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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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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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Formulation of extemporaneous paediatric liquid preparations in the hospital pharmacy
Klovrzová, Sylva ; Šklubalová, Zdeňka (advisor) ; Dittrich, Milan (referee) ; Masteiková, Ruta (referee)
Charles University in Prague, Faculty of Pharmacy in Hradci Králové Department of: Pharmaceutical Technology Candidate PharmDr. Sylva Klovrzová Supervisor doc. PharmDr. Zdeňka Šklubalová, Ph.D. Title of Doctoral Thesis: Formulation of extemporaneous paediatric liquid preparations in the hospital pharmacy In the paediatric population, oral solutions and/or suspensions represent a suitable alternative to preparation of hard capsules in the pharmacy. This thesis aims at formulation of stable liquid oral preparations with cardiologic drugs, propranol- hydrochloride, sotalol-hydrochloride and furosemide, for the children aged from newborn to approximately 6 year. At the formulation of the preparation compositions, the simple routine preparation in a pharmacy was the main target as well as the use of excipients safe for paediatric population in the minimal necessary amount. Using a high performance liquid chromatography, chemical stability of the active ingredient and, simultaneously, the preservative was determined in all formulated preparations stored at two different temperatures at time points over minimum 180 days. In order to achieve this, the specific analytical methods were developed and validated at the department of Analytical chemistry, Faculty of Pharmacy in Hradec Králové. However, the...
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