Exploration of moisture activated dry granulation for the development of gastroretentive tablets aided by SeDeM diagram.

Moisture activated dry granulation (MADG) is an attractive granulation process. However, only a few works have explored modified drug release achieved by MADG, and to the best of the authors knowledge, none of them have explored gastroretention. The aim of this study was to explore the applicability of MADG process for developing gastroretentive placebo tablets, aided by SeDeM diagram. Floating and swelling capacities have been identified as critical quality attributes (CQAs). After a formulation screening step, the type and concentration of floating matrix formers and of binders were identified as the most relevant critical material attributes (CMAs) to investigate in ten formulations. A multiple linear regression analysis (MLRA) was applied against the factors that were varied to find the design space. An optimized product based on principal component analysis (PCA) results and MLRA was prepared and characterized. The granulate was also assessed by SeDeM. In conclusion, granulates lead to floating tablets with short floating lag time (<2 min), long floating duration (>4 h), and showing good swelling characteristics. The results obtained so far are promising enough to consider MADG as an advantageous granulation method to obtain gastroretentive tablets or even other controlled delivery systems requiring a relatively high content of absorbent materials in their composition.

Exposure to Smartphones and Tablets, Physical Activity and Sleep in Children From 5 to 10 Years Old: A Systematic Review and Meta-Analysis.

OBJECTIVE: To conduct a systematic review and meta-analysis to verify the association between smartphone/tablet exposure and physical activity and sleep in children from 5 to 10 years old. Data Source: This study followed the guidelines of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and included studies that met eligibility criteria based on the "PECO" strategy: participants (children from 5 to 10 years old), exposure (smartphone and tablet use), and outcome (physical activity and sleep). STUDY INCLUSION AND EXCLUSION CRITERIA: The inclusion criteria were observational studies published in indexed scientific journals and written in Portuguese, English, and Spanish that verified the association of exposure to smartphones/tablets with physical activity and sleep in children aged 5 to 10 years of both sexes. Studies were considered eligible only if they met the previous criteria. Data Extraction: The search was conducted in January 2023 on databases from electronic journals without the restriction of the period. To meta-analyze were extracted and grouped using models of fixed and random effects, the coefficients Odds Ratio (OR), Beta (ß), Standard Error (SE), and Confidence Intervals of 95% (95%CI). Data Synthesis: 2396 potentially relevant papers were identified, and 17 met the inclusion criteria. RESULTS: It can be verified that there was an inverse association between smartphones with physical activity and sleep. Studies indicate that for every additional hour of smartphone and tablet use, sleep can be expected to decrease by an average of 11 minutes (ß = - 0.11; 95%CI = -0.13; -0.09). Children using smartphones and tablets were 1.79 times (OR = 1.79; 95%CI = 1.72-1.86) more likely to have shorter sleep duration and 1.53 times (OR = 1.53; 95%CI = 1.41-1.65) more likely to have worse sleep quality. Children with shorter smartphone and tablet usage were 1.19 times more likely to be active (OR = 1.19; 95% CI = 1.03-1.37). CONCLUSION: Children of 5 to 10 years who are more often exposed to smartphones and tablets are prone to have worse quality and quantity of sleep, as well as less practice of physical activity. Health promotion actions can be encouraged based on the results, aiming to reduce the use time of these devices and improve children's health and quality of life.

