Assessment of the ability of Pseudomonas aeruginosa and Staphylococcus aureus to create biofilms during wound healing in a rat model treated with carboxymethyl cellulose/carboxymethyl chitosan hydrogel containing EDTA.

The primary objective of this study was to develop a carboxymethyl cellulose (CMC) and carboxymethyl chitosan (CMCS) hydrogel containing ethylene diamine tetra acetic acid (EDTA) as the materials for wound healing. CMC and CMCS solutions were prepared with a concentration of 4% (w/v). These solutions were made using normal saline serum with a concentration of 0.5% (v/v). Additionally, EDTA with the concentrations of 0.01%, 0.05%, 0.1%, 0.5%, 1%, and 2% (w/v) was included in the prepared polymer solution. The analysis of the hydrogels revealed that they possess porous structures with interconnected pores, with average in size 88.71 ± 5.93 µm. The hydrogels exhibited a swelling capacity of up to 60% of their initial weight within 24 h, as indicated by the weight loss and swelling measurements. The antibacterial experiments showed that the formulated CMC/CMCS/EDTA 0.5% hydrogel inhibited the growth of Staphylococcus aureus and Pseudomonas aeruginosa. Moreover, the produced hydrogels were haemocompatible and biocompatible. At the last stage, the evaluation of wound healing in the animal model demonstrated that the use of the produced hydrogels significantly improved the process of wound healing. Finally, the findings substantiated the effectiveness of the formulated hydrogels as the materials for promoting wound healing and antibacterial agents.

Composite films based on carboxy methyl cellulose and sodium alginate incorporated Thymus vulgaris purified leaves extract for food application: Assessment, antimicrobial and antioxidant properties.

The current study was conducted to develop biodegradable films with matrix composed from carboxymethyl cellulose (CMC), sodium alginate (SA) and different concentrations from Thymus vulgaris purified leaves extract (TVE). The color properties, physical properties, shape of surface, manners of crystallinity, mechanical properties and thermal properties of produced films were investigated. The continuous addition of TVE up to 1.6 % inside films matrix imparted the yellow color of extract that increased opacity to 2.98 and reduced moisture, swelling, solubility and water vapor permeability (WVP) of films up to 10.31 %, 30.17 %, 20.18 % and (1.12× 10-10 g.m-1 s-1 pa-1), respectively. Furthermore, the surface micrographs showed smoother surface after using small concentrations of TVE and turned to irregular with rough surface at higher concentrations. The FT-IR analysis indicated typically bands that demonstrated physical interaction between TVE extract and CMC/SA matrix. The fabricated films showed suitable thermal stability with decreasing trend by incorporation of TVE inside CMC/SA films. Furthermore, the developed CMC/SA/TVE2 showed significant effects on preserving the levels of moisture content, titrable acidity, force to puncture and sensory properties of cheddar cheese during cold storage days compared with commercial packaging materials.

Fabrication of carboxymethyl chitosan/oxidized carboxymethyl cellulose composite film and its assessment for coating preservation of strawberry.

In the current study, a novel chitosan-based composite, carboxymethyl chitosan (CMCHS)/oxidized carboxymethyl cellulose (OCMC) was fabricated and characterized. The composite film (CMCHS 1.5%w/v + OCMC 0.8%w/v) was more uniform and had better tensile properties, UV blocking, water vapor permeability, and antifungal properties than pure CMCHS film. Preservation experiments showed that the CMCHS/OCMC film was more efficient for retaining the quality decrease of strawberry during storage. By the end of 7 days' storage, the hardness, contents of organic acid, soluble solids, and reducing sugar of coated strawberries were increased by 35.1%, 38.5%, 14.1%, and 3.5%, respectively, compared to the control group; and the decay rate of strawberries in CMCHS/OCMC group also dropped to 36%, about 42% decrease than that in control, suggesting the promising application of CMCHS/OCMC composite in coating preservation.

Synergetic reinforcing effect of graphene oxide and nanosilver on carboxymethyl cellulose/sodium alginate nanocomposite films: Assessment of physicochemical and antibacterial properties.

