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Formulation of freeze dried tablets for buccal application of vaccines
Vuová, Ngoc Lien ; Šklubalová, Zdeňka (advisor) ; Holas, Ondřej (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical Technology Mentor: Doc. PharmDr. Zdeňka Šklubalová, Ph.D. Student: Ngoc Lien Vuová Title of Thesis: Formulation of freeze dried tablets for buccal application of vaccines Mucosal vaccines represent an attractive way of vaccination with an advantage of inducing both systemic and local immunity. The aim of this diploma thesis was designing a composition of freeze-dried tablets for buccal administration of a model Bordetella pertusis vaccine. The easy removal from blister, firmness and aesthetic appearance as well as the appropriate taste and mucoadhesivity were the required product quality parameters. The excipients were characterised by differential scanning calorimetry, osmolality and pH measurement; the mechanical properties and disintegration time of freeze-dried tablets were evaluated. Among the variety of studied excipients and their combinations, dextran 40 as the main component of the preparation provided the best results. For the further modification of properties, the addition of fish gelatin, iota carrageenan and macrogol 300 is suitable. Freeze-dried tablets containing trehalose, mannitol and povidon 25 did not achieve the desirable quality parameters. Freeze- dried tablets containing iota carrageenan...
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Formulation of freeze dried tablets for buccal application of vaccines
Vuová, Ngoc Lien ; Šklubalová, Zdeňka (advisor) ; Holas, Ondřej (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical Technology Mentor: Doc. PharmDr. Zdeňka Šklubalová, Ph.D. Student: Ngoc Lien Vuová Title of Thesis: Formulation of freeze dried tablets for buccal application of vaccines Mucosal vaccines represent an attractive way of vaccination with an advantage of inducing both systemic and local immunity. The aim of this diploma thesis was designing a composition of freeze-dried tablets for buccal administration of a model Bordetella pertusis vaccine. The easy removal from blister, firmness and aesthetic appearance as well as the appropriate taste and mucoadhesivity were the required product quality parameters. The excipients were characterised by differential scanning calorimetry, osmolality and pH measurement; the mechanical properties and disintegration time of freeze-dried tablets were evaluated. Among the variety of studied excipients and their combinations, dextran 40 as the main component of the preparation provided the best results. For the further modification of properties, the addition of fish gelatin, iota carrageenan and macrogol 300 is suitable. Freeze-dried tablets containing trehalose, mannitol and povidon 25 did not achieve the desirable quality parameters. Freeze- dried tablets containing iota carrageenan...
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Lyophilization of polymeric nanomaterials
Švehlíková, Ingrid ; Holas, Ondřej (advisor) ; Smékalová, Monika (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Pharmaceutical Technology Consultant: PharmDr. Ondřej Holas, PhD. Student: Ingrid Švehlíková Title od thesis: Lyophilization of polymeric nanoparticles Lyophilization is a widely used drying method with extensive application possibilities in the drug preparation. Its importance in pharmacy is growing because it is one of the important methods of stabilizing active substances, especially proteins. A detailed understanding of the properties of the drug and the physicochemical phenomena of the individual phases of lyophilization is a basic prerequisite for the preparation of a safe, effective and stable drug. Biomedical nanoparticles as drug carriers are the type of the dosage forms in which lyophilization is also used. A series of lyophilization experiments were performed using trehalose, mannitol, dextran and xylitol as cryo and lyoprotectant. The parameters assessed were particle size, PDI, appearance and lyophilisate reconstitution. The properties of nanoparticles prepared by nanoprecipitation from PLGA polymer were evaluated. Furthermore, experiments were performed to validate the deep-freezing method as an alternative method to lyophilization for long-term storage of nanoparticles. The nanoparticles were stored in...
