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The stability of captopril in a dry syrup and dispersible tablet formula

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dc.contributor.advisor L"otter AP, Prof en
dc.contributor.advisor Du Preez JL, Dr en
dc.contributor.author Kriel C en
dc.date.accessioned 2016-09-22T07:19:04Z
dc.date.available 2016-09-22T07:19:04Z
dc.date.created 2002 en
dc.date.submitted 2003 en
dc.identifier.uri http://hdl.handle.net/20.500.11892/13708
dc.description.abstract Objective:<br> Captopril is very unstable in the presence of water and oxygen and the aim of this study was to conduct a study to help with the development of stable liquid oral products. The treatment of hypertension and congestive heart failure in paediatrics and geriatric patients who have trouble swallowing captopril tablets will be the main benefit should these products be successful. The proposed liquid oral products could be in the form of dry powders for solution (dry syrup with the aim at paediatric patients) or dispersible tablets (with the aim at geriatric patients).<br><br> Experimental methods:<br> A preformulation study was conducted to determine the compatibility of captopril with the various excipients used in each formula using differential scanning calorimetry (DSC) and high performance liquid chromatography (HPLC). Different formulations were then manufactured in the form of dry powders for solution and dispersible tablets based on the results obtained from the excipient compatibility study. The dry powders for solution were assayed at day 0 using a stability indicating HPLC method, then stored at 25&deg;C with 60% relative humidity and 40&deg;C with 75% relative humidity and assayed again at day 30, 60 and 90. The reconstituted solutions were tested at day 0, stored at 5&deg;C with 60% relative humidity and tested at days 14 and 28. The dispersible tablets were assayed at day 0, stored at 25&deg;C and 60% relative humidity and 40&deg;C and 75% relative humidity and tested after 1 month, 2 months and 3 months.<br><br> Results: <br>The results obtained by HPLC of the excipient compatibility study, showed in contrary to those obtained by DSC, that captopril was visibly compatible with ascorbic acid, citric acid, tartaric acid and mannitol and that no real conclusion could be drawn that indicates incompatibilities with the other excipients that were tested. The dry syrup at both the stored temperatures absorbed too much moisture and therefore the stability was insufficient. The reconstituted syrup proved to be stable over the 28 day period, and the dispersible tablets stored at 25&deg; and 40&deg; were both stable over the 3 month period.<br><br> Conclusion:<br> Captopril proved to be stable in the dispersible tablet formulation and it appeared to be superior to that of the dry syrup due to the possibility of moisture absorption into the dry syrup containers (moisture was avoided to a greater extent than in the dry syrup containers). The control of moisture absorption into the containers could be achieved by placing dessicants in the tablet containers or placing dessicants in the lids of the dry syrup containers. It was then concluded that dispersible tablets were simple and effective alternative dosage forms to be taken by paediatric and geriatric patients. en
dc.language English en
dc.subject Medical sciences: Pharmacology and therapeutics en
dc.subject Drugs (Materia medica) en
dc.title The stability of captopril in a dry syrup and dispersible tablet formula en
dc.type Masters degree en
dc.description.degree MSc en

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