cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.14290756.v1
title: Review of the efficacy and safety of over-the-counter medicine

description: Over-the-counter medicines are available without prescription because of their safety and effectiveness, to treat minor ailments and symptoms. The objective of the study was to analyze the availability and quality of systematic reviews published about nonprescription medicines, identifying the groups for which there are gaps in evidence. We identified published articles through the Cochrane Database of Systematic Review and MEDLINE, from the start of the database until May 2012, using the search terms "nonprescription drugs," "over the counter," and "OTC." We searched for articles that describe systematic reviews addressing the efficacy and safety of drugs dispensed without a prescription, according to the lists published by the Association of the European Self-Medication Industry and in Brazil, in the clinical conditions listed in Groups and Specified Therapeutic Indications. We included 49 articles, 18 articles were of moderate quality and 31 of high quality. Of the studies, 74.5% demonstrated efficacy in favor of the use of drugs evaluated. Of the 24 studies that evaluated safety, 21% showed evidence unfavorable to the drug. Overall, the evidence found in the studies included in the overview is favorable to the use of the drugs evaluated. However, there are gaps in evidence for some therapy groups.
DOI: 10.6084/m9.figshare.14290761.v1
title: Amiodarone hydrochloride: enhancement of solubility and dissolution rate by solid dispersion technique

description: abstract Amiodarone HCl is an antiarrhythmic agent, which has low aqueous solubility and presents absorption problems. This study aimed to develop inclusion complexes containing hydrophilic carriers PEG 1500, 4000 and 6000 by fusion and kneading methods in order to evaluate the increase in solubility and dissolution rate of amiodarone HCl. The solid dispersion and physical mixtures were characterized by X-ray diffraction, FT-IR spectra, water solubility and dissolution profiles. Both methods and carriers increased the solubility of drug, however PEG 6000 enhanced the drug solubility in solid dispersion better than other carriers. Different media were evaluated for the solubility study, including distilled water, acid buffer pH 1.2, acetate buffer pH 4.5 and phosphate buffer pH 6.8 at 37 ºC. Based on the evaluation of the results obtained in the study phase solubility carriers PEG 4000 and PEG 6000 were selected for the preparation of the physical mixture and solid dispersion. All formulations were prepared at drug-carrier ratios of 1:1 to 1:10(w/w). The results of in vitro release studies indicated that the solid dispersion technique by fusion method in proportion of 1:10 (w/w) increased significantly the dissolution rate of the drug. X-ray diffraction studies showed reduced drug crystallinity in the solid dispersions. FT-IR demonstrated interactions between the drug and polymers.
DOI: 10.6084/m9.figshare.14290755
title: Development of alternative methods for the determination of raloxifene hydrochloride in tablet dosage form

description: Three methods are proposed for the quantitative determination of raloxifene hydrochloride in pharmaceutical dosage form: ultraviolet method (UV) high performance liquid chromatography (HPLC) and micellar capillary electrophoresis (MEKC). These methods were developed and validated and showed good linearity, precision and accuracy. Also they demonstrated to be specific and robust. The HPLC and MEKC methods were tested in regards to be stability indicating methods and they showed to have this attribute. The UV method used methanol as solvent and optimal wavelength at 284 nm, obeying Lambert-Beer law in these conditions. The chromatographic conditions for the HPLC method included: NST column C18 (250 x 4.6 mm x 5 µm), mobile phase water:acetonitrile:triethylamine (67:33:0,3 v/v), pH 3.5, flow rate 1.0 mL min<sup>-1</sup>, injection volume 20.0 µl, UV detection 287 nm and analysis temperature 30 °C. The MEKC method was performed on a fused-silica capillary (40 cm effective length x 50 µm i.d.) using as background electrolyte 35.0 mmol L<sup>-1</sup> borate buffer and 50.0 mmol L<sup>-1</sup> anionic detergent sodium dodecyl sulfate (SDS) at pH 8.8. The capillary temperature was 32°C, applied voltage 25 kV, UV detection at 280 nm and injection was perfomed at 45 mBar for 4 s, hydrodimanic mode. In this MEKC method, potassium diclofenac (200.0 µg mL<sup>-1)</sup> was used as internal standard. All these methods were statistically analyzed and demonstrated to be equivalent for quantitative analysis of RLX in tablets and were successfully applied for the determination of the drug.
DOI: 10.6084/m9.figshare.14290757
title: Development and validation of a new and economical stability indicating RP-HPLC method for cefixime trihydrate

