Estrategia para optimizar la seguridad del paciente en el servicio de dispensación en farmacia comunitaria. Propuesta de listados de verificación / Strategy to optimize patient safety in community pharmacy dispensing service. Checklists Proposed

La dispensación es el servicio más demandado e importante dentro de las labores que realiza el farmacéutico, en su día a día, en la farmacia comunitaria. El objetivo de la dispensación es garantizar el acceso del paciente al medicamento de manera adecuada y controlada. En dicho proceso, el farmacéutico comunitario tiene la obligación, como profesional de la salud, de participar de forma activa y comprometida en la detección de posibles errores de medicación o relacionados con la misma. El Grupo de Trabajo de Seguridad del Paciente de SEFAC ha elaborado, como comienzo de una serie de futuros proyectos, unos listados de verificación y decálogos de buenas prácticas sobre medicamentos formulados en forma de parches transdérmicos, comprimidos bucodispersables o formas de liberación modificada. Con esta iniciativa se pretende, mediante una entrevista previa con el paciente y el uso de estas herramientas, minimizar en la medida de lo posible, los errores o problemas que puedan surgir con dichos medicamentos velando finalmente por la seguridad del paciente. A lo largo del 2023 se espera comenzar un pilotaje en farmacias comunitarias colaboradoras con el Grupo de Trabajo de Seguridad del paciente de SEFAC y así poder recoger y notificar los resultados que se obtengan (AU)

Parches transdérmicos anticonceptivos: evaluación de tecnología sanitaria / Contraceptive transdermal patches: health technology assessment

INTRODUCCIÓN: La anticoncepción es un derecho, y es obligación del Estado garantizar el acceso a métodos anticonceptivos efectivos, seguros y de calidad. Se realizó una evaluación de tecnología sanitaria sobre los parches anticonceptivos transdérmicos. MÉTODOS: Un equipo multidisciplinario e independiente designado por el Comité Provincial de Biotecnologías de Neuquén buscó información epidemiológica, regulatoria y evidencias científicas sobre eficacia, seguridad y adherencia. Se analizó y sistematizó siguiendo metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) y CASPe (Critical Appraisal Skills Programme Español). RESULTADOS: El único parche autorizado en Argentina para su comercialización libera 33,9 µg/día de etinilestradiol y 203 µg/día de norelgestromina. Su prospecto en Argentina, EE.UU. y Europa lo asocia al doble de riesgo de enfermedad tromboembólica venosa si se compara con las píldoras anticonceptivas que provee el Estado. Esto coincide con resultados de estudios de cohortes de alta calidad. Los parches proveen similar eficacia anticonceptiva a corto plazo, pero con altas tasas de abandono en el seguimiento. La Organización Mundial de la Salud no los ha incluido en su listado de medicamentos esenciales. Los parches son más costosos que otros métodos disponibles. DISCUSIÓN: Sobre la base de los principios de beneficencia, no maleficencia, de precaución y de proporcionalidad, no se recomienda la incorporación de parches.(AU)

INTRODUCTION: Contraception is a right, being an obligation of the State to guarantee access to effective, safe and quality contraceptive methods. A health technology assessment was carried out on transdermal contraceptive patches. METHODS: A multidisciplinary and independent team appointed by the Provincial Biotechnology Committee of Neuquén searched for epidemiological and regulatory information and scientific evidence on efficacy, safety and adherence. It was analyzed and systematized following the GRADE (Grading of Recommendations Assessment, Development and Evaluation) and CASPe (Critical Appraisal Skills Programme Español) methodology. RESULTS: The only patch authorized for commercialization in Argentina releases 33.9 µg/day of ethinylestradiol and 203 µg/day of norelgestromin. Its package insert in Argentina, the US and Europe highlights that the risk of venous thromboembolic disease is twice as high compared to the contraceptive pills provided by the State. This is consistent with results from high-quality cohort studies. Patches provide similar short-term contraceptive efficacy, but with high dropout rates at follow-up. The World Health Organization has not included them in its list of essential medicines. Patches are more expensive than other available methods. DISCUSSION: Based on the principles of beneficence, non-maleficence, precaution and proportionality, the incorporation of patches is not recommended.(AU)

Treatment of postoperative localized neuropathic pain with topical 5% lidocaine. Case report / Tratamento de dor neuropática pós-operatória localizada com lidocaína tópica a 5%. Relato de caso

ABSTRACT BACKGROUND AND OBJECTIVES: Post-surgical neuropathic pain (NP) is an important clinic condition, with recurring pain and that may be a result of transection, contusion, nerve inflammation or stretching and lasting for 3-6 months. Having into consideration the prevalence of postoperative localized NP, its impact in quality of life of patients, its complexity of diagnosis and treatment and available treatment options, the aim of this report was to present efficacy, safety and tolerability outcomes of 5% lidocaine transdermal patch use as a single treatment or in combination with other therapeutic options by describing and analyzing four clinical cases. CASES REPORT: Four patients aged between 43 and 70 years old and complains of postoperative localized NP were managed with 5% lidocaine transdermal patch in prolonged treatment, with significant improvement in pain scores. CONCLUSION: The outcomes of the described cases revealed that postoperative localized NP management was successful with 5% lidocaine transdermal patch. Moreover, it was possible to observe that its association to other treatments (pharmacological or not) has proved efficacy with no negative impact the tolerability of the treatment or the patient routine and comfort.

RESUMO JUSTIFICATIVA E OBJETIVOS: A dor neuropática (DN) pós-operatória é um problema clínico relevante, com dor persistente, que pode ser resultado de transecção, contusão, alongamento ou inflamação do nervo, durando geralmente cerca de 3-6 meses após a cirurgia. Tendo em consideração a prevalência estimada da DN localizada pós-operatória, seu impacto na qualidade de vida dos pacientes, sua complexidade diagnóstica e terapêutica, e as opções de tratamento disponíveis, o presente estudo teve como objetivo apresentar os desfechos de eficácia, segurança e tolerabilidade do uso do emplastro de lidocaína a 5% nesta condição clínica, seja como fármaco isolado ou em combinação com outras classes terapêuticas. RELATO DOS CASOS: Quatro pacientes com idades entre 43 e 70 anos e com história de DN localizada pós-operatória foram manejados com emplastro de lidocaína a 5% em tratamento prolongado, com melhora significativa do nível de dor. CONCLUSÃO: Os resultados dos casos apresentados neste estudo revelam que o manejo da DN localizada pós-operatória foi eficaz com a utilização do emplastro de lidocaína a 5%. Além disso, foi possível observar que sua associação com outros tratamentos (farmacológicos ou não) mostrou-se efetiva, sem impactar negativamente a tolerabilidade do tratamento ou o conforto do paciente.

