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Influence of fillers and disintegrants type on properties of tablets with high dose drug.
Tranová, Thao ; Mužíková, Jitka (advisor) ; Svačinová, Petra (referee)
Charles University, Faculty of Pharmacy in Hradci Králové Department of: Pharmaceutical technology Consultant: doc. PharmDr. Jitka Mužíková, Ph.D. Student: Thao Tranová Title of Thesis: Influence of fillers' and disintegrants' type on properties of tablets with high dose drug The work engages in the study of fillers' and extragranular superdisintegrants' influence on properties of tablets with high dose drug. Two types of granulate with lactose or microcrystalline cellulose were produced in high shear granulator. Eleven tablets groups with different type and amount of superdisintegrants were prepared from the granulates. Tablets contained 2 %, 3.7 %, 5.4 % of sodium croscarmellose or 2 % and 5.4 % of crospovidone. The tested parameters of tablets were friability, hardness, disintegration time and density. Accelerated stability studies lasting 6 months at temperature of 40 řC and relative humidity 75 % were done. The tablets were evaluated after 1.5, 3 and 6 months. All tablets had adequate friability, hardness, disintegration and density at T0. Increasing concentration of superdisintegrant decreased disintegration time. Tablets containing microcrystalline cellulose and sodium croscarmellose disintegrated faster than tablets containing lactose or crospovidone. Tablets with sodium croscarmellose had...
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Eye drops with timolol
Luknár, Petr ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Eyes drops are the most commonly used form of topical ocular drugs application. Eyes drops with timolol have been used for treatment of increased intraocullar tension, chronic open- angle glaucoma for a long time. The work was focused on the weight of the eyes drops, contains 0,5% timolol, produced by five different dropper tips, the influence of the effective orifice diameter of the dropper, psysico-chemical properties of the solution and the dispending angle. The weight of drops dispended under vertical dropping (90ř) was directly proporcional to the effective orifice diameter of the dropper tip and the surface tension. The density, viskosity and osmolarity of the solution had no influence on the drops weight. Changing the dispensing angle from 90ř to 45ř,significantly decreased the drop weight in a first case, dropper K1. Droppers K2 - K4 after tilting increased the drops weight , which was caused by the laterál formation of drops. Dropper tip K5 was dispending equal drops weight for both of the dispending angels. This dropper tip K5 contains the dispending system COMOD, which uses special dosing pump. Experimantaly investigated drops weight for vertical dropping were compared to producer's statements (datas). The most significant differences were noticed in experiments with dispending systems K1...
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Evaluation and optimisation of a granulation process on a laboratory scale fluid bed granulator.
Stoniš, Jan ; Mužíková, Jitka (advisor) ; Řehula, Milan (referee)
The fluid bed granulation is a well-established method how to improve such properties of powders as flowability and increase content uniformity of the tablets. In this thesis, there was evaluated a granulation process on a lab scale fluid Glatt bed granulator and optimized for highest possible yield. Product yield in the size range of 80-90 % of granules and process reproducibility were stated as most effective. The product was analysed for its particle size distribution, the API distribution within the different particle size fractions and the flowability of the final granules. For process optimization, the most critical parameters such as spraying rate, particle size of raw materials and fluid bed pressure were identified and evaluated. As the highest-yielding dosage for the powder binder was found the spraying rate of 9 g/min. Changes in bed fluid pressure and nozzle pressure showed no significant improvement. Different grades of caffeine were compared for their impact on the granulation properties. Sieved caffeine enhanced yield of the product and reproducibility compared to bulk or disagglomerated caffeine.
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Optimization of the composition of the directly compressible tableting material with beta-glucan.
