RHEOLOGICAL PROPERTIES OF POWDER MIXTURES AS A FACTOR OF HARD GELATIN CAPSULE FILLING PERFORMANCE

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22310%2F21%3A43922606" target="_blank" >RIV/60461373:22310/21:43922606 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.icct.cz/cs/Amca-ICCT/media/content/2021/proceedings/ICCT2021-Proceedings.pdf" target="_blank" >https://www.icct.cz/cs/Amca-ICCT/media/content/2021/proceedings/ICCT2021-Proceedings.pdf</a>

DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

RHEOLOGICAL PROPERTIES OF POWDER MIXTURES AS A FACTOR OF HARD GELATIN CAPSULE FILLING PERFORMANCE

Popis výsledku v původním jazyce

Hard gelatin capsules are commonly used dosage form. For larger-scale productions, there are several types of automated capsule filling equipment. The two most used types of filling machines operate using dosing disc and dosator concepts. Each type works in different operation regime and under different conditions. Therefore, the requirements on the powder flow properties can be quite complex and need to be studied and adapted to the specific filling technique for failsafe operations. Given the knowledge of complexity of flow property requirement, the objective of this study is to deliver a case study dealing with investigation and optimization of real powder mixture for capsule filling in different types of machines. The mixture composes of active pharmaceutical ingredient (API), corn starch and liquid dimethicone. It is prepared in several steps including creation of premix (dimethicone and a defined amount of starch), active mixture (API and defined amount of starch) and their mixing with remaining starch to obtain final mixture. In addition to the original mixture, several modified mixtures were evaluated differing in the mixing time of final mixture and the amount of starch in premix. Rheological properties were characterized using powder rheometer FT4 data and Carr’s compressibility index (CI). Main attention was paid to influence of premix preparation and final mixture mixing time. Obtained values of CI occurred in range 30-48 %. Lower values corresponded to mixtures with shorter mixing time and higher amount of starch in premix indicating their better flow properties. Based on the fundamental literature suggesting optimal value of CI in range 18-30 % (dosing disc) and in range 25-35 % (dosator), the best flowing mixtures were supposed to be successfully processable using dosator. In case of dosing disc, no mixture met the criteria required. Further optimization or re-formulation is necessary to process the formulation in this type of filling machines.

Název v anglickém jazyce

RHEOLOGICAL PROPERTIES OF POWDER MIXTURES AS A FACTOR OF HARD GELATIN CAPSULE FILLING PERFORMANCE

Popis výsledku anglicky

Hard gelatin capsules are commonly used dosage form. For larger-scale productions, there are several types of automated capsule filling equipment. The two most used types of filling machines operate using dosing disc and dosator concepts. Each type works in different operation regime and under different conditions. Therefore, the requirements on the powder flow properties can be quite complex and need to be studied and adapted to the specific filling technique for failsafe operations. Given the knowledge of complexity of flow property requirement, the objective of this study is to deliver a case study dealing with investigation and optimization of real powder mixture for capsule filling in different types of machines. The mixture composes of active pharmaceutical ingredient (API), corn starch and liquid dimethicone. It is prepared in several steps including creation of premix (dimethicone and a defined amount of starch), active mixture (API and defined amount of starch) and their mixing with remaining starch to obtain final mixture. In addition to the original mixture, several modified mixtures were evaluated differing in the mixing time of final mixture and the amount of starch in premix. Rheological properties were characterized using powder rheometer FT4 data and Carr’s compressibility index (CI). Main attention was paid to influence of premix preparation and final mixture mixing time. Obtained values of CI occurred in range 30-48 %. Lower values corresponded to mixtures with shorter mixing time and higher amount of starch in premix indicating their better flow properties. Based on the fundamental literature suggesting optimal value of CI in range 18-30 % (dosing disc) and in range 25-35 % (dosator), the best flowing mixtures were supposed to be successfully processable using dosator. In case of dosing disc, no mixture met the criteria required. Further optimization or re-formulation is necessary to process the formulation in this type of filling machines.

Druh

D - Stať ve sborníku

CEP obor

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OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

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Návaznosti

S - Specificky vyzkum na vysokych skolach

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název statě ve sborníku

Proceedings of the 8th International Conference on Chemical Technology

ISBN

978-80-88307-08-2

ISSN

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e-ISSN

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Počet stran výsledku

6

Strana od-do

193-198

Název nakladatele

Czech Society of Industrial Chemistry

Místo vydání

Prague

Místo konání akce

Praha

Datum konání akce

3. 5. 2021

Typ akce podle státní příslušnosti

WRD - Celosvětová akce

Kód UT WoS článku

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