In vitro transdermal drug permeation tests: a regulatory scenario evaluation

SUMMARY Introduction: The Transdermal Drug Delivery Systems (TDDS) could circumvent the inconveniences of oral administration, increasing treatment adhesion. Meanwhile, despite being highly widespread systems, there are discrepancies between the performance and quality control methodologies recommended by the leading regulatory agencies, which is an issue for the pharmaceutical industry. Aim: To identify and to compare the requirements for TDDS regulatory approval by important agencies, focusing on the in vitro release and drug permeation studies, which are crucial tests for the evaluation of safety, efficacy, and performance of these systems. Methods: The documents that regulate the scope of TDDS in FDA, EMA and Anvisa were analyze, as well as the contributions of OECD. In addition, an approaching regarding the pharmacopeial requirements was made regarding USA, Europe, and Brazil. Results and conclusion: Concerning the regulatory approval aspects, the FDA is reviewing its documents because the current guidance is not specific to transdermal systems. On the other hand, the EMA presents a unique guideline that includes specific requirements for TDDS. The USA and the European Pharmacopoeias have specific mentions to performance and quality control of TDDS, while the Brazilian Pharmacopoeia does not mention this dosage form. Recently, Anvisa published a guide, which helps Brazilian manufacturers concerning the tests required for the regulatory approval of a new TDDS. The launch of this standardized national statute associated with the use of a validated in vitro release and permeation tests represents a remarkable breakthrough regarding TDDS.

Introducción: los sistemas de administración de fármacos transdérmicos (TDDS) podrían sortear los inconvenientes de la administración por vía oral, aumentando la adherencia al tratamiento. Mientras tanto, a pesar de ser sistemas muy extendidos, existen discrepancias entre las metodologías de desempeño y control de calidad recomendadas por las principales agencias reguladoras, lo cual es un problema para la industria farmacéutica. Objetivo: identificar y comparar los requisitos para la aprobación regulatoria de TDDS por parte de las principales agencias reguladoras, enfocándose en los estudios de liberación in vitro y premiación de fármacos. Métodos: se analizaron los documentos que regulan el alcance de la TDDS en la FDA, EMA y Anvisa, así como los aportes de la OCDE. Además, se realizó un planteamiento sobre los requisitos de las farmacopeas de los Estados Unidos, Europa y Brasil. Resultados y conclusión: la FDA está revisando los aspectos de aprobación regulatoria porque la guía actual no es específica para los sistemas transdérmicos. Por otro lado, la EMA presenta una guía única que incluye requisitos específicos para TDDS. Las farmacopeas de los Estados Unidos e Europa tienen menciones específicas al rendimiento y control de calidad de TDDS, mientras que la Farmacopea brasileña no menciona esta forma de dosificación. Recientemente, Anvisa publicó una guía que ayuda a los fabricantes brasileños en cuanto a las pruebas requeridas para la aprobación regulatoria de un nuevo TDDS. El lanzamiento de este estatuto nacional estandarizado asociado con el uso de pruebas validadas de liberación y premiación in vitro representa un avance notable con respecto a TDDS.

Introdução: os sistemas de liberação transdérmica (SLT) são capazes de contornar as desvantagens da administração oral de medicamentos, aumentando a adesão ao tratamento. Entretanto, apesar de serem sistemas difundidos, existem discrepâncias entre as metodologias de desempenho e controle de qualidade recomendadas pelas agências regulatórias, dificultando o desenvolvimento destes pela indústria farmacêutica. Objetivo: identificar e comparar os requisitos para aprovação regulatória de SLT por importantes agências regulatórias, com foco nos estudos de liberação e permeação de fármacos in vitro, testes fundamentais para avaliação da segurança, eficácia e desempenho desses sistemas. Métodos: foram analisados os documentos que regulam o escopo dos SLT publicados pela FDA, EMA e Anvisa e as contribuições da OCDE. Além disso, foi realizada a abordagem sobre os requisitos farmacopeicos nos Estados Unidos, Europa e Brasil. Resultados e conclusão: FDA está revisando os aspectos de aprovação regulatória, pois os documentos atuais não são específicos para os SLT. Em contraponto, a EMA apresenta uma diretriz única que inclui requisitos específicos para estes sistemas. Em relação às farmacopeias, enquanto EUA e Europa apresentam recomendações específicas para desempenho e controle de qualidade dos SLT, a Farmacopeia brasileira não menciona esta forma farmacêutica. Recentemente, a Anvisa publicou um guia com os testes necessários para o registro destes sistemas. O lançamento de tal publicação, associado a ensaios devidamente validados representam um avanço notável no escopo regulatório dos SLT.

Uso de parches de capsaicina al 8 % para el tratamiento del dolor neuropático lumbar / Use of 8 % capsaicin patches for the treatment of lumbar neuropathic pain

Introducción: El dolor neuropático lumbar es una patología frecuente en la clínica diaria, con un tratamiento complejo, tanto farmacológico como intervencionista. Estos tratamientos podemos complementarlos con un parche transdérmico de capsaicina al 8 %. La capsaicina es agonista selectivo de los receptores TRPV1 (receptor transitorio vanilla de 1) cuya activación bloquea la liberación de sustancia P, muy implicada en el proceso de la inflamación. Objetivos: Valorar la utilidad del parche de capsaicina al 8 % como complemento en pacientes con dolor neuropático lumbar. Como objetivo secundario, valorar los efectos adversos del parche de capsaicina tanto en el momento de aplicación como a los 3 meses. Pacientes y métodos: Estudio retrospectivo, observacional y descriptivo, en el que se incluyeron 20 pacientes con dolor neuropático lumbar, tratados con parche de capsaicina al 8 % (Qutenza® como complemento al tratamiento habitual de esta patología. Se utilizaron 3 test para valorar el dolor: EVA (escala visual analógica del dolor), DN4 y LANSS para dolor neuropático. Los 3 test fueron pasados a los pacientes antes de la aplicación del parche y a los 3 meses de este. Resultados: Al inicio, el 95 % de los pacientes incluidos en el estudio presentaban dolor muy severo (EVA 8-9). A los 3 meses, el 85 % de los pacientes refieren dolor moderado (EVA 5-6). Con respecto al test DN4 observamos una disminución de los valores de algo más de 2 puntos. En el test LANSS encontramos una disminución de más de 5 puntos en estos 3 meses. La aplicación del parche no causó efectos secundarios significativos. Conclusiones: El parche de capsaicina al 8 % se ha mostrado eficaz y seguro como tratamiento complementario para el dolor neuropático lumbar.(AU)