Srbová, Alena ; Mužíková, Jitka (advisor) ; Šklubalová, Zdeňka (referee)
Diploma thesis deals with optimization of directly compressible tableting material, containing the biggest possible amount of beta-glucan and 30 mg of ascorbic acid. Five directly compressible dry binders were tested: sorbitol, microcrystalline cellulose, dibasic calcium phosphate, mixture of sorbitol and microcrystalline cellulose in the ratio 3:1 and mixture of dibasic calcium phosphate and microcrystalline cellulose in the ratio 3:1. Tested beta-glucan content was 30, 40 and 50 %. Powder flowability, bulk and tapped density of directly compressible tableting materials were tested. The evaluated parameters were tensile strength of tablets, disintegration time and friability of the compressed tablets. Fraction of beta-glucan particles ranging from 180 to 300 µm was selected for the preparation of directly compressible tableting materials. Sorbitol (Merisorb® 200) was selected as the most optimal dry binder, magnesium stearate in concentration of 1% was used as a lubricant. Compression forces have to grow with increasing concentrations of beta-glucan, directly compressible tableting material containing 30 % of beta-glucan has optimal compression force 9 kN, tableting material containing 40 % of beta-glucan has 11 kN and tableting material containing 50 % of beta-glucan has 14 kN. Tablets made from...
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A Study of the Properties of Compacts from silicified microcrystalline celluloses.
Nováková, Petra ; Mužíková, Jitka (advisor) ; Šnejdrová, Eva (referee)
V práci je studována pevnost tablet v tahu a doba rozpadu výlisků ze silicifikovaných mikrokrystalických celulos, Prosolv SMCC 90 a Prosolv HD 90, v závislosti na lisovací síle, přídavku dvou typů mazadel a dvou léčivých látek. Mazadla byla stearan hořečnatý a stearylfumarát sodný v koncentraci 0,5%, aktivní látky kyselina askorbová a acetylsalicylová v koncentraci 50%. Prosolv SMCC 90 byl lépe lisovatelný než Prosolv HD 90; výlisky měly vyšší pevnost a ta se zvyšovala s lisovací silou. Prosolv HD 90 byl více citlivý na přídavek mazadel a větší pokles pevnosti byl zaznamenán v přítomnosti stearylfumarátu sodného. Vliv mazadel na pevnost tablet v přítomnosti léčivých látek nebyla stejná. Doba rozpadu výlisků z Prosolvu HD 90 bez i s mazadly byla kratší než z Prosolvu SMCC 90 a zvyšovala se s rostoucí lisovací silou. Doba rozpadu se prodloužila přídavkem mazadel a významně byla zkrácena přídavkem léčivých látek. Výlisky s kyselinou askorbovou měly kratší dobu rozpadu než s kyselinou acetylsalicylovou a doba rozpadu nebyla výrazně ovlivněna přítomností mazadel.
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Osmolality of parenteral preparations. Parenteral mixtures 1.
Bouallagui, Veronika ; 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: Veronika Bouallagui Title of Thesis: Osmolality of parenteral preparations. Parenteral mixtures 1. In this work, density and osmolality of isotonic solutions of sodium chloride and glucose and their mixtures was measured in the molal and / or molar concentration, respectively. Osmolality was directly proportional to the increasing concentration of substance, but this is true only for solutions themselves substances; osmolality was affected by the ratio of sodium chloride and glucose in mixtures. The density of the solutions was measured at 20řC and 25řC, the average density at 20řC was used for the conversion of molality to molarity and vice versa, to estimate the osmolarity and to estimate the partial specific volume Vg (ml/g) and molal volume Vmol (ml/mol) of the solute. Partial specific volume and molal volume of glucose not relate directly to concentration of substance while decreased for sodium chloride with decreasing concentration of substance. Resulting value Vg and Vmol for mixtures of both compounds were affected by the concentration and the ratio of the two components in the mixture. Out of the three methods...
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A study of the properties of tablets made of directly compressible isomalt.
Pavlasová, Veronika ; Mužíková, Jitka (advisor) ; Šnejdrová, Eva (referee)
A study of the properties of tablets made of directly compressible isomalt. Summary The thesis deals with the study of properties of tablets from two types of directly compressible isomalt - namely galenIQTM 720 and galenIQTM 721. The focus of the study was given to the dependence of tensile strenght and disintegration time of the tablets, both on the compression force, the addition of lubricants, namely magnesium stearate and sodium stearyl fumarate (Pruv) with concentrations 0,5% and 1%, and a 50% addition of model active intgredients, namely ascorbic acid and acetylsalicylic acid. The compression forces were used 6, 8 and 10 kN, tablets containing drugs were compressed only with a force of 10 kN. The tensile streght of tablets from both substances increased with increasing compression force, the presence of lubricants did not result any decrease in the strenght. The disintegration time of tablets was longer with substance galenIQTM 720, it was prolonged by lubricants and increased with increasing compression force for both substances. The presence of drugs decreased the tensile strenght, tablets containing acetylsalicylic acid shown higher tensile strenght. For both drugs was not significant difference in the context of the type of isomalt or lubricants. The disintegration time of tablets was shorter...
