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Evaluating Corchorus Olitorius Plant Mucilage in the formulation of Oro-Dispersible Paediatric Sildenafil tablets

Author: Njoroge A. N. , Tirop L. J.
Is Part Of: Pharmaceutical Journal of Kenya, Volume 23, No. 4 (2018)
Sildenafil citrate, used in management of pulmonary arterial hypertension, is available in adult tablet dosage forms, from which paediatric doses are prepared extemporaneously. Sildenafil citrate oro-dispersible tablets in paediatric strengths, made from Corchorus olitorius (jute) plant mucilage as the natural superdisintegrant, provides for a dose specific, more stable, cheap and convenient dosage form in this population.
Typically synthetic superdisintegrants, namely croscarmellose sodium, crospovidone and sodium starch glycolate, are used in the formulation of oro-dispersible tablets. This work aimed to formulate paediatric oro-dispersible tablets of Sildenafil citrate, using mucilage of jute plant (Corchorus olitorius) as a novel natural superdisintegrant. The mucilage was successfully extracted with 96% ethanol and characterized, demonstrating favorable parameters for use as a tablet superdisintegrant. Twelve batches of Sildenafil oro-dispersible tablets were formulated by direct compression, at three levels of the novel superdisintegrant as well as the common synthetic superdisintegrants, and evaluated.
The Corchorus olitorius mucilage batches showed characteristic mean in-vitro dispersion times of 20.67, 19.33 and 18.67s for the 5 mgs, 7.5 mgs and 10 mgs (4%, 6%, 8% w/w) tablet concentrations, respectively. The in-vitro dispersion time of tablets containing Corchorus olitorius mucilage compared closely with that of tablets containing croscarmellose sodium and sodium starch glycolate. The in-vitro dispersion time was observed to decrease with increasing concentrations of the mucilage powder. The tablets complied with all compedial tests for quality with the exception of the friability test. Corchorus olitorius mucilage may be used safely at higher concentrations to achieve lower in-vitro dispersion times. Further studies to establish the optimum superdisintegrant concentration should be considered.

Keywords: Oro-dispersible tablet, Sildenafil citrate, Superdisintegrant, Corchorus olitorius mucilage
Publisher: The Pharmaceutical Society of Kenya
ISSN: 2411-6386