Incorporating single or combined nanofillers in polymeric matrices is a promising approach for developing antimicrobial materials for applications in wound healing and packaging etc. This study reports a facile fabrication of antimicrobial nanocomposite films using biocompatible polymers sodium carboxymethyl cellulose (CMC) and sodium alginate (SA) reinforced with nanosilver (Ag) and graphene oxide (GO) using the solvent casting approach. Eco-friendly synthesis of Ag nanoparticles within a size range of 20-30 nm was carried out within the polymeric solution. GO was introduced into the CMC/SA/Ag solution in different weight percentages. The films were characterized by UV-Vis, FT-IR, Raman, XRD, FE-SEM, EDAX, and TEM. The results indicated the enhanced thermal and mechanical performance of CMC/SA/Ag-GO nanocomposites with increased GO weight %. The antibacterial efficacy of the fabricated films was evaluated on Escherichia coli (E. coli) and Staphylococcus aureus (S. aureus). The CMC/SA/Ag-GO2% nanocomposite exhibited the highest zone of inhibition of 21.30 ± 0.70 mm against E. coli and 18.00 ± 1.00 mm against S. aureus. The CMC/SA/Ag-GO nanocomposites exhibited excellent antibacterial activity as compared to CMC/SA and CMC/SA-Ag due to the synergetic bacterial growth inhibition activities of the GO and Ag. The cytotoxic activity of the prepared nanocomposite films was also assessed to investigate their biocompatibility.

High performance, cost-effective and ecofriendly flocculant synthesized by grafting carboxymethyl cellulose and alginate with itaconic acid.

Natural polymer flocculant possesses an exciting prospect in water treatment due to its non-toxicity, wide source, low cost and biodegradability. In this work, we have successfully synthesized the anionic terpolymer of carboxymethyl cellulose-itaconic acid­sodium alginate (CIS) by microwave-assisted copolymerization. By studying the flocculation properties towards cationic dye of crystal violet (CV), the optimum synthesis conditions were determined. The maximum removal rate of 100 mg/L CV simulated wastewater was 92.2 % with CIS concentration of 30 mg/L. The flocculation kinetic results showed the rapid dye removal rate and the dye decolorization ratio of 89.8 % could be obtained at 75 s. Moreover, the CIS flocculant showed excellent flocculation effects in ambient pH of 4-10, flocculation temperature of 10-40 °C, and various inorganic salts. In general, the anionic CIS flocculant shows excellent cost effectiveness, where the predicted operation cost of as-prepared CIS is about 60 % of conventional polyacrylamide flocculant. It also has the advantages of excellent ecofriendliness and rich raw material source, indicative its potential applications of wastewater treatment.

Sequestration and toxicological assessment of emerging contaminants with polypyrrole modified carboxymethyl cellulose (CMC/PPY): Case of ibuprofen pharmaceutical drug.

Ibuprofen (IBU) is a non-steroidal anti-inflammatory drug released into water bodies causing toxic biological effects on living organisms. The current study aims to eliminate IBU from aqueous solutions by a novel carboxymethylcellulose/polypyrrole (CMC/PPY) composite with high removal efficiency. Pyrrole was polymerized to polypyrrole whose average size was about 20 nm on the CMC surface. The maximum removal percentage of IBU by CMC/PPY composite was optimized at initial concentration 10 mg/L, dosage 0.02 g, and pH 7 with adsorption capacity of 72.30 (mg/g) and removal of 83.17 %. IBU adsorption onto CMC/PPY theoretically fits into the Langmuir isotherm and Elovich-kinetic models. Fish and Phytotoxicity assessment were performed with zebrafish and seeds of Vigna mungo (VM) and Vigna radiata (VR). The toxicity study reveals that before adsorption, IBU shows high toxicity towards the zebrafish mortality (33 %), growth inhibition (58.52 % for VM, 60.84 % for VR), and germination (86.66 % for VM and 90 % for VR). As CMC/PPY adsorbs IBU, toxicity drastically decreases. Before adsorption, LC50 was 233.02 mg/L. After adsorption, the LC50 increases to 2325.07 mg/L as IBU molecules get adsorbed by CMC/PPY. These findings show the feasibility of preparing CMC/PPY composite to effectively remove pharmaceutical pollutant IBU from aqueous solutions with their toxicological assessment.

A standardized assessment of moldability parameters of thermoplastic materials used in orthotic manufacturing.

OBJECTIVE: To establish parameters for standardized assessment of the moldability of thermoplastic materials used in orthotic manufacturing and to develop tests for quantification of moldability parameters by simulating the demands of clinical practice, in order to enable accurate and controlled analysis of material properties. PRIMARY OUTCOME MEASUREMENTS: Two commercially available materials were submitted to tests for standardized measurement of moldability. Results were correlated with manufacturer information. Moldability assessment was based on two parameters (conformation and fit), expressed as percentages. RESULTS: Tests, standardized molding procedures and measurements were described. Quantitative data (conformation and fit expressed in percentages) were derived from a pilot study comparing Aquaplast-T™ and Ezeform™. Findings of that study revealed that Aquaplast-T™ is more moldable than Ezeform™ and support technical information provided by the manufacturer. CONCLUSIONS: The assessment method described enabled objective and repeatable measurement of the moldability of materials used in orthotic manufacturing and represent a significant advancement in comparative analysis of materials, with potential positive impacts on therapeutic procedures and clinical decision-making. Tests developed in this study can be used to quantify data provided by manufacturers in order to allow their use by researchers and professionals in rehabilitation.

Hyaluronate carboxymethylcellulose sheets for the prevention of adhesive complications: a model-based cost-utility analysis.

AIM: Clinical trials suggest that hyaluronate carboxymethylcellulose (HA/CMC) prevents adhesion-related complications after intra-abdominal surgery, but at a high upfront cost. This study evaluated the cost-effectiveness of HA/CMC for patients undergoing curative-intent open colorectal cancer surgery. METHODS: Using a Markov Monte Carlo microsimulation model, we conducted a cost-utility analysis comparing the cost-effectiveness of HA/CMC at curative-intent open colorectal cancer surgery versus standard management. We considered a scenario where HA/CMC was used at the index operation only, as well as where it was used at the index operation and any subsequent operations. The perspective was that of the third-party payer. Costs and utilities were discounted 1.5% annually, with a 1-month cycle length and 5-year time horizon. Model input data were obtained from a literature review. Outcomes included cost, quality-adjusted life-years (QALYs), small bowel obstructions (SBOs) and operations for SBO. RESULTS: Using HA/CMC at the index operation results in an incremental cost increase of CA$316 and provides 0.001 additional QALYs, for an incremental cost-effectiveness ratio of CA$310,000 per QALY compared to standard management. In our simulated cohort of 10,000 patients, HA/CMC prevented 460 SBOs and 293 surgeries for SBO. Probabilistic sensitivity analysis found that HA/CMC was cost-effective in 18.5% of iterations, at a cost-effectiveness threshold of CA$50,000 per QALY. Results of the scenario analysis where HA/CMC was used at the index operation and any subsequent operations were similar. CONCLUSIONS: Hyaluronate carboxymethylcellulose prevents adhesive bowel obstruction after open colorectal cancer surgery but is unlikely to be cost-effective given minimal long-term impact on healthcare costs and QALYs.

Immobilization of Cr(VI) in Soil Using a Montmorillonite-Supported Carboxymethyl Cellulose-Stabilized Iron Sulfide Composite: Effectiveness and Biotoxicity Assessment.

