Ziprasidone Hydrochloride Loaded Nanostructured Lipid Carriers (Nlcs) for Intranasal Delivery: Optimization and in Vivo Studies

Sivadasu, Praveen; Gowda, D. V.; Hatna, Siddaramaiah; Hemalatha, S

doi:10.22159/ijap.2020v12i1.35683

Cited by 6 publications

(4 citation statements)

References 26 publications

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“…This study underscored the potential of lipid-based formulations as an effective strategy for precise central nervous system targeting, showcasing their versatility across diverse therapeutic applications. Adding to the body of evidence, Sivadasu et al [ 63 ] delved into the exploration of ziprasidone hydrochloride-loaded nanostructured lipid carriers for intranasal delivery. The formulation not only demonstrated promising results in terms of optimization but also exhibited notable outcomes in rigorous in vivo studies.…”

Section: Discussionmentioning

confidence: 99%

Navigating the Nose-to-Brain Route: A Systematic Review on Lipid-Based Nanocarriers for Central Nervous System Disorders

Agosti,

Zeppieri,

Antonietti

et al. 2024

Pharmaceutics

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Background: The blood–brain barrier (BBB) regulates brain substance entry, posing challenges for treating brain diseases. Traditional methods face limitations, leading to the exploration of non-invasive intranasal drug delivery. This approach exploits the direct nose-to-brain connection, overcoming BBB restrictions. Intranasal delivery enhances drug bioavailability, reduces dosage, and minimizes systemic side effects. Notably, lipid nanoparticles, such as solid lipid nanoparticles and nanostructured lipid carriers, offer advantages like improved stability and controlled release. Their nanoscale size facilitates efficient drug loading, enhancing solubility and bioavailability. Tailored lipid compositions enable optimal drug release, which is crucial for chronic brain diseases. This review assesses lipid nanoparticles in treating neuro-oncological and neurodegenerative conditions, providing insights for effective nose-to-brain drug delivery. Methods: A systematic search was conducted across major medical databases (PubMed, Ovid MEDLINE, and Scopus) up to 6 January 2024. The search strategy utilized relevant Medical Subject Heading (MeSH) terms and keywords related to “lipid nanoparticles”, “intranasal administration”, “neuro-oncological diseases”, and “neurodegenerative disorders”. This review consists of studies in vitro, in vivo, or ex vivo on the intranasal administration of lipid-based nanocarriers for the treatment of brain diseases. Results: Out of the initial 891 papers identified, 26 articles met the eligibility criteria after a rigorous analysis. The exclusion of 360 articles was due to reasons such as irrelevance, non-reporting selected outcomes, the article being a systematic literature review or meta-analysis, and lack of method/results details. This systematic literature review, focusing on nose-to-brain drug delivery via lipid-based nanocarriers for neuro-oncological, neurodegenerative, and other brain diseases, encompassed 60 studies. A temporal distribution analysis indicated a peak in research interest between 2018 and 2020 (28.3%), with a steady increase over time. Regarding drug categories, Alzheimer’s disease was prominent (26.7%), followed by antiblastic drugs (25.0%). Among the 65 drugs investigated, Rivastigmine, Doxorubicin, and Carmustine were the most studied (5.0%), showcasing a diverse approach to neurological disorders. Notably, solid lipid nanoparticles (SLNs) were predominant (65.0%), followed by nanostructured lipid carriers (NLCs) (28.3%), highlighting their efficacy in intranasal drug delivery. Various lipids were employed, with glyceryl monostearate being prominent (20.0%), indicating preferences in formulation. Performance assessment assays were balanced, with in vivo studies taking precedence (43.3%), emphasizing the translation of findings to complex biological systems for potential clinical applications. Conclusions: This systematic review reveals the transformative potential of intranasal lipid nanoparticles in treating brain diseases, overcoming the BBB. Positive outcomes highlight the effectiveness of SLNs and NLCs, which are promising new approaches for ailments from AD to stroke and gliomas. While celebrating progress, addressing challenges like nanoparticle toxicity is also crucial.

