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Liquid paediatric preparations 1. Sotalol hydrochloride.
Kříž, Tomáš ; Šklubalová, Zdeňka (advisor) ; Ondrejček, Pavel (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical Technology Consultant: Doc. PharmDr. Zdenka Šklubalová, Ph.D. Student: Tomáš Kříž Title of Thesis: Liquid paediatric preparations 1. Sotalol hydrochloride The aim of this work was to formulate suitable paediatric oral solution with sotalol hydrochloride 5 mg/ml using a minimum amount of excipients. After the preformulation study, eight aqueous solutions of sotalol hydrochloride were compounded using citric acid and dibasis sodium phosphate dodecahydrate to stabilize pH value, potassium sorbate as a preservative, and simple sucrose syrup and/or sodium saccharin, respectively, as sweeteners. Density and osmolality of the formulations were estimated. The solutions were stored at two different temperatures of 2-8 řC and/or 2-8 řC, respectively, and the pH values were measured during 90 days. All studied formulations showed stable pH values at both temperatures of storage, except for an aqueous sotalol hydrochloride solution. Some of the formulations were proposed for validated stability study with a determination of the concentration of sotalol hydrochloride and potassium sorbate using HPLC.
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Effect of paracetamol on the parameters of compression equation
Mařanová, Lucie ; Řehula, Milan (advisor) ; Ondrejček, Pavel (referee)
Evaluation of the tableting mixtures containing the paracetamolum by the parameters of the equation of compression The diploma thesis deals with effect of paracetamol on the parameters of compression equation. These parameters characterize compression process in the individual phases of compression: precompression phase, phase of elastic deformation and phase of plastic deformation. Paracetamolum was studied in the five mixtures, where it occurred in different ratio with microcrystalline cellulose. Looseness, Carr's index and Hausner ratio were evaluated for each mixture. The sizes of reductions ai, sizes of energies Ei and Ri, "half-pressures" pHi and the velocity constants 1/ti were calculated using three-exponential equation of compression for the individual phases of pressing. The results showed poor flow properties of tableting mixtures and thus its unsuitability for direct compression. The results of the study have revealed that increasing amounts of paracetamolum in the mixture increase reduction of volume a1 and velocity of volume change 1/t1 in dependence on the amount of the extruded air and decrease the required energy due to the smooth surface and less friction during the precompression phase. Reduction of volume a2 decrease with the increase of content of paracetamol due to...
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The study of directly compressible tableting materials with granulated α-lactose monohydrate and lubricants
Šturmová, Zuzana ; Mužíková, Jitka (advisor) ; Ondrejček, Pavel (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department: Pharmaceutical Technology Candidate: Mgr. Zuzana Šturmová Consultant: PharmDr. Jitka Mužíková, Ph.D. Title of the Thesis: The study of directly compressible tableting materials with granulated α-lactose monohydrate and lubricants This thesis evaluates granulated lactose Lactopress® Granulated in combination with four types of lubricants in terms of flow properties, compressibility, ejection force, tensile strenght and disintegration time of tablets. Examined lubricants include magnesium stearate, calcium stearate, sodium-stearyl fumarate and glycerol-dibehenate at concentration 1 %. The compressibility is evaluated by energetic profile of compression. Lubricants increased flowability of granulated lactose, most magnesium stearate. The total energy of compression increased with compression force, higher values showed tableting materials with sodium-stearyl fumarate and glycerol-dibehenate. The plasticity decreased with compression force, higher values showed tableting materials with glycerol- dibehenate. The lowest values of ejection force showed tableting materials with magnesium stearate and calcium stearate. Tableting materials with glycerol-dibehenate had extremely high values of ejection forces, and therefore...