Introduction: Lumbar neuropathic pain is a common pathology in daily clinical practice, with a complex treatment, both pharmacological and interventional. These treatments can be complemented with an 8 % capsaicin transdermal patch. Capsaicin is a selective agonist of TRPV1 receptors (transient receptor vanilla 1) whose activation blocks the release of substance P, which is heavily involved in the inflammatory process. Objectives: To assess the usefulness of the capsaicin 8 % patch as an adjunct in patients with lumbar neuropathic pain. As a secondary objective, to assess the adverse effects of the capsaicin patch both at the time of application and after 3 months. Patients and methods: Retrospective, observational and descriptive study, which included 20 patients with lumbar neuropathic pain, treated with capsaicin patch 8 % (Qutenza® as an adjunct to the usual treatment of this pathology. Three tests were used to assess pain: VAS (visual analogue pain scale), DN4 and LANSS for neuropathic pain. The 3 tests were administered to the patients before the application of the patch and 3 months after the patch was applied. Outcomes: At baseline, 95 % of patients included in the study had very severe pain (VAS 8-9). At 3 months, 85 % of patients reported moderate pain (VAS 5-6). With respect to the DN4 test, we observed a decrease in values of slightly more than 2 points. In the LANSS test we found a decrease of more than 5 points in these 3 months. The application of the patch did not cause significant side effects. Conclusions: The 8 % capsaicin patch has been shown to be effective and safe as an adjunctive treatment for lumbar neuropathic pain.(AU)

[Transdermal buprenorphine for acute postoperative pain: a systematic review]. / Uso da buprenorfina transdérmica na dor aguda pós­operatória: revisão sistemática.

BACKGROUND AND OBJECTIVES: Postoperative pain is still a major concern in several surgical procedures. Multimodal analgesia is best for postoperative pain management; however, opioid therapy is still the main treatment for pain after surgical procedures. Transdermal buprenorphine is a partial µ agonist opioid widely used for chronic pain syndromes, with limited evidence for acute postoperative pain. A systematic review of studies examining transdermal buprenorphine for acute pain management after surgery was conducted. CONTENTS: Data from PubMed, Embase, The Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL via EBSCOhost, and LILACS were reviewed, including randomized clinical trials that evaluated total postoperative pain, postoperative analgesic consumption, drug-related side effects and patient satisfaction with analgesia regimen. Data from nine studies (615 patients) were included in this review. Most studies initiated transdermal buprenorphine use 6 to 48 hours before surgery, maintaining use from 1 to 8 days after the procedure. Most studies showed lower or similar postoperative pain scores, postoperative analgesic consumption and patient satisfaction comparing buprenorphine to placebo, tramadol, celecoxib, flurbiprofen and parecoxib. The incidence of side effects varied between studies, with most showing no increase in drug-related side effects with buprenorphine use, except one study, which compared buprenorphine to oral tramadol, and one to transdermal fentanyl. However, most results were derived from evidence with an overall high or unclear risk of bias. CONCLUSIONS: Although more studies are necessary, initial results show that transdermal buprenorphine seems to be an effective and safe opioid choice for management of acute postoperative pain.

Transdermal buprenorphine for acute postoperative pain: a systematic review / Uso da buprenorfina transdérmica na dor aguda pós-operatória: revisão sistemática

Background and objectives: Postoperative pain is still a major concern in several surgical procedures. Multimodal analgesia is best for postoperative pain management; however, opioid therapy is still the main treatment for pain after surgical procedures. Transdermal buprenorphine is a partial µ-agonist opioid widely used for chronic pain syndromes, with limited evidence for acute postoperative pain. A systematic review of studies examining transdermal buprenorphine for acute pain management after surgery was conducted. Contents: Data from PubMed, Embase, The Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL via EBSCOhost, and LILACS were reviewed, including randomized clinical trials that evaluated total postoperative pain, postoperative analgesic consumption, drug-related side effects and patient satisfaction with analgesia regimen. Data from nine studies (615 patients) were included in this review. Most studies initiated transdermal buprenorphine use 6 to 48 hours before surgery, maintaining use from 1 to 28 days after the procedure. Most studies showed lower or similar postoperative pain scores, postoperative analgesic consumption and patient satisfaction comparing buprenorphine to placebo, tramadol, celecoxib, flurbiprofen and parecoxib. The incidence of side effects varied between studies, with most showing no increase in drug-related side effects with buprenorphine use, except one study, which compared buprenorphine to oral tramadol, and one to transdermal fentanyl. However, most results were derived from evidence with an overall high or unclear risk of bias. Conclusions: Although more studies are necessary, initial results show that transdermal buprenorphine seems to be an effective and safe opioid choice for management of acute postoperative pain

Justificativa e objetivos: A dor pós-operatória ainda é uma queixa importante em vários procedimentos cirúrgicos. A analgesia multimodal é a melhor conduta para a dor pós-operatória, embora a terapia com opioides ainda seja o principal tratamento para a dor após procedimentos cirúrgicos. A buprenorfina transdérmica é um opioide agonista µ amplamente prescrito nas síndromes de dor crônica, mas com limitada evidência do seu uso para dor aguda no pós-operatório. Realizamos revisão sistemática de estudos que examinaram o papel da buprenorfina transdérmica no tratamento da dor aguda pós-operatória. Conteúdo: Revisamos os dados de PubMed, Embase, Registro Central de Ensaios Controlados Cochrane (CENTRAL), CINAHL via EBSCOhost e LILACS, incluindo estudos clínicos randomizados que avaliaram a dor pós-operatória total, consumo de analgésicos pós-operatórios, efeitos colaterais relacionados a medicamentos e satisfação do paciente com esquema de analgesia. Dados de nove estudos (615 pacientes) foram incluídos nesta revisão. A maioria dos estudos iniciou o uso transdérmico de buprenorfina 6 a 48 horas antes da cirurgia, mantendo o uso de 1 a 28 dias após o procedimento. A maioria dos estudos encontrou valores semelhantes ou menores para o escore de dor pós-operatória, consumo pós-operatório de analgésicos e satisfação do paciente quando a buprenorfina foi comparada ao placebo, tramadol, celecoxibe, flurbiprofeno e parecoxibe. A incidência de efeitos colaterais oscilou nos estudos, e a maioria não mostrou aumento de efeito colateral relacionado ao uso de buprenorfina, exceto em dois estudos, um que comparou buprenorfina ao tramadol oral e outro ao fentanil transdérmico. No entanto, a maioria dos resultados foi obtida a partir de evidências com um risco geral alto ou risco de viés impreciso. Conclusões: Embora sejam necessários mais estudos, os resultados iniciais mostram que a buprenorfina transdérmica parece ser uma forma de administração segura e efetiva de opioide no tratamento da dor aguda pós-operatória

Cognitive function assessment in elderly patients with overactive bladder treated with transdermal oxybutynin. / Evaluación de la función cognitiva en pacientes de edad avanzada con vejiga hiperactiva tratados con oxibutinina transdémica.

