Anastrozole Nanoparticles for Transdermal Delivery through Microneedles: Preparation and Evaluation

doi:10.47750/pnr.2022.13.03.152

Cited by 3 publications

(1 citation statement)

References 16 publications

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“…Hematoxylin and eosin (H and E) stains were used to identify the prepared microscope slides. The epidermis, dermis, and subcutaneous tissues were distinct and well-defined in untreated tissue slides (arrows), as in (Figure 5, II-D) [31]. Identical observation results were found for slides obtained from the group treated with CA gel, as shown in (Figure 5, II-A).…”

Section: The In Vivo Local Skin Irritation and Histopathologysupporting

confidence: 68%

Preparation, Evaluation, and Histopathological Studies of Ondansetron-Loaded Invasomes Transdermal Gel

SALIH,

MUHAMMED

2024

jrp

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Ondansetron is a serotonin receptor antagonist for treating nausea and vomiting. Its multiple daily doses and extensive first-pass metabolism faced parenteral and oral administration challenges. The transdermal route enhances its bioavailability as it bypasses the first-pass effect. Invasome vesicles improve the skin permeation of ondansetron via its unique components, lecithin, limonene, and ethanol, which are considered efficient permeation enhancers. The current study intends to develop a gel containing ondansetron as invasomes vesicles with appropriate texture and efficient skin penetration. Two gelling agents, hydroxypropyl methylcellulose K4M and carbopol 934P, were used at two concentrations (0.5 and 1%, w/w). Formulas were evaluated regarding pH, content uniformity, viscosity, spreadability, and ex vivo permeation. The selected formula (F3), which contained ondansetron (5%, w/w) and used carbopol 934P at (0.5%, w/w), was homogeneous, with proper viscosity (21,500 ± 390 mPa.s) at rest and enough spreadability (3.4 ± 0.45 cm). The ex vivo permeation showed permeation flux (Jss) was (280.4 ± 3.5 g/cm2.h) with a shorter lag time (0.5 ± 0.1 h). Characterization studies revealed nanosized vesicles (Dav. = 202.9 ± 0.5 nm) as spherical shapes dispersed within a gel matrix. In vivo, skin irritation and histopathology studies using male Wistar albino rats demonstrated that (F3) was biocompatible, with no irritation reported for six consecutive days. In conclusion, the invasomes gel of ondansetron utilizing carbopol (0.5%, w/w) was prepared for transdermal delivery, offering effective permeation and safe application. An invasomes-loaded gel is considered a novel formulation, giving an efficient and realistic therapeutic option for treating vomiting.

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Section: The In Vivo Local Skin Irritation and Histopathologysupporting

confidence: 68%

Preparation, Evaluation, and Histopathological Studies of Ondansetron-Loaded Invasomes Transdermal Gel

SALIH,

MUHAMMED

2024

jrp

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Biowaiver as a Bioequivalence Study Option

Volkova

Medvedev

Fisher

et al. 2024

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements for this procedure, as described in a variety of documents, differ in certain features and aspects. These differences need to be analysed.The aim of the study was to compare international and Russian regulatory approaches to the Biopharmaceutics Classification System-based biowaivers, provide recommendations on comparative dissolution testing, and outline opportunities for streamlining the regulatory framework of the Eurasian Economic Union (EAEU).In this article, the authors analyse biowaiver requirements and describe procedures for assessing the permeability and pH-dependent solubility of medicines, comparing dissolution profiles in various media that simulate the gastrointestinal environment, and interpreting test results. This paper shows the role of excipients in the solubility and permeability of an active substance. The authors recommend a methodological approach to the biowaiver procedure for replacing in vivo bioequivalence studies with in vitro tests under the current EAEU regulatory framework and list the characteristics of medicines that limit the applicability of the procedure. In conclusion, this article provides a rationale for harmonising the existing guidelines and requirements.

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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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Anastrozole Nanoparticles for Transdermal Delivery through Microneedles: Preparation and Evaluation

Cited by 3 publications

References 16 publications

Preparation, Evaluation, and Histopathological Studies of Ondansetron-Loaded Invasomes Transdermal Gel

Preparation, Evaluation, and Histopathological Studies of Ondansetron-Loaded Invasomes Transdermal Gel

Biowaiver as a Bioequivalence Study Option

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

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