A novel composite of montmorillonite-supported carboxymethyl cellulose-stabilized nanoscale iron sulfide (CMC@MMT-FeS), prepared using the co-precipitation method, was applied to remediate hexavalent chromium (Cr(VI))-contaminated soil. Cr(VI)-removal capacity increased with increasing FeS-particle loading. We tested the efficacy of CMC@MMT-FeS at three concentrations of FeS: 0.2, 0.5, and 1 mmol/g, hereafter referred to as 0.2 CMC@MMT-FeS, 0.5 CMC@MMT-FeS, and 1.0 CMC@MMT-FeS, respectively. The soil Cr(VI) concentration decreased by 90.7% (from an initial concentration of 424.6 mg/kg to 39.4 mg/kg) after 30 days, following addition of 5% (composite-soil mass proportion) 1.0 CMC@MMT-FeS. When 2% 0.5 CMC@MMT-FeS was added to Cr(VI)-contaminated soil, the Cr(VI) removal efficiency, as measured in the leaching solution using the toxicity characteristic leaching procedure, was 90.3%, meeting the environmental protection standard for hazardous waste (5 mg/kg). The European Community Bureau of Reference (BCR) test confirmed that the main Cr fractions in the soil samples changed from acid-exchangeable fractions to oxidable fractions and residual fractions after 30 days of soil remediation by the composite. Moreover, the main complex formed during remediation was Fe(III)-Cr(III), based on BCR and X-ray photoelectron spectroscopy analyses. Biotoxicity of the remediated soils, using Vicia faba and Eisenia foetida, was analyzed and evaluated. Our results indicate that CMC@MMT-FeS effectively immobilizes Cr(VI), with widespread potential application in Cr(VI)-contaminated soil remediation.

Novel low-cost carboxymethyl cellulose microspheres with excellent fertilizer absorbency and release behavior for saline-alkali soil.

Saline-alkali soil and fertilizer loss severely restrict agriculture on the Songnen Plain in China. To resolve this problem, carboxymethyl cellulose immobilized slow-release fertilizer microspheres (CFM) with homogeneity pore structure, high porosity, biodegradable biological macromolecules and excellent fertilizer absorbency were synthesized by the combination of inverse emulsion polymerization and microfluidic method. By optimizing the synthesis conditions, the water absorption of CFM reached 8725 g g-1 in deionized water. The absorbency behaviors of CFM were highly sensitive to pH, ionic strength, and ionic species. In 5 g L-1 urea solution, the adsorption capacity of CFM was 3342.84 g g-1. The CFM showed excellent urea retention at 80 °C for 5 h and sustained release performance in soil. Besides, degradation rate of CFM was closed to 98.2% in Aspergillus niger at the third day. CFM had the advantages of high pH sensitivity, salt resistance, and good fertilizer absorbency and retention. Therefore, it will be prospecting fertilizer sustained release agent in agriculture.

Use of intranasal submucosal fillers as a transient implant to alter upper airway aerodynamics: implications for the assessment of empty nose syndrome.

BACKGROUND: Empty nose syndrome (ENS) is a debilitating condition associated with inferior turbinate tissue loss. Surgical augmentation of the inferior meatus has been proposed to treat ENS, although efficacy data with validated, disease-specific questionnaires is limited. Instead we evaluated submucosal injection of a transient, resorbable filler into the inferior meatus to favorably alter nasal aerodynamics in ENS patients. METHODS: Patients with a history of inferior turbinate reduction, diagnosed with ENS via Empty Nose Syndrome 6-Item Questionnaire (ENS6Q) and cotton testing, were enrolled and underwent submucosal injection of carboxymethylcellulose/glycerin gel (Prolaryn®) into the inferior meatuses between July 2014 and May 2018. This material likely resorbs over several months. Outcomes included comparisons of preinjection and postinjection symptoms at 1 week, 1 month, and 3 months using the ENS6Q, 22-item Sino-Nasal Outcome Test (SNOT-22), Generalized Anxiety Disorder 7-item scale (GAD-7), and Patient Health Questionnaire-9 (PHQ-9). RESULTS: Fourteen patients underwent injections. Mean ENS6Q scores significantly decreased from baseline at 1 week (20.8 vs 10.5; p < 0.0001), and remained reduced but upward-trending at 1 month (13.7, p = 0.002) and 3 months (15.5, p > 0.05) following injections. Mean SNOT-22 scores significantly decreased at 1 week (p = 0.01) and 1 month (p = 0.04), mean GAD-7 at 1 month (p = 0.02) and 3 months (p = 0.02), and mean PHQ-9 at 1 week (p = 0.01) and 1 month (p = 0.004) postinjection. CONCLUSION: Transient, focal airway bulking via submucosal filler injection at sites of inferior turbinate tissue loss markedly benefits ENS patients, suggesting that aberrant nasal aerodynamics from inferior turbinate tissue loss contributes to (potentially reversible) ENS symptoms.