Quantitative relationship between physical activity and antihypertensives in elderly women / Relación cuantitativa entre actividad física y antihipertensivos en ancianas / Relação quantitativa entre atividade física e anti-hipertensivos em idosas

ABSTRACT Introduction: Physical activity is an important tool to manage systemic arterial hypertension. However, less is known about the relationship of physical activity with the number of antihypertensive drugs used by older adults. Objective: The aim of this study was to compare the number of antihypertensive drugs used by older female adults (aged ≥ 60 years) with a low level of physical activity with the number used by those with a high level of physical activity, and to verify how many participants used more than two antihypertensive drugs. Methods: Twenty-eight physically active older women with systemic arterial hypertension who participated in a physical activity program for community-dwelling older female adults were divided into two groups: participants who presented lower habitual physical activity levels were placed in group 1 and participants that presented higher habitual physical activity levels were placed in group 2, according to the Baecke questionnaire. In addition, the number of antihypertensive drugs used by participants was collected. Results: The number of prescribed antihypertensive drugs was 2.0 (median) for both groups investigated. There was no significant difference between groups regarding the number of antihypertensive tablets prescribed (p>0.05). Although there was no statistical difference, a higher proportion of participants from the lower physical activity group used more than two antihypertensive drugs. Conclusion: The level of habitual physical activity did not affect the number of antihypertensive tablets used by hypertensive elderly women. Level of evidence II; Therapeutic studies - investigation of treatment results.

RESUMEN Introducción: La actividad física es una herramienta importante para el manejo de la hipertensión arterial sistémica. Sin embargo, se sabe poco sobre la relación de la actividad física con la cantidad de medicamentos antihipertensivos utilizados por las ancianas. Objetivo: El objetivo de este estudio fue hacer una comparación entre el número de medicamentos antihipertensivos utilizados por mujeres adultas mayores (≥ 60 años) y bajo nivel de actividad física con el número utilizado por aquellas con alto nivel de actividad física, y verificar cuántas de las participantes usaron más de dos medicamentos antihipertensivos. Métodos: Veintiocho ancianas físicamente activas con hipertensión arterial sistémica que participaron en un programa de actividad física para mujeres adultas mayores residentes en la comunidad fueran divididas en dos grupos: las participantes que presentaron niveles más bajos de actividad física habitual se ubicaron en el grupo 1 y las participantes que presentaron los mayores niveles de actividad física se ubicaron en el grupo 2, según el cuestionario de Baecke. Además, se recogió el número de medicamentos antihipertensivos utilizados por las participantes. Resultados: El número de comprimidos antihipertensivos prescritos fue de 2,0 (mediana) para ambos grupos investigados. No hubo diferencia significativa entre los grupos en cuanto al número de medicamentos antihipertensivos prescritos (p>0,05). Aunque no hubo diferencia estadística, una mayor proporción de participantes del grupo de menor actividad física usó más de dos medicamentos antihipertensivos. Conclusión: El nivel de actividad física habitual no afectó el número de comprimidos antihipertensivos utilizados por las ancianas hipertensas. Nivel de evidencia II; Estudios terapéuticos: investigación de los resultados del tratamiento.

RESUMO Introdução: A atividade física é uma importante ferramenta no manejo da hipertensão arterial sistêmica. No entanto, pouco se sabe sobre a relação entre a atividade física e a quantidade de anti-hipertensivos usados por idosos. Objetivo: O objetivo deste estudo foi realizar uma comparação entre o número de anti-hipertensivos usados por idosas (≥ 60 anos) com baixo nível de atividade física com o número usado por aquelas com alto nível de atividade física, verificando quantas participantes usaram mais de dois anti-hipertensivos. Métodos: Vinte e oito idosas fisicamente ativas com hipertensão arterial sistêmica que participavam de um programa de atividade física para idosas da comunidade foram divididas em dois grupos: as participantes que apresentaram níveis mais baixos de atividade física habitual foram colocadas no grupo 1 e as participantes que apresentaram maiores níveis de atividade física foram colocados no grupo 2, de acordo com o questionário de Baecke. Ademais, coletou-se o número de medicamentos anti-hipertensivos utilizados pelas participantes. Resultados: O número de fármacos anti-hipertensivos prescritos foi de 2,0 (mediana) para ambos os grupos investigados. Não houve diferença significativa entre os grupos quanto ao número de comprimidos anti-hipertensivos prescritos (p>0,05). Embora não tenha havido diferença estatística, uma maior proporção de participantes entre o grupo de menor atividade física utilizava mais de dois anti-hipertensivos. Conclusão: O nível de atividade física habitual não afetou a quantidade de comprimidos anti-hipertensivos utilizados pelas idosas hipertensas. Nível de evidência II; Estudos terapêuticos - Investigação dos resultados do tratamento.