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Section: Discussionmentioning

confidence: 99%

Navigating the Nose-to-Brain Route: A Systematic Review on Lipid-Based Nanocarriers for Central Nervous System Disorders

Agosti,

Zeppieri,

Antonietti

et al. 2024

Pharmaceutics

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“…Ziprasidone-loaded NLCs were developed and tested by Sivadasu et al 185 for schizophrenia management. In vivo biodistribution studies revealed higher ziprasidone concen-trations in the brain at all time points following intranasal administration compared to the IV route with lower T max .…”

Section: Intranasal Drug Delivery Nanosystems For Targeted Drug Deliv...mentioning

confidence: 99%

Versatile Nanoparticulate Systems as a Prosperous Platform for Targeted Nose–Brain Drug Delivery

Taha,

Shetta,

Nour

et al. 2024

Mol. Pharmaceutics

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The intranasal route has proven to be a reliable and promising route for delivering therapeutics to the central nervous system (CNS), averting the blood−brain barrier (BBB) and avoiding extensive first-pass metabolism of some drugs, with minimal systemic exposure. This is considered to be the main problem associated with other routes of drug delivery such as oral, parenteral, and transdermal, among other administration methods. The intranasal route maximizes drug bioavailability, particularly those susceptible to enzymatic degradation such as peptides and proteins. This review will stipulate an overview of the intranasal route as a channel for drug delivery, including its benefits and drawbacks, as well as different mechanisms of CNS drug targeting using nanoparticulate drug delivery systems devices; it also focuses on pharmaceutical dosage forms such as drops, sprays, or gels via the nasal route comprising different polymers, absorption promoters, CNS ligands, and permeation enhancers.

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“…Quality by design (QbD) is an essential concept for modern manufacturing processes of pharmaceutical products. [2][3][4][5] A scientific understanding of the manufacturing processes is crucial to realizing QbD. However, the mechanism underlying wet-granulation and tableting is unclear because of the complexity of the manufacturing processes, and consequently, it is difficult to identify critical process parameters (CPPs), critical material attributes (CMAs), as well as critical quality attributes (CQAs).…”

Section: Introductionmentioning

confidence: 99%

“…[6][7][8] These techniques provide systematic means to define CPPs, CMAs, and CQAs; however, a risk priority number (RPN) must be employed based on the expert knowledge. [4][5][6][7] Because the RPN is arbitrarily determined, we often encounter difficulties in objective scoring of RPN.…”

Section: Introductionmentioning

confidence: 99%

Latent Structure Analysis of Wet-Granulation Tableting Process Based on Structural Equation Modeling

Katayama

Itakura

Todo

et al. 2021

CHEMICAL & PHARMACEUTICAL BULLETIN

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Quality by design (QbD) is an essential concept for modern manufacturing processes of pharmaceutical products. Understanding the science behind manufacturing processes is crucial; however, the complexity of the manufacturing processes makes implementing QbD challenging. In this study, structural equation modeling (SEM) was applied to understand the causal relationships between variables such as process parameters, material attributes, and quality attributes. Based on SEM analysis, we identified a model composed of the above-mentioned variables and their latent factors without including observational data. Difficulties in fitting the observed data to the proposed model are often encountered in SEM analysis. To address this issue, we adopted Bayesian estimation with Markov chain Monte Carlo simulation. The tableting process involving the wet-granulation process for acetaminophen was employed as a model case for the manufacturing process. The results indicate that SEM analysis could be useful for implementing QbD for the manufacturing processes of pharmaceutical products.

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Ziprasidone Hydrochloride Loaded Nanostructured Lipid Carriers (Nlcs) for Intranasal Delivery: Optimization and in Vivo Studies

Cited by 6 publications

References 26 publications

Navigating the Nose-to-Brain Route: A Systematic Review on Lipid-Based Nanocarriers for Central Nervous System Disorders

Navigating the Nose-to-Brain Route: A Systematic Review on Lipid-Based Nanocarriers for Central Nervous System Disorders

Versatile Nanoparticulate Systems as a Prosperous Platform for Targeted Nose–Brain Drug Delivery

Latent Structure Analysis of Wet-Granulation Tableting Process Based on Structural Equation Modeling

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