Formulation development and stability studies of quinine sulphate suppositories for paediatric use Quinine sulphate suppositories for paediatric use

Rectal administration is preferred to oral and parenteral routes in paediatric population because it is relatively painless while avoiding nausea, vomiting and first pass metabolism. With emergence of chloroquine resistance, quinine is still one of the accepted chemotherapeutic agents against Plasmodium falciparum. The aim of this study is to develop paediatric suppositories of quinine sulphate using FattibaseTM to aid stability, adequate release, ease of administration and affordability. Physical appearance, weight uniformity, hardness, melting range, liquefaction time, drug content uniformity, FTIR and release profile of the suppositories were determined at 27.0±2.0 ᵒC and 4.0±0.5 ᵒC after 0, 1, 4 and 8 weeks. Statistical analysis was done using two-way ANOVA.  FTIR analysis revealed no significant modification occurred in the chemical structure of quinine throughout storage. For suppositories stored at 27.0±2.0 ᵒC, hardness and liquefaction time increased significantly with time. Release of quinine from the fattibaseTM was sustained (quantity released at 120 min, Q120 = 52.16 - 71.16%). Storage time had significant influence (p< 0.05) on all the parameters while storage temperature significantly influenced hardness, liquefaction time, Q120 and drug content. Quinine sulphate suppositories made with fattibaseTM were stable throughout the period of study and will be suitable for peadiatric use