A Novel Handrub Tablet Loaded with Pre- and Post-Biotic Solid Lipid Nanoparticles Combining Virucidal Activity and Maintenance of the Skin Barrier and Microbiome.

OBJECTIVE: This study aimed to develop a holobiont tablet with rapid dispersibility to provide regulation of the microbiota, virucidal activity, and skin barrier protection. METHODS: A 23 factorial experiment was planned to define the best formulation for the development of the base tablet, using average weight, hardness, dimensions, swelling rate, and disintegration time as parameters to be analyzed. To produce holobiont tablets, the chosen base formulation was fabricated by direct compression of prebiotics, postbiotics, and excipients. The tablets also incorporated solid lipid nanoparticles containing postbiotics that were obtained by high-pressure homogenization and freeze-drying. The in vitro virucidal activity against alpha-coronavirus particles (CCoV-VR809) was determined in VERO cell culture. In vitro analysis, using monolayer cells and human equivalent skin, was performed by rRTq-PCR to determine the expression of interleukins 1, 6, 8, and 17, aquaporin-3, involucrin, filaggrin, FoxO3, and SIRT-1. Antioxidant activity and collagen-1 synthesis were also performed in fibroblast cells. Metagenomic analysis of the skin microbiome was determined in vivo before and after application of the holobiont tablet, during one week of continuous use, and compared to the use of alcohol gel. Samples were analyzed by sequencing the V3-V4 region of the 16S rRNA gene. RESULTS: A handrub tablet with rapid dispersibility was developed for topical use and rinse off. After being defined as safe, the virucidal activity was found to be equal to or greater than that of 70% alcohol, with a reduction in interleukins and maintenance or improvement of skin barrier gene markers, in addition to the reestablishment of the skin microbiota after use. CONCLUSIONS: The holobiont tablets were able to improve the genetic markers related to the skin barrier and also its microbiota, thereby being more favorable for use as a hand sanitizer than 70% alcohol.

Corrigendum: Electronic application for rabies management improves surveillance, data quality, and investigator experience in Haiti.

[This corrects the article DOI: 10.3389/fvets.2023.1052349.].

Electronic application for rabies management improves surveillance, data quality, and investigator experience in Haiti.

Background: Integrated bite case management (IBCM) is a multi-sectoral response to animal-bites which reduces human and canine rabies mortality through animal quarantine, bite-victim counseling, and vaccination tracking. Haiti's national rabies surveillance program was established in 2013 using paper-based IBCM (pIBCM) with adoption of an electronic smartphone application (eIBCM) in 2018. Methods: We evaluated the feasibility of implementing the electronic app in Haiti and compared pIBCM and eIBCM data quality collected January 2013-August 2019. Deaths prevented, cost-per-death averted, and cost-per-investigation during use of pIBCM and eIBCM were estimated using a previously validated rabies cost-effectiveness tool that accounted for bite-victim demographics; probability of acquiring rabies; post-exposure prophylaxis; and costs including training, supplies, and salaries. We compared pIBCM and eIBCM based on data comprehensiveness, completeness, and reporting efficiency. Surveys were administered to IBCM staff to evaluate the usefulness, simplicity, flexibility, and acceptability of eIBCM. Results: Of 15,526 investigations, 79% were paper-based and 21% electronic. IBCM prevented 241 (estimated) human rabies deaths. Using pIBCM, cost-per-death averted was $2,692 and the cost-per-investigation was $21.02; up to 55 data variables were collected per investigation; data transmission took 26 days to reach national staff, and 180 days until analysis. Using eIBCM, the cost-per-death averted was $1,247 and the cost-per-investigation was $22.70; up to 174 data variables were collected per investigation; data transmission took 3 days to reach national staff, and 30 days until analysis. Among 12,194 pIBCM investigations, 55% were mappable by commune, compared to 100% of eIBCM investigations mappable by GPS. Animal case definitions were incorrectly ascribed by investigators in 5.5% of pIBCM investigations and zero for eIBCM; typically, errors were in determining probable vs. suspect case assignments. Overall, eIBCM was well-accepted by staff, who reported the app is easy-to-use, facilitates investigations, and compared to pIBCM hastens data reporting. Discussion: In Haiti, eIBCM showed improved data completeness, data quality, and shorter notification times with minimal increase in operational cost. The electronic app is simple-to-use and facilitates IBCM investigations. Rabies endemic countries could refer to eIBCM in Haiti as a cost-effective means to reduce human rabies mortality and improve surveillance capacity.