INTRODUCTION AND OBJECTIVES: Older patients with overactive bladder under antimuscarinic treatment are especially susceptible to cognitive impairment. The aim was to assess short term changes in cognitive function in elderly patients with overactive bladder treated with transdermal oxybutynin. MATERIALS AND METHODS: Observational, retrospective, multicentre study in patients with overactive bladder aged 65-80 years undergoing treatment with transdermal oxybutynin. Before and after one month of treatment, cognitive function using the Memory Alteration Test and Clock-Drawing Test, changes in symptoms with validated questionnaires, patient perception of treatment response using Treatment Benefit Scale and treatment adherence with the modified Morisky-Green test, were assessed. RESULTS: From 85 eligible patients, 70 completed the assessment (mean age: 71.4±4.5; BMI: 28.7±3.1kg/m2). No cognitive impairment was observed after one month with transdermal oxybutynin: Memory Alteration Test (+1 point; 95%CI: 0.0-1.5), Clock-Drawing Test (0 points; 95%CI: 0.0-0.0). A statistically significant improvement (P<.001) was observed in all urinary storage symptoms, except stress urinary incontinence. There was an improvement in the Bladder Control Self-Assessment Questionnaire (symptom score: -2.27; 95%CI: -2.8, -1.7; P<.001; bother score: -2.73; 95%CI: -3.3, -2.1; P<.001). 70% of patients reported either a stable or improved bladder condition according to the Patient Perception of Bladder Condition questionnaire. 72.8% of patients reported that their urinary problems had improved or greatly improved with an 84.3% treatment adherence. CONCLUSIONS: No cognitive impairment was observed in elderly patients after one month of treatment with transdermal oxybutynin; urinary urgency symptoms improved and there was adequate treatment adherence.

Molécula 1 de Adhesión Intercelular Soluble en menopáusicas tratadas con estradiol oral o transdérmico / Soluble Intercellular Adhesion Molecule 1 In Postmenopausal Women Treated With Oral Or Transdermal Estradiol

El objetivo de la investigación fue comparar las modificaciones de las concentraciones plasmáticas de la molécula 1 de adhesión intercelular soluble en menopáusicas tratadas con estradiol oral o transdérmico después de 3 meses de uso. Se realizó una investigación con una muestra de 140 pacientes menopáusicas que asistieron a la consulta de Medicina Interna, Endocrinología y Menopausia del Hospital Central Dr. Urquinaona, Maracaibo, Venezuela. Se asignó a 70 pacientes tratamiento con estradiol oral (grupo A) y a 70 pacientes tratamiento con estradiol transdérmico (grupo B). Se evaluaron las concentraciones plasmáticas de molécula 1 de adhesión intercelular soluble antes y después de 3 meses de tratamiento. (p = ns). Las concentraciones plasmáticas de la molécula 1 de adhesión intercelular soluble demostraron una reducción después de 3 meses de tratamiento en ambos grupos (grupo A: 279,1 +/- 76,5 ng/ml al inicio comparado con 241,7 +/- 68,4 ng/ml después del tratamiento y grupo B: 251,9 +/- 73,2 ng/ml después del tratamiento comparado con el valor promedio inicial de 288,7 +/- 62,7 ng/ml; p < 0,05). Se concluye que el uso de estradiol transdérmico puede ser una alternativa eficaz al uso de estradiol oral después de 3 meses de uso, debido a que ambos tratamientos producen disminuciones en las concentraciones plasmáticas de molécula 1 de adhesión intercelular soluble.

The objective of research was: to compare modifications of plasma concentrations of solubleintercellular adhesion molecule 1 in postmenopausal women treated with oral or estradiol after 3 months of use. This study included 140 postmenopausal women attending the Internal Medicine, Endocrinology and Menopause Departments at the Hospital Central "Dr. Urquinaona", Maracaibo, Venezuela. Seventy patients were assigned to be treated with oral estradiol (group A) and 70 patients were treated with transdermal estradiol (group B). Plasma concentrations of soluble intercellular adhesion molecule 1 were measured before and after 3 months of treatment. There were no statically significant differences in general characteristics between the two treatment groups (p = ns). In both groups, soluble intercellular adhesion molecule 1 was reduced after 3 months of treatment (group A: 279.1 +/- 76.5 ng/ml before treatment compared with 241.7 +/- 68.4 ng/ml after treatment and group B: 251.9 +/- 73.2 ng/ml after treatment compared with initial mean value of 288.7 +/- 62.7 ng/ml; p < 0.05). It is concluded that transdermal estradiol could be an effective alternative to oral estradiol after 3 months of use since both treatments decreased plasma concentrations of soluble intercellular adhesion molecule 1. KEYWORDS: Estradiol; Menopause; Transdermal; soluble intercellular adhesión.

Formulation and evaluation of transdermal drug-delivery system of isosorbide dinitrate / Formulação e avaliação de sistema transdérmico droga-entrega de dinitrato de isossorbida

The purpose of this study was to develop a reservoir-type transdermal delivery system for isosorbide dinitrate (ISDN). The developed patch consisted of five layers from bottom to top, namely, a temporary liner, an adhesive layer, a rate-controlling membrane, a reservoir and a backing. The effects of chemical penetration enhancers, reservoir materials and rate-controlling membranes on the release behaviour of ISDN from the transdermal patch were studied, and the in vitro release of ISDN from the developed patch was studied and compared with the commercially available ISDN patch. The results showed that there was no significant difference in permeation rates between the developed reservoir-type patch and the commercially available ISDN patch (p> 0.05). Moreover, the cumulative release ratio of the commercially available ISDN patch in 48 h was up to 89.8%, whereas the developed patch was only 34.9%, which meant the sustained release time of the developed patch was much longer than the commercially available ISDN patch, and would promote the satisfaction of the patient...

O objetivo do presente estudo foi desenvolver um sistema de liberação transdérmico do tipo reservatório para o dinitrato de isossorbida (ISDN, abrevitura em Inglês). A formulação transdérmica desenvolvida constou de cinco camadas de baixo para cima, ou seja, um revestimento temporário, uma camada adesiva, uma membrana controladora da taxa de liberação, um reservatório e um reforço. Estudaram-se os efeitos dos potenciadores de penetração química, materiais do reservatório e membranas de controle da taxa de liberação no comportamento da formulação transdérmica de dinitrato de isossorbida. A liberação in vitro da formulação transdérmica de dinitrato de isossorbida desenvolvida foi estudada em comparação com a formulação de dinitrato de isossorbida disponível comercialmente. Os resultados mostraram que não existem diferenças significativa nas taxas de permeação entre o tipo de reservatório desenvolvido e o de dinitrato de isossorbida desenvolvido comercialmente (p>0,05). Ademais, a taxa de liberação cumulativa da formulação de dinitrato de isossorbida disponível comercialmente em 48 horas foi de até 89,8% e a da formulação desenvolvida, de apenas de 34,9%, o que provou que a liberação sustentada da formulação desenvolvida foi muito maior do que a de dinitrato de isossorbida desenvolvida comercialmente, o que promoveria a satisfação do paciente...

