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      Integration of an anti-tumor drug into nanocrystalline assemblies for sustained drug release†

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          Abstract

          A bio-inspired approach was used to integrate an anti-tumor drug into nanocrystalline assemblies for sustained drug release.

          Abstract

          Delicate mesoscopic architectures, bearing complex forms with multiple hierarchy levels, lead to significant functions in biogenic minerals. Herein, a bio-inspired approach was developed to fabricate comet-shaped assemblies of an anti-tumor drug – 10-hydroxycamptothecin (HCPT). The anti-solvent co-precipitation of HCPT and the excipient – PEG- b-PLGA – within the emulsifier leads to the immediate nucleation of comet bundles, followed by a secondary nucleation to generate the comet head, which is an assembly of nanofibers aligned almost in parallel. The continuous manufacturing furnishes drug–excipient hybrid particles with high drug-loading and a sustained drug release profile. This simple and efficient bio-inspired approach led to a promising sustained local drug delivery system, and could be extended to the fabrication of other functional organic materials bearing mesoscopic structural units.

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          Nucleation of crystals from solution: classical and two-step models.

          James S Myerson, Deniz Erdemir, Benjamin Lee (2009)
          Crystallization is vital to many processes occurring in nature and in the chemical, pharmaceutical, and food industries. Notably, crystallization is an attractive isolation step for manufacturing because this single process combines both particle formation and purification. Almost all of the products based on fine chemicals, such as dyes, explosives, and photographic materials, require crystallization in their manufacture, and more than 90% of all pharmaceutical products contain bioactive drug substances and excipients in the crystalline solid state. Hence control over the crystallization process allows manufacturers to obtain products with desired and reproducible properties. We judge the quality of a crystalline product based on four main properties: size, purity, morphology, and crystal structure. The pharmaceutical industry in particular requires production of the desired crystal form (polymorph) to assure the bioavailability and stability of the drug substance. In solution crystallization, nucleation plays a decisive role in determining the crystal structure and size distribution. Therefore, understanding the fundamentals of nucleation is crucial to achieve control over these properties. Because of its analytical simplicity, researchers have widely applied classical nucleation theory to solution crystallization. However, a number of differences between theoretical predictions and experimental results suggest that nucleation of solids from solution does not proceed via the classical pathway but follows more complex routes. In this Account, we discuss the shortcomings of classical nucleation theory and review studies contributing to the development of the modern two-step model. In the two-step model that was initially proposed for protein crystallization, a sufficient-sized cluster of solute molecules forms first, followed by reorganization of that cluster into an ordered structure. In recent experimental and theoretical studies, we and other researchers have demonstrated the applicability of the two-step mechanism to both macromolecules and small organic molecules, suggesting that this mechanism may underlie most crystallization processes from solutions. Because we have observed an increase in the organization time of appropriate lattice structures with greater molecular complexity, we propose that organization is the rate-determining step. Further development of a clearer picture of nucleation may help determine the optimum conditions necessary for the effective organization within the clusters. In addition, greater understanding of these processes may lead to the design of auxiliaries that can increase the rate of nucleation and avoid the formation of undesired solid forms, allowing researchers to obtain the final product in a timely and reproducible manner.
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            Oriented attachment and mesocrystals: non-classical crystallization mechanisms based on nanoparticle assembly.

            Markus Niederberger, Helmut Cölfen (2006)
            In this review, we highlight particle based crystallization pathways leading to single crystals via mesoscopic transformation. In contrast to the classical mechanism of atom/molecule mediated growth of a single crystal, the particle mediated growth and assembly mechanisms are summarized as "non-classical crystallization", including exiting processes like oriented attachment and mesocrystal formation. Detailed investigations of non-classical crystallization mechanisms are a recent development, but evidence for these pathways is rapidly increasing in the literature. A major driving force for these investigations originates from biomineralization, because it seems that these crystallization routes are frequently applied by natural organisms. We give a non-exhaustive literature survey on these two mechanisms with a focus on recent examples and studies, which are dedicated to a mechanistic understanding. Furthermore, conditions are introduced for which these non-classical crystallization mechanisms can be expected, as they are always an alternative reaction pathway to classical crystallization.
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              Control of protein crystal nucleation around the metastable liquid-liquid phase boundary.

              O Galkin, P Vekilov (2000)
              The capability to enhance or suppress the nucleation of protein crystals opens opportunities in various fundamental and applied areas, including protein crystallography, production of protein crystalline pharmaceuticals, protein separation, and treatment of protein condensation diseases. Herein, we show that the rate of homogeneous nucleation of lysozyme crystals passes through a maximum in the vicinity of the liquid-liquid phase boundary hidden below the liquidus (solubility) line in the phase diagram of the protein solution. We found that glycerol and polyethylene glycol (which do not specifically bind to proteins) shift this phase boundary and significantly suppress or enhance the crystal nucleation rates, although no simple correlation exists between the action of polyethylene glycol on the phase diagram and the nucleation kinetics. The control mechanism does not require changes in the protein concentration, acidity, and ionicity of the solution. The effects of the two additives on the phase diagram strongly depend on their concentration, which provides opportunities for further tuning of nucleation rates.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Chem Sci
                Journal ID (iso-abbrev): Chem Sci
                Title: Chemical Science
                Publisher: Royal Society of Chemistry
                ISSN (Print): 2041-6520
                ISSN (Electronic): 2041-6539
                Publication date (Print): 1 March 2015
                Publication date (Electronic): 6 January 2015
                Volume: 6
                Issue: 3
                Pages: 1650-1654
                Affiliations
                [a ] Institute of Soft Matter and Biomimetics , College of Materials , Xiamen University , Xiamen 361005 , China . Email: houzhenqing@ 123456xmu.edu.cn ; Email: yuan.jiang@ 123456xmu.edu.cn ; Fax: +86-592-2183058
                [b ] Department of Chemistry , College of Chemistry & Chemical Engineering , Xiamen University , Xiamen 361005 , China
                [c ] The First Affiliated Hospital of Xiamen University , Xiamen University , Xiamen 361003 , China
                Author notes

                ‡These authors contributed equally to this work.

                Article
                Publisher ID: c4sc03392b
                DOI: 10.1039/c4sc03392b
                PMC ID: 5483847
                PubMed ID: 28694944
                SO-VID: 5d26035d-6e19-419f-974a-6379874ef887
                Copyright © This journal is © The Royal Society of Chemistry 2015
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution 3.0 Unported License ( http://creativecommons.org/licenses/by/3.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 5 November 2014
                Date accepted : 28 December 2014
                Categories
                Subject: Chemistry

                Notes

                †Electronic supplementary information (ESI) available. See DOI: 10.1039/c4sc03392b


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