Stable sugar and sugar-free suspensions of pretomanid
BACKGROUND: Pretomanid (PMD) tablets are indicated as part of a combination regimen for the treatment of adults with pulmonary extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant TB. No commercial liquid formulation is currently available for patients unable to swa...
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| Veröffentlicht in: | The international journal of tuberculosis and lung disease 2022-12, Vol.26 (12), p.1112-1117 |
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| container_title | The international journal of tuberculosis and lung disease |
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| creator | Taneja, R. Nahata, M. C. Scarim, J. Pande, P. G. Scarim, A. Hoddinott, G. Fourie, C. L. Jew, R. K. Schaaf, H. S. Garcia-Prats, A. J. Hesseling, A. C. |
| description | BACKGROUND: Pretomanid (PMD) tablets are indicated as part of a combination regimen for the treatment of adults with pulmonary extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant TB. No commercial liquid formulation is currently available for
patients unable to swallow these tablets.OBJECTIVE: To develop stable extemporaneous liquid formulations of PMD that can be stored at room temperature or 30°C for at least 4 weeks.METHODS: Crushed PMD tablets were formulated into 20 mg/mL suspensions in a simple syrup
and sugar-free formulation. The PMD formulations were stored at room temperature and at 30°C for 30 days in dispensing bottles. Appearance, pH, potency and microbial counts of the suspensions were determined on Days 0, 15 and 30.RESULTS: The potency of PMD remained at 99.7-103.4%
of the theoretical concentration in each formulation. The appearance, pH and microbial count did not change during the 30-day storage period. Simple syrup formulations did not require preservatives for microbial stability.CONCLUSIONS: PMD oral suspension formulations in simple syrup
or in sugar-free vehicle were easily prepared by utilising commonly available equipment and ingredients and were stable for 30 days. These formulations are appropriate alternatives for patients with swallowing difficulties. |
| doi_str_mv | 10.5588/ijtld.22.0330 |
| format | Article |
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patients unable to swallow these tablets.OBJECTIVE: To develop stable extemporaneous liquid formulations of PMD that can be stored at room temperature or 30°C for at least 4 weeks.METHODS: Crushed PMD tablets were formulated into 20 mg/mL suspensions in a simple syrup
and sugar-free formulation. The PMD formulations were stored at room temperature and at 30°C for 30 days in dispensing bottles. Appearance, pH, potency and microbial counts of the suspensions were determined on Days 0, 15 and 30.RESULTS: The potency of PMD remained at 99.7-103.4%
of the theoretical concentration in each formulation. The appearance, pH and microbial count did not change during the 30-day storage period. Simple syrup formulations did not require preservatives for microbial stability.CONCLUSIONS: PMD oral suspension formulations in simple syrup
or in sugar-free vehicle were easily prepared by utilising commonly available equipment and ingredients and were stable for 30 days. These formulations are appropriate alternatives for patients with swallowing difficulties.</description><identifier>ISSN: 1027-3719</identifier><identifier>EISSN: 1815-7920</identifier><identifier>DOI: 10.5588/ijtld.22.0330</identifier><identifier>PMID: 36447311</identifier><language>eng</language><publisher>France: International Union Against Tuberculosis and Lung Disease</publisher><subject>Adult ; Anti-Tuberculosis ; Formulations ; Humans ; Liquid ; Medicine ; Microorganisms ; Multidrug resistance ; Nitroimidazoles ; Patients ; pH effects ; Preservatives ; Room temperature ; Stability ; Sugar ; Syrup ; Syrups ; Tablets ; Tuberculosis, Multidrug-Resistant</subject><ispartof>The international journal of tuberculosis and lung disease, 2022-12, Vol.26 (12), p.1112-1117</ispartof><rights>Copyright International Union against Tuberculosis and Lung Disease (IUATLD) 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36447311$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Taneja, R.</creatorcontrib><creatorcontrib>Nahata, M. C.</creatorcontrib><creatorcontrib>Scarim, J.</creatorcontrib><creatorcontrib>Pande, P. G.</creatorcontrib><creatorcontrib>Scarim, A.</creatorcontrib><creatorcontrib>Hoddinott, G.</creatorcontrib><creatorcontrib>Fourie, C. L.</creatorcontrib><creatorcontrib>Jew, R. K.</creatorcontrib><creatorcontrib>Schaaf, H. S.</creatorcontrib><creatorcontrib>Garcia-Prats, A. J.</creatorcontrib><creatorcontrib>Hesseling, A. C.</creatorcontrib><title>Stable sugar and sugar-free suspensions of pretomanid</title><title>The international journal of tuberculosis and lung disease</title><addtitle>Int J Tuberc Lung Dis</addtitle><description>BACKGROUND: Pretomanid (PMD) tablets are indicated as part of a combination regimen for the treatment of adults with pulmonary extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant TB. No commercial liquid formulation is currently available for
patients unable to swallow these tablets.OBJECTIVE: To develop stable extemporaneous liquid formulations of PMD that can be stored at room temperature or 30°C for at least 4 weeks.METHODS: Crushed PMD tablets were formulated into 20 mg/mL suspensions in a simple syrup
and sugar-free formulation. The PMD formulations were stored at room temperature and at 30°C for 30 days in dispensing bottles. Appearance, pH, potency and microbial counts of the suspensions were determined on Days 0, 15 and 30.RESULTS: The potency of PMD remained at 99.7-103.4%
