Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes
Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is th...
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Gespeichert in:
| Autor*in: |
A. A. Drannikov [verfasserIn] I. S. Vatlin [verfasserIn] M. E. Trusova [verfasserIn] A. Di Martino [verfasserIn] S. V. Krivoshchekov [verfasserIn] A. M. Guriev [verfasserIn] M. V. Belousov [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Russisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: Разработка и регистрация лекарственных средств - LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020, 11(2022), 2, Seite 102-108 |
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| Übergeordnetes Werk: |
volume:11 ; year:2022 ; number:2 ; pages:102-108 |
| Links: |
Link aufrufen |
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| DOI / URN: |
10.33380/2305-2066-2022-11-2-102-108 |
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| Katalog-ID: |
DOAJ035196416 |
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| 520 | |a Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. | ||
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10.33380/2305-2066-2022-11-2-102-108 doi (DE-627)DOAJ035196416 (DE-599)DOAJ6043f3af2c3a48dba5e7f64450573bb7 DE-627 ger DE-627 rakwb rus HD9665-9675 A. A. Drannikov verfasserin aut Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. грамицидин с антибиотик β-циклодекстрин комплекс включения Pharmaceutical industry I. S. Vatlin verfasserin aut M. E. Trusova verfasserin aut A. Di Martino verfasserin aut S. V. Krivoshchekov verfasserin aut A. M. Guriev verfasserin aut M. V. Belousov verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 11(2022), 2, Seite 102-108 (DE-627)1760622966 26585049 nnns volume:11 year:2022 number:2 pages:102-108 https://doi.org/10.33380/2305-2066-2022-11-2-102-108 kostenfrei https://doaj.org/article/6043f3af2c3a48dba5e7f64450573bb7 kostenfrei https://www.pharmjournal.ru/jour/article/view/1223 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 11 2022 2 102-108 |
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10.33380/2305-2066-2022-11-2-102-108 doi (DE-627)DOAJ035196416 (DE-599)DOAJ6043f3af2c3a48dba5e7f64450573bb7 DE-627 ger DE-627 rakwb rus HD9665-9675 A. A. Drannikov verfasserin aut Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. грамицидин с антибиотик β-циклодекстрин комплекс включения Pharmaceutical industry I. S. Vatlin verfasserin aut M. E. Trusova verfasserin aut A. Di Martino verfasserin aut S. V. Krivoshchekov verfasserin aut A. M. Guriev verfasserin aut M. V. Belousov verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 11(2022), 2, Seite 102-108 (DE-627)1760622966 26585049 nnns volume:11 year:2022 number:2 pages:102-108 https://doi.org/10.33380/2305-2066-2022-11-2-102-108 kostenfrei https://doaj.org/article/6043f3af2c3a48dba5e7f64450573bb7 kostenfrei https://www.pharmjournal.ru/jour/article/view/1223 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 11 2022 2 102-108 |
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10.33380/2305-2066-2022-11-2-102-108 doi (DE-627)DOAJ035196416 (DE-599)DOAJ6043f3af2c3a48dba5e7f64450573bb7 DE-627 ger DE-627 rakwb rus HD9665-9675 A. A. Drannikov verfasserin aut Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. грамицидин с антибиотик β-циклодекстрин комплекс включения Pharmaceutical industry I. S. Vatlin verfasserin aut M. E. Trusova verfasserin aut A. Di Martino verfasserin aut S. V. Krivoshchekov verfasserin aut A. M. Guriev verfasserin aut M. V. Belousov verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 11(2022), 2, Seite 102-108 (DE-627)1760622966 26585049 nnns volume:11 year:2022 number:2 pages:102-108 https://doi.org/10.33380/2305-2066-2022-11-2-102-108 kostenfrei https://doaj.org/article/6043f3af2c3a48dba5e7f64450573bb7 kostenfrei https://www.pharmjournal.ru/jour/article/view/1223 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 11 2022 2 102-108 |
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10.33380/2305-2066-2022-11-2-102-108 doi (DE-627)DOAJ035196416 (DE-599)DOAJ6043f3af2c3a48dba5e7f64450573bb7 DE-627 ger DE-627 rakwb rus HD9665-9675 A. A. Drannikov verfasserin aut Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. грамицидин с антибиотик β-циклодекстрин комплекс включения Pharmaceutical industry I. S. Vatlin verfasserin aut M. E. Trusova verfasserin aut A. Di Martino verfasserin aut S. V. Krivoshchekov verfasserin aut A. M. Guriev verfasserin aut M. V. Belousov verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 11(2022), 2, Seite 102-108 (DE-627)1760622966 26585049 nnns volume:11 year:2022 number:2 pages:102-108 https://doi.org/10.33380/2305-2066-2022-11-2-102-108 kostenfrei https://doaj.org/article/6043f3af2c3a48dba5e7f64450573bb7 kostenfrei https://www.pharmjournal.ru/jour/article/view/1223 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 11 2022 2 102-108 |
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10.33380/2305-2066-2022-11-2-102-108 doi (DE-627)DOAJ035196416 (DE-599)DOAJ6043f3af2c3a48dba5e7f64450573bb7 DE-627 ger DE-627 rakwb rus HD9665-9675 A. A. Drannikov verfasserin aut Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. грамицидин с антибиотик β-циклодекстрин комплекс включения Pharmaceutical industry I. S. Vatlin verfasserin aut M. E. Trusova verfasserin aut A. Di Martino verfasserin aut S. V. Krivoshchekov verfasserin aut A. M. Guriev verfasserin aut M. V. Belousov verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 11(2022), 2, Seite 102-108 (DE-627)1760622966 26585049 nnns volume:11 year:2022 number:2 pages:102-108 https://doi.org/10.33380/2305-2066-2022-11-2-102-108 kostenfrei https://doaj.org/article/6043f3af2c3a48dba5e7f64450573bb7 kostenfrei https://www.pharmjournal.ru/jour/article/view/1223 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 11 2022 2 102-108 |