Use of a "tablet pole" for the administration of ivermectin for strongyloidiasis in a field study in Ecuador.

BACKGROUND: Establishment of efficient control programs for strongyloidiasis, the infection by Strongyloides stercoralis, is among the World Health Organization (WHO) targets for 2030. Ivermectin is a drug of choice for strongyloidiasis, but its weight-based administration can be unfeasible in remote areas. We evaluated a WHO tablet pole for administration of ivermectin in school-age children living in remote villages in Ecuador. METHODS: Children were enrolled in 16 villages in Esmeraldas Province of Ecuador, between July 2021 and June 2022. The pole identified four height intervals corresponding to ivermectin doses going from one to four tablets. For each child, we calculated the dose (µg/kg) administered with both weight-based and pole-based administration. Results were classified as follows: optimal dose, acceptable, overdose, underdose. Agreement between the two methods for estimating the number of tablets was assessed with Cohen's kappa coefficient. Estimations were reported with 95% confidence intervals (CIs). RESULTS: Total of 778 children (47.3% female) were enrolled, with median age of 9.59 years (interquartile range: 7.42‒11.22). Optimal dose was achieved for a higher proportion of children when assessed with weight (37.9%) than with pole (25.7%). Underdose and overdose were more frequent with the pole (8.3% and 19.2% children, respectively) than with the weight-based (3.7% and 6.0%, respectively) administration. Agreement between weight-based and pole-based administration was moderate: 0.56 (95% CI 0.51, 0.61). The two methods indicated the same number of tablets in 71.6% (95% CI 0.684, 0.748) cases. CONCLUSIONS: In our setting, the tablet pole could be a valid alternative. The tool needs further evaluation in different populations.

The effectiveness of a tablet-based video game that stimulates cognitive, emotional, and social skills in developing academic skills among preschoolers: study protocol for a randomized controlled trial.

BACKGROUND: Evidence suggests that children from low-income families begin the preschool stage with less academic and non-academic skills development compared to higher-income families. There are several successful experiences of early stimulation of cognitive and social-emotional skills; however, there is scarce evidence of the effectiveness of a video game that incorporates the stimulation of these skills simultaneously. This study aims to evaluate the effectiveness of a video game in stimulating cognitive, emotional, and social competence skills in developing academic skills in socioeconomically disadvantaged preschool children. METHODS: A cluster-randomized controlled trial design will be used. A tablet-based video game that stimulates cognitive and socio-emotional skills to improve the development of academic skills is compared with a tablet-based game where students draw and paint with no explicit stimulation of cognitive and socio-emotional skills. Eighteen schools and 750 Chilean preschool students will be recruited. The effectiveness of the intervention will be assessed using a direct evaluation of children on literacy learning and pre-calculation skills at baseline, immediately after stimulation, and at 6, 12, 18, and 24 months post-intervention. The mediating effect of working memory, inhibitory control, emotion recognition, and prosocial behaviours will be assessed on the effectiveness of the intervention. DISCUSSION: The proposed study will be the first to test the effectiveness of a tablet-based video game stimulating cognitive and social-emotional skills to improve academic skills in socioeconomically disadvantaged preschool children in Chile, controlling for gender, age (in months), mental health, and baseline conditions of stimulated skills. TRIAL REGISTRATION: ClinicalTrials.gov NCT05224700. Registered on February 2022.

