Mikrokristāliskās celulozes daudzuma izmaiņu ietekme uz pelešu īpašībām.
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Date
2021
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Rīgas Stradiņa universitāte
Rīga Stradiņš University
Rīga Stradiņš University
Abstract
Farmaceitiskās peletes ir aglomerāti, kas izgatavoti no smalkām pulverveida daļiņām, ko raksturo gandrīz sfēriska vai cilindriska forma, vidējais diametrs 0,2 – 2,0 mm un šaurs pelešu izmēra sadalījums. Pelešu virsma ir gluda un ar zemu porainību. Visjaunākā pelešu ražošanas metode ir tiešā peletizācija. Mikrokristāliskā celuloze kopā ar laktozi ir visplašāk lietotā izejvielu/palīgvielu kombinācija pelešu ražošanā. Mikrokristāliskās celulozes procentuālais saturs peletēs nosaka to, cik aktīvās vielas varēs iestrādāt peletē.
Pētījuma mērķis ir noskaidrot kā mainās pelešu kvalitātes rādītāji, mainot mikrokristāliskās celulozes procentuālo saturu peletēs. Pētijumā ir aprakstīta literatūra par peletēm, pelešu gatavošanai izmantojamām palīgvielām, pelešu ražošanas metodēm un pelešu kvalitātes rādītājiem. Pētījuma praktiskajā daļā tika saražotas 7 placebo pelešu sērijas, kur kā izejvielas tika izmantotas MCC un laktoze. Katra sērija ir ar atšķirīgu MCC un laktoze procentuālo sastāvu. MCC un laktoze ir attiecībā no 80% līdz 20%. Ražošanas procesā katrai sērijai tika noteikts mitrums. Saražotajām sērijām tika noteikts tilpuma blīvums, pelešu izmērs, birstamība un mitrums pēc žāvēšanas.
Kvalitātes rādītājiem atbilstošas peletes izdevās saražot izmantojo MCC no 30% - 80%. Balstoties uz pelešu izmēra sadalījuma rezultātiem visoptimālākais MCC procentuālais sastāvs peletēm ir 40%, jo tad ir visviendabīgākais pelešu izmēra sadalījums. Peletēm ar lielāku MCC procentuālo saturu ir īsāks birstamības laiks, jo peletes ir viendabīgākas un sfēriskākas.
Pharmaceutical pellets are agglomerates made of fine powdered particles, characterised by a nearly spherical or cylindrical shape, a mean diameter of 0,2 – 2,0 mm and a narrow size distribution. Pellets surface is smooth and with low porosity. The most recent method of producing pellets is direct pelletization. The most widely used combination in the production of pellets is microcrystalline cellulose together with lactose. The percentage of microcrystalline cellulose in pellets determines how many active substances can be incorporated into the pellet. The aim of this study is to investigate how pellets characteristics change by changing the percentage of microcrystalline cellulose in pellets. At the theoretical part of study literature about pellets, excipients for pelletization process, pelletization methodes and pellets characteristics is being viewed. In the practical part of the study produced 7 series of placebo pellets with microcrystalline cellulose and lactose as raw material were used. Each series is composed of a different percentage of microcrystalline cellulose and lactose. Microcrystalline cellulose and lactose are between 20% and 80%. Humidity was determined for each series in the production process. The volume density, size distribution, flowability and humidity after drying were determined for the produced series. To produce spherical agglomerates with suitable characteristics, pellets needs to contain 30% - 80% microcrystalline cellulose. Based on the result, the most optimal percentage of microcrystalline cellulose for pellets is 40% because then there is the most homogenous size distribution. Pellets with higher percentage of microcrystalline cellulose have a shorter flowability time because pellets are more uniform and spherical.
Pharmaceutical pellets are agglomerates made of fine powdered particles, characterised by a nearly spherical or cylindrical shape, a mean diameter of 0,2 – 2,0 mm and a narrow size distribution. Pellets surface is smooth and with low porosity. The most recent method of producing pellets is direct pelletization. The most widely used combination in the production of pellets is microcrystalline cellulose together with lactose. The percentage of microcrystalline cellulose in pellets determines how many active substances can be incorporated into the pellet. The aim of this study is to investigate how pellets characteristics change by changing the percentage of microcrystalline cellulose in pellets. At the theoretical part of study literature about pellets, excipients for pelletization process, pelletization methodes and pellets characteristics is being viewed. In the practical part of the study produced 7 series of placebo pellets with microcrystalline cellulose and lactose as raw material were used. Each series is composed of a different percentage of microcrystalline cellulose and lactose. Microcrystalline cellulose and lactose are between 20% and 80%. Humidity was determined for each series in the production process. The volume density, size distribution, flowability and humidity after drying were determined for the produced series. To produce spherical agglomerates with suitable characteristics, pellets needs to contain 30% - 80% microcrystalline cellulose. Based on the result, the most optimal percentage of microcrystalline cellulose for pellets is 40% because then there is the most homogenous size distribution. Pellets with higher percentage of microcrystalline cellulose have a shorter flowability time because pellets are more uniform and spherical.
Description
Rūpnieciskā farmācija
Industrial pharmacy
Veselības aprūpe
Health Care
Industrial pharmacy
Veselības aprūpe
Health Care
Keywords
Peletes, tiešā peletizācija, mikrokristāliskā celuloze, kvalitātes rādītāji, Pellets, direct pelletization, microcrystalline cellulose, characteristics