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Study of excipients' influence on the drug dissolution from tablets
Ouzký, Miroslav ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical Technology Supervisor: Consultants: Assoc. Prof. PharmDr. Zdeňka Šklubalová, Ph.D. Mgr. Jana Brokešová, Mgr. Daniel Pěček Student: Miroslav Ouzký Title of Thesis: Study of excipientsʼ influence on the drug dissolution from tablets The aim of this work was to study the influence of excipients on the dissolution of the high-dose active substance from tablets. The tablets were compressed from the granules prepared by wet-granulation method. 11 batches of tablets which contained two different fillers: either lactose or microcrystalline cellulose, respectively; and extragranularly added disintegrant: either croscarmellose or crospovidone, respectively, in three concentration levels of 2 %, 3,7 % or 5,4 % were prepared. Tablets were packed into aluminium/PVC blisters. The paddle dissolution test was used to determine the release of the active substance into phospate buffer pH 7,2 at the time of preparation (time 0) and at the time points 1.5, 3 and 6 months of stability assay at 40 řC and 75 % relative air humidity. The results show that the drug release from tablets containing microcrystalline celulose was generally faster than from those containing lactose. The same was true for tablets to which croscarmellose was...
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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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The study of influence of the measurement method on static angle of repose of free-flowable excipients
Mrázková, Aneta ; Šklubalová, Zdeňka (advisor) ; Svačinová, Petra (referee)
Charles University, Faculty of Pharmacy in Hradci Králové Department of: Pharmaceutical technology Supervisor: doc. PharmDr. Zdeňka Šklubalová, Ph.D. Consultant: Mgr. Žofie Trpělková Student: Aneta Mrázková Title of Thesis: The study of influence of the measurement method on static angle of repose of free-flowable excipients. Good flow and consolidation properties of powders represent significant characteristics of pharmaceutical excipients They are important for manufacturing of powders into solid dosage forms. Flow behavior of 6 free flowing excipients was evaluated in this diploma thesis. The main target was a study of the influence of the masurement method and the orifice size of a conical hopper on static angle of repose (AOR). The automatic tester and the prototype for measuring AOR having orifice sizes in a range of 6-15 mm were used for the measurement. A significant difference between the results of these two methods (P <0.01) was observed. The decrease in AOR was detected when increased the orifice diameter, the effect was significant (P <0.01) only in automatic tester for two out of six measured powders. Surprisingly, the significant influence of the orifice size on AOR was registered for a sweetener Palatinose with protype equipment.
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The study of influence of the measurement method on static angle of repose of free-flowable excipients
Mrázková, Aneta ; Šklubalová, Zdeňka (advisor) ; Svačinová, Petra (referee)
Charles University, Faculty of Pharmacy in Hradci Králové Department of: Pharmaceutical technology Supervisor: doc. PharmDr. Zdeňka Šklubalová, Ph.D. Consultant: Mgr. Žofie Trpělková Student: Aneta Mrázková Title of Thesis: The study of influence of the measurement method on static angle of repose of free-flowable excipients. Good flow and consolidation properties of powders represent significant characteristics of pharmaceutical excipients They are important for manufacturing of powders into solid dosage forms. Flow behavior of 6 free flowing excipients was evaluated in this diploma thesis. The main target was a study of the influence of the masurement method and the orifice size of a conical hopper on static angle of repose (AOR). The automatic tester and the prototype for measuring AOR having orifice sizes in a range of 6-15 mm were used for the measurement. A significant difference between the results of these two methods (P <0.01) was observed. The decrease in AOR was detected when increased the orifice diameter, the effect was significant (P <0.01) only in automatic tester for two out of six measured powders. Surprisingly, the significant influence of the orifice size on AOR was registered for a sweetener Palatinose with protype equipment.
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Homogenization of powder blends using a Turbula mixer.
Litošová, Martina ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
1 Abstract Charles University, Faculty of Pharmacy in Hradci Králové Department of: Department of Pharmaceutical Technology Supervisor: Doc. PharmDr. Zdeňka Šklubalová, Ph. D. Consultant PharmDr. Karel Palát, CSc., Mgr. Žofie Trpělková Student: Martina Litošová Title of Thesis: Homogenization of powder blends using a Turbula mixer. In this experimental work, the influencing of the homogeneity of the powder mixture of acetylsalicylic acid (ASA) and microcrystalline cellulose (Avicel PH102) due to the rotational speed of the mixing container in a range of 23−101 rpm, and the mixing time was studied using the Turbula shaker mixer. Within time interval 2-62 minutes, the content of ASA in samples was measured by near-infrared spectrometry. The expression of standard deviation was used to evaluate the homogeneity of samples. The best results were detected at a rotational speed of 34 rpm within time interval of 14−30 min.
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Assessment of liquisolid powders compressibility with regards to the used amount of coating material
Žihlová, Veronika ; Vraníková, Barbora (advisor) ; Šklubalová, Zdeňka (referee)
Charles University, Faculty of pharmacy in Hradec Králové Department: Department of pharmaceutical technology Consultant: PharmDr. Barbora Vraníková, Ph.D. Student: Veronika Žihlová Title of thesis: Assessment of liquisolid powders compressibility with regards to the used amount of coating material Preparation of liquisolid system is a novel method capable to convert a drug in the liquid state into a dry powder with sufficient flow properties. This method allows to improve the bioavailability of poorly water-soluble drugs or to prepare dosage forms with controlled release. This thesis is focused on the determination of flow and viscoelastic properties of liquisolid powder mixtures containing Neusilin® US2 (carrier), polyethylene glycol 400 (non-volatile solvent) and varying amounts of Syloid® 244 FP (coating material). Subsequently, the properties of tablets prepared from the mixtures were evaluated in compliance with Czech Pharmacopoeia (e.g. mass uniformity, pycnometric density, height, diameter, hardness friability and disintegration time of tablets). According to the obtained results, it can be concluded that the best flow properties implied mixtures with lower content of Syloid® 244 FP. Tablets made with the ratio of the carrier and the coating material equal to 50 showed the best properties...
