Overcoming Recruitment Challenges: A Pilot Study in Arab Americans

While diabetes prevalence and cardiovascular risk factors have been increasing among Arab populations worldwide, few studies of Arab Americans have been conducted because of the difficulty in recruiting Arab American participants. Cultural sensitivity and social awareness of different immigrant groups could ensure successful recruitment and retention in clinical studies. While the primary objective of our overall research project was to determine the prevalence of metabolic syndrome in Arab Americans, the focus of this article is to describe the methodology used to overcome challenges in recruiting and enrolling Arab Americans for a community-based study. We used novel methods, including open houses, religious-based venues, and engagement of community leaders, to encourage participation in this clinical and epidemiological study. A community-based approach involving community leaders and educators was useful in recruiting and encouraging participation in this study. As a result, we were able to collect clinical and anthropometric data from 136 Arab American men and women living in the Washington, DC, area and obtain information regarding their chronic diseases, mental health, and acculturation into U.S. culture and lifestyle. Our sampling methodology may serve as a model of a successful recruitment and enrollment strategy, and may assist other researchers to ensure sufficient power in future studies. Engagement of minority participants in clinical studies will enable the creation of targeted clinical intervention and prevention programs for underrepresented and understudied populations

Quantitative determination of artificial sweeteners and sucrose in energy drinks and mango juice available in Dhaka city

Energy drinks and mango juice are popular beverages. Apart from the natural ingredients and some additives present in these drinks, sugar is an important component of both. It has been established that, other than providing sweetness, sugars are potent to bring about health consequences for their consumers. Sweeteners, both artificial (aspartame, sodium cyclamate, and saccharin) and natural (sucrose), were our centers of interest. This study aimed to determine the presence and levels of these sweeteners in energy drinks and mango juice. Spectrophotometric methods were used to determine the concentration of the mentioned sugars. For this purpose, a total of 42 samples of 7 different brands were collected from different locations in Dhaka city, Bangladesh. The methods were found to be linear over the concentration range of 10-26 µg/mL (r2=0.9989), 137-320 µg/mL (r2=0.9891), 2.5-24 µg/mL (r2=0.9915) and 2354-2784 µg/mL (r2=0.9985) for aspartame, sodium cyclamate, saccharin, and sucrose, respectively. Mango juice contained a relatively lower amount of saccharin compared to energy drinks. In the case of aspartame, one brand of energy drinks had the least amount. Moreover, both energy drinks and mango juice had a similar content of sodium cyclamate, but one brand of mango juice had a relatively low content of sodium cyclamate

COVID-19: Is There Evidence for the Use of Herbal Medicines as Adjuvant Symptomatic Therapy?

Background: Current recommendations for the self-management of SARS-Cov-2 disease (COVID-19) include self-isolation, rest, hydration, and the use of NSAID in case of high fever only. It is expected that many patients will add other symptomatic/adjuvant treatments, such as herbal medicines. Aims: To provide a benefits/risks assessment of selected herbal medicines traditionally indicated for “respiratory diseases” within the current frame of the COVID-19 pandemic as an adjuvant treatment. Method: The plant selection was primarily based on species listed by the WHO and EMA, but some other herbal remedies were considered due to their widespread use in respiratory conditions. Preclinical and clinical data on their efficacy and safety were collected from authoritative sources. The target population were adults with early and mild flu symptoms without underlying conditions. These were evaluated according to a modified PrOACT-URL method with paracetamol, ibuprofen, and codeine as reference drugs. The benefits/risks balance of the treatments was classified as positive, promising, negative, and unknown. Results: A total of 39 herbal medicines were identified as very likely to appeal to the COVID-19 patient. According to our method, the benefits/risks assessment of the herbal medicines was found to be positive in 5 cases (Althaea officinalis, Commiphora molmol, Glycyrrhiza glabra, Hedera helix, and Sambucus nigra), promising in 12 cases (Allium sativum, Andrographis paniculata, Echinacea angustifolia, Echinacea purpurea, Eucalyptus globulus essential oil, Justicia pectoralis, Magnolia officinalis, Mikania glomerata, Pelargonium sidoides, Pimpinella anisum, Salix sp, Zingiber officinale), and unknown for the rest. On the same grounds, only ibuprofen resulted promising, but we could not find compelling evidence to endorse the use of paracetamol and/or codeine. Conclusions: Our work suggests that several herbal medicines have safety margins superior to those of reference drugs and enough levels of evidence to start a clinical discussion about their potential use as adjuvants in the treatment of early/mild common flu in otherwise healthy adults within the context of COVID-19. While these herbal medicines will not cure or prevent the flu, they may both improve general patient well-being and offer them an opportunity to personalize the therapeutic approaches

Design, Fabrication and Evaluation of Drug Release Kinetics from Aceclofenac Matrix Tablets using Hydroxypropyl Methyl