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Evaluation of tensile strength of tablets containing theophylline
Janoutová, Hana ; Šklubalová, Zdeňka (advisor) ; Ondrejček, Pavel (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Pharmaceutical Technology Consultant: Doc. PharmDr. Zdeňka Šklubalová, Ph.D. Student: Hana Janoutová Title of Thesis: Evaluation of tensile strength of tablets containing theophylline The aim of this thesis was to determine tensile strength of tablets containing theophylline. Tensile strength was studied as a function of the composition of mixtures of the used fillers and especially on their ratio. In the theoretical part, the used materials - lactose SpheroLac 100, microcrystalline cellulose Comprecel 102, dibasic calcium phosphate dihydrate Di-Cafos D160, anhydrous dibasic calcium phosphate Di-Cafos A150, theophylline and magnesium stearate are described. This work also evaluates force-displacement record, tensile strength and various factors that affect tensile strength. Parameters of force-displacement record and tensile strength of the tablets compressed with compresssion force 10 kN were evaluated in the experimental part. The measured results show that higher values of precompression energy (E1) and energy of plastic deformation (E2) were detected in mixtures A, C and E which contain Comprecel 102, and the lowest values were detected in mixtures B which contain Sphero-Lac 100 and Di-Cafos D160. Values of energy...
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A study of the compressibility of directly compressible tableting materials for matrix tablets with ascorbic acid.
Mačková, Hana ; Mužíková, Jitka (advisor) ; Ondrejček, Pavel (referee)
This thesis evaluates and compares compressibility of directly compressible tableting materials for the preparation of matrix tablets containing ascorbic acid. Avicel® PH 102 was used as the dry binder. The hydrophilic matrix tablets contained carbomers (Carbopol® 71G NF) or hypromellose (MethocelTM K15M) in concentration of 20 % or both in concentration of 10 % , the lipophilic matrix tablets contained glycerol dibehenate (Compritol® 888 ATO). The dual matrix tablets contained both types of retarding materials in concentration of 10 %. Sodium stearyl fumarate was used as the lubricant in concentration of 1 %. The compressibility was evaluated by means of the energy profile of the compression process and determination of tensile strength of the tablets. The total energy of compression increased with the increase of compression force, the tableting material with 20 % of MethocelTM K15M showed the highest values. Plasticity decreased with compression force, the tableting material with 20 % of Carbopol® G and the tableting material with MethocelTM K15M showed the highest values. The tensile strength of tablets increased with compression force, the strongest tablets were the ones containing 20 % of Compritol® 888 ATO, with the exception of compression force of 8 kN. In this case the strongest tables...
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A study of directly compressible tableting materials and matrix tablets with polyvinyl alcohol.
Vildová, Lucie ; Mužíková, Jitka (advisor) ; Ondrejček, Pavel (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department: Pharmaceutical Technology Student: Lucie Vildová Consultant: PharmDr. Jitka Mužíková, Ph.D. Title of the Diploma Thesis A study of directly compressible tableting materials and matrix tablets with polyvinyl alcohol This work evaluates and compares the properties of directly compressible tableting materials and matrix tablets containing the combination of α-lactose monohydrate and microcrystalline cellulose in the ratio of 3:1 in a physical mixture and in a coprocessed dry binder. Polyvinyl alcohol is used as the retarding agent at the concentrations of 30, 40 and 50 %. Tested parameters are compressibility, tensile strength of tablets and the rate of drug release from tablets. Compressibility is evaluated by means of the energy profile of the compression process. Dissolution testing is performed using rotating basket method. The values of total energy of compression, plasticity and tensile strength of the tablets were higher in the tableting materials with the coprocessed dry binder. Increasing additions of polyvinyl alcohol decreased the values of total energy of compression, plasticity, tensile strength of tablets and drug release rate. The dissolution behavior of tablets, which contained physical mixture or coprocessed dry...
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The influence of the tableting speed on the parameters of the stress relaxation test
Borkovcová, Renáta ; Svačinová, Petra (advisor) ; Ondrejček, Pavel (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical technology Consultant: PharmDr. Petra Svačinová, Ph.D. Student: Renáta Borkovcová Title of Thesis: The influence of the tableting speed on the parameters of the stress relaxation test This diploma thesis evaluates the influence of tableting speed on the viscoelasticity parameters of stress relaxation test and tensile strength of tablets. Microcrystalline cellulose Avicel® PH-200, lactose monohydrate SpheroLac® 100, calcium hydrogen phosphate dihydrate Di-Cafos® D 160 and potato starch were used as model excipients and magnesium stearate was used as lubricant. The theoretical part is devoted to informations about tablets as a dosage form and description of excipients, which where used in experimental part. Subsequently, plasticity and elasticity of material were characterized and methods of their evaluation were described. The stress relaxation test and its evaluation using the three exponential equation were characterized in more detail. The following chapters describe the influence of tableting speed and lubricants on tensile strength of tablets. The experimental part deals with viscoelastic properties of individual materials and their mixtures with lubricant at concentration of 1 %. This properties were...
