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Highlighted Article:Experimental Studies on the Systemic Toxicity and Biodistribution of Synthesized Calcium Phosphate Nanoparticles After Oral Administration in Rats

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Experimental Studies on the Systemic Toxicity and Biodistribution of Synthesized Calcium Phosphate Nanoparticles After Oral Administration in Rats

Author(s):

Jagdish C. Joshi, Anuradha Bhardwaj, Indrajit Roy, Kavita Gulati and Arunabha Ray Pages 202 - 212 ( 11 )

Abstract:

Background and Objective: Nanoparticles have special properties, such as higher surface-to-volume ratio and higher reactivity, which increases cell penetrability and enhance their applicability in the field of medicine, especially in the case where other drugs are ineffective. Calcium phosphate nanoparticles (CPNP) and their encapsulation with therapeutic and/or diagnostic agents is such an agent synthesized. However, there are concerns related to the colloidal stability of these nanoparticles, which are reflected in their tendency to form aggregates in the physiological milieu. Therefore, successful translation of these nanoparticles from laboratory to the clinic requires studies of biodistribution and biocompatibility of nanoparticles for in vivo biomedical applications.

Method: Calcium phosphate nanoparticles synthesized and were tagged with a fluorophore and surface stabilized with trisilanol for stable aqueous dispersion. The in vivo biodistribution and sub-acute toxicological studies were done for orally-administered calcium phosphate nanoparticles.

Results: The biodistribution studies indicated that these nanoparticles were not prone to rapid degradation or excretion in the body, were long-circulating, and could appreciably permeate to the brain. Body/organ weight and biochemical analyses did not reveal much difference between nanoparticle-administered and saline-administered (control) groups. Finally, histopathological analyses of major organs such as liver, lungs, heart, stomach and kidney, did not reveal significant abnormalities in the treatment groups.

Conclusion: Thus, it is evident from these sub-acute toxicity studies that the nanoparticles appear to be non-toxic to rats following oral administration. These observations can have significant implications in calcium-phosphate nanoparticle-mediated non-toxic drug delivery to target organs, such as brain, via non-invasive, oral route.

Keywords:

Bio-distribution, calcium phosphate nanoparticles, sub-acute toxicity, brain, heart, lungs.

Affiliation:

Department of Pharmacology, VP Chest Institute, University of Delhi, Delhi-110007, India.

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Most Accessed Article: Polymer-Drug Nanoconjugate – An Innovative Nanomedicine: Challenges and Recent Advancements in Rational Formulation Design for Effective Delivery of Poorly Soluble Drugs

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Polymer-Drug Nanoconjugate – An Innovative Nanomedicine: Challenges and Recent Advancements in Rational Formulation Design for Effective Delivery of Poorly Soluble Drugs

Author(s):

Amos O. Abioye, George Tangyie Chi, Adeola T. Kola-Mustapha, Ketan Ruparelia, Ken Beresford and Randolph Arroo Pages 38 - 79 ( 42 )

Abstract:

Background: Over the last four decades, the use of water soluble polymers in rational formulation design has rapidly evolved into valuable drug delivery strategies to enhance the safety and therapeutic effectiveness of poorly soluble drugs, particularly anticancer drugs. Novel advances in polymer chemistry have provided new generations of well defined polymeric architectures for specific applications in polymer-drug conjugate design.

However, total control of crucial parameters such as particle size, molecular weight distribution, polydispersity, localization of charges, hydrophilic-lipophilic balance and non site-specific coupling reactions during conjugation has been a serious challenge.

Objective: This review briefly describes the current advances in polymer-drug nanoconjugate design and various challenges hindering their transformation into clinically useful medicines.

Method: Existing literature was reviewed.

Results: This review provides insights into the significant impact of covalent and non-covalent interactions between drug and polymer on drug loading [or conjugation] efficiency, conjugate stability, mechanism of drug release from the conjugate and biopharmaceutical properties of poorly soluble drugs. The utility values and application of Quality by Design principles in rational design, optimization and control of the Critical Quality Attributes [CQA] and Critical Process Parameters [CPP] that underpin the safety, quality and efficacy of the nanoconjugates are also presented.

Conclusion: It was apparent that better understanding of the physicochemical properties of the nanoconjugates as well as the drug-polymer interaction during conjugation process is essential to be able to control the biodistribution, pharmacokinetics, therapeutic activity and toxicity of the nanoconjugates which will in turn enhance the prospect of successful transformation of these promising nanoconjugates into clinically useful nanomedicines.

Keywords:

Controlled biodistribution, critical quality attributes, nanoconjugate stability, polymer-drug nanoconjugates, poorly soluble drugs, rational formulation design.

Affiliation:

Leicester School of Pharmacy, De Montfort University, The Gateway, Leicester, LE1 9BH, UK.

Graphical Abstract: