Label Claim Research Articles

Analysis of Tianeptine in Dietary Supplements

In the United States (US), tianeptine is sold as a dietary supplement under the trade name Tianaa™. Tianeptine is a synthetic drug prescribed by physicians as an antidepressant in parts of Europe, Asia and South America. The drug is not permitted for use by physicians in the US, because it is a μ-opioid receptor agonist with a propensity for severe addiction. As the incidence of Tianaa™-related opioid addiction across the southern US escalates, the current study aimed to quantify tianeptine in over-the-counter Tianaa™ White, Red, and Green products. The results of this investigation measured tianeptine levels between 3.1 and 10.9 mg per 531 mg capsules. Tianaa™ White capsules consistently contained the least tianeptine, while Green had the most. The close inspection of Tianaa™ products showed that capsule mass varied by as much as 16% from label claim, and the amount of tianeptine per capsule varied by as much as 35% from the average measured amount for each product. Tianaa™ Red contains kava leaf extract, which led to the identification of four kavapyrone components by mass spectrometry. The data presented provide insight into tianeptine quantity and capsule mass variation for Tianaa™ supplements sold to customers naive to the risk of addiction.

Effects of wet granulation process variables on the quantitative assay model of transmission Raman spectroscopy for pharmaceutical tablets

Transmission Raman spectroscopy (TRS) is a process analytical technology tool for nondestructive analysis of drug content in tablets. Although wet granulation is the most used tablet manufacturing method, most TRS studies have focused on tablets manufactured via direct compression. The effects of upstream process parameter variations, such as granulation, on the prediction performance of TRS quantitative models are unknown. We evaluated the effects of process parameter variations during granulation on the prediction performance of the TRS quantitative model. Tablets with a drug concentration of 1%w/w were used. We developed PLS calibration models for the drug concentration range of 70–130% label claims. Subsequently, we predicted the drug content of the tablets with different granulation parameters. The results of our study demonstrate that the variation in the predicted recovery due to the variation in granulation parameters was practically acceptable. The calibration model showed a good prediction performance for tablets manufactured at different granulation scales and thicknesses. Therefore, we conclude that TRS quantitative models are robust to variations in upstream processes, such as granulation and downstream variations in tableting parameters. These results suggest that TRS is a versatile non-destructive quantitative analysis method that can be applied in tablet manufacturing.

On assessing the viral safety of individual units of the substance "Human plasma for fractionation" by nucleic acid amplification

Scientific relevance. The absence of blood-borne viruses in human plasma-derived medicinal products must be ensured by the control of raw materials and the manufacturing process.Aim. This study aimed to analyse system suitability criteria for analytical procedures to assess the viral safety of individual units of the substance "Human plasma for fractionation" in terms of the content of nucleic acids of blood-borne viruses, considering the requirements of the European Pharmacopoeia.Materials and methods. The authors analysed individual units of the substance "Human plasma for fractionation" (hereinafter, plasma). The study used the International Standards (ISs) for human immunodeficiency virus RNA, hepatitis A virus (HAV) RNA, hepatitis C virus (HCV) RNA, hepatitis B virus (HBV) DNA, and parvovirus B19 DNA, as well as nucleic acid detection kits for these viruses based on polymerase chain reaction (PCR).Results. HCV RNA was not detected in any of the eight plasma samples studied, and parvovirus B19 DNA was detected in one of the samples at a concentration not exceeding 104 IU/mL. Three tests with the corresponding ISs showed that the studied reagent kits detected HCV RNA at a concentration of 102 IU/mL and parvovirus B19 DNA (M1 genotype) at a concentration of 104 IU/mL. In additional tests that were conducted in two samples considering the requirements of the European Pharmacopoeia for the detection of HCV RNA and parvovirus B19 DNA, a new batch of reagent kit I detected the HCV RNA IS at a concentration of 102 IU/mL only in one of three replicates, which did not correspond to the claimed sensitivity of the reagent kit. HCV RNA was not detected in either replicate in one of two plasma samples spiked with the HCV RNA IS at concentrations of 102 and 103 IU/mL, possibly because of plasma inhibitory properties. The sensitivity of the reagent kits to parvovirus B19 DNA corresponded to the label claims; the study did not show any inhibitory properties of the plasma samples.Conclusions. Polymerase chain reaction testing of the viral safety of plasma intended for manufacturing medicinal products should include control samples calibrated in IU/mL. Further research and appropriate pharmacopoeial reference materials are needed to set system suitability criteria for analytical procedures using such control samples.

