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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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Formulation of Propranolol Pediatric Oral Preparations.
Klovrzová, Sylva ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Pharmaceutical Technology Candidate Mgr. Sylva Klovrzová Consultant doc. PharmDr. Zdeňka Šklubalová, Ph.D. Title of Thesis Formulation of propranolol pediatric oral preparations. The theoretical part of this thesis is focused on the specific needs of the pediatric population in relationship to the administration of a medicine, the dosage form and excipients, the use of which should follow guidances of the European Medicines Agency (EMA). Liquid dosage forms, especially oral solutions and suspensions, are described in more detail. Additionally, the requirements on the physical, chemical and microbiological stability are reviewed. In the experimental section we studied the previously published liquid formulations with propranolol hydrochloride obtained from commercial tablets. Their physical stability and pH were observed during a 1-3 month period. No tested formulation complied completely with all the requirements of trials, including optimal composition, stability and palatability of preparations. Three new formulations of suspensions and nine new formulations of solutions of propranolol in a concentration range of 2-8 mg/ml were therefore proposed. The formulations were stabilized with buffering agents and either...
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Study of influence of the solution volume on weight of eye drops
Luknárová, Radka ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Study of influence of the solution volume on weight of eye drops Radka Luknárová Summary The work was focused on the influence of three selected factores on weight of eye drops: type of liquid, dispensing angle and volume of liquid. The comercially available dropping system used for the purpose of this investigation was formed by white plastic vial and white plastic dropper tip. The weight of drop of water and comercially product ATROPIN POS® (containins 0,5% atropine sulphate) was measured under two dispensing angles (90ř and 45ř). According to gained results, the weight of drop was significantly lower in the case of Atropine sulphate solution (p < 0,01) then in the case of water. This can be explained by lower surface tension caused by the presence of antimicrobial preservative and surfactant Benzalkonium chloride. The average weight of Atropine sulphate solution was cca 33 mg when dropped under dispensing angle 90ř.When the dispensing angles was lowered to 45ř, the weight of solution was only 29 mg, which is significantly lower value (p < 0,01). On the other hand, no significant differences of weight of drop were found for different filling volumes ranging between 2 - 10 ml. The chosen dispensing system allowed for only little variability of weight of drop under standard conditions ( 90ř, dropping speed...
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A study of the compaction process and the properties of tablets containing microcrystalline cellulose and colloidal silicon dioxide
Louženská, Markéta ; Mužíková, Jitka (advisor) ; Svačinová, Petra (referee)
The thesis deals with the comparison of compressibility and properties of tablets containing silicified microcrystalline cellulose and physical mixtures of microcrystalline cellulose with different types of colloidal silicon dioxide. The used excipients were silicified microcrystalline cellulose Prosolv® SMCC 90, microcrystalline cellulose Avicel® PH-102 and colloidal silicon dioxide Aerosil® 200 and 255. Tablets were compressed at three compression forces 2.5, 3 and 3.5 kN. The energy profile of compression, the tensile strength of tablets and the disintegration time of tablets were evaluated. The effect of 1 % magnesium stearate on these parameters under various mixing conditions and its homogenity in the tablet were evaluated. Total energy of compression increased with the growing compression force, it was the highest at Prosolv® SMCC 90. Plasticity decreased with compression force, mixtures of Avicel® PH-102 with both types of Aerosil showed its the highest values. These mixtures provided tablets with lower strength than Avicel® PH-102 and Prosolv® SMCC 90. Disintegration time of tablets increased with the growing compression force and it was longer in the case of tablets from Prosolv® SMCC 90 and Avicel® PH-102. The addition of magnesium stearate decreased tensile strength of tablets most in...
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Osmolality of parenteral preparations. Parenteral mixtures 3.
Štorková, Alena ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Charles University in Prague, Faculty of Pharmacy in Hradci Králové Department of: Department of Pharmaceutical Technology Consultant: Doc. PharmDr. Zdeňka Šklubalová, Ph.D. Student: Alena Štorková Title of Thesis: Osmolality of parenteral preparations. Parenteral mixtures 3. In this work the density and osmolality of aqueous solutions of potassium chloride in the concentration range 0,01 - 0,2 mol/kg and/or mol/l, respectively, and the mixtures of isotonic solutions of potassium chloride and sodium lactate and their partial solutions were measured. The average density of solutions at 20 řC was used for the conversion of molarity to molality and vice versa, as well as for the estimation of osmolarity, the partial specific volume Vg (ml/g) and the molal volume Vmol (ml/mol) of the dissolved solute. The detected Vg and Vmol of potassium chloride and sodium lactate were compared with results obtained at isotonic mixtures of both solutes. The values of the experimentally determined osmolality, the partial specific and the molal volumes were influenced by the mixture composition. The osmolality of the molal solutions was used for the estimation of the molal osmotic coefficient, which decreases with the increase in the concentration. According to USP, the method using the experimentally determined...
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Osmolality of parenteral preparations. Sodium chloride.
Kmoníčková, Lucie ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Charles University in Prague, Faculty of Pharmacy in Hradci Králové Department of Pharmaceutical Technology Consultant: Doc. PharmDr. Zdeňka Šklubalová, PhD. Student: Lucie Kmoníčková Title of Thesis: Osmolality of parenteral preparations. Sodium chloride. The objective of this diploma theses was to study the relationship between the concentration of aqueous solutions of sodium chloride and the solution density and osmolality. Solutions of sodium chloride were prepared in molality and/or molarity in range of 0.01 to 0.2 mol/kg and/or mol/l, respectively. The solution densities were measured using a densimeter in temperature range of between 15 and 40řC. The dependence of the solution density on temperature was described by the quadratic regresions with the coefficient of determination ranging from 0.9998 to 1.0000. At constant temperature, the direct proportion between density and the solution concentration was observed. The average density of solutions at 20 řC was used for mutual conversion between molality and molarity. Osmolality of the molal and/or molar solutions of sodium chloride was directly proportional to the concentration. Using the methods listed in USP, osmolarity of the sodium chloride molar solutions was expressed. No differences in the accuracy of the investigated methods of...