description: ABSTRACT The present work describes the development of a new high performance liquid chromatographic (HPLC) method for the determination of Cefixime trihydrate under different stress conditons as specified by ICH. For the analysis, a Phenomenex (250 x 4.6 mm, 5 µm particle size) ODS column and a SPD 20 A UV detector at 289 nm was used. The selected mobile phase was 10 mM disodium hydrogen phosphate (with 0.5% TEA, pH adjusted to 6.3 with OPA) and methanol in the ratio of 75:25 (v/v) in isocratic mode at a flow rate of 1 mL.min-1.The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9997 in the concentration range of 5-100 μg.mL-1. The stress degradation was performed using acid, alkali, water, hydrogen peroxide and uv light.
DOI: 10.6084/m9.figshare.14290759
title: Formulation and characterization of self emulsifing pellets of carvedilol

description: The purpose of present study was aimed at developing self emulsifying drug delivery system in liquid and then in pellet form that would result in improved solubility, dissolution and permeability of the poorly water soluble drug carvedilol. Pellets were prepared using extrusion-spheronization technique incorporating liquid SEDDS (carvedilol, capmul MCM EP, cremophore EL, tween 20, propylene glycol), adsorbents ( and crospovidone), microcrystalline cellulose and binder (povidone K-30). Ternary phase diagram was constructed to identify different oil-surfactant-cosurfactant mixtures according to the proportion of each point in it. The optimal CAR-SEDDS pellets showed a quicker redispersion with a droplet size of the reconstituted microemulsion being 160.47 nm, which was almost unchanged after solidification. SEM analysis confirmed good spherical appearance of solid pellets; DSC and XRD analysis confirmed that there was no crystalline carvedilol in the pellets. Pellets were then capable of transferring lipophilic compounds into the aqueous phase and significantly enhancing its release with respect to pure drug.
DOI: 10.6084/m9.figshare.14290764
title: A critical analysis of the hepatotoxicity cases described in the literature related to Herbalife (r) products

description: Abstract The aim of this study was to assess the hepatotoxicity cases described in the literature, attributed to the consumption of Herbalife(r) products, and to determine whether a causal relationship exists between the reported cases of liver injury and the use of these products. A literature search was performed on the PubMed, LILACS and PAHO databases. Seven publications reporting a total of 53 cases of hepatotoxicity linked to the use of Herbalife(r) products were retrieved. All of the studies lacked sufficient information to some degree, whether related to patients' history, concomitant use of medication and/or other compounds (including alcohol), observations on interrupted use (dechallenge), results found with markers, viral serology and autoantibodies or observations concerning re-exposure to the products. In addition to these items, the lack of clear information on the type of products evaluated and their respective composition is an important factor to be considered. Furthermore, data quality was also questionable due to the presence of confounding factors, absence of proper exclusion of alternative explanations, and the use of questionable methods for attributing causality. Hence, an association between hepatotoxicity and consumption of these products cannot be proven based on the data collected and rigorous scientific analysis.
DOI: 10.6084/m9.figshare.14290764.v1
title: A critical analysis of the hepatotoxicity cases described in the literature related to Herbalife (r) products

description: Abstract The aim of this study was to assess the hepatotoxicity cases described in the literature, attributed to the consumption of Herbalife(r) products, and to determine whether a causal relationship exists between the reported cases of liver injury and the use of these products. A literature search was performed on the PubMed, LILACS and PAHO databases. Seven publications reporting a total of 53 cases of hepatotoxicity linked to the use of Herbalife(r) products were retrieved. All of the studies lacked sufficient information to some degree, whether related to patients' history, concomitant use of medication and/or other compounds (including alcohol), observations on interrupted use (dechallenge), results found with markers, viral serology and autoantibodies or observations concerning re-exposure to the products. In addition to these items, the lack of clear information on the type of products evaluated and their respective composition is an important factor to be considered. Furthermore, data quality was also questionable due to the presence of confounding factors, absence of proper exclusion of alternative explanations, and the use of questionable methods for attributing causality. Hence, an association between hepatotoxicity and consumption of these products cannot be proven based on the data collected and rigorous scientific analysis.
DOI: 10.6084/m9.figshare.14290759.v1
title: Formulation and characterization of self emulsifing pellets of carvedilol