Evaluating the performance of a new carboxymethyl cellulose dressing in the community setting.

This article describes a single-centre, non-comparative evaluation set out to assess the clinical performance and patient acceptability of a new carboxymethyl cellulose (CMC) wound dressing. Twenty patients in a community setting, aged between 34-97 years, were recruited. The progression of various types of wounds with different levels of exudate was documented over 4 weeks. No adherence to the wound bed or painful removal was reported in 18 patients, and the peri-wound skin was the same or had improved in all patients. When compared with the previous CMC dressing used by the authors, the new CMC dressing reported a longer wear time. These findings show a positive clinical performance and suggest a potential financial advantage when using the new dressing.

Carboxymethyl Cellulose, Trichloroacetic Acid, and Unna Boot for Healing Venous Ulcers: A Comparative Study of Their Efficacy and Socioeconomic Impact.

Chronic ulcers are defined as a breakdown of the long-term cutaneous barrier or frequent recurrence of breakdowns. Dressings are a form of treatment and, in view of the variety and high cost of the products on the market, three agents were selected for this investigation, regarding their efficacy and cost/benefit ratio. The objective of the investigation was to evaluate and compare the efficacy, costs, and benefits of carboxymethylcellulose in paste at 20% (CMC 20%), trichloroacetic acid at 90% (TCA 90%), and Unna boot for treatment of chronic venous ulcers. Three groups of 30 patients each were chosen randomly for ambulatory treatment with TCA 90% (G1), CMC 20% (G2), and Unna boot (G3). The evolution of the cicatricial process of each group separately and between groups was analyzed with measurement of the lesion areas in square centimeters (cm2) and observation of the amount of exudate from observation of the photographic record, until their healing, in the maximum period of 20 weeks. A significant reduction of lesion areas in all groups was observed (P=.0001), with a median reduction of 7.6 cm2 (38.1%) for G1, 3.9 cm2 (38.8%) for G2, and 16.2 cm2 (77.8%) for G3. There was a significant difference in the absolute delta of the lesion areas (P=.0001) of the groups. The three types of treatments promoted effective improvement, with acquisition and utilization of all three products in the public health services being recommended.

Torsemide Fast Dissolving Tablets: Development, Optimization Using Box-Bhenken Design and Response Surface Methodology, In Vitro Characterization, and Pharmacokinetic Assessment.

The present study planed to develop new fast dissolving tablets (FDTs) of torsemide. Solid dispersions (SDs) of torsemide and sorbitol (3:1) or polyvinylpyrrolidone (PVP) k25 were prepared. The prepared SDs were evaluated for in-vitro dissolution. Fourier transform infrared spectroscopy and differential scanning calorimetry for SDs revealed no drug/excipient interactions and transformation of torsemide to the amorphous form. Torsemide/sorbitol SD was selected for formulation of torsemide FDTs by direct compression method. Box-Bhenken factorial design was employed to design 15 formulations using croscarmellose sodium and crospovidone at different concentrations. The response surface methodology was used to analyze the effect of changing these concentrations (independent variables) on disintegration time (Y1), percentage friability (Y2), and amount torsemide released at 10 min. The physical mixtures of torsemide and the used excipients were evaluated for angle of repose, Hausner's ratio, and Carr's index. The prepared FDTs tablets were evaluated for wetting and disintegration time, weight variation, drug content, percentage friability, thickness, hardness, and in vitro release. Based on the in-vitro results and factorial design characterization, F10 and F7 were selected for bioavailability studies following administration to Albino New Zealand rabbits. They showed significantly higher C max and (AUC0-12) and shorter T max than those obtained after administration of the corresponding ordinary commercial Torseretic ® tablets. Stability study was conducted for F10 that showed good stability upon storage at 30°C/75% RH and 40°C/75% RH for 3 months.

