Stability and activity of hydroxyethyl starch-coated polyplexes in frozen solutions or lyophilizates

Noga, Matthäus; Edinger, Daniel; Wagner, Ernst; Winter, Gerhard; Besheer, Ahmed

doi:10.1016/j.ijpharm.2014.04.020

Cited by 11 publications

(5 citation statements)

References 36 publications

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“…Another carbohydrate that has been used in lieu of MAG is trehalose, a disaccharide of glucose. Trehalose has an established track record as a super-hydrophilic functionality incorporated into gene delivery vehicles with the added benefit of serving as a lyoprotectant. ,,, Reineke and coworkers were first to produce trehalose-containing glycopolymers via click polymerization . Their work demonstrated the stability and efficiency to deliver nucleic acids to cells with a trehalose-containing polymer in serum or serum-free media.…”

Section: Chemical Design Of Polymeric Cationic Vectorsmentioning

confidence: 99%

Polymeric Delivery of Therapeutic Nucleic Acids

et al. 2021

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The advent of genome editing has transformed the therapeutic landscape for several debilitating diseases, and the clinical outlook for gene therapeutics has never been more promising. The therapeutic potential of nucleic acids has been limited by a reliance on engineered viral vectors for delivery. Chemically defined polymers can remediate technological, regulatory, and clinical challenges associated with viral modes of gene delivery. Because of their scalability, versatility, and exquisite tunability, polymers are ideal biomaterial platforms for delivering nucleic acid payloads efficiently while minimizing immune response and cellular toxicity. While polymeric gene delivery has progressed significantly in the past four decades, clinical translation of polymeric vehicles faces several formidable challenges. The aim of our Account is to illustrate diverse concepts in designing polymeric vectors towards meeting therapeutic goals of in vivo and ex vivo gene therapy. Here, we highlight several classes of polymers employed in gene delivery and summarize the recent work on understanding the contributions of chemical and architectural design parameters. We touch upon characterization methods used to visualize and understand events transpiring at the interfaces between polymer, nucleic acids, and the physiological environment. We conclude that interdisciplinary approaches and methodologies motivated by fundamental questions are key to designing high-performing polymeric vehicles for gene therapy.

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Section: Chemical Design Of Polymeric Cationic Vectorsmentioning

confidence: 99%

Polymeric Delivery of Therapeutic Nucleic Acids

et al. 2021

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“…For example, Noga et al [21] used HESdecorated polyplex and reported higher stability with minimal aggregation effect compared to PEG-polyplex. In a further study, HES exhibited potential shielding property for the targeted delivery of nucleic acid and increased transfection efficiency compared to PEG [10,17,21].…”

Section: Introductionmentioning

confidence: 90%

“…Moreover, the nondegradability of PEG in vivo is another issue that leads to severe toxicity due to assemblage inside the body, if given in maximum dose [16]. Likewise, PEG-based chemotherapeutics lose stability upon rehydration due to PEG crystallization upon lyophilization [17]. Furthermore, the structure of PEG has been shown to contain relatively less reactive sites, which do not allow any ligands or conjugates to get attached to the PEG surface in a convenient manner [18].…”

Section: Introductionmentioning

confidence: 99%

Hydroxyethyl Starch-Based Functionalization of Gold Nanorods: A Possible Alternative to Polyethylene Glycol as a Surface Modifier

Pandey

Khadka

Wan

2021

Journal of Nanomaterials

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PEGylation refers to the process of functionalizing nanoparticles with polyethylene glycol (PEG) to avoid unspecific uptake by the mononuclear phagocyte system and prolong the circulation half-life of nanomedicines. Immunogenicity and nonbiodegradability are the major limitations in PEGylation that can be resolved by substituting PEG with biofriendly polymers, such as hydroxyethyl starch (HES). In the current study, thiolated hydroxyethyl starch (HES-SH, 130/0.4) was harnessed to stabilize gold nanorods (AuNRs) and compared with PEG-SH-coated AuNRs at different aspects of characterization and photothermal analysis. Our results confirm that AuNRs were functionalized successfully with both HES-SH and PEG-SH, where the initial spectra and colloidal stability of gold nanorods were restored after functionalization. In addition, the photothermal conversion stability of gold nanorods was maintained during both HESylation and PEGylation without affecting the heat generation. In summary, we presume that HES-SH can be used as a surface modifier to stabilize gold nanorods and might be used as a promising alternative to PEG.

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“…In this context, Noga et al [ 103 ] studied the effect of F/T (-50 ºC/10 ºC) and freeze-drying on the particle size of hydroxyethyl starch (HES)- and PEG-coated polyplexes. PEG-coated polyplexes exhibited a significant increase in particle size up to 3000 nm after 3 F/T cycles.…”

Section: Pharmaceutical Applications Of Freeze-thawmentioning

confidence: 99%

Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach

et al. 2023

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The freeze-thaw (F/T) method is commonly employed during the processing and handling of drug substances to enhance their chemical and physical stability and obtain pharmaceutical applications such as hydrogels, emulsions, and nanosystems (e.g., supramolecular complexes of cyclodextrins and liposomes). Using F/T in manufacturing hydrogels successfully prevents the need for toxic cross-linking agents; moreover, their use promotes a concentrated product and better stability in emulsions. However, the use of F/T in these applications is limited by their characteristics (e.g., porosity, flexibility, swelling capacity, drug loading, and drug release capacity), which depend on the optimization of process conditions and the kind and ratio of polymers, temperature, time, and the number of cycles that involve high physical stress that could change properties associated to quality attributes. Therefore, is necessary the optimization of F/T conditions and variables. The current research regarding F/T is focused on enhancing the formulations, the process, and the use of this method in pharmaceutical, clinical, and biological areas. The present review aims to discuss different studies related to the impact and effects of the F/T process on the physical, mechanical, and chemical properties (porosity, swelling capacity) of diverse pharmaceutical applications with an emphasis on their formulation properties, the method and variables used, as well as challenges and opportunities in developing. Finally, we review the experimental approach for choosing the standard variables studied in the F/T method applying the systematic methodology of quality by design.

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Stability and activity of hydroxyethyl starch-coated polyplexes in frozen solutions or lyophilizates

Cited by 11 publications

References 36 publications

Polymeric Delivery of Therapeutic Nucleic Acids

Polymeric Delivery of Therapeutic Nucleic Acids

Hydroxyethyl Starch-Based Functionalization of Gold Nanorods: A Possible Alternative to Polyethylene Glycol as a Surface Modifier

Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach

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