description: The purpose of present study was aimed at developing self emulsifying drug delivery system in liquid and then in pellet form that would result in improved solubility, dissolution and permeability of the poorly water soluble drug carvedilol. Pellets were prepared using extrusion-spheronization technique incorporating liquid SEDDS (carvedilol, capmul MCM EP, cremophore EL, tween 20, propylene glycol), adsorbents ( and crospovidone), microcrystalline cellulose and binder (povidone K-30). Ternary phase diagram was constructed to identify different oil-surfactant-cosurfactant mixtures according to the proportion of each point in it. The optimal CAR-SEDDS pellets showed a quicker redispersion with a droplet size of the reconstituted microemulsion being 160.47 nm, which was almost unchanged after solidification. SEM analysis confirmed good spherical appearance of solid pellets; DSC and XRD analysis confirmed that there was no crystalline carvedilol in the pellets. Pellets were then capable of transferring lipophilic compounds into the aqueous phase and significantly enhancing its release with respect to pure drug.
DOI: 10.6084/m9.figshare.14290763
title: Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for 99mTc labeling

description: ABSTRACT Cleaning validation, a requirement of the current Good Manufacturing Practices (cGMP) for Drugs, consists of documented evidence that cleaning procedures are capable of removing residues to predetermined acceptance levels. This report describes a strategy for the selection of the worst case product for the production of lyophilized reagents (LRs) for labeling with 99mTc from the Instituto de Pesquisas Energéticas e Nucleares (IPEN-CNEN/São Paulo). The strategy is based on the calculation of a "worst case index" that incorporates information about drug solubility, cleaning difficulty, and occupancy rate in the production line. It allowed a reduction in the required number of validations considering the possible manufacturing flow of a given product and the subsequent flow, thus facilitating the process by reducing operation time and cost. The products identified as "worst case" were LRs PUL-TEC and MIBI-TEC.
DOI: 10.6084/m9.figshare.14290765
title: Pharmacotherapy review: a proposal to improve medication adherence among hypertensive patients

description: Abstract Pharmacotherapy review is a structured assessment of medicines, which aims to obtain a partnership with patients to achieve drug treatment goals and agreement about drug dosage, as well as when and how the drugs should be administered. The objective was to analyze the influence of pharmacotherapy review, by scheduling drug administration to improve medication adherence among antihypertensive patients. This study was an uncontrolled intervention developed in three distinct stages. The first stage included data collection on the profile of patients and their medications, and a preliminary assessment of medication adherence. In the second stage, the review report was delivered to patients. In the third stage, the results of blood pressure and medication adherence were assessed. The influence of the revision was measured through statistical tests (p&lt;0.05). The study included 40 patients with a mean age of 58.0 (SD:11.3) years; 72.5% were women. Thirty-three (82.5 %) patients required some intervention, after when there was a significant increase in the number of daily doses (p=0.039) and drug intakes (p=0.025). There was a significant increase in the adherence rate, according to both the Morisky-Green test (p&lt;0.001) and self-reported assessment (p=0.004). There was also an improvement in the levels of systolic (p&lt;0.001) and diastolic (p=0.002) blood pressure and in the number of patients with controlled hypertension (p=0.006). The pharmaceutical service enhanced medication adherence and control of systemic blood pressure; however, it increased the complexity of treatment.
DOI: 10.6084/m9.figshare.14290767
title: Level of satisfaction of clients of public pharmacies dispensing high-cost drugs in Espírito Santo, Brazil

