Optimization of Crushed Drug-sensitive Antituberculosis Medication when Administered Via a Nasogastric Tube

Overview

Journal Microbiol Spectr

Specialty Microbiology

Date 2023 Nov 22

PMID 37991379

Authors

Cassius M Phogole

Jocelyn de Jong

Usha Lalla

Eric Decloedt

Tracy Kellermann

Affiliations

Soon will be listed here.

Abstract

The incidence of tuberculosis (TB) in intensive care units (ICUs) can be as high as 3% in high-burden settings, translating to more than 7,500 patients admitted to the ICU annually. In resource-limited settings, the lack or absence of intravenous formulations of drug-sensitive antituberculosis medications necessitates healthcare practitioners to crush, dissolve, and administer the drugs to critically ill patients via a nasogastric tube (NGT). This off-label practice has been linked to plasma concentrations below the recommended target concentrations, particularly of rifampicin and isoniazid, leading to clinical failure and the development of drug resistance. Optimizing the delivery of crushed drug-sensitive antituberculosis medication via the NGT to critically ill patients is of utmost importance.

References

Benet L, Hosey C, Ursu O, Oprea T . BDDCS, the Rule of 5 and drugability. Adv Drug Deliv Rev. 2016; 101:89-98. PMC: 4910824. DOI: 10.1016/j.addr.2016.05.007. View

Dheda K, Gumbo T, Gandhi N, Murray M, Theron G, Udwadia Z . Global control of tuberculosis: from extensively drug-resistant to untreatable tuberculosis. Lancet Respir Med. 2014; 2(4):321-38. PMC: 5526327. DOI: 10.1016/S2213-2600(14)70031-1. View

Bayraktar Ekincioglu A, Demirkan K . Clinical nutrition and drug interactions. Ulus Cerrahi Derg. 2015; 29(4):177-86. PMC: 4382818. DOI: 10.5152/UCD.2013.112013. View

Arca H, Mosquera-Giraldo L, Pereira J, Sriranganathan N, Taylor L, Edgar K . Rifampin Stability and Solution Concentration Enhancement Through Amorphous Solid Dispersion in Cellulose ω-Carboxyalkanoate Matrices. J Pharm Sci. 2017; 107(1):127-138. DOI: 10.1016/j.xphs.2017.05.036. View

Zhu L, Zhou Q . Therapeutic concerns when oral medications are administered nasogastrically. J Clin Pharm Ther. 2013; 38(4):272-6. DOI: 10.1111/jcpt.12041edit. View

Murakami T . Absorption sites of orally administered drugs in the small intestine. Expert Opin Drug Discov. 2017; 12(12):1219-1232. DOI: 10.1080/17460441.2017.1378176. View

Zangenberg N, Mullertz A, Kristensen H, Hovgaard L . A dynamic in vitro lipolysis model. I. Controlling the rate of lipolysis by continuous addition of calcium. Eur J Pharm Sci. 2001; 14(2):115-22. DOI: 10.1016/s0928-0987(01)00169-5. View

Koegelenberg C, Nortje A, Lalla U, Enslin A, Irusen E, Rosenkranz B . The pharmacokinetics of enteral antituberculosis drugs in patients requiring intensive care. S Afr Med J. 2013; 103(6):394-8. DOI: 10.7196/samj.6344. View

Davit B, Kanfer I, Tsang Y, Cardot J . BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements. AAPS J. 2016; 18(3):612-8. PMC: 5256598. DOI: 10.1208/s12248-016-9877-2. View

10.

Ramachandran G, Chandrasekaran P, Gaikwad S, Agibothu Kupparam H, Thiruvengadam K, Gupte N . Subtherapeutic Rifampicin Concentration Is Associated With Unfavorable Tuberculosis Treatment Outcomes. Clin Infect Dis. 2019; 70(7):1463-1470. PMC: 7931830. DOI: 10.1093/cid/ciz380. View

11.

Silva D, Al-Gousous J, Davies N, Chacra N, Webster G, Lipka E . Simulated, biorelevant, clinically relevant or physiologically relevant dissolution media: The hidden role of bicarbonate buffer. Eur J Pharm Biopharm. 2019; 142:8-19. DOI: 10.1016/j.ejpb.2019.06.006. View

12.

Ruzsikova A, Souckova L, Suk P, Opatrilova R, Kejdusova M, Sramek V . Quantitative analysis of drug losses administered via nasogastric tube--In vitro study. Int J Pharm. 2014; 478(1):368-371. DOI: 10.1016/j.ijpharm.2014.11.065. View

13.

Enimil A, Eley B, Nuttall J . The initial intravenous treatment of a human immunodeficiency virus-infected child with complicated abdominal tuberculosis. South Afr J HIV Med. 2020; 21(1):1121. PMC: 7479423. DOI: 10.4102/sajhivmed.v21i1.1121. View

14.

Aburub A, Risley D, Mishra D . A critical evaluation of fasted state simulating gastric fluid (FaSSGF) that contains sodium lauryl sulfate and proposal of a modified recipe. Int J Pharm. 2007; 347(1-2):16-22. DOI: 10.1016/j.ijpharm.2007.06.018. View

15.

Motiei M, de Gouveia L, Sopik T, Vicha R, Skoda D, Cisar J . Nanoparticle-Based Rifampicin Delivery System Development. Molecules. 2021; 26(7). PMC: 8038351. DOI: 10.3390/molecules26072067. View

16.

Khoshakhlagh P, Johnson R, Langguth P, Nawroth T, Schmueser L, Hellmann N . Fasted-state simulated intestinal fluid "FaSSIF-C", a cholesterol containing intestinal model medium for in vitro drug delivery development. J Pharm Sci. 2015; 104(7):2213-24. DOI: 10.1002/jps.24470. View

17.

Becker C, Dressman J, Junginger H, Kopp S, Midha K, Shah V . Biowaiver monographs for immediate release solid oral dosage forms: rifampicin. J Pharm Sci. 2009; 98(7):2252-67. DOI: 10.1002/jps.21624. View

18.

Mackie A, Mulet-Cabero A, Torcello-Gomez A . Simulating human digestion: developing our knowledge to create healthier and more sustainable foods. Food Funct. 2020; 11(11):9397-9431. DOI: 10.1039/d0fo01981j. View

19.

Salviato Balbao M, Bertucci C, Bergamaschi M, Queiroz R, Malfara W, Dreossi S . Rifampicin determination in plasma by stir bar-sorptive extraction and liquid chromatography. J Pharm Biomed Anal. 2009; 51(5):1078-83. DOI: 10.1016/j.jpba.2009.11.001. View

20.

Fox D, OConnor R, Mallon P, McMahon G . Simultaneous determination of efavirenz, rifampicin and its metabolite desacetyl rifampicin levels in human plasma. J Pharm Biomed Anal. 2011; 56(4):785-91. DOI: 10.1016/j.jpba.2011.07.041. View