"SonoBandage" a transdermal ultrasound drug delivery system for peripheral neuropathy

Langer, Matt; Lewis, Sabrina E.; Fleshman, Shane; Lewis, G. H.

doi:10.1121/1.4801417

Cited by 5 publications

(4 citation statements)

References 19 publications

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“…4,5 The stirring rate was set at 100 rpm, and the temperature was adjusted at 32 ± 0.5 °C. [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32] Aliquots (1 mL) of the receptor compartments were collected and immediately replaced…”

Section: Ex-vivo Drug Permeation Studiesmentioning

confidence: 99%

“…7 Low frequency ultrasound (LFU) waves were previously applied to enhance the transdermal delivery of various drugs like caffeine, fentanyl and insulin. 18,19 On the other hand, the transdermal permeation of other drugs like salicylic acid 20 and ondansetron hydrochloride 10 was promoted following the application of high frequency ultrasound (HFU) waves. Aldwaikat et al 21 reported that drug enhancement ratio is inversely correlated to the ultrasound frequency.…”

Section: Introductionmentioning

confidence: 99%

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<p>Low-Frequency versus High-Frequency Ultrasound-Mediated Transdermal Delivery of Agomelatine-Loaded Invasomes: Development, Optimization and in-vivo Pharmacokinetic Assessment</p>

Tawfik¹,

Tadros²,

Mohamed³

et al. 2020

IJN

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Aim Agomelatine (AGM) is the first melatonergic antidepressant. It suffers from low oral bioavailability (<5%) due to extensive hepatic metabolism. The current work aimed to develop an alternative AGM-loaded invasomes to enhance transdermal drug bioavailability. Methodology AGM-loaded invasomes were developed using two drug: lipid ratios (1:10 or 1:7.5), four terpene types (limonene, cineole, fenchone or citral) and two terpene concentrations (0.75% or 1.5%, w/v). They were characterized for drug entrapment efficiency (EE%), particle size (PS), zeta potential (ZP) and drug released percentages after 0.5h (Q 0.5h ) and 8h (Q 8h ). The optimum invasomes (I1, I2 and I4) were evaluated for morphology, drug-crystallinity, and ex-vivo drug flux. The variables influencing sonophoresis of the best achieved invasomal gel system (I2) were optimized including, ultrasound frequency (low, LFU or high, HFU), mode (pulsed or continuous), application period (10 min or 15 min) and duty cycle (50% or 100%). AGM pharmacokinetics were evaluated in rabbits following transdermal application of I2-LFU-C4 system, relative to AGM oral dispersion. Results The superiority of I2 invasomes [comprising AGM and phosphatidylcholine (1:10) and limonene (1.5% w/v)] was statistically revealed with respect to EE% (78.6%), PS (313 nm), ZP (−64 mV), Q 0.5h (30.1%), Q 8h (92%), flux (10.79 µg/cm2/h) and enhancement ratio (4.83). The optimum sonophoresis conditions involved application of LFU in the continuous mode for 15 min at a 100% duty cycle (I2-LFU-C4 system). The latter system showed significantly higher C max , and relative bioavailability (≈ 7.25 folds) and a similar T max (0.5 h). Conclusion I2-LFU-C4 is a promising transdermal system for AGM.

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Section: Ex-vivo Drug Permeation Studiesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

<p>Low-Frequency versus High-Frequency Ultrasound-Mediated Transdermal Delivery of Agomelatine-Loaded Invasomes: Development, Optimization and in-vivo Pharmacokinetic Assessment</p>

Tawfik¹,

Tadros²,

Mohamed³

et al. 2020

IJN

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“…This outcome may be explained by increased penetration of diclofenac into the joint space leading to inhibition of COX1 and COX2 pathways [20,38], thus relieving the inflammatory response in the joint. Masterson et al (2020) demonstrated SAM increased transdermal diclofenac delivery 3.8 fold greater than topical application alone [51], which were similar to the results of transdermal salicylic acid delivery with SAM by Langer et al (2013) [49]. The sustained treatment and continued pain reduction over the 7-days suggest the potential of lower levels of cytokines to retain pain at a decreased intensity.…”

