Botulinum toxin A dissolving microneedles for hyperhidrosis treatment: design, formulation and <i>in vivo</i> evaluation

Malek-Khatabi, Atefeh; Rad-Malekshahi, Mazda; Shafiei, Morvarid; Sharifi, Fatemeh; Motasadizadeh, Hamidreza; Ebrahiminejad, Vahid; Rad-Malekshahi, Mazdak; Akbarijavar, Hamid; Faraji Rad, Zahra

doi:10.1039/d3bm01301d

Cited by 4 publications

(3 citation statements)

References 75 publications

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“…The application of MN technology is becoming a promising method for TDD. [ 71,72 ] This study introduced a procedure for replicating PVA/PVP DMNPs using TPP, soft embossing, and PDMS micromolding techniques. The proposed manufacturing method used MNs made of IP‐S and Zeonor 1060R thermoplastic as primary and secondary master structures to create PVA/PVP DMNPs.…”

Section: Discussionmentioning

confidence: 99%

Influence of Low‐Frequency Vibration and Skin Strain on Insertion Mechanics and Drug Diffusion of PVA/PVP Dissolving Microneedles

Ebrahiminejad,

Malek‐khatabi,

Faraji Rad

2024

Adv Materials Technologies

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Microneedles (MNs) offer a promising solution for increasing the effectiveness of transdermal drug delivery and diagnostics. However, challenges such as large‐scale manufacturing, partial MN penetration, and uncontrolled drug delivery limit the effectiveness of the technology. To overcome these challenges, current research examines the effects of skin strain and vibration on MN insertion and drug delivery. A novel multifeatured impact applicator are developed for improving skin insertion that features a combination of skin stretching, eccentric rotating mass (ERM), and linear resonant actuator (LRA) micro‐vibration capabilities. In addition, a scalable replication method for dissolving microneedle patches (DMNPs) are developed using two‐photon polymerization (TPP) and soft embossing processes. The DMNPs are used to evaluate the diffusion and concentration of a model drug, fluorescein sodium salt (FSS), when applied using ERM and LRA micro‐vibration at different frequencies. Additionally, a new computer simulation method is presented to model the MN insertion into the multilayered hyperelastic skin model, incorporating skin strain and vibrational effects. The results indicate that applying skin strain and vibration decreases the force required for MN insertion and enhances the dissolution and diffusion depth of the drug in the skin, which can enhance the drug permeability and effectiveness of MN devices.

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Section: Discussionmentioning

confidence: 99%

Influence of Low‐Frequency Vibration and Skin Strain on Insertion Mechanics and Drug Diffusion of PVA/PVP Dissolving Microneedles

Ebrahiminejad,

Malek‐khatabi,

Faraji Rad

2024

Adv Materials Technologies

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“…In addition to liposome formulations, microneedle devices (DMNPs) were prepared to test the functionality of the BoNT/A/DMNPs on the hyperhidrosis mouse footpad, showing drastically reduced sweat gland activity. Those innovative results demonstrate that these devices such as microneedles (DMNPs) can be an effective and painless alternative to hypodermic injections when treating hyperhidrosis with BoNT/A [ 179 , 180 ].…”

Section: Future Approaches and Perspectivesmentioning

confidence: 99%

Embracing the Versatility of Botulinum Neurotoxins in Conventional and New Therapeutic Applications

Rasetti-Escargueil,

Palea

2024

Toxins

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Botulinum neurotoxins (BoNTs) have been used for almost half a century in the treatment of excessive muscle contractility. BoNTs are routinely used to treat movement disorders such as cervical dystonia, spastic conditions, blepharospasm, and hyperhidrosis, as well as for cosmetic purposes. In addition to the conventional indications, the use of BoNTs to reduce pain has gained increased recognition, giving rise to an increasing number of indications in disorders associated with chronic pain. Furthermore, BoNT-derived formulations are benefiting a much wider range of patients suffering from overactive bladder, erectile dysfunction, arthropathy, neuropathic pain, and cancer. BoNTs are categorised into seven toxinotypes, two of which are in clinical use, and each toxinotype is divided into multiple subtypes. With the development of bioinformatic tools, new BoNT-like toxins have been identified in non-Clostridial organisms. In addition to the expanding indications of existing formulations, the rich variety of toxinotypes or subtypes in the wild-type BoNTs associated with new BoNT-like toxins expand the BoNT superfamily, forming the basis on which to develop new BoNT-based therapeutics as well as research tools. An overview of the diversity of the BoNT family along with their conventional therapeutic uses is presented in this review followed by the engineering and formulation opportunities opening avenues in therapy.

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“…BTX-A is an exotoxin synthesized by the gram-positive anaerobic bacterium Clostridium botulinum 8 . It induces muscle contraction relaxation and inflammatory pain relief by not only inhibiting acetylcholine exocytosis from nerve end plates but also blocking the release of substance P and glutamate 9 .…”

Section: Introductionmentioning

confidence: 99%

Effects of botulinum toxin type A in patients with painful temporomandibular joint disorders: a systematic review and meta-analysis

Zhu,

Huang,

Wang

et al. 2024

Annals of Medicine &Amp; Surgery

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Objective: To assess the therapeutic efficacy of botulinum toxin type A (BTX-A) for managing myofascial pain related to temporomandibular disorders (TMDs). Methods: This study was conducted according to the PRISMA 2020 statement guidelines. The PubMed, Embase, and Cochrane Library databases were searched. Only randomized controlled trials (RCTs) were included. The primary outcome was pain score on the visual analogue scale (VAS), and the secondary outcomes were maximum mouth opening (MMO) and adverse effects. The Cochrane risk of bias tool was used to assess risk bias. A meta-analysis of studies with the same interventions, controls, assessment methods and follow-up durations was performed. Results: A total of 519 studies were retrieved, of which 20 RCTs were included in the qualitative analysis and 6 were included in the meta-analysis. The results showed that, compared with placebo, BTX-A injection was more effective at relieving myofascial pain, and its effect was similar to that of conventional methods. However, there was no difference in MMO between the two groups. After study assessment with the RoB 2.0 tool, six studies showed a low risk of bias, 13 studies showed some concerns regarding the reported results, and only one study showed a high risk of bias. Adverse effects of BTX-A injection were observed in four studies. Conclusions: In conclusion, BTX-A is effective at relieving pain in TMD patients but does not improve mouth opening. To minimize adverse effects, we recommend a low dose of BTX-A for TMD patients who do not experience complete pain relief from conservative treatments.

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Botulinum toxin A dissolving microneedles for hyperhidrosis treatment: design, formulation and in vivo evaluation

Abstract: Multiple periodic injections of botulinum toxin A (BTX-A) are the standard treatment of hyperhidrosis which causes excessive sweating. However, BTX-A injections can create problems, including incorrect and painful injections, the...

Cited by 4 publications

References 75 publications

Influence of Low‐Frequency Vibration and Skin Strain on Insertion Mechanics and Drug Diffusion of PVA/PVP Dissolving Microneedles

Influence of Low‐Frequency Vibration and Skin Strain on Insertion Mechanics and Drug Diffusion of PVA/PVP Dissolving Microneedles

Embracing the Versatility of Botulinum Neurotoxins in Conventional and New Therapeutic Applications

Effects of botulinum toxin type A in patients with painful temporomandibular joint disorders: a systematic review and meta-analysis

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