Liberación de pravastatina sódica formulada en matrices poliméricas a base de Quitosan/Pluronic F ̶ 127 / Release of pravastine sodium formulated in polymer chitosan/pluronic f-127 matrices

Introducción: el desarrollo de medicamentos transdérmicos manifiesta gran interés en los últimos años debido a las ventajas que ofrece; sin embargo, muchos de los sistemas desarrollados utilizan componentes solubles lo cual podría llevar a una ineficacia terapéutica si la matriz polimérica del sistema se solubiliza muy rápido, por ello se ensayan polímeros insolubles que permitan modular la liberación de un ingrediente farmacéuticamente activo. Objetivo: evaluar la liberación de pravastatina sódica en matrices poliméricas insolubles de quitosan/PF-127 con el método de paleta sobre disco para obtener su perfil cinético de liberación, con la finalidad de proponerse como matrices viables para la elaboración de parches transdérmicos. Métodos: se realizaron estudios de contenido químico, diámetro y espesor de las películas, calorimetrías de barrido diferencial y estudios de liberación. La cuantificación del principio activo se realizó mediante espectrofotometría UV-Vis a 238 nm. Resultados: se obtuvieron parches transdérmicos con buena uniformidad de contenido, espesor, diámetro, con una buena estabilidad en base a los estudios de calorimetría. El uso de PF-127 incrementó o retardó la liberación de pravastatina de la matriz polimérica dependiendo de su concentración y al realizarse los perfiles cinéticos de liberación las formulaciones se ajustaron a una cinética de orden 0 que describe el comportamiento de algunos sistemas transdérmicos. Conclusiones: los resultados manifiestan la posibilidad de usar esta matriz polimérica insoluble de quitosana con PF-127 para modular la liberación de pravastatina sódica y de fármacos con estructura similar a la misma por vía transdérmica, lo que generará de esta manera nuevas alternativas a las formas farmacéuticas orales para el tratamiento de padecimientos y enfermedades(AU)

Introduction: the development of transdermal drugs has aroused great interest in recent years due to their advantages, however many of the drug delivery systems use soluble matrix components which could trigger therapeutic problems due to a rapid release of the active ingredient. Therefore, insoluble polymers are being tested that can modulate the release of a pharmaceutically active ingredient. Objective: to evaluate the release of pravastatin sodium in insoluble polymer chitosan/PF-127 matrices by VER to obtain kinetic profile of release in order to submit them as viable systems for the manufacture of transdermal patches. Methods: studies on the chemical content, diameter and thickness of films, differential scanning calorimetry and release studies were performed. The UV-Vis spectrophotometry at 238 nm allowed quantitating the active principle. Results: transdermal patches with adequate uniform drug content, suitable thickness and diameter with good stability, based on calorimetric studies, were obtained. The use of PF-127 increased or delayed the release of pravastatin sodium from the polymeric matrix depending on concentration. When performing the kinetic profiles of release, the formulations were regulated to zero kinetic that describes the behavior of some transdernal systems. Conclusions: the results demonstrated the possibility of using these insoluble polymer chitosan/PF-127 matrices to modulate the release of pravastin sodium and of other structurally similar drugs, thus creating new alternatives to existing pharmaceutical oral forms for treatment of diseases(AU)

Proyecto PIENSA (Programa de Investigación y Educación en Salud Reproductiva): impacto de la asesoría en la elección anticonceptiva en mujeres peruanas

Introducción: La necesidad insatisfecha de anticoncepción sigue siendo alta en el Perú y a nivel mundial. La asesoría adecuada del profesional de la salud ha demostrado maximizar el uso y cumplimiento de métodos anticonceptivos que se ajusten a las necesidades de cada mujer. Objetivos: Medir el impacto de la asesoría brindada por profesionales de salud ginecoobstetras en la elección de un método anticonceptivo hormonal de autoadministración -píldora diaria, parche transdérmico semanal y anillo vaginal mensual-, así como los factores determinantes de ello. Diseño: Estudio observacional, descriptivo y transversal. Lugar: Lima, Piura, Chiclayo y Trujillo, Perú. Institución: Proyecto Latinoamericano PIENSA: Programa de Investigación y Educación en Salud Anticonceptiva. Participantes: Quinientos ochenta y un mujeres de 18 a 40 años que acudieron a la consulta de 40 ginecoobstetras que brindaron asesoría sobre métodos anticonceptivos. Intervenciones: Se realizó una asesoría estandarizada con material didáctico que contenía información sobre efectividad, mecanismo de acción, modo de uso, beneficios y riesgos, así como idoneidad, respecto a las necesidades individuales. Principales medidas de resultados: Elección original y elección final del método anticonceptivo luego de la asesoría, y factores involucrados. Resultados: La elección inicial del método fue de 57% la píldora, 15% el anillo vaginal y 13% el parche transdérmico; luego de la asesoría fue: 38% la píldora, 33% el anillo vaginal, y 19% el parche transdérmico. Resultó estadísticamente significativa la preferencia entre las usuarias del anillo vaginal de 15% a 33% y la preferencia del parche transdérmico de 13 a 19%; p<0,005. La razón principal para la elección del método fue la facilidad de uso. Conclusiones: Las mujeres peruanas participantes del proyecto PIENSA eligieron inicialmente la píldora diaria, cuyo porcentaje disminuyó luego de la asesoría por un profesional de la salud. Asimismo, el número de mujeres que eligieron los métodos de parche transdérmico y anillo vaginal se incrementó significativamente.

Introduction: Unmet needs for contraception are high in Peru and worldwide. Proper advice from health professionals maximizes use and compliance of contraceptive methods meeting the needs of every woman. Objectives: To determine the impact and determinant factors of gynecologists advice for women choosing a self-administered hormonal contraceptive method, either daily pill, weekly transdermal patch or monthly vaginal ring. Design: Observational, descriptive and transversal study. Location: Lima, Piura, Chiclayo, and Trujillo, Peru. Institution: Latin Project PIENSA: Program for Research and Education on Contraceptive Health. Participants: Five hundred eighty-one women aged 18 to 40 attended by 40 gynecologists providing advice on contraception. Interventions: Standardized counseling with educational material including information on effectiveness, mechanism of action, user mode, benefits and risks as well as suitability in regards to individual needs was conducted. Main outcome measures: Original choice and final election of contraceptive method following counseling as well as factors involved. Results: Initial method choice was 57% for the pill, 15% for the vaginal ring, and 13% for transdermal patch. Following advice election was for pill 38%, vaginal ring 33%, and transdermal patch 19%. Statistically significant preference from 15% to 33% was found in vaginal ring users, and 13% to 19% for transdermal patch; p <0,005. The main reason for methods choice was ease of use. Conclusions: Peruvian women participating in PIENSA Project initially chose the daily contraceptive pill; but this election decreased following health professional counseling. The number of women who chose transdermal patch and vaginal ring increased significantly.

