reference standards get extracted each with their respective λmax and quantification will be done at the same λmax in a single sequence data setup. This method was standardized using Single Signal Multi-Standards, Single Signal Single Standard, Multi-Signal Single Standard, for all individual reference standards, mixed reference standards, plant extracts, and Ayurvedic formulations. The results of our study demonstrate that higher assay reported total actives 5.04% by conventional detection and for current proposed method 13.81% with shorter span of analysis time and lesser solvent consumption. It helps to decide the actual standardization label claim on product which drives better commercial costings, and dosage regimen claims. Graphical Abstract

Plant-based meat alternatives in South Africa: An analysis of products on supermarket shelves.

All over the world, the development of products that resemble meat but contain predominantly plant-sourced ingredients is a prime focus. Meat obtained by rearing animals is associated with a range of important issues related to the sustainability of the planet. Locally, the topic is trending and the cause of various debates among industry role players. This study aimed to explore and analyze plant-based meat alternative (PBMA) products in the South African retail market as well as review internal (nutritional content and ingredients) and external (country of origin, cost/kg, and label claims) factors of the products. This study also compared the nutritional content of PBMA and comparative meat products. Seventy-eight PBMA products were included: plant-based sausages (n = 23), burgers (n = 31), chicken-style (n = 11), mince (n = 8), and an "other" (n = 5) category providing for a variety of product lines. Information from product packaging (total fat, saturated fat, fiber, protein, sugar, sodium, carbohydrates, and energy density) was extracted for all PBMA (n = 78) and comparative meat product lines (n = 28). Meat products tended to be comparatively higher in saturated fat, while PBMAs were higher in carbohydrate, sugar, and dietary fiber content. Sodium content of plant-based mince was approximately five times higher than beef mince. On-pack claims for PBMAs included vegetarian/vegan/plant based (80% of products), high in/source of protein (48%), containing no genetically modified organisms (GMOs; 16%), and gluten free (26%). The plant protein trend has prompted innovation in PBMAs, however, wide nutrient ranges and higher sodium levels highlight the importance of nutrition guidelines for their development to ensure healthier product offerings to consumers. The findings of this study may assist in exploration of consumers' preferences/attitudes or engagement with PBMA products, which could, in turn, guide new product development within the category. However, information about possible barriers, drivers, consumer expectations, and attitudes toward these products is also required.

Development and Validation of an Innovative Stability Indicating Method Using UVSpectroscopy Techniques for Ritonavir in Bulk Drug and Pharmaceutical Dosage Forms

Ritonavir is a protease inhibitor used to treat HIV/AIDS. It is seldom employed for its antiviral activity but instead as a booster for other protease inhibitors. Our study's significant objective is to develop a new, simple, accurate, precise, and reproducible UV spectrophotometric approach for investigation by apotheosis to analyze ritonavir. Three alternative simple, accurate, and precise UV spectrophotometric techniques-the, zero-order (method A), first-order (method B), and the area under the curve (method C) spectrophotometric methods have been established for the measurement of ritonavir in bulk and pharmaceutical dosage. The drug was dissolved in ethanol, and then 0.063 M Phosphate buffer solution (pH 7.0), and the observed λmax are 271 nm for the zero-order spectrophotometric method (method A), 258 nm for the first-order spectrophotometric method, 260–281 nm for the area under the curve spectrophotometric method (method C). Under the optimum conditions, linear relationships with good correlation coefficients 0.9994–0.9999 were found between the reading and the corresponding concentration of the drug in the range of 10-50 μg/ml. The proposed methods can detect the analyte in the lower limits of 0.24 to 0.38 μg/ml. The precision of the methods was satisfactory, and the percentage relative standard deviation values did not exceed 2%. The proposed methods were successfully applied to the analysis of ritonavir in its bulk and commercial formulations with good repeatability and reproducibility; the label claim percentages ranged from 99.56 to 99.64 ± (0.34-0.63) % w/v. The research findings of the current approach were shown to be more accurate and trustworthy for ritonavir in pharmaceutical dosage forms and bulk pharmaceuticals compared to those previously reported by the spectrophotometric approaches. The proposed techniques can be used for routine inspections without causing any interference from excipients or other substances because of the quick and repeatable analysis.