Apósito de espuma con hidrofibra / Foam dressing with hydrofiber

ANTECEDENTES: Se solicita al IETSI la evaluación y Validación de la tecnología "Aposito de Espuma con Hidrofibra" segun CARTA Número 6413-GRAR-EsSalud-2016. El apósito de espuma con hidrofibra, especificamente descrito como "apósito de hidrofibra de carboximetilcelulosa sódica 100% con plata iónica, con espuma de poliuretano y recubrimiento impermeable", consiste en un film externo impermeable de poliuretano y una almohadilla multicapa absorvente. la almohadilla contiene una capa de espuma de poliuretano y una capa no tejida de hidrofibra. La hidrofibra contiene plataiónica al 1.2% con activdad antimicrobiana. Esta indicado en el manejo de heridas crónicas o agudas tales como úlceras vasculares, de presión (estadio II -IV), úlceras de pie diabético, heridas quirúrgicas, heridas traumáticas, entre otros. Los apósitos antimicrobianos que contienen plata, se utilizan para prevenir o tratar la infección en una amplia variedad de heridas. Según lo solicitado, el uso en EsSalud seria para aumentar las tasas de curación de úlceras de presión.METODOLOGÍA: El análisis ha consistido en una búsqueda y evaluación de la evidencia científica actual sobre el uso de la tecnologia. Se realizó una evaluación de estudios descriptivos, guías, revisiones sistemáticas, meta-análisis, ensayos clínicos, entre otros. En las seguientes bases de datos referenciales hasta diciembre 2016: Pubmed, Science Direct, EMBASE, EBSCO, Scielo, así como información proporcionada por grupos internacionales o agencias internacionales que realizan revisiones sistemáticas, evaluación de tecnologías sanitarias tales como The Cochrane Library y el National Institute for Health and Clincial Excelence (NICE). para la búsqueda se usaron los siguientes términos generales: "apósitos de plata" "apósito de espuma con hidrofibra", apósito de hidrofibra de carboximetilcelulosa con plata iónico". ANALISES DE LA EVALUACIÓN: Según la evidencia cientifica revisada, se encontró información acerca del dispositivo "Aposito de espuma con hidrofibra". Se presenta la evidencia científica encontrada. Meta-análisis y Revisiones Sistemáticas sobre Apósitos que contiene plata en el manejo de heridas no cicatrizantes. Ensayos Clínicos en "Apósito de Hidrofibra de Carboximetilcelulosa sódica 100% con plata iónica". CONCLUSIÓN: No se encontró evidencia que resplade la efectividad del Dispositivo Médico "Apósito de Espuma con Hidrofibra de carboximetilcelulosa sódica 100% con plata iónica" frente al tratamiento estándar con sulfadiazina de plata de heridas agudas o crónicas no cicatrizantes (úlceras de presión) empleado actualmente en EsSalud. Además, son pocos los estudios disponibles donde se considera la curación completa de la herida como criterio de valoración principal. Los pacientes con úlceras de presión fueron evaluados en conjunto con otros tipos de heridas por lo que es necesario ampliar más estudios que incluyan mayor tiempo de duración del tratamiento y resultados a largo plazo en este subgrupo de pacientes.

ASSESSMENT OF A STABLE COSMETIC PREPARATION BASED ON ENZYMATIC INTERESTERIFIED FAT, PROPOSED IN THE PREVENTION OF ATOPIC DERMATITIS.

Atopic dermatitis is one of the most common skin disorders seen in infants, children and adults. Proper prevention might slow the atopic symptoms. The purpose of the work was a sensory analysis, an evaluation of moistening properties and stability of emulsions based on an enzymatic interesterified fat blend (mutton tallow and walnut oil) and homogenized at different revolutions and different contents of thickener. The emulsions were evaluated with respect to sensory and skin moisturizing properties by 78 respondents. Stability tests, particle size, distribution, dispersity index, morphology structure of the emulsions were determinated too. Taking into consideration all properties of the emulsions, emulsion IV (containing 0.9 g carboxymethyl cellulose and homogenized at 18000 rpm) and emulsion V (1.5 g of carboxymethyl cellulose and homogenized at 24000 rpm) were found to be of optimum composition. The emulsions exhibited good stability, were highly rated in sensory terms and displayed optimum moistening properties. It has been proven that model emulsions based on interesterified fats containing partial acylglicerols, with optimum carboxymethyl cellulose content and specific revolutions at the time of homogenization are an opportunity for developing preparations targeted at skins requiring special care (e.g., with atopic dermatitis or psoriasis). The work proved the use of enzymatic process to create the emulsifier, which represents the innovative contribution of this work. Also it showed an additional application of enzymatic interesterified fats which since has been used only in food industries.

