Background. Capsules are solid drug forms that are well accepted by patients. Capsules usually consist of a medicinal substance with therapeutic benefits plus excipients. From a pharmaceutical point of view, DNA coding sequences can be treated as active substances.Objectives. To develop and assess gelatin capsules containing DNA based on the methods included in the Polish Pharmacopoeia XI, as well as non-pharmacopeial methods. Materials and methods.The mass uniformity of the obtained capsules was estimated. The stability of the DNA was verified using polymerase chain reaction (PCR) method. A study of the disintegration time of the gene capsules containing DNA mixed with lactose, and placebo capsules with lactose only was also performed. A dissolution test under conditions similar to the nature and specificity of the active substance (DNA) was performed. The transduction activity of the obtained capsules was assessed in cell culture conditions.Results. The DNA and lactose-based gene capsules were obtained. The capsules were characterized by mass uniformity and stability over time. Efficient transduction of B16-F10 cancer cells with the gene product from the capsule was observed using fluorescence microscopy. Groups of green fluorescent protein-positive cells were observed in the microscope field of view. Conclusions.The findings showed that it is possible to obtain a solid pharmaceutical form of the drug, i.e., a capsule containing DNA as an active substance. The gene capsules enabled the introduction of DNA into cells. This method may have valuable implications for increasing the availability of gene-based drugs for patients.

Eosinophilic esophagitis (EoE) is a chronic disease, characterized clinically by esophageal disfunction. Topical corticosteroids (tCS), predominantly fluticasone and budesonide, are considered the effective first line treatment, as well as an option of maintenance therapy in EoE. The way that tCS are administered significantly affects their effectiveness. There is still no ready-to-use steroid drug to be applied topically to the esophagus in children—a few experimental viscous slurries (mainly of budesonide) have been shown in trials to be more effective than steroids administered via metered dose inhalers (MDIs) and swallowed. The best examined steroid solvent of all is sucralose, a high-intensity artificial sweetener. Although it has been shown in a critical review that it is non-toxic and safe for all consumers, there are still some concerns among patients about its potential adverse effect on humans. Due to that fact, we developed a new viscous formulation and evaluated its effectiveness in the treatment of children with EoE. In an open, prospective, single-center study, we administered our new formulation of viscous budesonide twice daily for 8 weeks in patients with an active EoE. After treatment, we performed a control gastroscopy with the collection and evaluation of histopathological samples. We have proven our formulation effectiveness at 64%, as far as histological remission is concerned. We have also shown a reduction in the mean endoscopic reference score (EREFS) from 3.1 points at the beginning of the study to 1.6 points at the end of the study. Bearing in mind how important the acceptance of the solvent is for long-time compliance, especially among children, we also decided to assess the taste of the formulation. Therefore, we asked 46 adults and 10 children to swallow a sample of the solvent and fill in a short anonymous questionnaire about its taste, smell, consistency and easiness of swallowing. General acceptance for the proprietary solvent was high, reaching 7.5/10 among adults and 6.5/10 in children. To be able to compare the results of our preliminary experience, we reviewed the studies which evaluated substances that have been used so far as steroid solvents for the treatment of EoE. The overall effectiveness of the oral viscous budesonide (OVB) ranged from 65% to 90%, which is consistent with the results obtained in our study. Unfortunately, the high heterogeneity of the studies did not allow us to draw reliable conclusions.

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