A Rapid, Simplified and Validated Reverse Phase Liquid Chromatography Method for Quantitation of Molnupiravir and Its Generic Versions

Molnupiravir, an orally active RdRp inhibitor, though originally developed to use against influenza, has become a promising therapeutic candidate for COVID-19 infection by acting as prodrug of the nucleoside analog b-d-N4-hydroxycytidine (NHC or EIDD- 931) in the isopropyl ester form. Accordingly, it has been approved by MHRA, UK in November 2021 to use against COVID-19. This work presents the development and validation of a high-performance liquid chromatography (HPLC) method for the rapid and accurate assessment of molnupiravir. The objective of this approach is to ensure the quality control of Lagevrio® capsules and their generic versions available in Bangladesh. The separation was carried out by isocratic elution through C18 column (4.6 mm × 250 mm i.d., 5 µ particle size) at 40 °C temperature at a constant flow rate of 1.0 mL/min using acetonitrile and 1% orthophosphoric acid as buffer (20:80, v/v). A 10 mL sample was injected and elution was monitored at 210 nm wavelength. The calibration curve over the concentration range of 80-120% were found to be linear (r2 = 0.9998), the %RSD for intra-day (0.31%) and inter-day (0.73%) precision indicate good precision where %recovery was found in the acceptable range of 99.9-100.4% as per ICH guidelines. The method was successfully applied to commercial pharmaceuticals, Lagevrio® and its generic versions and and the results were found to be consistent with the label claims (95-105%).

PSV-1 Pasture Does Not Impact Pork Quality of Finishing Hogs

Abstract Sales of certified organic pork continue to increase, and an increasing number of young farmers are looking to rear hogs with organic or other niche labeling claims that require outdoor access. There is limited research available to support pastured pork operations in developing best management practices for rearing pigs in outdoor environments. The goal of this study was to evaluate the impact of housing on swine performance and pork quality and to build best management strategies for raising hogs on pasture. Pigs (n = 50) from the same sire and farrowing cohort were obtained from 10 separate litters. Pigs were grouped into separate treatments according to average body weights (BW) with equal sex rations among both groups: Indoor (n = 25), and Outdoor (n = 25), with 5 hogs per pen within each treatment. The Indoor groups were housed on 7m2 of solid concrete flooring in a ventilation-controlled barn; the Outdoor groups were housed on native grass pasture with pen size being 23m2, and a third shaded with 40% shade cloth. Outdoor pens were rotated to new grass every 14 days to manage soil destruction, while Indoor pigs remained in original pens for the duration of the project. Water access was provided via a nipple drinker system and fed a standard grow-finish ration ad libitum for both groups. All pigs were slaughtered at 26 weeks of age, with the Indoor group averaging BW of 126kg, and the Outdoor group averaging BW of 111kg (P &amp;lt; 0.05). Hot carcass weights were also larger (P &amp;lt; 0.001) of the Indoor group. All pork quality measurements were taken at the 10th rib. Color and marbling scores were not shown to vary between the treatment groups (P ≥ 0.17). Colorimeter values (L*, A*, B*) were similar across treatments as well (P ≥ 0.41). However, loin eye area exhibited a trend with the Outdoor group having a smaller average size (P = 0.07) In addition to this, pH values were also shown to vary at 0h (P = 0.03), 6h (P = 0.01), and 24h (P &amp;lt; 0.01) postmortem, with the Indoor group having the higher ultimate pH. Based on these data, pasture reduced final market size and loin eye area of hogs, but not overall pork quality. Although pH was reduced for the Outdoor group, no values showed a rapid decline in pH that would indicate a PSE pork product. Further, average pH between treatments were within 0.2 at all sampling times. Further research is needed to evaluate efficacy of best management practices to improve efficiency of pig growth rate on pasture and to ensure that pork quality will not be reduced.

Comparison of Key Nutrient Content of Commercial Puppy Foods with Canine Dietary Requirements

A balanced diet significantly impacts a dog’s development with regards to energy, growth, immunity, and overall health. Customizing a dog’s diet according to its age, size, and activity level is imperative for its welfare. Unbalanced diets can lead to nutritional deficiencies. This study assesses the key nutrient content of puppy diets that display information on EPA and DHA fatty acids. The diets fulfilled nutritional requirements for protein and fat according to the European Pet Food Industry Federation (FEDIAF) but varied in terms of levels of essential fatty acids. The nutrient levels in certain diets did not correspond to the label claims. None of the diets fulfilled the EPA and DHA claims, indicating an inconsistent ratio of n−6 to n−3. Additionally, trans fat such as C18:1 elaidic acid was present in all diets.