Mucoadhesive controlled-release formulations containing morin for the control of oral biofilms.

This study aimed to evaluate the antimicrobial and anti-biofilm activity of morin on polymicrobial biofilms and its cytotoxicity in controlled-release films and tablets based on gellan gum. Polymicrobial biofilms were formed from saliva for 48 h under an intermittent exposure regime to 1% sucrose and in contact with films or tablets of gellan gum containing 2 mg of morin each. Acidogenicity, bacterial viability, dry weight and insoluble extracellular polysaccharides from biofilms were evaluated. The cytotoxicity of morin was evaluated in oral keratinocytes. Morin released from the systems reduced the viability of all the microbial groups evaluated, as well as the dry weight and insoluble polysaccharide concentration in the matrix and promoted the control of acidogenicity when compared with the control group without the substance. Morin was cytotoxic only at the highest concentration evaluated. In conclusion, morin is an effective agent and shows antimicrobial and anti-biofilm activity against polymicrobial biofilms.

Optimization and Quest of HPMC loaded Stavudine Controlled Release Dosage Development by Central Composite Design utilizing Reduced Factorial Screening Technique

Abstract The current research focused on screening and finding the significant independent variables in stavudine loaded tablet, followed by optimizing the best formulation using central composite design. The objective of the study to develop stavudine loaded controlled release tablet utilizing reduced factorial design, followed by optimization technique as well as characterization of prepared tablets. Preliminary trial batches were prepared using different grades of hydroxypropyl methylcellulose. The resolution-IV reduced factorial design was selected to screen the significant independent variables in the dosage form design. A total number of eight runs were prepared and responses were recorded. The signified factors identified by half-normal and Pareto chart. The prepared tablets are evaluated for various physiochemical characterizations. Three dependent responses such as hardness, dissolution at 6 hour and 12 hours are considered in optimization process. Later on, drug-polymer interaction study was carried out. The principal of the study design based on finding the best formulation with prefixed set parameter values utilizing the concept of screening technique. It observed that HPMC K15M (57.18 %), HPMC K100 (66.32 %) and PVP K30 (7.97 %) as best composition in a formulation batch would fulfill the predetermined parameter with specific values.

Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach

Abstract The purpose of this study is to optimize the composition of extragranular excipients (EGE) and mixing time of granules with EGE of paracetamol tablet formulation using Design of Experiments (DoE) approach. The effect of the composition of EGE and the mixing time of granules with EGE on granule and tableting properties of paracetamol tablet formulation was investigated using a combined model of mixture and process factors (Design-Expert 12). A total of 18 tablet formulations were manufactured by wet granulation using varying compositions of EGE and varying mixing time. Granule and tablet properties of each formulation were evaluated as response variables for the design, data generated were fitted into models and analysed to generate a design space that was used for optimization studies. The proposed EGE composition as predicted by the design was confirmed and validated after preparation and evaluation of the granule and tablet properties. The optimized composition for the EGE that yielded granules and tablets of desirable characteristics was found to be maize starch (5 %), talc (4.9 %) and magnesium stearate (0.1 %) with a mixing time of 2 min. The tablets produced with the optimized composition had better mechanical strength and disintegration time than the formulation prepared using an existing formula of maize starch (7.8 %), talc (2 %) and magnesium stearate (0.2 %) that were obtained using the One Variable at a Time (OVAT) approach. This study confirmed the relevance of quality by design in development of pharmaceutical formulations.