Evaluación del gel antiadherencial post quirúrgico: hialuronato de sodio más carboximetilcelulosa y alginato / Evaluation of post-surgical antiadherence gel: sodium hyaluronate plus carboxymethylcellulose and alginate

INTRODUCCIÓN: las adherencias generalmente se originan en respuesta al corte, isquemia, y lesión durante la cirugia abdominal o pélvica. Las adherencias pueden lener un efecto beneficioso, sin embargo cuando se originan en exceso ocasionan incomodidad, dolor, y hasta severos problemas de salud en los pacientes. OBJETIVO: La presente evaluación tiene como objetivo determinar la eficacia y seguridad del agente antiadherencial: hialuronato de sodio más carboximetilcelulosa y alginato. METODOLOGÍA: Se realiza una búsqueda sistemática de evidencia cientifica hasta marzo del 2016 acerca de la eficacia y seguridad del agente: hialuronato de sodio más carboximetilcelulosa y alginato. RESULTADOS: Se encuentra una serie de efectos adversos reportados en los estudios junto con una serie de deficiencias metodológicas lo que se considera que las investigaciones publicadas hasta la actualidad (marzo del 2016) son insuficientes para poder determinar la eficacia y seguridad del gel antiadherencial postquirúrgico (hialuronato de sodio más carboximetilcelulosa). CONCLUSIÓN: El Instituto de Evaluación de Tecnologías en Salud e Investigación - IETSI, no aprueba el uso del gel antiadherencial en sus presentaciones: hialuronato de sodio más carboximetilcelulosa, alginato o la combinación de hialuronato de sodio más carboximetilcelulosa y alginato; para la reducción de adherencias abdominales y pélvicas.

Evaluación del gel antiadherencial post quirúrgico: hialuronato de sodio más carboximetilcelulosa y alginato / Evaluation of post-surgical antiadherence gel: sodium hyaluronate plus carboxymethylcellulose and alginate

INTRODUCCIÓN: Antecedentes: Las adherencias son bandas de tejido similar el tejido cicatricial que se forman entre superfícies dentro del organismo y hacen que estas se unan. Se forman más frecuentemente en el abdomen y pelvis después de cirugias intestinales o de los órganos femeninos, estas producen diversar molestias como distención o hinchazón abdominal, estreñimiento, náuseas y vomitos, incluso dolor pélvico intenso y crónico. Las adherencias son parte de un proceso fisiopatológico desencadenado o en respuesta al corte, isquemia, abrasión del peritoneo durante la cirugia. Las zonas alteradas sufren de regeneración mesotelial y fibrosis resultando en la formación de adherencias entre los tejidos serosos dañados. Las adherencias pueden tener un efecto beneficioso, ya que permite neovscularización de zonas isquémicas del intestino, tales como en las anastomosis, pero generalmente ocasionan probelmas cuando se vuelven excesivas. Las adherencias son la principal causa de obstrucción intestinal que causa el 70% de readmisiones hospitalarias. El hialuronato de sodio más carboximetilcelulosa, es descrito como un agente antiadherente no tóxico, no inmunogénico y biocompatible que reduce la incidencia y extensión de las adherencias postoperatorias. Compuesto de hialuronato de sodio y carboximetilcelulosa está modificado químicamente para retardar su tasa de degradación y deputación después de entrar en contato con el organismo. METODOLOGÍA: Se realizó una búsqueda bibliográfica de la literatura con respecto a la eficacia y seguridad del uso del Gel Antiadherencial Post quirúrgico. Se seleccionaron artículos científicos: evaluación de tecnologías santiarias, revisiones sistemáticas, met-análisis y ensayos clínicos. Se realizó una búsqueda dentro de la información generada por grupos que realizan revisiones sistemáticas, evaluación de tencologías sanitarias y guías de práctica clínica, tales como The Cochrane Library y The National Institute for Health and Care Excelence (NICE). Además, se hizo una búsqueda en www.clinicaltrials.gov, para poder identificar ensayos aún en elaboración o que no hayan sido publicados. CONCLUSIONES: Las investigaciones publicadas hasta marzo del 2016 son insuficientes para poder determinar la eficacia y seguridad del gel antiadherencial postquirúrgico (hialuronato de sodio más carboximetilcelulosa). Los resultados de los estudios preclínicos son discordantes con los ensayos clínicos realizados posteriomente. El Instituto de Tecnologías en Salud e Investigación-IETSI, no aprueba el uso del gel antiadherencial en sus presentaciones: (hialuronato de sodio más carboximetilcelulosa, alginato o la combinación de hialuronato de sodio más carboximetilcelulosa y alginato; para la reducción de adherencias abdominlaes y pélvicas.