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A. Drannikov</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. 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HD9665-9675 Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes грамицидин с антибиотик β-циклодекстрин комплекс включения |
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investigation of the influence of formulation method on technological parameters of gramicidin s and β-cyclodextrin inclusion complexes |
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Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes |
| abstract |
Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. |
| abstractGer |
Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. |
| abstract_unstemmed |
Introduction. Gramicidin S is a peptide antibiotic that has been widely used for more than 70 years. Gramicidin S is available in the form of tablets with a low dosage, which leads to possible deviations in the "Uniformity of dosage" parameter during manufacturing. Another limitation is the presence of lactose and sucrose in the formulation, which limits the drug application by patients demonstrating intolerance. As an alternative, we propose inclusion complexes of gramicidin S with β-cyclodextrin.Aim. The work aims to describe the influence of the methodology to prepare the inclusion complex on the characteristics and properties of the final product.Materials and methods. The gramicidin S – β-cyclodextrin inclusion complex has been prepared by dry mixing, paste complexation, co-precipitation and fluid-bed complexation. The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients. |
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Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes |
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A. Drannikov</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Investigation of the Influence of Formulation Method on Technological Parameters of Gramicidin S and β-cyclodextrin Inclusion Complexes</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Introduction. 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The complex formation has been confirmed by 1H NMR spectroscopy, differential scanning calorimetry and thermogravimetry while the morphology and size by scanning electron microscopy for the solid and dynamic light scattering for the solution. The flowability, slope angle, bulk density of the obtained powders were estimated using the methods described in Russian Pharmacopoeia of the XIV edition.Results and discussion. In the present work, we prepared a set of gramicidin S and β-cyclodextrin inclusion complexes by various approaches. The thermal analysis demonstrated a significant change in the peak referring to phase transition of the substances, indicating the interaction between the components. The 1H NMR spectroscopy reveals that the L-ornithine amino group is the part of gramicidin S involved in the complexation. Evaluating the technological properties of gramicidin S and β-cyclodextrin inclusion complexes significant variability, which is associated with the particle morphology. Complexes obtained using co-precipitation and fluid-bed complexation methods are more suitable for producing gramicidin S tablet production by direct compression technology.Conclusion. Herein, we demonstrate that the formation of the gramicidin S and β-cyclodextrin inclusion complex occurs through the L-ornithine amino group in the gramicidin S. In addition, depending on the method significant differences in the particle size and shape have been observed. The obtained results could provide valuable information for the development of new gramicidin S buccal formulations, which are more consistent in the "Uniformity of dosage" and allow to avoid the use of lactose and sucrose as excipients.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">грамицидин с</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">антибиотик</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">β-циклодекстрин</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">комплекс включения</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Pharmaceutical industry</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">I. S. Vatlin</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">M. E. Trusova</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">A. Di Martino</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">S. V. Krivoshchekov</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">A. M. Guriev</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">M. V. Belousov</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="t">Разработка и регистрация лекарственных средств</subfield><subfield code="d">LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020</subfield><subfield code="g">11(2022), 2, Seite 102-108</subfield><subfield code="w">(DE-627)1760622966</subfield><subfield code="x">26585049</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:11</subfield><subfield code="g">year:2022</subfield><subfield code="g">number:2</subfield><subfield code="g">pages:102-108</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.33380/2305-2066-2022-11-2-102-108</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doaj.org/article/6043f3af2c3a48dba5e7f64450573bb7</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://www.pharmjournal.ru/jour/article/view/1223</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/2305-2066</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/2658-5049</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_DOAJ</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">11</subfield><subfield code="j">2022</subfield><subfield code="e">2</subfield><subfield code="h">102-108</subfield></datafield></record></collection>
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