Optimization of HPLC method using central composite design for estimation of Torsemide and Eplerenone in tablet dosage form

Abstract A simple, precise, accurate and robust high performance liquid chromatographic method has been developed for simultaneous estimation of Torsemide and Eplerenone in tablet dosage form. Design of experiment was applied for multivariate optimization of the experimental conditions of RP-HPLC method. A Central composite design was used to study the response surface methodology and to analyse in detail the effects of these independent factors on responses. Total eleven experiments along with 3 center points were performed. Two factors were selected to design the matrix, one factor is variation in ratio of Acetonitrile and the second factor is flow rate (mL/min). Optimization in chromatographic conditions was achieved by applying Central composite design. The optimized and predicted data from contour diagram comprised mobile phase (acetonitrile, water and methanol in the ratio of 50: 30: 20 v/v/v respectively), at a flow rate of 1.0 ml/min and at ambient column temperature. Using these optimum conditions baseline separation of both drugs with good resolution and run time of less than 5 minutes were achieved. The optimized assay conditions were validated as per the ICH guidelines (2005). Hence, the results showed that the Quality by design approach could successfully optimize RP-HPLC method for simultaneous estimation of Torsemide and Eplerenone.

Sustained release matrix tablet of 100 mg losartan potassium: Formulation development and in vitro characterization

Abstract Sustained release matrix tablets of 100 mg losartan potassium HCl were fabricated with two release retarding polymers namely HPMC K100 M and affinisol by direct compression method. Nine trial formulations were prepared by varying content of these polymers, each from 50 mg to 100 mg; keeping the total weight of the tablet 310 mg. The best formulation was selected based on in vitro drug release profile for 12 hours conducted in Type II dissolution apparatus at 50 rpm and water as dissolution medium. Pre-compression parameters such as bulk density, tap density, Carr's index and Hausner ratio were evaluated for the selected tablet. The tablets were subjected to thickness, weight variation test, drug content, hardness and friability. Drug release kinetics, surface morphology and accelerated stability study were investigated for that selected formulation. Formulation F4 with the composition of 75 mg HPMC K100M and 100 mg affinisol was selected as the best formulation that extended the drug release up to 12 hours. Pre-compression parameters and other tableting properties were within the Pharmacopoeia limit. Release kinetics analysis proved non-fickian zero-order drug release and that was further confirmed by surface morphology of the tablets before and after dissolution study visualized by SEM. The developed formulation was found to be stable for one month stored at 60 ○C.

In Vitro Evaluation of Dalbergia sissoo and Acacia modesta gum as Pharmaceutical Binders for Drug Delivery System

Abstract The present study aimed to compare the crude, modified and hydrolyzed gums of Dalbergia sissoo and Acacia modesta as a biodegradable binder for drug delivery system using acetaminophen as a model drug. The physiochemical properties such as pH, fluorescence analysis and swelling index were determined. The gums were hydrolyzed and modified. Acetaminophen tablets were prepared using wet granulation technique and the gum solutions were used as a binder. Hydroxypropyl methylcellulose was used as a synthetic binder. Different properties of granules and tablets were evaluated. Results showed that both gums were acidic in nature, while D. sissoo and A. modesta showed light brown and creamy color in fluorescence analysis. The swelling ratio was the highest in water followed by 0.1N HCl and least in phosphate buffer. The prepared tablets showed faster and slower dissolution profiles in the same dissolution system. The crude gums have the highest dissolution rate, and this rate was decreased in the case of modified and hydrolyzed gums samples. The crude gums showing slower release can be useful in sustained-release tablets, while the modified gums having faster release rate are helpful in conventional tablet formulation. Taken together, the selected gums could be a good model for evaluation as a binder or hydrophilic polymer in tablet formulation.