Quantitative surface topography assessment of directly compressed and roller compacted tablet cores using photometric stereo image analysis.

Surface topography, in the context of surface smoothness/roughness, was investigated by the use of an image analysis technique, MultiRay™, related to photometric stereo, on different tablet batches manufactured either by direct compression or roller compaction. In the present study, oblique illumination of the tablet (darkfield) was considered and the area of cracks and pores in the surface was used as a measure of tablet surface topography; the higher a value, the rougher the surface. The investigations demonstrated a high precision of the proposed technique, which was able to rapidly (within milliseconds) and quantitatively measure the obtained surface topography of the produced tablets. Compaction history, in the form of applied roll force and tablet punch pressure, was also reflected in the measured smoothness of the tablet surfaces. Generally it was found that a higher degree of plastic deformation of the microcrystalline cellulose resulted in a smoother tablet surface. This altogether demonstrated that the technique provides the pharmaceutical developer with a reliable, quantitative response parameter for visual appearance of solid dosage forms, which may be used for process and ultimately product optimization.

Assessment of powder blend uniformity: Comparison of real-time NIR blend monitoring with stratified sampling in combination with HPLC and at-line NIR Chemical Imaging.

Scope of the study was (1) to develop a lean quantitative calibration for real-time near-infrared (NIR) blend monitoring, which meets the requirements in early development of pharmaceutical products and (2) to compare the prediction performance of this approach with the results obtained from stratified sampling using a sample thief in combination with off-line high pressure liquid chromatography (HPLC) and at-line near-infrared chemical imaging (NIRCI). Tablets were manufactured from powder blends and analyzed with NIRCI and HPLC to verify the real-time results. The model formulation contained 25% w/w naproxen as a cohesive active pharmaceutical ingredient (API), microcrystalline cellulose and croscarmellose sodium as cohesive excipients and free-flowing mannitol. Five in-line NIR calibration approaches, all using the spectra from the end of the blending process as reference for PLS modeling, were compared in terms of selectivity, precision, prediction accuracy and robustness. High selectivity could be achieved with a "reduced" approach i.e. API and time saving approach (35% reduction of API amount) based on six concentration levels of the API with three levels realized by three independent powder blends and the additional levels obtained by simply increasing the API concentration in these blends. Accuracy and robustness were further improved by combining this calibration set with a second independent data set comprising different excipient concentrations and reflecting different environmental conditions. The combined calibration model was used to monitor the blending process of independent batches. For this model formulation the target concentration of the API could be achieved within 3 min indicating a short blending time. The in-line NIR approach was verified by stratified sampling HPLC and NIRCI results. All three methods revealed comparable results regarding blend end point determination. Differences in both mean API concentration and RSD values could be attributed to differences in effective sample size and thief sampling errors. This conclusion was supported by HPLC and NIRCI analysis of tablets manufactured from powder blends after different blending times. In summary, the study clearly demonstrates the ability to develop efficient and robust quantitative calibrations for real-time NIR powder blend monitoring with a reduced set of powder blends while avoiding any bias caused by physical sampling.