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Formulation of freeze dried tablets for oromucosal administration of peptides
Macáková, Eliška ; Šklubalová, Zdeňka (advisor) ; Holas, Ondřej (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical Technology Consultant: Doc. PharmDr. Zdeňka Šklubalová, Ph.D. Student: Eliška Macáková Title of Thesis: Formulation of freeze dried tablets for oromucosal administration of peptides Freeze-drying is one out of the important methods for stabilization of active substances, particularly peptides, in pharmacy. The formulation of freeze-dried buccal/sublingual tablets for administration of peptides into the oral cavity is the main target of this thesis. The aim is to propose the combination of appropriate excipients and their concentration to achieve the suitable organoleptic properties and disintegration time of the product cake. The measurement of pH, osmolality, the thermal properties of substances, as well as the evaluation of mechanical quality of tablets and their disintegration were used. In conclusion, the combination of excipients for the composition of matrix for the futher development.
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Formulation of freeze dried tablets for oromucosal administration of peptides
Macáková, Eliška ; Šklubalová, Zdeňka (advisor) ; Holas, Ondřej (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical Technology Consultant: Doc. PharmDr. Zdeňka Šklubalová, Ph.D. Student: Eliška Macáková Title of Thesis: Formulation of freeze dried tablets for oromucosal administration of peptides Freeze-drying is one out of the important methods for stabilization of active substances, particularly peptides, in pharmacy. The formulation of freeze-dried buccal/sublingual tablets for administration of peptides into the oral cavity is the main target of this thesis. The aim is to propose the combination of appropriate excipients and their concentration to achieve the suitable organoleptic properties and disintegration time of the product cake. The measurement of pH, osmolality, the thermal properties of substances, as well as the evaluation of mechanical quality of tablets and their disintegration were used. In conclusion, the combination of excipients for the composition of matrix for the futher development.
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New cryoprotectives in preservation of potentially probiotic bacteria of Bifidobacterium genus using freeze-drying procedure
Vrabcová, Petra ; Killer, Jiří (advisor) ; Jakub, Jakub (referee)
The probiotic bacteria of the genus Bifidobacterium are especially used in the dairy and pharmaceutical industry. They are present in the form of viable cells in pro(syn)biotic fermented milk, dried and freeze-dried products for its positive effects on the health. Lyophilization represents one of the widely used methods for long-term preservation of bifidobacteria. The lyophilization process is challenging, but very needed, and for this reason it is still necessary to explore new cryo(lyo)protective substances, which protect the microbial cultures more effectively before the negative effects of cryopreservation and lyophilization.
The aim of the thesis was to test the various mixtures of substances containing specific oligosaccharides, which have prebiotic properties, from the point of view of their potential cryo(lyo)protective effect of lyophilization process. For the purposes of the study, twelve bifidobacterial strains of human and animal origin were selected. As a potential cryo(lyo)protectives were used solutions on the basis of 5x concentrated TPY medium with addition of FOS, 10% fructooligosaccharides (FOS) and the solution on the basis of porcine gastric mucin. Number of viable cells was determined in lyophilisates enriched by the concrete solutions in the time intervals (30 days, 3 months and 6 months) after lyophilization and compared with the control lyophilized samples (fresh cultures without the additive solutions). The potential cryo(lyo)protective effectiveness of 5x concentrated TPY medium solution has been demonstrated only in B. boum, B. breve, B. longum subsp. infantis a Bombiscardovia coagulans, where decreased the number of viable cells about four orders of magnitude. The potential cryo(lyo)protective effectiveness in 10% FOS solution was found only in B. thermacidophilum subsp. porcinum and Bombiscardovia coagulans, where was found half the number of viable cells. The highest potential cryo(lyo)protective effectiveness was observed for a solution on the basis of porcine gastric mucin. The highest number of viable cells was demonstrated in B. animalis subsp. lactis, B. boum, B. longum subsp. infantis, B. longum subsp. longum, B. pseudolongum subsp. globosum and B. thermacidophilum subsp. porcinum lyophilisates using this potential cryo(lyo)protective solution.
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