Development and validation of simple, precise UV spectrophotometric methods for the quantification of Mebeverine HCl in API and Marketed Products

Simple, rapid, economic and sensitive UV spectrophotometric methods using three solvent mediums viz., 0.1N HCl, Phosphate buffer pH 6.8 and Phosphate buffer pH 7.4 were developed and validated for the estimation of Mebeverine HCl in active pharmaceutical form, Marketed tablets and capsules. The developed methods were validated in terms of linearity, accuracy, precision, and specificity, limit of detection and limit of quantification as per ICH guidelines. The purity of Mebeverine HCl was characterized by melting point and FTIR. At determined absorption maxima of 263 nm for all solvents proved to be linear in the range of 1-50 µg/ml and exhibited good correlation coefficient (R2 = 0.9999, 0.9992, 0.9999) and recovery of (99.00 – 104.55%). This method is applied for two marketed Mebeverine HCl brands and results were in good agreement with label claim. The methods were validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The obtained results proved that the method can be employed for the routine analysis of Mebeverine HCl in active pharmaceutical form as well as in the commercial marketed formulations viz., tablets and capsules.

Rampant online marketing of teeth whitening products: Evaluation of online information, labelling accuracy and quantitative analysis of high peroxide content gels

Background/Purpose: Online vendors seize the advantage of the high demand on home-use, do-it-yourself dental bleaching products. The study aims to present the uncontrolled online market of dental products and provide evidence of consumer safety risks associated with the utilization of high peroxide content bleaching products without dentist's supervision, and also to identify misleading and insufficient information on content and compromised product quality. Materials and methodsA complex risk-based methodology was used including website content evaluation focusing on ingredients, precautionary statements and directions for use provided by online retailers. Bleaching products were test procured in which packaging and labels were documented and assessed. Quality control was performed using the permanganometric method per the official European Pharmacopoeia. ResultsOne (16.7%) of six test procured peroxide gels was not delivered. Another arrived without enclosed description or instructions. The ingredient list was incomplete or missing for all (100%) online products, however, it was listed on the label or in enclosed documentation in four out of five (80%) samples. Precautionary statements were scarcely (16.7%) disclosed online, contrarily, safety claims were emphasized by most (83.3%) websites. Contraindications and adverse effects were mentioned in the majority (80%) of the delivered product labels. One sample contained no active principle, in two sample’ peroxide content exceeded the label's claim by 5.2–9.0% while in another two it was below the concentration indicated on the labels by 79.9–80.7%. ConclusionsDissimilarity in regulations elicits an opportunity for consumers to purchase inappropriately labeled, questionable quality, high peroxide content dental products without information regarding ingredients, application and risks. The uncontrolled market, easy access and unsupervised application of high peroxide-content teeth whiteners imply patient safety issues.

RP-HPLC Method Development and Validation for the Estimation of Lafutidine using Bulk and Pharmaceutical Dosage Forms

A simple and selective LC method is described for the determination of Lafutidine in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of Phosphate buffer (KH2PO4) pH4.0: Acetonitrile (30:70v/v/v), with detection of 299nm. Linearity was observed in the range 60-140µg/ml for Lafutidine (r2 =0.999) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. From the above experimental results and parameters it was concluded that, this newly developed method for the simultaneous estimation of Lafutidine was found to be simple, precise, accurate and high resolution and shorter retention time makes this method more acceptable and cost effective and it can be effectively applied for routine analysis in research institutions, quality control department in meant in industries, approved testing laboratories, bio-pharmaceutical and bio-equivalence studies.