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Adhesive properties of thin layers based on plasticized polyesters
Soukupová, Jana ; Šnejdrová, Eva (advisor) ; Šklubalová, Zdeňka (referee)
CHARLES UNIVERSITY Faculty of Pharmacy in Hradec Kralove Department of Pharmaceutical Technology Name: Jana Soukupova Title of diploma thesis: Adhesive properties of thin layers based on plasticized polyesters Supervisor: PharmDr. Eva Snejdrova, Ph.D. This diploma thesis deals with rheological, adhesive and dissolution properties of thin layers based on the branched polyester of D,L- lactic acid and glycolic acid, plasticized with methyl- salicylate, and loaded with salicylic acid. The theoretical section describes bioadhesion, its mechanism and theories, in vitro adhesive tests focused mainly on the method of rheological synergism, tensile and "wash off" tests. In the experimental section, the flow properties of plasticized polyesters, hydrated mucin from porcin stomach, and their mixtures were studied using absolute rotational rheometer. The analysis of the viscosity curves revealed that plasticized polyesters are Newtonian systems, mucin and its mixtures with polymer have pseudoplastic behaviour. Adhesive properties of the thin layers were established by equation of rheological synergism based on viscosity of polymer, mucin and their mixtures measured at shear rate of 10 s-1 . The adhesive properties of thin layers were also determined using tensile test on rheometer, and evaluated as the...
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A study of compressiblity and properties of tablets from coprocessed dry binder with manntol and croscarmellose sodium for orodispersible tablets.
Kamarýtová, Martina ; Mužíková, Jitka (advisor) ; Šklubalová, Zdeňka (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department: Pharmaceutical Technology Student: Martina Kamarýtová Consultant: PharmDr. Jitka Mužíková, Ph.D. Title of the Diploma Thesis: A study of compressibility and properties of tablets from coprocessed dry binder with mannitol and croscarmellose sodium for orodispersible tablets. This thesis deals with the study of directly compressible tableting materials and tablets with Parteck® ODT, which is designed for orodispersible tablets. The effect of three lubricants on the properties of tableting materials and tablets is evaluated. Tested lubricants are magnesium stearate, calcium stearate and sodium stearyl fumarate in concentrations of 0,5 and 1 %. Flow properties, compressibility, ejection force, tensile strength and disintegration time of tablets are tested. The compressibility is evaluated by the energy profile of compression process. Lubricants did not improve the flowability of Parteck® ODT. The total energy of compression increased with compression force and highest values were at the tableting material with 0,5 % magnesium stearate. The values of plasticity decreased with compression force, highest values were at the tableting material with 0,5 % sodium stearyl fumarate. The ejection force increased with compression force, the...
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Study of bulk and consolidation properties of size fractions of anhydrous lactose
Dostálová, Eliška ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical technology Supervisor: doc. PharmDr. Zdeňka Šklubalová, Ph.D. Consultant: Ing. Hana Hurychová Student: Eliška Dostálová Title of Thesis: Study of bulk and consolidation properties of size fractions of anhydrous lactose The bulk and consolidation behaviour of pharmaceutical excipients belong to their important properties. Properties of five size fractions of anhydrous lactose having the particle size in the range of 1-400 µm were studied in this thesis. The measurement was carried out by using static and dynamic pharmacopoeial methods. The bulk density and the tapped density, the angle of repose were evaluated as well as the true density of particles by using the gas pycnometry. The mass flow rate through the orifice of a model conical hopper by the force of gravity was estimated for the individual size fractions. The discharge rate through the orifice having the diameter in a range of 0.6-1.5 cm was modelled with the Beverloo et al and Jones < Pilpel power regression equations; the precision of the flow rate prediction was about 3 %. The best bulk properties were detected for the particle size fraction 246 µm. The results of the evaluation of the consolidation dynamic during the tapping of powder bed permitted...
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Study of the influence of particle size on the flow and consolidation behaviour of Tablettose 80
Hnatková, Monika ; Šklubalová, Zdeňka (advisor) ; Svačinová, Petra (referee)
Králové doc. PharmDr. Zdeňka Šklubalová, Ph.D. Ing. Hana Hurychová, Ph.D. Monika Hnatková The objective of this diploma thesis was to evaluate the flow and consolidation behaviour of the size fractions of lactose for direct compression - Tabletose® 80 in a range of 80-400 μm obtained by sieving. The nonlinear influence of the particle size on the flow rate was detected; the fractions of Tablettose® 80 with the mean size of 245 and 346 µm showed the best flowability. The influence of the diameter of the hopper opening on the flow rate was modeled using the Beverloo and/or Jones & Pilpel flow equation; the latter described the results better. The assessment of volume changes by gravitational tapping allowed to observe dynamics of consolidation and to express porosity factor for the powder bed, which enabled an estimation of the angle of internal friction.
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