Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability
Today, probiotics are predominantly used in liquid or semi-solid functionalized foods, showing a rapid loss of cell viability. Due to the increasing spread of antibiotic resistance, probiotics are promising in pharmaceutical development because of their antimicrobial effects. This increases the form...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-01-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/12/1/66 |
| _version_ | 1811300366686355456 |
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| author | Karl Vorländer Ingo Kampen Jan Henrik Finke Arno Kwade |
| author_facet | Karl Vorländer Ingo Kampen Jan Henrik Finke Arno Kwade |
| author_sort | Karl Vorländer |
| collection | DOAJ |
| description | Today, probiotics are predominantly used in liquid or semi-solid functionalized foods, showing a rapid loss of cell viability. Due to the increasing spread of antibiotic resistance, probiotics are promising in pharmaceutical development because of their antimicrobial effects. This increases the formulation requirements, e.g., the need for an enhanced shelf life that is achieved by drying, mainly by lyophilization. For oral administration, the process chain for production of tablets containing microorganisms is of high interest and, thus, was investigated in this study. Lyophilization as an initial process step showed low cell survival of only 12.8%. However, the addition of cryoprotectants enabled survival rates up to 42.9%. Subsequently, the dried cells were gently milled. This powder was tableted directly or after mixing with excipients microcrystalline cellulose, dicalcium phosphate or lactose. Survival rates during tableting varied between 1.4% and 24.1%, depending on the formulation and the applied compaction stress. More detailed analysis of the tablet properties showed advantages of excipients in respect of cell survival and tablet mechanical strength. Maximum overall survival rate along the complete manufacturing process was >5%, enabling doses of <inline-formula> <math display="inline"> <semantics> <mrow> <msup> <mrow> <mrow> <mn>6</mn> <mtext> </mtext> <mo>×</mo> <mtext> </mtext> <mn>10</mn> </mrow> </mrow> <mn>8</mn> </msup> </mrow> </semantics> </math> </inline-formula> colony forming units per gram (<inline-formula> <math display="inline"> <semantics> <mrow> <msubsup> <mrow> <mrow> <mi>CFU</mi> <mtext> </mtext> <mi mathvariant="normal">g</mi> </mrow> </mrow> <mrow> <mi>total</mi> </mrow> <mrow> <mo>−</mo> <mn>1</mn> </mrow> </msubsup> </mrow> </semantics> </math> </inline-formula>), including cryoprotectants and excipients. |
| first_indexed | 2024-04-13T06:50:04Z |
| format | Article |
| id | doaj.art-317c43c0ab19423394e31e683666c707 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-04-13T06:50:04Z |
| publishDate | 2020-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-317c43c0ab19423394e31e683666c7072022-12-22T02:57:26ZengMDPI AGPharmaceutics1999-49232020-01-011216610.3390/pharmaceutics12010066pharmaceutics12010066Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial ViabilityKarl Vorländer0Ingo Kampen1Jan Henrik Finke2Arno Kwade3Institute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, GermanyInstitute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, GermanyInstitute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, GermanyInstitute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, GermanyToday, probiotics are predominantly used in liquid or semi-solid functionalized foods, showing a rapid loss of cell viability. Due to the increasing spread of antibiotic resistance, probiotics are promising in pharmaceutical development because of their antimicrobial effects. This increases the formulation requirements, e.g., the need for an enhanced shelf life that is achieved by drying, mainly by lyophilization. For oral administration, the process chain for production of tablets containing microorganisms is of high interest and, thus, was investigated in this study. Lyophilization as an initial process step showed low cell survival of only 12.8%. However, the addition of cryoprotectants enabled survival rates up to 42.9%. Subsequently, the dried cells were gently milled. This powder was tableted directly or after mixing with excipients microcrystalline cellulose, dicalcium phosphate or lactose. Survival rates during tableting varied between 1.4% and 24.1%, depending on the formulation and the applied compaction stress. More detailed analysis of the tablet properties showed advantages of excipients in respect of cell survival and tablet mechanical strength. Maximum overall survival rate along the complete manufacturing process was >5%, enabling doses of <inline-formula> <math display="inline"> <semantics> <mrow> <msup> <mrow> <mrow> <mn>6</mn> <mtext> </mtext> <mo>×</mo> <mtext> </mtext> <mn>10</mn> </mrow> </mrow> <mn>8</mn> </msup> </mrow> </semantics> </math> </inline-formula> colony forming units per gram (<inline-formula> <math display="inline"> <semantics> <mrow> <msubsup> <mrow> <mrow> <mi>CFU</mi> <mtext> </mtext> <mi mathvariant="normal">g</mi> </mrow> </mrow> <mrow> <mi>total</mi> </mrow> <mrow> <mo>−</mo> <mn>1</mn> </mrow> </msubsup> </mrow> </semantics> </math> </inline-formula>), including cryoprotectants and excipients.https://www.mdpi.com/1999-4923/12/1/66compactionformulationfreeze-dryingprobiotics<i>saccharomyces cerevisiae</i> |
| spellingShingle | Karl Vorländer Ingo Kampen Jan Henrik Finke Arno Kwade Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability Pharmaceutics compaction formulation freeze-drying probiotics <i>saccharomyces cerevisiae</i> |
| title | Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability |
| title_full | Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability |
| title_fullStr | Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability |
| title_full_unstemmed | Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability |
| title_short | Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability |
| title_sort | along the process chain to probiotic tablets evaluation of mechanical impacts on microbial viability |
| topic | compaction formulation freeze-drying probiotics <i>saccharomyces cerevisiae</i> |
| url | https://www.mdpi.com/1999-4923/12/1/66 |
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