From high doses of oral rivastigmine to transdermal rivastigmine patches: user experience and satisfaction among caregivers of patients with mild to moderate Alzheimer disease.

INTRODUCTION: Rivastigmine, a treatment for mild to moderate Alzheimer disease (AD), is the first cholinesterase inhibitor to be available in the transdermal format. We aim to describe user experience and satisfaction with the rivastigmine patch, as well as any clinical changes perceived in patients. METHODS: Observational, cross-sectional, multicentre study with 239 investigators and 1851 informal caregivers of patients with mild to moderate AD. Patients were treated with transdermal rivastigmine patches for ≥ 6 months and had previously received high doses of oral rivastigmine. RESULTS: Mean caregiver age was 59.8±14.4 years and 70.9% were women. They spent 10.0±7.1hours per day providing care and 79.8% lived with the patient. Patch instructions were described as easy to follow by 97.1% of the caregivers and 92.1% of them rated patch application as easy or very easy. The most commonly cited disadvantage was adhesion problems (26.8%). Discontinuation of treatment was due to cutaneous reactions in most cases. Overall, 76.5% of the caregivers were satisfied or very satisfied with transdermal treatment and 77.4% considered that its interference with daily activities was minimal or null. The patch was preferred to oral treatment by 94.3% of caregivers. Clinical Global Impression of Change ratings improved according to 61.3% of the caregivers and 53% of the investigators. Few caregivers reported medication forgetfulness. CONCLUSIONS: Most caregivers of patients with mild to moderate AD preferred the transdermal format of rivastigmine to the oral format. Caregivers also reported overall satisfaction, ease of use, and reduced impact on daily activities for transdermal rivastigmine format, in addition to patient improvement compared to their condition under the previous treatment.

Microagujas y Transcutol® como promotores de la penetración transdérmica de sibutramina formulada en parche transdérmico / Microneedles and Transcutol® as transdermal penetration enhancers of sibutramine formulated in a transdermal patch

Introducción: la principal barrera de permeación que tenemos es la piel. A pesar de ser una barrera casi impermeable para la mayoría de sustancias, se han buscado maneras para mejorar su permeabilidad utilizando nuevas tecnologías como es el uso de microagujas o promotores químicos como el Transcutol®. Objetivo: desarrollar y caracterizar un parche transdérmico a base de clorhidrato de sibutramina como fármaco modelo, usando Transcutol® y microagujas como agentes promotores de la penetración transdérmica. Métodos: se realizó la caracterización fisicoquímica de los parches mediante estudios de microscopia con luz polarizada, estudios de bioadhesión y resistencia a la ruptura. Los estudios de difusión se efectuaron en celdas de difusión verticales tipo Franz, utilizando piel abdominal humana como membrana entre ambos compartimentos. La cuantificación del principio activo se realizó mediante electroforesis capilar. Resultados: se obtuvieron parches bioadhesivos, con una adecuada estabilidad del activo en la matriz polimérica de quitosán al no precipitarse. El uso de Transcutol® y microagujas incrementó el paso de clorhidrato de sibutramina a través de piel humana con respecto al parche control. Se obtuvieron valores de flujo de 0,0649 mg.cm-2.h-1 y 0,0816 mg.cm-2.h-1 en el parche con agente promotor y microagujas de 1 y 2 mm respectivamente, en comparación con los valores de flujo de 0,0527 mg.cm-2.h-1 y 0,0554 mg.cm-2.h-1 para el parche sin agente promotor (control) utilizando microagujas de 1 y 2 mm respectivamente. Conclusiones: los resultados ponen de manifiesto la posibilidad de usar Transcutol® y microagujas para incrementar el paso de fármacos potentes y con estructura similar a la sibutramina por vía transdérmica, lo que genera de esta manera nuevas alternativas a las formas farmacéuticas orales para el tratamiento de padecimientos y enfermedades(AU)

Introduction: the main permeation barrier is the skin. Although it is almost an impermeable barrier to most substances, new ways have been examined to improve its permeability by using new technologies such as microneedles and chemical enhancers like Transcutol®. Objective: to develop and to characterize a transdermal patch containing sibutramine hydrochloride as model drug and using microneedles and Transcutol® as transdermal drug delivery enhancers. Methods: Physicochemical characterization of sibutramine hydrochloride patches using polarized light microscopy, bioadhesion, tensile strength studies. The diffusion studies were performed in Franz-type diffusion cells with human abdominal skin as a sort of membrane between both compartments. The active ingredient was quantified through capillary electrophoresis. Results: bioadhesive patches were obtained, with adequate stability of sibutramine hydrochloride in the polymer matrix of chitosan. The use of microneedles and Transcutol® increased sibutramine hydrochloride delivery through the human skin when compared with the control patch. The flow rates were 0.0649 mg.cm-2.h-1 and 0,0816 mg.cm-2.h-1 in the enhanced patch by using 1 and 2 mm microneedles respectively, in comparison with flow rates of 0,0527 mg.cm-2.h-1 and 0.0554 mg.cm-2.h-1 for the control patch having no enhancing agent with 1 and 2 mm microneedles respectively. Conclusions: the results show that it is possible to use Transcutol® and microneedles to increase the delivery of potent drugs having a structure similar to that of sibutramine through transdermal administration. All this generates new alternatives to oral pharmaceuticals in order to treat ailments and diseases(AU)

Uso do fentanil transdérmico para analgesia pós-operatória em cirurgia de artrodese de coluna / Percutaneous fentanyl for postoperative spinal arthrodesis analgesia

