ArticleAAPS PharmSciTech2010
Naked plasmid DNA formulation: effect of different disaccharides on stability after lyophilisation.
Article in AAPS PharmSciTech, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 29 citations in OpenAlex.
- Thermostable unit solid dose formulations for subcutaneous administration of DNA vaccines.Molecular therapy. Nucleic acids · 2025Article
- Ministring DNA (msDNA): a novel linear covalently-closed DNA with enhanced stability for gene and cell therapy applications.Scientific reports · 2025Article
- Immunogenicity of trivalent DNA vaccine candidate encapsulated in Chitosan-TPP nanoparticles against EV-A71 and CV-A16.Nanomedicine (London, England) · 2024Article
- Review: Development of SARS-CoV-2 immuno-enhanced COVID-19 vaccines with nano-platform.Nano research · 2022Review
- Safety of Sars-Cov-2 vaccines administration for adult patients with hereditary fructose intolerance.Human vaccines & immunotherapeutics · 2021Article
- Mannose and Mannose-6-Phosphate Receptor-Targeted Drug Delivery Systems and Their Application in Cancer Therapy.Advanced healthcare materials · 2018Review
- Long Shelf Life of a Lyophilized DNA Aptamer Beacon Assay.Journal of fluorescence · 2017Article
- Genetic Immunization With In Vivo Dendritic Cell-targeting Liposomal DNA Vaccine Carrier Induces Long-lasting Antitumor Immune Response.Molecular therapy : the journal of the American Society of Gene Therapy · 2016Article
- Recent Advances and Future Direction in Lyophilisation and Desiccation of Mesenchymal Stem Cells.Stem cells international · 2016Review
- Development of Biodegradable Polycation-Based Inhalable Dry Gene Powders by Spray Freeze Drying.Pharmaceutics · 2015Article
- Predicting the Uncertain Future of Aptamer-Based Diagnostics and Therapeutics.Molecules (Basel, Switzerland) · 2015Review
- Safety and efficacy of DNA vaccines: plasmids vs. minicircles.Human vaccines & immunotherapeutics · 2014Article
- Accelerated stability studies for moisture-induced aggregation of tetanus toxoid.Pharmaceutical research · 2011Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Since plasmid DNA (pDNA) is unstable in solution, lyophilisation can be used to increase product shelf life. To prevent stress on pDNA molecules during lyophilisation, cryo- and lyoprotectants have to be added to the formulation. This study assessed the effect of disaccharides on naked pDNA stability after lyophilisation using accelerated stability studies. Naked pDNA was lyophilised with sucrose, trehalose, maltose or lactose in an excipient/DNA w/w ratio of 20. To one part of the vials extra residual moisture was introduced by placing the vials half opened in a 25 degrees C/60% RH climate chamber, before placing all vials in climate chambers (25 degrees C/60% RH and 40 degrees C/75% RH) for stability studies. An ex vivo human skin model was used to assess the effect of disaccharides on transfection efficiency. Lyophilisation resulted in amorphous cakes for all disaccharides with a residual water content of 0.8% w/w. Storage at 40 degrees C/75% RH resulted in decreasing supercoiled (SC) purity levels (sucrose and trehalose maintained approximately 80% SC purity), but not in physical collapse. The addition of residual moisture (values between 7.5% and 10% w/w) resulted in rapid collapse except for trehalose and decreasing SC purity for all formulations. In a separate experiment disaccharide formulation solutions show a slight but significant reduction (<3% with sucrose and maltose) in transfection efficiency when compared to pDNA dissolved in water. We demonstrate that disaccharides, like sucrose and trehalose, are effective lyoprotectants for naked pDNA.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.