Separation and quantification of azelnidipine and chlorthalidone in a synthetic mixture using optimized HPTLC method

A simple, accurate, and reliable high-performance thin-layer chromatographic technique has been developed and validated for the simultaneous quantitation of azelnidipine and chlorthalidone in bulk and synthetic mixtures. The procedure was carried out using a precoated silica gel 60 F254 TLC plate with a mobile phase of chloroform, ethyl acetate, and methanol in the ratio of 6.5:3.5:0.6 (by volume). Thin-layer chromatographic densitometry at 240nm was used to quantify medicines chromatographically. Over concentration ranges of 250.0 to 1000.0ng/band for chlorthalidone and 160.0 to 640.0ng/band for azelnidipine, the high-performance thin-layer chromatography technique was quantitated. This technique produced a tight and well-resolved band at retention factors of 0.67±0.02 and 0.24±0.02 for azelnidipine and chlorthalidone, respectively. Data from a linear regression study calibrating this method revealed a strong linear correlation between the two approaches, with regression coefficients of r2>0.99 for both. According to The International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use requirements, the procedures were validated for precision, robustness, accuracy, and specificity. The developed method was also used to simultaneously estimate azelnidipine and chlorthalidone in a synthetic mixture. The results were found to be in exemplary % assay with label claims.

What are Brazilian plant-based meat products delivering to consumers? A look at the ingredients, allergens, label claims, and nutritional value

The aim of this study was to analyze the labels of plant-based meat analogues (PBMAs) sold in Brazilian supermarkets. The study focused on ingredient lists, allergens, label claims, and nutritional values. Of the 59 products analyzed, 38 listed soy as the primary source of protein, while pea and wheat were the next most common sources. Sunflower oil was the most frequently listed lipid source, appearing in 19 of the products. The labels of 70% of the products made claims such as "100% vegetable," "no preservatives or colorings," and "source of fiber." Compared to traditional meat products, PBMAs showed wide variation in energy, protein, lipid, and carbohydrate values. The highest protein content was found in hamburgers, meat/chicken, sausage, and hotdogs, while hamburgers and meatballs had the highest saturated fat content. When compared to legislation on meat products, only 49% and 23% of the PBMAs met the minimum protein and maximum carbohydrate levels, respectively. These findings suggest that dedicated regulations for plant-based meat alternatives are necessary to ensure consumers can make informed choices and support the development of the plant-based meat industry.

Do clinical trials prepare to fail by failing to prepare? An examination of MS trials and recommendations for patient-reported outcome measure selection.

Many clinical trials use patient-reported outcome (PRO) measures, which can influence treatment decision-making, drug approval and label claims. Given that many PRO measure options exist, and there are conceptual and contextual complexities with PRO measurement, we aimed to evaluate how and why specific PRO measures have been selected for pivotal multiple sclerosis (MS) clinical trials. Specifically, we aimed to identify the reasons documented for PRO measure selection in contemporary phase III MS disease-modifying treatment (DMT) clinical trials. We searched for phase III clinical trials of MS DMTs published between 2015 and 2021 and evaluated trial protocols, or primary publications where available, for PRO measure selection information. Specifically, we examined study documents for their clarification of clinical concepts measured, definitions of concepts measured, explanations of which PRO measures were considered, why specific PRO measures were chosen, and trade-offs in PRO measure selection. We identified 1705 abstracts containing 61 unique phase III MS DMT clinical trials. We obtained and examined 27/61 trial protocols. Six protocols were excluded: four contained no mention of PRO measures and two contained redacted sections preventing adequate assessment, leaving 21 protocols for assessment. For the remaining 34 trials (61-27), we retrieved 31 primary publications; 15 primary publications mentioned the use of a PRO measure. None of the 36 clinical trials that mentioned the use of PRO measures (21 protocols and 15 primary publications) documented clear PRO or clinical outcome assessment (COA) measurement strategies, provided clear justifications for PRO selection, or reasons why specific PRO measures were selected when alternatives existed. PRO measure selection for clinical trials is not evidence-based or underpinned by structured systematic approaches. This represents a critical area for study design improvement as PRO measure results directly affect patient care, PRO measurement has conceptual and contextual complexities, and there is a wide range of options when selecting a PRO measure. We recommend trial designers use formal approaches for PRO measure selection to ensure PRO measurement-based decisions are optimised. We provide a simple, logical, five-stage approach for PRO measure selection in clinical trials.