JUSTIFICATIVA E OBJETIVOS: O controle da dor pós-operatória de moderada a intensa ainda é um problema na prática diária devido à dor nos intervalos entre a administração de doses de analgésicos e os efeitos adversos. O fentanil transdérmico apresenta analgesia constante por até 72 horas, tem sido usado para analgesia na dor aguda. O objetivo deste estudo foi avaliar a analgesia proporcionada pelo uso do fentanil transdérmico na dor aguda pós-operatória em pacientes submetidos à cirurgia de artrodese de coluna, bem como observar a incidência de efeitos adversos relacionados ao seu uso.MÉTODO: Foram incluídos 9 pacientes submetidos à artrodese de coluna sob anestesia geral com propofol, sufentanil e cisatracúrio e manutenção com remifentanil e isoflurano. Um adesivo de fentanil transdérmico de 12 µg/h foi aplicado antes da cirurgia e ao término da cirurgia,cetoprofeno, dipirona e tramadol foram administrados.Dipirona foi aplicada cada 6h como analgésico de resgate. A intensidade da dor foi avaliada a cada 12h pela escala analógica visual e o consumo de dipirona e cetoprofeno em intervalos 12h e os efeitos adversosforam anotados. RESULTADOS: Após 12h da aplicação do adesivo, a média da intensidade da dor era de 2,11 ± 2,84. O maiorvalor da intensidade da dor foi 60h após a aplicação do adesivo e os menores valores foram constatados entre 24e 72h depois da aplicação do adesivo de fentanil transdérmico.O maior consumo total de dipirona foi de 8000 mg no período compreendido entre 12 e 24h e entre 36 e 48h e o menor consumo foi de zero mg no período compreendidoentre 60 e 72h, porém não houve diferença estatisticamente significativa nos intervalos observados(p = 0,47). Os efeitos colaterais foram um caso de sonolência e outro de náuseas e vômitos.CONCLUSÃO: Os resultados deste estudo sugerem que o fentanil transdérmico mostrou-se seguro e efetivo para analgesia pós-operatória de cirurgia de coluna. Os resultados também evidenciaram que o fentanil transdérmico apresentou efeitos colaterais pouco relevantes.

BACKGROUND AND OBJECTIVES: Moderate to severe postoperative pain control is still a daily problem due to pain in the intervals between analgesic administration and adverse effects. Percutaneous fentanyl induces continuous analgesia for up to 72 hours and has been used to control acute pain. This study aimed at evaluating percutaneous fentanyl analgesia to control acute postoperative pain in patients submitted to spinal arthrodesis,as well as at observing the incidence of fentanyl-related adverse effects.METHOD: Participated in this study 9 patients submitted to spinal arthrodesis under general anesthesia with propofol, sufentanil and cisatracurium and maintenance with remifentanil and isoflurane. One 12 µg/h percutaneous fentanyl adhesive was applied before surgery and ketoprofen, dipirone and tramadol were administered at surgery completion. Dipirone was administered every 6 hours as rescue analgesic drug. Pain intensity was evaluated every 12 hours by the visual analog scale and dipirone and ketoprofen consumption in 12-hour intervals;adverse effects were recorded.RESULTS: Twelve hours after adhesive application,mean pain intensity was 2.11 ± 2.84. Highest pain intensity was observed 60 hours after adhesive application and lowest value was observed 24 and 72 hours after percutaneous fentanyl adhesive application. Highest total dipirone consumption was 8000 mg in the period between 60 and 72 hours and between 36 and 48 hours and the lowest consumption was zero mg in the period between 60 and 72 hours, but there has been no statistically significant difference in observed periods (p =0.47). Side effects were one case of sleepiness and oneof nausea and vomiting.CONCLUSION: This study results suggest that percutaneousfentanyl is safe and effective for postoperative spinal surgery pain. Results have also shown that percutaneousfentanyl has minor side effects.

A prospective study on the use of rivastigmine transdermal patch in Alzheimersdementia in a routine clinical setting

There is not much published literature on the use of rivastigmine patch in a "routine" clinical setting. Objectives: In this naturalistic longitudinal observational study we sought to evaluate the safety, tolerability and efficacy of the rivastigmine patch in patients with early and late onset moderate Alzheimer's disease in a routine clinical setting. Methods: Out of all routine clinical referrals, the first 30 patients with diagnosis of moderate Alzheimer's dementia who were started on rivastigmine patch were included in the study. Rivastigmine patch dose was titrated from 4.6 to 9.5 mg/ 24 hours as appropriate. The primary outcome measure was safety and tolerability, measured by the incidence of adverse events and discontinuation due to any reason. The secondary outcome measure was to examine improvement on global, functional and behavioral domains as demonstrated by the MMSE (Mini Mental State Examination) score, BADLS (Bristol Activities of Daily Living Skills) score, patient and carer feedback and clinical judgment. Results: Adverse events were reported in 20% of patients and 10% of total patients needed discontinuation of treatment. Improvement on global, functional and behavioral domains was observed in two thirds of patients whereas one third showed a relative decline. The most common side effect was skin irritation or erythema. Conclusions: The rivastigmine transdermal patch may provide a treatment option for those patients who require a change in their current oral cholinesterase inhibitor therapy due to safety or tolerability concerns.

Não há muita publicação na literatura sobre o uso do adesivo de rivastigmina na prática clínica. Objetivos: Em um estudo observacional longitudinal naturalístico nós tentamos avaliar a segurança, tolerabilidade e eficácia do adesivo transdérmico de rivastigmina em pacientes com doença de Alzheimer moderada de início precoce e tardio. Métodos: Os primeiros 30 pacientes ambulatoriais com DA moderada de clínicas de referência que iniciaram o uso de adesivo de rivastigmina foram incluídos no estudo. A dose foi escalonada de 4,6 a 9,5 mg/24 hs quando apropriado. As medidas de desfecho primário foram a segurança e tolerabilidade medidas pela incidência de eventos adversos e descontinuação por alguma razão. A medida de desfecho secundário foi a melhora global, funcional e comportamental, demonstrada pelos escores do Mini-Exame do Estado Mental (MEEM), escores na escala de Atividade de Vida Diária de Bristol, retorno do paciente e cuidador e julgamento clínico. Resultados: Eventos adversos foram reportados em 20% dos pacientes e 10% deles descontinuaram o tratamento. Melhora em domínios global, funcional e comportamental foi observada em dois terços dos pacientes, enquanto que, no terço restante um declínio relativo foi observado. O efeito colateral mais comum foi irritação ou eritema de pele. Conclusões: O adesivo transdérmico de rivastigmina pode ser uma opção terapêutica para aqueles pacientes que requeiram mudança na sua terapia oral com inibidor da colinesterase devido à sua segurança e tolerabilidade.