description: ABSTRACT The aim of this study was to evaluate the level of satisfaction of pharmaceutical services and to determine the socioeconomic profile of public pharmacy clients. This is a cross-sectional observational study using a quantitative approach. The sample was calculated from the monthly number of patients seen in pharmacies and was stratified for each pharmacy. Data were analysed using SPSS 11.5 software and by observing the simple relative frequencies for qualitative variables. For the quantitative variables, the analysis of variance (ANOVA) and post-hoc Fisher tests were performed. Data are expressed as mean ± standard deviation (SD). The results show that, in general, patients at "Farmácias cidadãs" are satisfied with the services. However, when stratified, we found that the greatest satisfaction was related only to structural and organizational aspects, while the pharmaceutical services are unsatisfactory. When relating satisfaction to the socioeconomic characteristics, a difference between waiting time (39.07 ± 19.53), attendance by pharmacist (8.91 ± 5.14) and education was observed. It is concluded that users are satisfied with the services of state "Farmácias cidadãs" of Espírito Santo, but there should be improvements in relation to pharmaceutical services and the interpersonal relationships between health professionals and users of the public health system in Brazil.
DOI: 10.6084/m9.figshare.14290761
title: Amiodarone hydrochloride: enhancement of solubility and dissolution rate by solid dispersion technique

description: abstract Amiodarone HCl is an antiarrhythmic agent, which has low aqueous solubility and presents absorption problems. This study aimed to develop inclusion complexes containing hydrophilic carriers PEG 1500, 4000 and 6000 by fusion and kneading methods in order to evaluate the increase in solubility and dissolution rate of amiodarone HCl. The solid dispersion and physical mixtures were characterized by X-ray diffraction, FT-IR spectra, water solubility and dissolution profiles. Both methods and carriers increased the solubility of drug, however PEG 6000 enhanced the drug solubility in solid dispersion better than other carriers. Different media were evaluated for the solubility study, including distilled water, acid buffer pH 1.2, acetate buffer pH 4.5 and phosphate buffer pH 6.8 at 37 ºC. Based on the evaluation of the results obtained in the study phase solubility carriers PEG 4000 and PEG 6000 were selected for the preparation of the physical mixture and solid dispersion. All formulations were prepared at drug-carrier ratios of 1:1 to 1:10(w/w). The results of in vitro release studies indicated that the solid dispersion technique by fusion method in proportion of 1:10 (w/w) increased significantly the dissolution rate of the drug. X-ray diffraction studies showed reduced drug crystallinity in the solid dispersions. FT-IR demonstrated interactions between the drug and polymers.
DOI: 10.6084/m9.figshare.14290765.v1
title: Pharmacotherapy review: a proposal to improve medication adherence among hypertensive patients

description: Abstract Pharmacotherapy review is a structured assessment of medicines, which aims to obtain a partnership with patients to achieve drug treatment goals and agreement about drug dosage, as well as when and how the drugs should be administered. The objective was to analyze the influence of pharmacotherapy review, by scheduling drug administration to improve medication adherence among antihypertensive patients. This study was an uncontrolled intervention developed in three distinct stages. The first stage included data collection on the profile of patients and their medications, and a preliminary assessment of medication adherence. In the second stage, the review report was delivered to patients. In the third stage, the results of blood pressure and medication adherence were assessed. The influence of the revision was measured through statistical tests (p&lt;0.05). The study included 40 patients with a mean age of 58.0 (SD:11.3) years; 72.5% were women. Thirty-three (82.5 %) patients required some intervention, after when there was a significant increase in the number of daily doses (p=0.039) and drug intakes (p=0.025). There was a significant increase in the adherence rate, according to both the Morisky-Green test (p&lt;0.001) and self-reported assessment (p=0.004). There was also an improvement in the levels of systolic (p&lt;0.001) and diastolic (p=0.002) blood pressure and in the number of patients with controlled hypertension (p=0.006). The pharmaceutical service enhanced medication adherence and control of systemic blood pressure; however, it increased the complexity of treatment.
DOI: 10.6084/m9.figshare.14290767.v1
title: Level of satisfaction of clients of public pharmacies dispensing high-cost drugs in Espírito Santo, Brazil