ABSTRACT: The objective of this study was to develop a sustained release matrix tablet of aceclofenac using hydroxypropyl methylcellulose (HPMC K15M and HPMC K100M CR) in various proportions as release controlling factor by direct compression method. The powders for tableting were evaluated for angle of repose, loose bulk density, tapped bulk density, compressibility index, total porosity and drug content etc. The tablets were subjected to thickness, weight variation test, drug content, hardness, friability and in vitro release studies. The in vitro dissolution study was carried out for 24 hours using United States Pharmacopoeia (USP) 22 paddle-type dissolution apparatus in phosphate buffer (pH 7.4). The granules showed satisfactory flow properties, compressibility index and drug content etc. All the tablets complied with pharmacopoeial specifications. The results of dissolution studies indicated that the formulations F-2 and F-3 could extend the drug release up to 24 hours. By comparing the dissolution profiles with the marketed product, it revealed that the formulations exhibited similar drug release profile. From this study, a decrease in release kinetics of the drug was observed when the polymer concentration was increased. Kinetic modeling of in vitro dissolution profiles revealed the drug release mechanism ranges from diffusion controlled or Fickian transport to anomalous type or non-Fickian transport, which was only dependent on the type and amount of polymer used. The drug release followed both diffusion and erosion mechanism in all cases. The drug release from these formulations was satisfactory after 3 months storage in 40 0 C and 75 % RH. Besides, this study explored the optimum concentration and effect of polymer(s) on acelofenac release pattern from the tablet matrix for 24 hour period. Key words: Aceclofenac, sustained release, hydrophillic matrix, HPMC, direct compression

Development and Validation of RP-HPLC Method for Quantitative Estimation of Vinpocetine in Pure and Pharmaceutical Dosage Forms

A simple, precise, specific, and accurate reversed phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for determination of vinpocetine in pure and pharmaceutical dosage forms. The different analytical performance parameters such as linearity, accuracy, specificity, precision, and sensitivity (limit of detection and limit of quantitation) were determined according to International Conference on Harmonization ICH Q2 (R1) guidelines. RP-HPLC was conducted on Zorbax C18 (150 mm length × 4.6 mm ID, 5 μm) column. The mobile phase was consisting of buffer (containing 1.54% w/v ammonium acetate solution) and acetonitrile in the ratio (40 : 60, v/v), and the flow rate was maintained at 1.0 mLmin−1. Vinpocetine was monitored using Agilent 1200 series equipped with photo diode array detector (λ = 280 nm). Linearity was observed in concentration range of 160–240 μgmL−1, and correlation coefficient was found excellent (R2 = 0.999). All the system suitability parameters were found within the range. The proposed method is rapid, cost-effective and can be used as a quality-control tool for routine quantitative analysis of vinpocetine in pure and pharmaceutical dosage forms

In vitro Release Kinetic Study of Esomeprazole Magnesium from Methocel K15M and Methocel K100 LVCR Matrix Tablets

ABSTRACT: In the present study esomeprazole sustained release tablet matrix was prepared by utilizing different grades of hydroxypropyl methylcellulose (HPMC) polymers such as Methocel K15M & Methocel K100 LVCR by direct compression method. Different amount of Methocel K15M was used to develop matrix builder in the seven proposed formulations (F1-F7) for the study of release rate retardant effect at 20%, 25%, 30%, 35%, 40%, 45 % and 50 % of total weight of tablet matrix respectively. The dissolution study of Methocel K15M based tablet matrices of those proposed formulations were carried out in the simulated gastric medium (pH 1.3) for first two hours and then in the simulated intestinal medium (pH 6.8) for 8 hours using USP dissolution apparatus II. The formulation F-5 (40%) and F-6 (45%) met the optimum release rate of esomeprazole for 10h period of in vitro dissolution study. The release kinetics of formulation F-5 and F-6 very closely followed Higuchi kinetic order than first order and zero order kinetics. Similarly Methocel K100 LVCR was used to develop matrix builder in another seven proposed formulations (F8-F14). It was found that formulations F-11 (35%), F-12 (40%) and F-13 (45%) met the desired release rate of esomeprazole for 10h period. The release kinetics of formulation F-11, F-12 and F-13 followed Higuchi kinetic order. Between these two polymers, Methocel K100 LVCR showed better release retardant effect than Methocel K15M

Full factorial design assisted RP-UHPLC method development and study of stressed degradation of molnupiravir

To combat the SARS-CoV-2 addition of molnupiravir into the current therapeutic regimen has added new hopes. But currently, not so many analytical methods are available for analyzing molnupiravir. The current study aimed at developing a suitable and efficient RP-UHPLC method for molnupiravir capitalizing full factorial design. The optimized method involved the use of trifluoroacetic acid (0.1%): methanol at a ratio of 65:35 (%, v/v) with fortis diphenyl HPLC column (150 mm x 4.6 mm i.d. [internal diameter], 5 μm particle size). The method was found highly specific (purity index <1.5), linear (0.5-100 μg.mL-1), accurate (~100%), precise, rugged, and robust (%RSD<2). A stress degradation study exhibited that 0.1N HCl at 100˚C (±1˚C) for 2 hours caused drug degradation crossing its limit (>10%), the drug is extremely susceptible to basic hydrolysis and 0.1N NaOH at room temperature for 1 min caused 65.43% degradation, exposure in 3% H2O2 at 100˚C (±1˚C) for 1 hours caused the drug degradation over 10%, and 5 days of exposure to short wavelength UV light caused 13.16% of drug degradation. The research work successfully developed an efficient and validated method for analyzing molnupiravir in the RP-UHPLC system. Moreover, the degradation study performed will aid in adding integral information related to the stability of the drug molecule