The study of the bioeffects of ultrasound and their etiology is of fundamental importance as a part of basic biophysics. In general, the most fruitful approach to the study of bioeffects of physical agents is the mechanistic one. The ultrasonic mechanisms include the mechanical effect, convective effect, cavitation effect, and thermal effect. In this research, the test skin was radiated the ultrasound using the medical equipment and analyzed the permeation of skin. However, it is not sufficiently to analyze the quantitative of the sonophoresis by the medical equipment setup. To solve the above-mentioned problem, the oscillation of the stratum corneum in response to the ultrasound radiation is simulated using Rayleigh-Plesset¡¦s bubble activation theory. To calculate the resonance frequency domain of bubbles attached of pig skin which is around 15 to 36 kHz that called low frequency and it caused gas body activation on test skin. We choose 20 kHz in the resonance frequency domain to compared with 10, 60 kHz as non-resonance frequency. 1.9 and 13.6 mW/cm2 of the sound intensity which are respectively lower and higher than cavitation threshold intensity are used. The result of low frequency sonophoresis presented that high permeation rate is caused by resonance frequency 20 kHz. And according to the experiment, it is also proved that the experiment of low frequency sonophoresis only took 1/160 of the sound intensity and 1/4 of the time for the high frequency sonophoresis. Furthermore, the research examined the uniformity of the sound field, and a wedge is designed to make a diffused field to compare the effect between a uniform one and its contrast. The result presented that the permeating drug with uninformative field is twice the amount of the normal exposure ultrasound field. Based on the above results, the changes of frequency, sound intensity and sound field uniformity, the enhancement effects of the sonophoresis will be achieved.

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Transdermal drug delivery (TDD) is limited by high resistance of the outer layer of the skin, namely stratum corneum which blocks any molecule that is larger than 500 Da. Research on TDD has become very active in recent years and various technologies have been developed to overcome the resistance of the stratum corneum. In particular, researchers have started to consider the possibility of combining the TDD technologies in order to achieve further increment for drug permeability. Microneedles (MNs) and sonophoresis are both promising technologies that can perform notable enhancement in drug permeation via different mechanisms and therefore give a good potential for combining with each other. We discuss the possible ways to achieve this combination as well as how this combination would increase the permeability. Some of the undeveloped (weaker) research areas of MNs and sonophoresis are also discussed in order to understand the true potential of combining the two technologies when they are developed further in the future. We propose several hypothetical combinations based on the possible mechanisms of MNs and sonophoresis.

A influência do ultra-som terapêutico na transmissão transcutânea (sonoforese) do diclofenaco sódico como gel tópico (Voltaren Emulgel) foi investigada em 14 voluntários humanos sadios (dez mulheres, quatro homens; 26,4 anos de idade, 62 Kg de peso corporal e 1,7 m de altura, em média). Foi realizada irradiação ultra-sônica prévia da pele (modo contínuo, 1 MHz de freqüência, intensidade de 0,5 W/centímetro quadrado) por 5 minutos em duas áreas de 225 centímetros quadrados (15 x 15 cm) de cada lado da região dorsal dos voluntários usando um gel comum para acoplamento do cabeçote, com subseqüente aplicação do gel de diclofenaco (2,5 g) em cada uma das áreas pré-determinadas e deixado por três horas. Os mesmos voluntários participaram desse procedimento duas vezes com um mês de intervalo, em média, sendo que na segunda vez com o equipamento desligado (procedimento placebo), para controle. Amostras de sangue (3 ml) foram coletadas de veias do antebraço imediatamente antes e com 60, 120 e 180 minutos do procedimento, para análise da massa plasmática do diclofenaco, por meio da cromatografia líquida de alta eficiência (HPLC). Os resultados demonstraram que a massa plasmática do diclofenaco estava significativamente mais elevada (p=0,01) aos 60 e 120 minutos após a irradiação com o ultra-som do que após o procedimento placebo. Dentro das condições em que este estudo foi realizado, os resultados permitem concluir que a irradiação prévia da pele com ultra-som terapêutico facilita a penetração transcutânea de diclofenaco sódico na forma de gel tópico / The influence of therapeutic ultrasound on the transdermal transmission (sonophoresis) of sodium diclofenac as a gel of topic application (Voltaren Emulgel) was investigated in 14 human healthy volunteers (ten women, four men, 26,4 years of age, 62 Kg of body weight and 1,7 m of height on average). Therapeutic ultrasound (continuous mode, 1 MHz frequency, 0,5 W/square centimeter) was applied for 5 minutes on two 225 square centimeters (15 x 15 cm) areas on each side of the dorsum of the volunteers using ultrasound transmission gel as a coupling agent. Following ultrasonic irradiation, the gel was removed and gloves were used to apply 2,5 g on each two defined areas. The same volunteers participated in procedures twice at one-month interval on average, however the second time with the equipment turned off (sham procedure) for control. Blood samples (3 ml) were withdrawn from forearm veins, near the elbow flexure, immediately before and at 60, 120 and 180 minutes from the procedure, for analysis of the plasmatic diclofenac mass by means of high performance liquid chromatography (HPLC). The results showed that the plasmatic diclofenac mass was significantly higher (p=0,01) at 60 and 120 minutes following the ultrasound irradiation than the sham procedure. The results presented in this study support that therapeutic ultrasound applied prior to application of sodium diclofenac gel does lead to enhanced penetration of the drug across the skin under the conditions of the investigation