description: ABSTRACT The aim of this study was to evaluate the level of satisfaction of pharmaceutical services and to determine the socioeconomic profile of public pharmacy clients. This is a cross-sectional observational study using a quantitative approach. The sample was calculated from the monthly number of patients seen in pharmacies and was stratified for each pharmacy. Data were analysed using SPSS 11.5 software and by observing the simple relative frequencies for qualitative variables. For the quantitative variables, the analysis of variance (ANOVA) and post-hoc Fisher tests were performed. Data are expressed as mean ± standard deviation (SD). The results show that, in general, patients at "Farmácias cidadãs" are satisfied with the services. However, when stratified, we found that the greatest satisfaction was related only to structural and organizational aspects, while the pharmaceutical services are unsatisfactory. When relating satisfaction to the socioeconomic characteristics, a difference between waiting time (39.07 ± 19.53), attendance by pharmacist (8.91 ± 5.14) and education was observed. It is concluded that users are satisfied with the services of state "Farmácias cidadãs" of Espírito Santo, but there should be improvements in relation to pharmaceutical services and the interpersonal relationships between health professionals and users of the public health system in Brazil.
DOI: 10.6084/m9.figshare.14290770
title: Medication reconciliation as a strategy for preventing medication errors

description: ABSTRACT One of the current barriers proposed to avoid possible medication errors, and consequently harm to patients, is the medication reconciliation, a process in which drugs used by patients prior to hospitalization can be compared with those prescribed in the hospital. This study describes the results of a pharmacist based reconciliation conducted during six months in clinical units of a university hospital. Fourteen patients (23.33%) had some kind of problem related to medicine. The majority (80%) of medication errors were due to medication omission. Pharmaceutical interventions acceptance level was 90%. The results suggest that pharmacists based reconciliation can have a relevant role in preventing medication errors and adverse events. Moreover, the detailed interview, conducted by the pharmacist, is able to rescue important information regarding the use of drugs, allowing to avoid medications errors and patient injury.
DOI: 10.6084/m9.figshare.14290775
title: Balneotherapy is a potential risk factor for Pseudomonas aeruginosa colonization

description: ABSTRACT The practice of immersion in burn patient has been abandoned in many parts of the world but in Brazil it is still common. The aim of this study was to ascertain if balneotherapy is a risk factor for Pseudomonas aeruginosa colonization in thermally injured patients. Eighteen patients from a Burn Center were studied for 14 weeks for Pseudomonas aeruginosa. Samples were collected by swabbing the exudate of wounds, before and after giving bath to the patients and from balneotherapy table. Pulsed-field gel electrophoresis was used to determine bacterial genetic relatedness. Thirty-seven P. aeruginosa isolates were detected from 292 swabs collected from patients' burn surface area and from the balneotherapy table. Profile analysis of P. aeruginosa DNA fragmentation showed 10 clones among the 37 strains analyzed. Type A is the most prevalent clone, with 23 strains distributed into eight subtypes. These were present in the swabs collected, before and after the patients' bath, from the surface of the bath table, suggesting that there was cross-contamination between the patients in different ways. This work demonstrates that balneotherapy is a risk factor in the Burn Center studied, because the same clone was found among P. aeruginosa isolates collected at various points and times.
DOI: 10.6084/m9.figshare.14290770.v1
title: Medication reconciliation as a strategy for preventing medication errors

description: ABSTRACT One of the current barriers proposed to avoid possible medication errors, and consequently harm to patients, is the medication reconciliation, a process in which drugs used by patients prior to hospitalization can be compared with those prescribed in the hospital. This study describes the results of a pharmacist based reconciliation conducted during six months in clinical units of a university hospital. Fourteen patients (23.33%) had some kind of problem related to medicine. The majority (80%) of medication errors were due to medication omission. Pharmaceutical interventions acceptance level was 90%. The results suggest that pharmacists based reconciliation can have a relevant role in preventing medication errors and adverse events. Moreover, the detailed interview, conducted by the pharmacist, is able to rescue important information regarding the use of drugs, allowing to avoid medications errors and patient injury.