Stability of lyophilized Meningococcal A conjugate vaccine, (MenAfriVac™) at elevated temperatures to support controlled temperature chain (CTC) claim

Meningococcal A Conjugate Vaccine (MenAfriVac) is the world’s first Monovalent Conjugate Vaccine against Neisseria Meningitidis serogroup A which has obtained Controlled Temperature Chain (CTC) label claim of “stable upto 40°C for 4 days prior to reconstitution” developed by Serum Institute of India Pvt. Ltd. Pune, India and the vaccine was granted permission from World health Organization. This paper elucidates and talks about the layout of various studies performed to characterize the product to declare as CTC at the time when the knowledge and mechanism to describe CTC was not fully known which in term helped to design the CTC guidelines.Product stability was assessed using clinical, consistency and regular lots released by NRA. The critical stability indicating parameters like free polysaccharide, molecular size distribution along with Potency and safety tests were carried out to support the product stability making sure it also qualifies for Vaccine Vial Monitor label claim of VVM30. An additional in use stability (reconstitution) was also performed. All studies indicated that the product remains stable at real time as well as elevated temperatures and well within the specifications approved by NRA and formed the strong basis for CTC claim which is now recommended by WHO.

Vitamin C bioaccessibility of commercially available dietary supplements: Quantity vs efficiency, does it matter?

Knowing the label claims and bioaccessibility of vitamin C supplements is essential for determining daily vitamin C intake. The purpose of the present study was to investigate the bioaccessibility of vitamin C in commercial dietary supplements by an in vitro digestion model. In our study, 17 products were examined, including 2 capsules, 15 tablets (9 of these 15 tablet were effervescent tablets). In most commercial dietary supplements, the measured amounts of vitamin C were very close to or higher than the declared amounts. The average measured vitamin C amount of the products were between 90.3 % and 107.5 % of the declared amount. The in vitro bioaccessibility of vitamin C in dietary supplements was ranged from 4.0 % to 88.0 %. We observed that the bioaccessibility of vitamin C is higher in mono-supplements compared to multi-supplements. Our results showed that the bioaccessibility of dietary supplements was highly variable. Differences in ingredients of dietary supplements may affect the bioaccessibility of vitamin C. Consequently, the ingredients of the vitamin C supplements and the coating technology used are likely to affect supplementation efficiency.

A robust nanoLC high-resolution mass spectrometry methodology for the comprehensive profiling of lactic acid bacteria in milk kefir

Consumer attention to functional foods containing probiotics is growing because of their positive effects on human health. Kefir is a fermented milk beverage produced by bacteria and yeasts. Given the emerging kefir market, there is an increasing demand for new methodologies to certify product claims such as colony-forming units/g and bacterial taxa. MALDI-TOF MS proved to be useful for the detection/identification of bacteria in clinical diagnostics and agri-food applications. Recently, LC-MS/MS approaches have also been applied to the identification of proteins and proteotypic peptides of lactic acid bacteria in fermented food matrices.Here, we developed an innovative nanoLC-ESI-MS/MS-based methodology for profiling lactic acid bacteria in commercial and artisanal milk kefir products as well as in kefir grains at the genus, species and subspecies level. The proposed workflow enables the authentication of kefir label claims declaring the presence of probiotic starters. An overview of the composition of lactic acid bacteria was also obtained for unlabelled kefir highlighting, for the first time, the great potential of LC-MS/MS as a sensitive tool to assess the authenticity of fermented foods.

Method Development and Validation of UV-Spectrophotometric Estimation of Hydroxychloroquine Sulphate in Bulk and Pharmaceutical Dosage Form

Aims: The devised method for estimating hydroxychloroquine sulphate in bulk and pharmaceutical dose forms (tablets) is the subject of this work. The method can therefore be applied to regular quantitative analysis and stability. The following describes the planned work's goal and scope:
 
 To create an appropriate spectrophotometric method for tablet-based hydroxychloroquine sulphate estimation.
 Carry out the method's validation.
 