Optimization of Diltiazem hydrochloride osmotic formulation using QBD approach

Abstract Diltiazem hydrochloride (DLH) is a calcium channel blocker useful for the treatment of angina pectoris, arrhythmia, and hypertension. DLH having a short half-life needs frequent administration for successful treatment but this poses a problem of poor patient compliance. These requirements are served by elementary osmotic pump tablets (EOP) based controlled-release (CR) systems. Quality by design (QbD) approach assists in screening various factors with subsequent assessment of critical parameters that can have a major impact on the scalability of EOP. Tablets were formulated using wet granulation method followed by osmotic coating. Factorial design based QbD strategy aided in defining the risk assessment of influential variables such as hydrophilic polymers and osmotic coat component on the in-vitro release kinetics of the designed EOP tablets. These formulated EOP systems followed zero-order kinetics, a characteristic feature of EOPs. EOP tablets were formulated applying a systematic QbD statistical approach. The formulated DLH EOP systems with improved concentration-independent behavior helped to address the challenges of IR formulation. Application of QbD strategy in ascertaining the scalability of DLH EOP formulation would help pharmaceutical industries in the translation of EOP based drug delivery systems from R&D to market.

Elucidating the Splitting Behavior of Tablets to Optimize the Pharmacotherapy in Veterinary Medicine.

It is well known that the splitting of tablets can bring serious risks to the health of the treated animals, e.g., the possible adverse reactions caused by overdoses of fenbendazole or aspirin. In this regard, this work aimed to evaluate, for the first time, the splitting behavior of commercial veterinary tablets and identifying the technological aspects that interfere in this process. Tablets were cut in halves using a tablet splitter and were analyzed regarding mass variation, mass loss, friability, and hardness. Microstructural and morphological evaluations were also performed. For most of the tablets, organic flavor additives provided more uniformity and cohesive matrix, which preserved its hardness after the cut and led to subdivision results within acceptable limits for mass measurements and friability. Apart from the microstructure, the most critical technological aspect for a correct splitting performance in such tablets was the presence of a score. Thus, the results presented here allow us to guide the manufacturing of veterinary drug products in order to produce tablets more adapted to the splitting process.

Tacit engagement using tablet-mediated learning for social good.

We discuss the effectiveness of mediated communication (internet communication via a computer tablet) and tacit engagement in a Project on mental health. The project is aimed at improving the wellbeing of adult women living with chronic mental disorders in long-term psychiatric internment. The computer tablets act as "portals" to provide access and conatct with the outside world for patients who have poor (if any) external social support. This support includes a patient-centred psycho-social care, and accompanying clinical and pharmaceutical treatment. Both patients and their relatives accepted the benefits of internet mediation, for very different reasons. For the patient, this is a flash of contact with humanity, and for the relatives the internet communication this proved to be an alternative to the need for physical proximity. As some patients had no relatives or friends to communicate (even remotely) with the outside world, and because there is a school next door to the clinic, we visualized that the communication between these two communities could provide both a therapeutic and poetic act of learning and compassion. The electronic portal could serve as a virtual bridge between two forbidden domains. Although awareness of students of the nearby school was raised about mental health, the use of internet mediation devoid of physical proximity made the students suspicious of the goal of the mediation. From the patient's side, however, each contact was an instance of joy. Several issues were raised from this exercise.

It is Possible to Achieve Tablets With Good Tabletability From Solid Dispersions - The Case of the High Dose Drug Gemfibrozil.