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Study of Factors Influencing Dose of Commercial Eye Drops
Solanská, Kateřina ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Pharmaceutical technology Candidate Mgr.Solanská Kateřina Consultant Doc. PharmDr. Zdeňka Šklubalová, Ph.D. Title of Thesis Study of factors influencing dose of commercial eye drops Five commercially produced ophthalmic preparations which differed in a dispensing system and a shape of the dropper tip were used in the thesis. The influence of the surface tension, viscosity, osmolality, density, and dispensing angle on the weight of the drops produced by original dispensing system, consisting of dropper tip and dropper bottle, was examined.To evaluate the influence properties of solutions, an uniform dropper tip and uniform dropper bottle were used. The weight of the eye drops were compared with the drop weight of water and the model solutions 0.01% and 0.02% benzalkonium chloride. Direct correlation proportion was found out between the surface tension and the weight of the drops. When the dispensing angle decreased from 90ř to 45řthe weight of the drops significantly decreased too. When the dropper tip was wetted the effective circuit of the dropper tip produced larger drops increasing variability of drop weigth together with the amout of applied drugs. Out of dropper systems tested, we can conclude that the lowest...
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A study of the compaction process and the properties of tablets made of spray dried lactoses
Šináglová, Pavla ; Mužíková, Jitka (advisor) ; Šklubalová, Zdeňka (referee)
The aim of this work was to compare two spray-dried lactoses Flowlac® 100 and SuperTab® 14SD from the standpoint of tensile strength and disintegration time of tablets, the effect of an addition of the lubricant magnesium stearate and silicified microcrystalline celulose (Prosolv® SMCC 90) on these properties, and also from standpoint of the energy profile of compression. The compression forces were 15, 16, 17 kN, in the case of mixtures with Prosolv® SMCC 90. The concentration of magnesium stearate was 0.5% and 1% and the concentration of Prosolv® SMCC 90 was 25%. The tablets were prepared using the material testing equipment T1-FRO50 TH.S1K Zwick/Roell. The tablets from SuperTab® 14SD were stronger than the tablets from FlowLac® 100 at the same compression forces. Influence of magnesium stearate depended on the compression force in the case of SuperTab® 14SD. The presence of magnesium stearate did not decrease the strength of tablets from Flowlac® 100. The addition of Prosolv® SMCC 90 increased the strength of tablets and made it equal for both lactoses. Disintegration time of tablets from both lactoses did not depend on the compression forces. An increased concentration of magnesium stearate prolonged the disintegration time of the tablets, in the case of FlowLac® 100 very significantly. The...
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A study of the properties of compacts from various types of directly compressible xylitol.
Komínková, Hana ; Mužíková, Jitka (advisor) ; Šnejdrová, Eva (referee)
The thesis deals with the study of properties of tablets from two types of directly compressible xylitol, namely Xylitab® 100 and Xylitab® 200. The focus of the study was the dependence of the tensile strength and disintegration time of the tablets on the compression force, the addition of lubricants, namely magnesium stearate and sodium stearyl fumarate (Pruv), with a concentration of 1%, and a 50% addition of model active ingredients, namely acetylsalicylic acid and ascorbic acid. The compression forces used were 6, 8, and 10 kN; tablets containing the drugs were only compressed with a force of 10 kN. The tensile strength of tablets from both dry binders increased with increasing compression force; the presence of the lubricants resulted in a slight decrease in the strength. The tensile strength of tablets from Xylitab® 100 was higher and more affected by the lubricants than that of tablets from Xylitab® 200. The disintegration time of tablets was longer in the case of tablets with Xylitab® 200; it increased with increasing compression 9. Souhrn 82 force, with the exception of Xylitab® 200 with magnesium stearate, and was prolonged by the lubricants, more by magnesium stearate. Tablets containing either of the drugs showed a higher tensile strength and a shorter disintegration time when Xylitab®...
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A study of the properties of tablets from coprocessed dry binder composed of mannitol and sorbitol.
Henychová, Petra ; Mužíková, Jitka (advisor) ; Šklubalová, Zdeňka (referee)
The thesis deals with the study of properties of tablet from directly compressible co-processed dry binder Compressol™S and from the mixtures of Mannogem™2080 and Sorbitab™SD 250 in the ratios 1:3, 1:1 and 3:1. The focus of the study was the dependence of the tensile strength and disintegration time of the tablets on the compression force, the addition of lubricants, namely magnesium stearate and sodium stearyl fumarate with concentration of 1% and addition of model active ingredients, namely acetylsalicylic acid and ascorbic acid in ratio 1:1 to dry binder. The tablets containing Compressol™S that were compressed with a force of 8 kN contained 0,5% of lubricants too. The used compression forces were 6, 8 and 10 kN, tablets containing drugs were only compressed with a force of 10 kN and only sodium stearyl fumarate as lubricant was used. The strength of tablets of Compressol™S increased with increasing compression force, it didn't decrease with increasing concentration of lubricants and more significant difference wasn't noted in the terms of lubricant used. The longer disintegration time was found for magnesium stearate. The tablets from the mixture of Mannogem™2080 and Sorbitab™SD 250 in the ratio of 1:3 were found as the hardest compared with other mixtures and the disintegration time was the...
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