Polymeric microneedles for transdermal delivery of nanoparticles: Frontiers of formulation, sterility and stability aspects

Salwa, -; Chevala, Naga Thirumalesh; Jitta, Srinivas Reddy; Marques, Shirleen Miriam; Vaz, Vanessa Marcia; Kumar, Lalit

doi:10.1016/j.jddst.2021.102711

Cited by 26 publications

(7 citation statements)

References 146 publications

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“…Terminal sterilization with gamma irradiation is a viable option when other methods of sterilization are incompatible. [45,47] ITZ has been previously shown to possess high radiochemical stability where the standard dose of sterilization radiation (25 kGy) does not alter its physical and chemical properties. [48] To investigate sterilization effects on ITZ-ArrayPatch, all experiments were repeated on samples that had been exposed to gamma radiation.…”

Section: Impact Of Terminal Sterilization On Itz-arraypatchmentioning

confidence: 99%

Glass Microneedles: A Case Study for Regulatory Approval Using a Quality by Design Approach

Sartawi,

Blackshields,

Ariamanesh

et al. 2023

Advanced Materials

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In this paper, we provide a roadmap for the regulatory approval of one of the exciting and dynamic drug delivery fields, microneedles, by using a Quality by Design (QbD) approach to pharmaceutical product development. In this regard, a quality target product profile (QTPP) and the critical quality attributes (CQA) of microneedles are identified. We discuss a case study of our recently patented method of fabricating glass microneedles entirely from a therapeutic agent, thus eliminating the requirement for additional excipients. The glass microneedle, ArrayPatch, is a propriety wearable device with platform potential consisting of an array of sharp, but painless, dissolvable microneedles manufactured with 100% drug. The microneedles penetrate the skin on application and dissolve to deliver a locally effective dose. The in‐vitro characterisation of the microneedle CQAs under WHO‐guided stability conditions will be described to assess the manufacturing readiness of ArrayPatch. A live technical video, is also provided, presenting a unique procedure of jugular vein cannulation through the ear vein of a pig animal model to study the in‐vivo pharmacokinetics of ArrayPatch compared to standard of care marketed products.This article is protected by copyright. All rights reserved

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Section: Impact Of Terminal Sterilization On Itz-arraypatchmentioning

confidence: 99%

Glass Microneedles: A Case Study for Regulatory Approval Using a Quality by Design Approach

Sartawi,

Blackshields,

Ariamanesh

et al. 2023

Advanced Materials

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show abstract

“…Several MNs types have been utilized for drug delivery, like solid MNs, hydrogel MNs, coated MNs, and dissolving MNs. These types vary in fabrication materials, strategies for drug delivery, and fabrication techniques (Salwa et al 2021;Bhattacharyya and Kotresh 2022). Dissolving MNs gained great importance due to their advantages, like higher drug loading, ease of fabrication by micromolding, and the fact that they don't associate with biohazard waste.…”

Section: Introductionmentioning

confidence: 99%

Formulation, in vitro and in vivo evaluation of olanzapine nanoparticles dissolving microneedles for transdermal delivery

Al-Shaibani,

Ghareeb

2024

PHAR

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Olanzapine (OLZ) is classified as a typical antipsychotic drug utilized for the treatment of schizophrenia. Its oral bioavailability is 60% due to its low solubility and pre-systemic metabolism. Hence, the present work aims to formulate and evaluate OLZ nanoparticles dissolving microneedles (MNs) for transdermal delivery to overcome the problems associated with drug administration orally. OLZ nanoparticles were prepared by the nanoprecipitation method. The optimized OLZ nanoparticle formula was utilized for the fabrication of dissolving MNs by loading OLZ nanodispersion into polydimethylsiloxane (PDMS) micromould cavities, followed by casting the polymeric solution of polyvinylpyrrolidone(PVP-K30) and polyvinyl alcohol (PVA) to form MN matrix. The results revealed that the optimized OLZ nanoparticle formula (NP-5) exhibited particle size 115.76±5.45 nm, entrapment efficiency 78.4±5.46, and zeta potential -19.01±1.6 mV. The results of MNs revealed that MN-4 exhibits a high drug content of 98.52%, and ex vivo permeation through rabbit skin exhibited that MN-4 permeates more effectively than a simple patch by approximately 5.16 fold. In vivo pharmacokinetics study revealed that the area under curve AUC 0-∞ of MN-4 was 6054.56±376 ng. h/ml as compared with AUC0-∞ of marketed OLZ tablet was 3975.77±373 ng. h/ml. It can be concluded that the dissolving MN-4 patch is considered a promising formula to overcome the problems associated with drug administration orally and could improve drug bioavailability, in addition to the ease of administering the medication to schizophrenic patients.

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“…In 2022, Oh and coworkers provided a comprehensive review of nanoparticle-integrated microneedles for the sustained release and delivery of macromolecules [ 105 ]. Several review articles have discussed the strategies of particle-integrated microneedles for transdermal delivery [ 28 , 106 ]. Different microneedle types (i.e., solid, hollow, coated, dissolving, and swelling microneedles) substantially enhance the transdermal delivery of small molecules, macromolecules, and particle systems.…”

Section: Introductionmentioning

confidence: 99%

Microneedle-Mediated Transdermal Delivery of Biopharmaceuticals

Nguyen

2023

Pharmaceutics

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Transdermal delivery provides numerous benefits over conventional routes of administration. However, this strategy is generally limited to a few molecules with specific physicochemical properties (low molecular weight, high potency, and moderate lipophilicity) due to the barrier function of the stratum corneum layer. Researchers have developed several physical enhancement techniques to expand the applications of the transdermal field; among these, microneedle technology has recently emerged as a promising platform to deliver therapeutic agents of any size into and across the skin. Typically, hydrophilic biomolecules cannot penetrate the skin by passive diffusion. Microneedle insertion disrupts skin integrity and compromises its protective function, thus creating pathways (microchannels) for enhanced permeation of macromolecules. Microneedles not only improve stability but also enhance skin delivery of various biomolecules. Academic institutions and industrial companies have invested substantial resources in the development of microneedle systems for biopharmaceutical delivery. This review article summarizes the most recent research to provide a comprehensive discussion about microneedle-mediated delivery of macromolecules, covering various topics from the introduction of the skin, transdermal delivery, microneedles, and biopharmaceuticals (current status, conventional administration, and stability issues), to different microneedle types, clinical trials, safety and acceptability of microneedles, manufacturing and regulatory issues, and the future of microneedle technology.

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Polymeric microneedles for transdermal delivery of nanoparticles: Frontiers of formulation, sterility and stability aspects

Cited by 26 publications

References 146 publications

Glass Microneedles: A Case Study for Regulatory Approval Using a Quality by Design Approach

Glass Microneedles: A Case Study for Regulatory Approval Using a Quality by Design Approach

Formulation, in vitro and in vivo evaluation of olanzapine nanoparticles dissolving microneedles for transdermal delivery

Microneedle-Mediated Transdermal Delivery of Biopharmaceuticals

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