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A study of the compaction process and the properties of tablets from different types of calcium hydrogen phosphate.
Koryťáková, Lenka ; Mužíková, Jitka (advisor) ; Svačinová, Petra (referee)
The thesis evaluates anhydrous and dihydrate calcium hydrogen phosphate from the view point of the tensile strength, disintegration time of tablets depending on the compression force. Two firm products - Anhydrous Emcompress® and Di-Cafos® A 60 are used as anhydrate and Emcompress® is used as dihydrate. A compression force together with lubricants (magnesium stearate, sodium stearyl fumarate) and an addition of microcrystalline cellulose (Vivapur® 102) are the influential factors. In addition to the characteristics of tablets, the energy balance of compression is also evaluated. Used compression forces were 12, 16 and 20 kN. The compression force 12 kN was used for the mixtures containing Vivapur® 102. Total energy of compression, energy for friction and energy accumulated by tablet after compression increased with compression force. The highest values were at Anhydrous Emcompress® , an addition Vivapur® 102 increased these values. There weren't more significant differences among the values of decompression energy. Plasticity decreased with the growing compression force, the highest values were at Anhydrous Emcompress® , Vivapur® 102 increased that. Tensile strength increased with compression force, Emcompress® provided the strongest tablets, Di-Cafos® A 60 provided at least strong tablets. Vivapur...
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A study of the compaction process and the properties of tablets made of agglomerated and granulated lactose
Neprašová, Marie ; Mužíková, Jitka (advisor) ; Ondrejček, Pavel (referee)
The thesis studied tensile strength, disintegration time of tablets and energy profile of compression of agglomerated lactose Tablettose® 80 and of granulated lactose SuperTab® 30GR. Tested parameters were studied depending on compression force, addition of two concentrations of the lubricant magnesium stearate (0.5 and 1%) and 25% microcrystalline cellulose Microcel® MC-200. The tablets were compressed using the material testing machine T1 - FRO 50 TH.A1K Zwick/Roell. Used compression forces were 11, 13 and 15 kN, in the case of mixtures with Microcel® MC-200 11 kN. Tensile strength of tablets increased with compression force at both lactoses and it was higher in the case of mixtures with SuperTab® 30GR. Magnesium stearate decreased the tensile strength of tablets from Tablettose® 80 for all compression forces. Addition Microcel® MC-200 increased the tensile strength of tablets from both lactoses, more in the case of Tablettose® 80. Disintegration time of tablets increased with compression force. Higher concentrations of magnesium stearate in tablets increased disintegration time. Comparison of disintegration time of tablets from both lactoses depended on concentration of magnesium stearate. Addition of Microcel® MC-200 significantly shortened disintegration time of tablets in both lactoses. The...
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Osmolality of Parenteral Preparations. Phosphates 1.
Pavelková, Martina ; 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: Mgr. Martina Pavelková Title of Thesis: Osmolality of parenteral preparations. Phosphates 1. The aim of this work was to prepare aqueous solutions of disodium hydrogen phosphate dodecahydrate, in the concentration range from 0.01 to 0.3 mol/kg respectively mol/l and to measure their density and osmolality. Density with increasing temperature in the range from 15řC to 40řC decreased nonlinearly; the relationship was described by quadratic regression equations. At constant temperature, the density of disodium hydrogen phosphate dodecahydrate, is directly proportional to the concentration. Osmolality increases with molal and molar concentration increases, the dependence was described by quadratic regression equation with a coefficient of determination 0.8759 for molal solutions and 0.8591 for molar solutions. From the measured values of osmolality was determined molal osmotic coefficient, whose values decrease when a concentration of the solution increased. The average density value of each of the solutions at temperature of 25řC were used for the mutual conversion between molality and molarity and to estimate the...
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