Buprenorfina transdérmica en el manejo del dolor crónico nociceptivo y neuropático no oncológico en ortopedia / Buprenorfine transdermal matrix patch in the treatment of chronic nociceptive non malignant pain and neurophatic pain in the orthopaedic patology

Objetivo: siendo el año del dolor musculoesquelético, es importante evitar el subtratamiento, dado la prevalencia de dolor crónico, los costos, limitación funcional y disminución de la calidad de vida en el paciente ortopédico, requiriéndose de vías menos invasivas, como la administración transdérmica, a través de sistema matricial de buprenorfina, en base a su liposolubilidad, y biodisponibilidad, sin riesgo de hiperalgesia ni afectación del sistema inmune, considerando su efecto techo en depresión respiratoria, y su empleo en comorbilidad renal y hepática. Material y métodos: estudio longitudinal, prospectivo, aleatorizado, de septiembre de 2008 a febrero de 2010, en el servicio de algología de orthocaz, unidad de ortopedia. N=108 de ambos sexos bajo consentimiento informado. Resultados: prevalencia de dolor en consulta externa de ortopedia r= 60-80 por ciento, x = 70, el crónico nociceptivo mayor de 30 por ciento y neuropático 1, 5 por ciento con predominio en el sexo femenino de 53,8 por ciento y, etiológicamente, el síndrome de columna fallida ocupa 40,7 por ciento, osteoartrosis 44, 4 por ciento, edad X= 66,59 años r= 20-85, dolor neuropático crónico secundario a metástasis en columna lumbar 3,7. La causa más común fue cáncer prostático, síndrome complejo regional 3,7 por ciento, el tamaño del efecto (EZ) fue de 1,2 el NNT= 4, a la 3ra semana se incrementó el dolor incidental e irruptivo, a partir del 10º día disminuyeron los efectos secundarios, como la somnolencia y nausea. Discusión y conclusiones: la osteoartritis, el síndrome de columna fallida, conducto lumbar estrecho mixto, síndrome complejo regional, secuelas de fracturas, prótesis fallidas, secuelas de displasia del desarrollo de la cadera, síndrome doloroso lumbar crónico, son padecimientos musculoesqueléticos en el que se aceptan el manejo de opiodes clase 3 de la OMS, de libración prolongada, como la buprenorfina...

Objetive: being the international year of the pain skeletal muscle, it is important to avoid the sub treatment, dice the prevalence of chronic pain, with the costs, functional limitation and diminution of the quality of life in the orthopedic patient requiring itself of less invasive routes as it is it the transdermal administration through matrix system of buprenorfina, on the basis of his high lip solubility without risk of hiperalgesia nor affectation of inmune system, considering his effect ceiling in respiratory depression, and its use in renal and hepatic comorbidity. Material and methodology: longitudinal, prospective study, randomized, of September of the 2008 to February 2010, in the service of algology of Orthocaz unit of N= orthopedics 108 both sexes, under informed consent. Results: Prevalence of pain in external consultation of orthopedics r= 60-80 per cent, x =70, the chronic greater nociceptive of 30 percent and neurophatic 1,5 percent with predominance in 53,8 percent feminine sex etiology the syndrome of insolvent column occupies 40,7 percent, osteoartrosis 44,4 percent, X= age 66,59 years, r= 20-85, secondary chronic neuropathic pain to metastasis in 3,7 lumbar column the cause most common prostate cancer, regional complex syndrome 3,7 percent the size of effect (EZ) the EU of 1,2 NNT= 4, to third week increase the incidental and irruptive pain, from the 10 day diminished the indirect effect, as drowsiness and feels nauseous. Discussion and and conclusions osteoarthritis, syndrome of insolvent column, lumbar conduit narrow compound, regional complex syndrome, sequels of fractures, prosthesis insolvent, sequels of dysplasia of the developement of the hip, chronic lumbar painful syndrome, are sufferings skeletal muscle in wich the handing of opiods is accepted class III, of the WHO of liberation prolonged as it is it buprenorfina transdermal, wih progressive degree, and to allow tolerability.

Farmacología y aplicabilidad de los andrógenos transdérmicos en hombres ancianos con hipogonadismo / Transdermal androgens: pharmacology and applicability to hypogonadal elderly men

Los geles de testosterona transdérmica han probado ser un medio eficaz para administrar testosterona a hombres con hipogonadismo. Se han utilizado parches, geles y cremas de formulaciones de testosterona transdérmica: Los parches presentaban problemas con la adherencia o irritabilidad cutánea. Los geles tienen una farmacocinética favorable, poca irritabilidad cutánea y han sido bien recibidos por médicos y usuarios, sin embargo, presentan el problema potencial de la transferencia del hombre a la mujer o a los hijos. Sería conveniente contar con más datos basados en estudios correctamente controlados y bien diseñados que muestren que los hombres de edad avanzada con hipogonadismo responden tan bien como los más jóvenes a la terapia con testosterona según todos los criterios de valoración. No obstante, los datos disponibles sobre los efectos de la testosterona en tejido adiposo, músculo y hueso indican que la edad no impide la respuesta. Por lo tanto, es nuestra opinión que la testosterona transdérmica puede administrarse a hombres de edad avanzada con concentraciones séricas de testosterona hipogonádicas y síntomas compatibles con una deficiencia de andrógenos. El rápido tiempo de consumo tanto de los parches como los geles, en comparación con los preparados de testosterona inyectables de acción prolongada, puede proporcionar una modalidad terapéutica preferida en los hombres de edad avanzada, quienes debido a su edad pueden correr mayor riesgo de eventos adversos, como el cáncer de próstata que responde a los andrógenos.

Farmacología y aplicabilidad de los andrógenos transdérmicos en hombres ancianos con hipogonadismo / Transdermal androgens: pharmacology and applicability to hypogonadal elderly men

Los geles de testosterona transdérmica han probado ser un medio eficaz para administrar testosterona a hombres con hipogonadismo. Se han utilizado parches, geles y cremas de formulaciones de testosterona transdérmica: Los parches presentaban problemas con la adherencia o irritabilidad cutánea. Los geles tienen una farmacocinética favorable, poca irritabilidad cutánea y han sido bien recibidos por médicos y usuarios, sin embargo, presentan el problema potencial de la transferencia del hombre a la mujer o a los hijos. Sería conveniente contar con más datos basados en estudios correctamente controlados y bien diseñados que muestren que los hombres de edad avanzada con hipogonadismo responden tan bien como los más jóvenes a la terapia con testosterona según todos los criterios de valoración. No obstante, los datos disponibles sobre los efectos de la testosterona en tejido adiposo, músculo y hueso indican que la edad no impide la respuesta. Por lo tanto, es nuestra opinión que la testosterona transdérmica puede administrarse a hombres de edad avanzada con concentraciones séricas de testosterona hipogonádicas y síntomas compatibles con una deficiencia de andrógenos. El rápido tiempo de consumo tanto de los parches como los geles, en comparación con los preparados de testosterona inyectables de acción prolongada, puede proporcionar una modalidad terapéutica preferida en los hombres de edad avanzada, quienes debido a su edad pueden correr mayor riesgo de eventos adversos, como el cáncer de próstata que responde a los andrógenos.(AU)