Clinical and interferon-modulating efficacy of a combination of rectal and topical dosage forms of interferon-α2b in acute respiratory infections

Kalyuzhin, O. V.; Понежева, Ж.Б.; Купченко, А. Н.; Шувалов, А.Н.; Guseva, Tatiana S.; Паршина, О В; Malinovskaya, V. V.; Акимкин, В. Г.

doi:10.26442/terarkh2018901148-54

Cited by 2 publications

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“…The main pharmacodynamic and pharmacokinetic parameters of any medication will depend on the choice of dosage form. The present-day pharmaceutical market for immunomodulatory pharmaceuticals, using IFNs as an example, offers various types of dosage forms: liquid, solid, soft, and gaseous [ 64 ]. When developing a method for controlling the quality of medications, an important goal was to understand the effect of different forms of the pharmaceutical on the conductivity of electromagnetic emission.…”

Section: Resultsmentioning

confidence: 99%

Controlling the Quality of Nanodrugs According to Their New Property—Radiothermal Emission

Petrov,

Galkina,

Koldina

et al. 2024

Pharmaceutics

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Previous studies have shown that complexly shaped nanoparticles (NPs) have their intrinsic radiothermal emission in the millimeter range. This article presents a method for controlling the quality of nanodrugs—immunobiological preparations (IBPs)—based on the detection of their intrinsic radiothermal emissions. The emissivity of interferon (IFN) medicals, determined without opening the primary package, is as follows (µW/m2): IFN-α2b—80 ± 9 (105 IU per package), IFN-β1a—40 ± 5 (24 × 106 IU per package), IFN-γ—30 ± 4 (105 IU per package). The emissivity of virus-like particles (VLP), determined using vaccines Gam-VLP-multivac (120 μg) in an injection bottle (crimp cap vials), was as follows: 12 ± 1 µW/m2, Gam-VLP—rota vaccines—9 ± 1 µW/m2. This study shows the reproducibility of emissivity over the course of a year, subject to the storage conditions of the immunobiological products. It has been shown that accelerated aging and a longer shelf life are accompanied by the coagulation of active NPs, and lead to a manyfold drop in emissivity. The dependence of radiothermal emission on temperature has a complex, non-monotonic nature. The emission intensity depends on the form of dosage, but remains within the order of magnitude for IFN-α2b for intranasal aqueous solution, ointments, and suppositories. The possibility of the remote quantitative control of the first phases of the immune response (increased synthesis of IFNs) to the intranasal administration of VLP vaccines has been demonstrated in experimental animals.

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Section: Resultsmentioning

confidence: 99%

Controlling the Quality of Nanodrugs According to Their New Property—Radiothermal Emission

Petrov,

Galkina,

Koldina

et al. 2024

Pharmaceutics

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“…One of the directions for the modification of interferon is the introduction of external agents to improve the therapeutic properties [9,10]. An example of the modification is the creation of PEGylated interferons by attaching molecules of polyethylene glycol (PEG) to them.…”

Section: Introductionmentioning

confidence: 99%

The Development and Study of the Toxicity of Suppositories With a Modified Substance of Interferon Alfa-2b

Анурова

E.O.²,

Shumkova³

et al. 2023

Int J App Pharm

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Objective: To develop a stable composition with the substance of PEGylated interferon alfa-2b, to study technological and biopharmaceutical characteristics of the dosage form, and to conduct preclinical studies on the chronic toxicity and local irritating effect. Methods: Solid fats Witepsol® H15, Witepsol® W 35, Suppocire® BS2X, and Suppocire® BM brands were used as the suppository bases. Polysorbate 80 was used as an emulsifier. Citric acid, ascorbic acid, sodium tetraborate, lactic acid, ethylenediaminetetetraacetic acid, tocopherol acetate was also introduced into the experimental samples. Fourteen experimental samples were screened for biological and technological indicators. Preclinical studies were performed for the optimal composition on the indicators of chronic toxicity and local irritant effect. Results: The study examined the cytotoxic effects on the Vero cell line of selected suppository bases and excipients, namely, pH regulators and antioxidants. With excipients that did not have cytotoxicity we obtained suppository compositions with the following quality indicators: cytotoxicity, specific activity of interferon, time of complete deformation of suppositories and their melting temperature. A total of 14 compositions were studied, of which 5 were selected on the basis of the results for the study of stability. Only one composition turned out to be stable for the time studied. Conclusion: The most stable in terms of “specific activity” was sample 7, its composition: Witepsol® H15/W35 70/30, polysorbate-80 0.15%, ethylenediaminetetraacetic acid (EDTA) 0.15%, sodium tetraborate 0.15%, tocopherol acetate 3.0%. Preclinical studies, that showed the absence of chronic toxicity and local irritant effect, were performed for this composition.

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Clinical and interferon-modulating efficacy of a combination of rectal and topical dosage forms of interferon-α2b in acute respiratory infections

Cited by 2 publications

References 0 publications

Controlling the Quality of Nanodrugs According to Their New Property—Radiothermal Emission

Controlling the Quality of Nanodrugs According to Their New Property—Radiothermal Emission

The Development and Study of the Toxicity of Suppositories With a Modified Substance of Interferon Alfa-2b

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