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A study of directly compressible tableting materials and tablets with the retarding component containing polyvinyl acetate and povidone.
Fousová, Dominika ; Mužíková, Jitka (advisor) ; Ondrejček, Pavel (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department Pharmaceutical Technology Student Dominika Fousová Consultant PharmDr. Jitka Mužíková, Ph.D. Title of the Diploma Thesis A study of directly compressible tableting materials and tablets with the retarding component containing polyvinyl acetate and povidone. Compressibility of directly compressible tableting materials used for manufacturing of prolonged release matrix tablets is being investigated in this thesis. Prosolv® SMCC 90 and MicroceLac® 100 were used as coprocessed dry binders. Kollidon® SR in concentration 20 % and 30 % as well as mixture of 10 % Kollidon® SR with Compritol® 888 ATO at the concentration of 10 % werechosen as retarding agents. Compressibility of each tableting blend was described using compression energy profile and tensile strenght of tablets. Rotating basket method was chosen for disolution testing. Values of all energies of the compression proces and plasticity were higher in the case of tableting materials with coprocessed dry binder Prosolv® SMCC 90. These tablets also showed higher tensile strenght. Tablets with 30 % of Kollidon® SR showed thehighest tensile strength and tablets with the combination of retarding agents Kollidon® SR and Compritol® 888 ATO showed the lowest tensile strength in the case...
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The influence of the tableting speed on the compaction process
Marcinek, Tomáš ; Ondrejček, Pavel (advisor) ; Jirásková, Johana (referee)
Charles University in Prague, Faculty of Pharmacy in Hradci Králové Department of Pharmaceutical Technology Consultant: Mgr. Pavel Ondrejček, Ph.D. Student: Tomáš Marcinek Title of Thesis: The influence of the tableting speed on the compaction process The main aim of this thesis was to determine the influence of tableting speed on the compaction process of four substances. The compaction process was evaluated by three- exponential equation. The parameters of this equation describe the individual phases of compression, the precompression phase, the phase of elastic deformation and the phase of plastic deformation. Furthermore, the effect of tableting speed on the compressibility of the material was studied using the force-displacement record. Finally, the influence of tableting speed on tensile strength of the prepared tablets was evaluated. Four materials were used for the evaluation. Microcrystalline cellulose Avicel PH-102 and dicalcium phosphate dihydrate DI-CAFOS were used as model fillers. Theophylline and paracetamol were used as model drugs. The course of the compaction process was evaluated at five compaction speeds. The results of this evaluation revealed different behavior of used materials. Furthermore different influence on the compaction process by changing compaction speed was...
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The study of directly compressible tableting materials with agglomerated α - lactose monohydrate and lubricants
Vyhlídalová, Barbora ; Mužíková, Jitka (advisor) ; Ondrejček, Pavel (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department Pharmaceutical Technology Candidate Mgr. Barbora Vyhlídalová Consultant PharmDr. Jitka Mužíková, Ph.D. Title of the Thesis The study of directly compressible tableting materials with agglomerated α - lactose monohydrate and lubricants This work deals with the study of tabletting materials, which contain agglomerated α- lactose monohydrate (Tablettosa® 80) and four types of lubricants at concentration of 1%. The used lubricants were magnesium stearate, calcium stearate, sodium-stearyl-fumarate and glyceryl behenate. Flow properties of the mixtures, energy profile of the compression process, ejection force, tensile strength and disintegration time of tablets were evaluated. The compression parameters and the properties of tablets were evaluated depending on the compressiion force. The flow properties were most improved by magnesium stearate. Glyceryl behenate didn't affect them. Total energy of the compression process increased with increasing compression force. The mixture with calcium stearate had the lowest value of total energy and the mixture with sodium-stearyl-fumarate had the highest value. Plasticity decreased with increasing compression force. Values of the ejection force showed that glyceryl behenate can't be used at...
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