of the theoretical concentration in each formulation. The appearance, pH and microbial count did not change during the 30-day storage period. Simple syrup formulations did not require preservatives for microbial stability.CONCLUSIONS: PMD oral suspension formulations in simple syrup
or in sugar-free vehicle were easily prepared by utilising commonly available equipment and ingredients and were stable for 30 days. These formulations are appropriate alternatives for patients with swallowing difficulties.</description><subject>Adult</subject><subject>Anti-Tuberculosis</subject><subject>Formulations</subject><subject>Humans</subject><subject>Liquid</subject><subject>Medicine</subject><subject>Microorganisms</subject><subject>Multidrug resistance</subject><subject>Nitroimidazoles</subject><subject>Patients</subject><subject>pH effects</subject><subject>Preservatives</subject><subject>Room temperature</subject><subject>Stability</subject><subject>Sugar</subject><subject>Syrup</subject><subject>Syrups</subject><subject>Tablets</subject><subject>Tuberculosis, Multidrug-Resistant</subject><issn>1027-3719</issn><issn>1815-7920</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU2LFDEQhoMo7rp69CoDXrz0bKry2UdZP1ZYWGTXc6juTg899KTHJL2gv97O9qggmEtewsOT4i3GXgPfKmXt5bDPY7dF3HIh-BN2DhZUZWrkT5fM0VTCQH3GXqS05xwBwDxnZ0JLaQTAOVN3mZrRb9K8o7ih0K2p6qMvj-noQxqmkDZTvzlGn6cDhaF7yZ71NCb_6nRfsG-fPt5fXVc3t5-_XL2_qVqpIFeEjVDCkmy80UCohVSaN1b2qK1uvG1kLdBYWwsgwF63VqtadOSV5aYHccHerd5jnL7PPmV3GFLrx5GCn-bk0EihuDbGLOjbf9D9NMewTFcoXddQG7FQ1Uq1cUop-t4d43Cg-MMBd6VP99inQ3Slz4V_c7LOzcF3f-jfBS7A1xUYws6HTH9_HVo3zFRkZQ1lC-4BdQB0yBEBuXFcSnCd72kes8sU3e6nS3pxfvifcxWeZuRlyseD-hQWO8Vckha_ADmdn9E</recordid><startdate>20221201</startdate><enddate>20221201</enddate><creator>Taneja, R.</creator><creator>Nahata, M. 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J. ; Hesseling, A. C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c451t-a2b3538a4be761a2634560b84f2686be8b4932788931a12f6c86593dae5807f13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adult</topic><topic>Anti-Tuberculosis</topic><topic>Formulations</topic><topic>Humans</topic><topic>Liquid</topic><topic>Medicine</topic><topic>Microorganisms</topic><topic>Multidrug resistance</topic><topic>Nitroimidazoles</topic><topic>Patients</topic><topic>pH effects</topic><topic>Preservatives</topic><topic>Room temperature</topic><topic>Stability</topic><topic>Sugar</topic><topic>Syrup</topic><topic>Syrups</topic><topic>Tablets</topic><topic>Tuberculosis, Multidrug-Resistant</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Taneja, R.</creatorcontrib><creatorcontrib>Nahata, M. C.</creatorcontrib><creatorcontrib>Scarim, J.</creatorcontrib><creatorcontrib>Pande, P. G.</creatorcontrib><creatorcontrib>Scarim, A.</creatorcontrib><creatorcontrib>Hoddinott, G.</creatorcontrib><creatorcontrib>Fourie, C. L.</creatorcontrib><creatorcontrib>Jew, R. K.</creatorcontrib><creatorcontrib>Schaaf, H. S.</creatorcontrib><creatorcontrib>Garcia-Prats, A. J.</creatorcontrib><creatorcontrib>Hesseling, A. C.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>The international journal of tuberculosis and lung disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Taneja, R.</au><au>Nahata, M. C.</au><au>Scarim, J.</au><au>Pande, P. G.</au><au>Scarim, A.</au><au>Hoddinott, G.</au><au>Fourie, C. L.</au><au>Jew, R. K.</au><au>Schaaf, H. S.</au><au>Garcia-Prats, A. J.</au><au>Hesseling, A. C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Stable sugar and sugar-free suspensions of pretomanid</atitle><jtitle>The international journal of tuberculosis and lung disease</jtitle><addtitle>Int J Tuberc Lung Dis</addtitle><date>2022-12-01</date><risdate>2022</risdate><volume>26</volume><issue>12</issue><spage>1112</spage><epage>1117</epage><pages>1112-1117</pages><issn>1027-3719</issn><eissn>1815-7920</eissn><abstract>BACKGROUND: Pretomanid (PMD) tablets are indicated as part of a combination regimen for the treatment of adults with pulmonary extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant TB. No commercial liquid formulation is currently available for
patients unable to swallow these tablets.OBJECTIVE: To develop stable extemporaneous liquid formulations of PMD that can be stored at room temperature or 30°C for at least 4 weeks.METHODS: Crushed PMD tablets were formulated into 20 mg/mL suspensions in a simple syrup
and sugar-free formulation. The PMD formulations were stored at room temperature and at 30°C for 30 days in dispensing bottles. Appearance, pH, potency and microbial counts of the suspensions were determined on Days 0, 15 and 30.RESULTS: The potency of PMD remained at 99.7-103.4%
of the theoretical concentration in each formulation. The appearance, pH and microbial count did not change during the 30-day storage period. Simple syrup formulations did not require preservatives for microbial stability.CONCLUSIONS: PMD oral suspension formulations in simple syrup
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| ispartof | The international journal of tuberculosis and lung disease, 2022-12, Vol.26 (12), p.1112-1117 |
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| source | MEDLINE; PubMed Central; Alma/SFX Local Collection |
| subjects | Adult Anti-Tuberculosis Formulations Humans Liquid Medicine Microorganisms Multidrug resistance Nitroimidazoles Patients pH effects Preservatives Room temperature Stability Sugar Syrup Syrups Tablets Tuberculosis, Multidrug-Resistant |
| title | Stable sugar and sugar-free suspensions of pretomanid |
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