 Methodology: These techniques include the area under curve (AUC) method-I and the A1% solution method based on absorbance measurement, or method-II, both of which are chosen at wavelengths of 329.4 nm using a UV-visible spectrophotometer with a 1 cm matched quartz cell and 0.01N acetic acid with water as a solvent.
 Results: Plots of the hydroxychloroquine sulphate absorption spectra in 0.01N acetic acid were made. 329.4 nm was found to be the average maximum. With correlation coefficients of 0.9992 and 0.999 (r2>0.999) for AUC and 1%, respectively, and a linear connection between the absorbance and drug concentration in concentration ranges of 5-35 g/mL, it is clear that the method is linear. The percentage of medication calculated by various methods was close to 100.12, and 99.41% of the results were consistent with the label claim of the commercially available tablet formulation. As per ICH requirements, the validation parameter research was completed.
 Conclusion: The described UV methods offer good accuracy and precision with reduced limits of detection and quantification. They are straightforward, trustworthy, and highly selective. These disclosed methods are ideal for routine quantitative analysis in pharmaceutical dosage forms due to the decreased time required for analysis of hydroxychloroquine sulphate. The time-saving, low-cost alternative to the expensive high-performance liquid chromatographic technology is the applied spectrophotometric approaches.

Application of Principal Component Analysis and DoE-Driven Green Analytical Chemistry Concept to Liquid Chromatographic Method for Estimation of Co-formulated Anti-Hypertensive Drugs.

The fixed-dose combination (FDC) of metoprolol succinate (MTS), cilnidipine (CDN), and telmisartan (TST) is used for the management of hypertension. Numerous reversed phase (RP)-HPLC methods have been reported in the literature for chromatographic analysis of MTS, CDN, and TST. According to the concept of green analytical chemistry (GAC), toxic organic solvents should be avoided or minimized during chromatographic method development for the safety of analysts and the protection of the environment. The reported RP-HPLC methods have been developed using acetonitrile (ACN) or methanol as an organic component of the mobile phase and diluent for sample preparation. These organic solvents are considered toxic solvents as per the International Council for Harmonization (ICH) Q3C (R6) guideline and Pfizer medicinal chemistry solvent selection (PMCSS) guide. We aimed to develop an environment-friendly and economical RP-HPLC-photo-diode array (PDA) method for the analysis of MTS, CDN, and TST using less toxic organic solvents to support the concept of GAC. The method development was carried out by the implementation of chemometrics and design of experiments (DoE) to avoid wastage of organic solvent. Principal component analysis (PCA) was applied as a chemometric tool for the identification of critical method risk variables (MRVs) and method performance attributes (MPAs). The identified critical MRVs and MPAs were further studied by DoE-based response surface modelling for optimization of the method. The chromatographic analysis of MTS, CDN, and TST was carried out using a Shim-pack ODS column as a stationary phase and ethanol as an organic modifier in the mobile phase. The developed method was applied to the assay of FDCs and results were found to be in compliance with the label claim. The greenness profiles of reported and present RP-HPLC methods were evaluated by national environmental method index (NEMI) and analytical greenness (AGREE) methods. The developed method was found to be green, robust, and economical as compared to published methods for the analysis. Development and validation of an RP-HPLC method for simultaneous estimation of MTS, CDN, and TST using safe organic solvents. Implementation of a analytical quality by design (AQbD) approach in method development using PCA and DoE. Application of the method for assay of FDCs of MTS, CDN, and TST.

Exploration of price variation, elemental profile, and fortification of commercial Indian edible salts with iodine, potassium, iron, magnesium, and calcium

The different types of edible rock salts (black, and pink) are fetching premium price compared to white sea salt. Survey of 300 individuals indicated that black rock salt is mainly used for sprinkling and sea salt for cooking. Further, people are switching to white rock salt for cooking due to the influence of traditional knowledge, friends, advertisements, and label claims. The elemental profile of commercial salt samples were analyzed to identify a scientific basis for this. We collected 14 different colored (black, pink) edible salt samples from supermarkets, local shops and health food shops in Mohali, Punjab, India. Various analytical and biochemical investigations were used for the analysis of 25 elements, vitamin and phenolic content. The recommended level of iodine (I) fortification (≥50% RDA) was found only in 20% of the salts studied. The potassium (K) fortification (10-20 % K/Na) was found only in two salts. One salt sample crossed the toxic limits of lead (Pb). Black salt exhibited the highest iron (Fe) (10-20% RDA). Other claimed nutrients/mineral Ca, Mg, vitamin and phenolic content was not observed in any salt (< 5 % RDA).In conclusion, taste, tradition, and social media affect salt preference, and our research provides the scientific data.