A influência do ultra-som terapêutico na transmissão transcutânea (sonoforese) do diclofenaco sódico como gel tópico (Voltaren Emulgel) foi investigada em 14 voluntários humanos sadios (dez mulheres, quatro homens; 26,4 anos de idade, 62 Kg de peso corporal e 1,7 m de altura, em média). Foi realizada irradiação ultra-sônica prévia da pele (modo contínuo, 1 MHz de freqüência, intensidade de 0,5 W/centímetro quadrado) por 5 minutos em duas áreas de 225 centímetros quadrados (15 x 15 cm) de cada lado da região dorsal dos voluntários usando um gel comum para acoplamento do cabeçote, com subseqüente aplicação do gel de diclofenaco (2,5 g) em cada uma das áreas pré-determinadas e deixado por três horas. Os mesmos voluntários participaram desse procedimento duas vezes com um mês de intervalo, em média, sendo que na segunda vez com o equipamento desligado (procedimento placebo), para controle. Amostras de sangue (3 ml) foram coletadas de veias do antebraço imediatamente antes e com 60, 120 e 180 minutos do procedimento, para análise da massa plasmática do diclofenaco, por meio da cromatografia líquida de alta eficiência (HPLC). Os resultados demonstraram que a massa plasmática do diclofenaco estava significativamente mais elevada (p=0,01) aos 60 e 120 minutos após a irradiação com o ultra-som do que após o procedimento placebo. Dentro das condições em que este estudo foi realizado, os resultados permitem concluir que a irradiação prévia da pele com ultra-som terapêutico facilita a penetração transcutânea de diclofenaco sódico na forma de gel tópico / The influence of therapeutic ultrasound on the transdermal transmission (sonophoresis) of sodium diclofenac as a gel of topic application (Voltaren Emulgel) was investigated in 14 human healthy volunteers (ten women, four men, 26,4 years of age, 62 Kg of body weight and 1,7 m of height on average). Therapeutic ultrasound (continuous mode, 1 MHz frequency, 0,5 W/square centimeter) was applied for 5 minutes on two 225 square centimeters (15 x 15 cm) areas on each side of the dorsum of the volunteers using ultrasound transmission gel as a coupling agent. Following ultrasonic irradiation, the gel was removed and gloves were used to apply 2,5 g on each two defined areas. The same volunteers participated in procedures twice at one-month interval on average, however the second time with the equipment turned off (sham procedure) for control. Blood samples (3 ml) were withdrawn from forearm veins, near the elbow flexure, immediately before and at 60, 120 and 180 minutes from the procedure, for analysis of the plasmatic diclofenac mass by means of high performance liquid chromatography (HPLC). The results showed that the plasmatic diclofenac mass was significantly higher (p=0,01) at 60 and 120 minutes following the ultrasound irradiation than the sham procedure. The results presented in this study support that therapeutic ultrasound applied prior to application of sodium diclofenac gel does lead to enhanced penetration of the drug across the skin under the conditions of the investigation