BACKGROUND: Solid Dispersions (SDs) have been extensively used to increase the dissolution of poorly water-soluble drugs. However, there are few studies exploring SDs properties that must be considered during tablet development, like tabletability. Poorly water-soluble drugs with poor compression properties and high therapeutic doses, like gemfibrozil, are an additional challenge in the production of SDs-based tablets. OBJECTIVE: This study evaluates the applicability of SDs to improve both tabletability and dissolution rate of gemfibrozil. A SD-based tablet formulation was also proposed. METHODS: SDs were prepared by ball milling, using hydroxypropyl methylcellulose (HPMC) as a carrier, according to a 23 factorial design. The formulation variables were gemfibrozil:HPMC ratio, milling speed, and milling time. The response in the factorial analysis was the tensile strength of the compacted SDs. Dissolution rate and solid-state characterization of SDs were also performed. RESULTS: SDs showed simultaneous drug dissolution enhancement and improved tabletability when compared to corresponding physical mixtures and gemfibrozil. The main variable influencing drug dissolution and tabletability was the gemfibrozil:HPMC ratio. Tablets containing gemfibrozil- HPMC-SD (1:0.250 w/w) and croscarmellose sodium showed fast and complete drug release, while those containing the same SD and sodium starch glycolate exhibited poor drug release due to their prolonged disintegration time. CONCLUSION: SDs proved to be effective for simultaneously improving tabletability and dissolution profile of gemfibrozil. Tablets containing gemfibrozil-HPMC-SD and croscarmellose sodium as disintegrating agent showed improved drug release and good mechanical strength, demonstrating the potential of HPMC-based SDs to simultaneously overcome the poor dissolution and tabletability properties of this drug.

Fractal and Polarization Properties of Light Scattering Using Microcrystalline Pharmaceutical Aggregates.

Fractal and polarization analysis of diffusively scattered light is applied to determine the complex relationship between fractal dimension of structural morphology and concentration of chemically active ingredients in two pharmaceutical mixture systems including a series of binary mixtures of acetaminophen in lactose and three multicomponent blends with a proprietary active ingredient. A robust approach is proposed to identify and filter out multiple- and single-scattering components of scattering indicatrix. The fractal dimension extracted from scattering field reveals complex structural details of the sample, showing strong dependence on low-dose drug concentration in the blend. Low-angle diffraction shows optical "halo" patterns near the angle of specular reflection caused by light refraction in microcrystalline aggregates. Angular measurements of diffuse reflection demonstrate noticeable dependence of Brewster's angle on drug concentration. It is shown that the acetaminophen microcrystals produce scattered light depolarization due to their optical birefringence. The light scattering measurement protocol developed for diffusively scattered light by microcrystalline pharmaceutical compositions provides a novel approach for the pattern recognition, analysis and classification of materials with a low concentration of active chemical ingredients.

A Brief Digital Cognitive Assessment for Detection of Cognitive Impairment in Cuban Older Adults.

BACKGROUND: Rapid technological advances offer a possibility to develop cost-effective digital cognitive assessment tools. However, it is unclear whether these measures are suitable for application in populations from Low and middle-income countries (LMIC). OBJECTIVE: To examine the accuracy and validity of the Brain Health Assessment (BHA) in detecting cognitive impairment in a Cuban population. METHODS: In this cross-sectional study, 146 participants (cognitively healthy = 53, mild cognitive impairment (MCI) = 46, dementia = 47) were recruited at primary care and tertiary clinics. The main outcomes included: accuracy of the BHA and the Montreal Cognitive Assessment (MoCA) in discriminating between controls and cognitively impaired groups (MCI and dementia) and correlations between the BHA subtests of memory, executive functions, and visuospatial skills and criterion-standard paper-and-pencil tests in the same domains. RESULTS: The BHA had an AUC of 0.95 (95% CI: 0.91-0.98) in discriminating between controls and cognitively impaired groups (MCI and dementia, combined) with 0.91 sensitivity at 0.85 specificity. In discriminating between control and MCI groups only, the BHA tests had an AUC of 0.94 (95% CI: 0.90-0.99) with 0.71 sensitivity at 0.85 specificity. Performance was superior to the MoCA across all diagnostic groups. Concurrent and discriminant validity analyses showed moderate to strong correlations between the BHA tests and standard paper-and-pencil measures in the same domain and weak correlations with standard measures in unrelated domains. CONCLUSION: The BHA has excellent performance characteristics in detecting cognitive impairment including dementia and MCI in a Hispanic population in Cuba and outperformed the MoCA. These results support potential application of digital cognitive assessment for older adults in LMIC.