Physicochemical and In-Vitro Bioequivalence Analysis of Some Oral Solid-Dosage Metronidazole Formulations

Background: Metronidazole is a 5-nitroimidazole antimicrobial agent, widely used in the treatment of infections caused by Trichomonas vaginalis, such as trichomoniasis, pseudomembranous colitis, and symptomatic amoebiasis resulting from anaerobic bacteria. Aim: The study aimed to qualitatively determine the quality and in-vitrobioequivalence of selected brands of metronidazole tablet dosage forms used in the management of infectious diseases. Method: The British Pharmacopeia (BP) Standard methods were followed to conduct weight uniformity, disintegration time, hardness, and friability tests. For the Thin Layer Chromatographic (TLC) Fingerprinting, 0.1g of the brands were weighed and dissolved ins 50 ml methanol (50%). The stock solution was prepared using 50% methanol and 50% dichloromethane and was transferred into the Chamber and allowed to stand for about 45 minutes; the plates were viewed under UV-VIS Spectrophotometer at 365 nm. Result: All the brands complied with the acceptable friability limit, and disintegrated within the appropriate time of not more than 15 minutes as specified in BP, for uncoated tablets. The tablets were found to have a dissolution profile of at least 70% of the active ingredient taken at 45 minutes from the dissolution medium as stated in BP. The analysis showed the consistency of concentration of the selected tablet brands with the label claims. Conclusion: The TLC procedure used in the analysis was accurate and precise, no interference was observed from the excipients. Thus, this method can be used in the routine quality control of metronidazole solid dosage form.

A COMPARATIVE QUALITY STUDY OF SELECTED AUTHORIZED AND SMUGGLED MEDICINES IN ADEN, YEMEN

In Yemen, most of the medicines are imported. Drugs that enter the country by legal means undergo some tests by Supreme Board for Drugs and Medical Appliances (SBDMA) to evaluate the quality of the product. However, some medicines enter the country illegally (smuggling) and this makes them bypass the evaluation of their quality by the SBDMA. This work was carried out to determine the physical quality control parameters of authorized and smuggled drug products marketed in Aden pharmacies. The authorized and smuggled brands of cefuroxime (CEF), atorvastatin (ATR), and carvedilol (CAR) tablets available in Aden pharmacies were selected. The tablets were evaluated for their physical properties and quality control parameters including weight variation, hardness, friability, and disintegration test. The level of drug content also was evaluated using UV spectroscopy. The physical assessment showed that the authorized and smuggled brands of the same products were uniform in shape, color, packing, and labeling information except for the registration number and manufacture date which were present only on the authorized brands. The three authorized and smuggled brands of CEF, ATR, and CAR complied with the official specifications for weight version, diameter, thickness and hardness, friability, and disintegration tests except for the hardness value of ATR. All authorized brands agreed with the label claims whereas some smuggled brands contained the appropriate active ingredients but did not contain the right amounts.

Objective assessment of the variation in number of doses of generic timolol eye drops along with their cost effectiveness.

First, this study aims to ascertain if truly the generic timolol eye drops circulating in Abuja and it environ are interchangeable. Secondly, we explore their cost effectiveness in naira based on the dispensing position. Using official guidelines, we assessed seven generic timolol ophthalmic preparations for organoleptic, pH, viscosity, sterility, and assay test. After this, they were tested in the vertical (90 ⁰) and horizontal (30 ⁰) positions for filled volume in a bottle, the total number of drops per bottle, drops per mL; and eventually the total number of bottles needed per year, cost per year and their cost effectiveness per mmHg were extrapolated. All brands were colorless and devoid of particulate contamination. Assay, pH, and viscosity values were within the compendia specification (BP and USP) for eye drops. The sterility assay showed no evidence of bacterial or fungi growth. All brands had actual filled volume less than or equal to the stated label claim. Their drops per 5 mL bottle range from 141-169 and 122-139 when dispensed in vertical and horizontal positions respectively; while for brands with 10 mL label volume, they range from 305-321 and 299-309 drops per bottle for vertical and horizontal dispensing respectively. Brand T1 (which is the most expensive) would need two bottles less in a year if the medication were to be dispensed vertically, amounting to N 3,200.00 ($ 7.04) reduction in treatment cost and a 45 % improvement in cost-effectiveness per intraocular pressure (IOP) reduction per year. In conclusion, the dispensing technique played a significant role in the number of drops per bottle, this would however impact on the treatment cost of glaucoma patient placed on timolol eye drop.

