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The pharmaceutical development of a fixed combination anti-tuberculosis dosage form

A research report submitted to the Faculty of Health Sciences, University of the
Witwatersrand In partial fulfilment of the requirements for the degree of Master of
Science in medicine (Pharmaceutical affairs)
Johannesburg, 1998 / Despite the availability of highly effective treatment regimens for tuberculosis, cure rates
remain low for tuberculosis mainly due to patient non-compliance which results in the
occurrence of multi drug resistance tuberculosis. To avoid the problem of further creation
and propagation of multi drug-resistant tuberculosis, patients should be given fixed-dose
combinations of anti-tubercular drugs whenever self-administration of drugs iJ permitted.
During this study, an anti-tuberculosis extemporaneous powder for suspension was
optimized in order to formulate a fixed combination of rifampicin. isoniazid, pyrazinamide
and ethambutol hydrochloride as a powder to be ' . constituted with water by the patient prior
to administration. Once an effective manufacturing method was established, different
suspending agents were evaluated by their influence on powder flow properties and
sedimentation volume on the powder blends. Sodium starch glycollate was chosen as the
suspending agent of choice because as the concentration of sodium starch glycollate was
increased, the powder flow properties of the powder blends improved. The sedimentation
volume also. increased with the increasing concentration of sodium starch glycollate in the
powder blends. A suitable flavour and colour was also determined to increase the
acceptability of the preparation to the patient. Liquorice flavour was the most acceptable in
terms of colour and flavour. An evaluation of the dissolution characteristics of the
extemporaneous powder for suspension was also conducted in comparison to the dissolution
profiles from commercially available tablet dosage forms. The dissolution rates from the
powder tor suspension for rifampicin, isoniazid and pyrazinamide was faster than from the
commercially available tablet dosage form, while the dissolution race of ethambutol HCl
from the powder closely resembles the dissolution profile from the Rolab-Ethambutol HCIR
tablet dosage form
Therefore. a fixed combination powder for suspension was achieved and with its ease of
administration would increase the compliance amongst tuberculosis patients. and increase
therapeutic outcomes. / MT2017

Identiferoai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:wits/oai:wiredspace.wits.ac.za:10539/22170
Date January 1998
CreatorsEbrahim, Salima
Source SetsSouth African National ETD Portal
LanguageEnglish
Detected LanguageEnglish
TypeThesis
FormatOnline resource (50 leaves), application/pdf, application/pdf

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