Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes. Final order.

The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.

Transdermal iontophoretic delivery of timolol maleate

Transdermal iontophoresis would be a promising method for the systemic delivery of water soluble and ionic drugs of relatively high molecular size, including peptides. The objective of the present study was to investigate the effect of biological variable such as guinea pig and human cadaver skin and other variables like drug concentration, current density on the transdermal iontophoretic transport of timolol maleate. The permeation profile of drug using solution and gel formulation was studied and compared. For better bioavailability, better patient compliance, and enhanced delivery, an iontophoretic drug delivery system of a timolol maleate matrix gel was formulated using Carbopol 974P. The study was conducted using silver-silver chloride electrodes across the guinea pig and human cadaver skin. Viscosity measurements and flux calculations indicated the suitability of the Carbopol 974P gel for transdermal iontophoretic delivery of timolol maleate. Anodal iontophoresis with silver-silver chloride electrode significantly increased the timolol maleate skin permeation as compared with the passive permeation study. The amount of timolol maleate transported during iontophoresis was significantly different among the different skins. However, iontophoretic gel formulations provided required flux of drug through human cadaver skin.

A iontoforese transdérmica seria um método promissor para a liberação sistêmica de fármacos solúveis em água e iônicos de relativamente elevado tamanho molecular, incluindo peptídeos. O objetivo do presente estudo foi investigar o efeito da variável biológica, tais como cobaia e pele de cadáver humano, e outras variáveis como concentração do fármaco, densidade de corrente sobre o transporte transdérmico iontoforético de maleato de timolol. Comparou-se o perfil de permeação do fármaco usando a formulação de solução e de gel. Para melhor biodisponibilidade, melhor adesão do paciente e liberação aprimorada, formulou-se sistema de liberação iontoforética gel de maleato de timolol usando Carbopol 974P. O estudo foi conduzido usando eletrodos de prata-cloreto de prata na cobaia e na pele de cadáver humano. Medidas de viscosidade e de fluxo indicaram a adequação do gel Carbopol 974 P para liberação iontoforética transdérmica do maleato de timolol. A iontoforese anódica com eletrodo de prata-cloreto de prata aumentou significativamente a permeação dérmica do maleato de timolol, comparativamente à permeação passiva. A quantidade de maleato de timolol transportado durante a iontoforese foi significativamente diferente entre as diferentes peles . No entanto, as formulações iontoforéticas de gel forneceram o fluxo necessário do fármaco através da pele de cadáver humano.

Interés del tratamiento osteopático en la enfermedad de De Quervain. A propósito de un caso / Interest of the osteopathic treatment in ''De Quervain'' disease. '' A case report

Diseño: estudio de casos. Objetivos: describir la aplicación de técnicas osteopáticas en el tratamiento fisioterápico en un caso de enfermedad de De Quervain. Paciente y método: mujer de 29 años que presenta enfermedad de De Quervain bilateral de 8 meses de evolución. La paciente refería dolor constante de intensidad 7/10 en escala visual analógica (EVA). La movilidad estaba conservada. El balance muscular era doloroso para la extensión y abducción del pulgar y la prueba Filkenstein positiva bilateral. Los tests osteopáticos mostraron lesión de la cabeza radial en anterioridad en el codo derecho y en posterioridad en el izquierdo. El tratamiento consistió en iontoforesis con diclofenaco, ejercicios activos y tratamiento manual de elastificación de los músculos afectados. A partir de la quinta sesión se incluyeron técnicas osteopáticas de ambos codos, que consistieron en bombeos, técnicas articulatorias y manipulación. Resultados: tras 8 sesiones de tratamiento se alcanzó una importante reducción del dolor (2/10 en EVA) y normalización de la exploración. Conclusiones: la aplicación de un tratamiento fisioterapéutico consistente en iontoforesis, tratamiento manual, ejercicios de flexibilización durante 4 sesiones, seguido de 4 sesiones en las que se realiza además tratamiento con técnicas osteopáticas consistentes en bombeos, técnicas articulatorias y manipulación, ha demostrado, en este caso clínico, ser de gran utilidad en la resolución de los síntomas de la paciente. Dados los escasos efectos secundarios de este tratamiento, pensamos que podría plantearse como una opción terapéutica previa al tratamiento quirúrgico(AU)

Objectives: Describe the application of osteopathic techniques in the physiotherapytreatment of a case of De Quervain Disease.Patient and method: A 29-year old woman who had bilateral De Quervain Disease of 8month’s evolution. The patient reported constant pain, scoring 7/10 intensity on the VisualAnalogue Scale (VAS). Mobility was conserved. Muscular balance was painful for extensionand abduction of the thumb and Filkenstein test was positive for bilateral involvement.The osteopathic tests showed a lesion in the anterior position in the right elbow and posterior one in the left elbow. The treatment consisted of iontophoresis with dichlofenac,active exercises and manual treatment of elasticity of the muscles affected. After the 5th sessions, osteopathic techniques for both elbows were included. These consisted inpumping, articulation and manipulation techniques.Results: There was a significant reduction in pain after 8 treatment sessions (2/10 onVAS), normalization being found in the examination.Conclusions: Application of a physiotherapy treatment, that consisted in iontophoresis,manual treatment, flexibility exercises for 4 sessions, followed by 4 sessions in which treatment was performed with osteopathic techniques, that consisted in pumping, articulation and manipulation techniques, has been demonstrated to be of great use in this clinical case to resolve the patient’s symptoms. Given the scarce side effects of thistreatment, we consider that it should be proposed as a therapeutic option prior to surgical treatment(AU)