Section: Discussionmentioning

confidence: 75%

“…SAM applies continuous long-duration ultrasound along with localized delivery of diclofenac to decrease patients' knee OA pain and improve joint function. In prior preclinical research, SAM has demonstrated the 3.8x increase of diclofenac penetration into and across the skin [49], along with drug delivery enhancement of other drugs over 4-hour treatment protocols [49,50].…”

Section: Discussionmentioning

confidence: 99%

Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study

Madzia¹,

Agrawal²,

Jarit³

et al. 2020

TOORTHJ

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Background: Sustained Acoustic Medicine (SAM) is an emerging, non-invasive, non-narcotic, home-use ultrasound therapy for the daily treatment of joint pain. The aim of this multi-site clinical study was to examine the efficacy of long-duration continuous ultrasound combined with a 1% diclofenac ultrasound gel patch in treating pain and improving function in patients with knee osteoarthritis. Methods: The Consolidated Standards of Reporting Trials (CONSORT) were followed. Thirty-two (32) patients (18-males, 14-females) 54 years of average age with moderate to severe knee pain and radiographically confirmed knee osteoarthritis (Kellgren-Lawrence (KL) grade II/III) were enrolled for treatment with the SAM device and diclofenac patch applied daily to the treated knee. SAM ultrasound (3 MHz, 0.132 W/cm2, 1.3 W) and 6 grams of 1% diclofenac were applied with a wearable device for 4 hours daily for 1 week, delivering 18,720 Joules of ultrasound energy per treatment. The primary outcome was the daily change in pain intensity using a numeric rating scale (NRS 0-10), which was assessed prior to intervention (baseline, day 1), before and after each daily treatment, and after 1 week of daily treatment (day 7). Rapid responders were classified as those patients exhibiting greater than a 1-point reduction in pain following the first treatment. Change in Western Ontario McMaster Osteoarthritis Questionnaire (WOMAC) score from baseline to day 7 was the secondary functional outcome measure. Additionally, a series of daily usability and user experience questions related to devising ease of use, functionality, safety, and effectiveness, were collected. Data were analyzed using t-tests and repeated measure ANOVAs. Results: The study had a 94% retention rate, and there were no adverse events or study-related complaints across 224 unique treatment sessions. Rapid responders included 75% of the study population. Patients exhibited a significant mean NRS pain reduction over the 7-day study of 2.06-points (50%) for all subjects (n=32, p<0.001) and 2.96-points (70%) for rapid responders (n=24, p<0.001). The WOMAC functional score significantly improved by 351 points for all subjects (n=32, p<0.001), and 510 points for rapid responders (n=24, p<0.001). Over 95% of patients found the device safe, effective and easy to use, and would continue treatment for their knee OA symptoms. Conclusion: Sustained Acoustic Medicine combined with 1% topical diclofenac rapidly reduced pain and improved function in patients with moderate to severe osteoarthritis-related knee pain. The clinical findings suggest that this treatment approach may be used as a conservative, non-invasive treatment option for patients with knee osteoarthritis. Additional research is warranted on non-weight bearing joints of the musculoskeletal system as well as different topical drugs that could benefit from improved localized delivery. Clinical Trial Registry Number: (NCT04391842).

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Low-Frequency Sonophoresis as an Active Approach to Potentiate the Transdermal Delivery of Agomelatine-Loaded Novasomes: Design, Optimization, and Pharmacokinetic Profiling in Rabbits

et al. 2021

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"SonoBandage" a transdermal ultrasound drug delivery system for peripheral neuropathy

Cited by 5 publications

References 19 publications

<p>Low-Frequency versus High-Frequency Ultrasound-Mediated Transdermal Delivery of Agomelatine-Loaded Invasomes: Development, Optimization and in-vivo Pharmacokinetic Assessment</p>

<p>Low-Frequency versus High-Frequency Ultrasound-Mediated Transdermal Delivery of Agomelatine-Loaded Invasomes: Development, Optimization and in-vivo Pharmacokinetic Assessment</p>

Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study

Low-Frequency Sonophoresis as an Active Approach to Potentiate the Transdermal Delivery of Agomelatine-Loaded Novasomes: Design, Optimization, and Pharmacokinetic Profiling in Rabbits

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