AWARENESS OF AGRO INPUT DEALERS ABOUT INSECTICIDE LABEL CLAIMS

Insecticide label claims are important sources of information for the farmers and the agro input dealers who sell them. They provide information about the active ingredients, mode of action, target pests, dosage, application method, safety precautions and environmental impact of the insecticides. However, the awareness level of the agro input dealers about these label claims is not well known. This study aimed to assess the awareness level of 120 agro-input dealers in Beed district of Maharashtra state, India, about the insecticide label claims and their toxicity labels. The study also examined the relationship between the profile of the agro input dealers and their awareness level, and identified the constraints and suggestions of the agro-input dealers regarding the insecticide label claims. The study used a structured questionnaire to collect data from the respondents through personal interview method. The data were analysed using frequency, percentage, mean, standard deviation and correlation coefficient. The results showed that the majority of the agro-input dealers had low to medium level of awareness about the insecticide label claims and their toxicity labels. The profile variables such as age, education, experience, training and membership in association had significant positive correlation with their awareness level. The major constraints faced by the agro input dealers were lack of training, inadequate display of label claims, complex language of label claims and low literacy level of farmers. The major suggestions given by the agro input dealers were to provide regular training, simplify the language of label claims, increase the font size and colour contrast of label claims and educate the farmers about the importance of label claims.

An assessment of qualitative and quantitative cannabinoids analysis in selected commercially available cannabis oils in Argentina

In recent years, the therapeutic use of cannabis products, especially cannabis oils, has increased significantly, due to the pharmacological potential of their cannabinoids, for the treatment of conditions, such as pain management, cancer, and epilepsy. In Argentina, patients with medical prescriptions can access to cannabis oil, through self-cultivation, a third-person (grower or importer), or a civil organization authorized for that purpose. However, these products remain largely unregulated in Argentina, and information available regarding labeling accuracy, especially cannabidiol (CBD)/ Δ9-tetrahydrocannabinol (Δ9-THC) concentrations are inconsistent or nonexistent, nor long-term product stability, and lot to lot variability. Understanding these properties is fundamental if these products are to be used in patients with a determinate pathology. Therefore, we analyzed commercially available cannabis oils (n: 500) in Argentina for qualitative and quantitative cannabinoids content. In order to provide a detailed overview of their cannabinoids profiles, and determine Δ9-THC, CBD, and cannabinol (CBN) concentrations, samples were diluted and analyzed by gas chromatography– mass spectrometry (GC/MS). Most of the samples tested positive for cannabinoids (n: 469) with Δ9-THC and CBD as the predominant cannabinoids. Among products tested, only 29.8% (n: 149) gave specific CBD label claims, and testing indicated a CBD tested positive of 70.5% (n: 105). For products (n: 17) with a THC-free label claim, testing indicated 76.5% (n: 13) of Δ9-THC positive, and cannabinoids were not detected in four products. Δ9-THC concentrations ranged from 0.1 to 143.0 mg/mL, CBD concentrations from 0.1 to 125.3 mg/mL, and CBN concentrations from 0.04 to 60.10 mg/mL; CBN/ Δ9-THC ratios ranged from 0.0012 to 2.31, and CBD/ Δ9-THC ratios from 0.0008 to 178.87. Furthermore, the (Δ9-THC + CBN)/CBD ratio of most samples was greater than one. In summary, our results indicate that cannabis oil products show wide variability in cannabinoids content, purity, and labeling.