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The evaluation of the efficacy of incorporation of quercetin in nanoparticles is crucial, both for the development and quality control of pharmaceutical formulations. The validation of analytical methods for the precise quantification of quercetin is useful for the evaluation of various potential quercetin delivery systems and quercetin pharmacokinetics. This work aimed to validate a high-performance liquid chromatography with diode array detection (HPLC-DAD) method for quercetin detection and quantification in nanoparticles. Different mobile phase conditions and detection wavelengths (254 and 368 nm) were tested, and the major validation parameters were assessed (precision, accuracy, linearity, sensitivity, stability, and selectivity). The best peak resolution was obtained when quercetin was analyzed at 368 nm with a mobile phase of 1.5% acetic acid and a water/acetonitrile/methanol ratio of 55:40:5. Under these conditions, quercetin also eluted rapidly (retention time of 3.6 min). The method proved to be linear (R2 > 0.995), specific, and repeatable (variation coefficient between 2.4% and 6.7%) and presented intermediate precision (variation coefficient between 7.2% and 9.4%). The accuracy of the analysis ranged between 88.6% and 110.7%, and detection and quantification limits were 0.046 and 0.14 µg/mL, respectively. Quercetin solutions were more stable when stored at 4 °C than at room temperature or -20 °C. This validated method satisfied more parameters of bias assessment than most recent methods for quercetin determination and presented itself as more sensitive and efficient than general spectrophotometric methods. The method was successfully used for the analysis of quercetin incorporation in nanoparticles and will be evaluated in the future for its adequacy for the determination of quercetin in more complex matrices.
RESUMO
The use of information and communication technologies (ICTs) has revolutionized the provision of health services, often referred to as eHealth, benefiting community pharmacies that can offer new services in innovative formats, namely through telepharmacy. This study aimed to explore the perceptions of pharmacy professionals (i.e., pharmacists and pharmacy technicians) on the provision of new services. The study consisted of administering an online questionnaire to pharmacy professionals nationwide. The questionnaire was developed by the research team, based on focus group methodology, from which an inductive analysis led to the categories that made up the dimensions of the survey. Participants were 95 pharmacy professionals with a mean age of 33.69 years old (SD = 10.75). Almost 79% were women. The results show overall receptivity to the development of new services in community pharmacies. Suggestions for the development of the new services, conditions necessary for their implementation, potential obstacles, and strategies to promote adherence to the new services, among others, are identified. The knowledge thus acquired will help community pharmacies to develop innovative solutions in counselling, pharmacotherapy monitoring, and pharmacovigilance, for example, of herb/dietary supplement-drug adverse reactions and interactions. Based on this information, new services can become more accessible, namely through the use of ICTs.
RESUMO
The common cold is one of the most frequent viral infections in humans. Although benign, its symptoms result in economic burden and can lead to severe or even fatal complications in children, elderly and groups with comorbidities. The main purpose of the treatment is the relief of symptoms; however, the medication is often associated with adverse effects. Iota-carrageenan is a polysaccharide that reveals antiviral activity by binding to viruses, inhibiting its replications and, consequently, its viral propagation. This systematic review of the literature aims to compare the effectiveness of an iota-carrageenan nasal spray to placebo. This systematic review was conducted through research in Cochrane Database, PubMed, Science Direct, SpringerLink, Oxford Journals, Elsevier, ClinicalKey, Wiley Online Library, Embase databases, in order to collect randomized and controlled clinical trials. In total, the research provided four articles regarding clinical trials for comparing iota-carrageenan nasal spray with placebo. The results show it has potent antiviral activity compared to placebo and a favorable safety profile. Although further research is needed, the concept of a physical barrier capable of reducing viral penetration of epithelial cells in the nasal mucosa is appealing, and could lead to alternative approaches, with positive impact on global health.
RESUMO
BACKGROUND: In an adaptive trial, the researcher may have the option of responding to interim safety and efficacy data in a number of ways, including narrowing the study focus or increasing the number of subjects, balancing treatment allocation or different forms of randomization based on responses of subjects prior to treatment. This research aims at compiling the technical, statistical, and regulatory implications of the employment of adaptive design in a clinical trial. METHODS: Review of adaptive design clinical trials in Medline, PubMed, EU Clinical Trials Register, and ClinicalTrials.gov. Phase I and seamless phase I/II trials were excluded. We selected variables extracted from trials that included basic study characteristics, adaptive design features, size and use of independent data-monitoring committees (DMCs), and blinded interim analysis. RESULTS: The research retrieved 336 results, from which 78 were selected for analysis. Sixty-seven were published articles, and 11 were guidelines, papers, and regulatory bills. The most prevalent type of adaptation was the seamless phase II/III design 23.1%, followed by adaptive dose progression 19.2%, pick the winner / drop the loser 16.7%, sample size re-estimation 10.3%, change in the study objective 9.0%, adaptive sequential design 9.0%, adaptive randomization 6.4%, biomarker adaptive design 3.8%, and endpoint adaptation 2.6%. Discussion DISCUSSION: It is possible to infer that the use of Adaptive Design is an ethical and scientific advantage when properly planned and applied, since it increases the flexibility of the trial, shortens the overall clinical investigation time of a drug, and reduces the risk of patient exposure to adverse effects related to the experimental drug. Its greater methodologic and analytic complexity requires an adequate statistical methodology. CONCLUSIONS: The application of "adaptive clinical designs" for phase II/III studies appear to have been limited to trials with a small number of study centers, with smaller extensions of time and to experimental drugs with more immediate clinical effects that are amenable to risk/benefit decisions based on interim analyses. According to the reviewed studies, simple adaptive trial designs-such as early study terminations due to futility and sample size re-estimation-are becoming widely adopted throughout the pharmaceutical industry, especially in phase II and III studies. The pharmaceutical industry and contract research organizations (CROs) are implementing simple adaptations more frequently and the more complex adaptations-biomarker adaptive design, endpoint adaptation-are more sporadic.
