Physical, microbiological, toxicological and clinical studies of transdermal medication of balanites and lupin in the treatment of cutaneous leishmaniasis


Research type: Research Paper

Authors: Mohammed, Hoyam Saad Ali .

Abstract: Pentostam is the drug of choice in the treatment of cutaneous leishmaniaisis (CL) long time ago in the world and particularly in Sudan. It is administered by 1.V, I..M and I.L routes. These routes of administration haver several disavantages. They are summarized in exposing the patients to serious systemic side effects besid their use is harboured by both shortage of experinced personnel and patient's compliance. The patients consume a lot of time and expenses to come frequently ot the hospital from far places. Beside the pain at the sitee of infectin (as in the case of L.L route) is not tolerable by the patient. Also pentostam is an expensive drug, therefore, the aim of the study is to formulate stable, suitable, cheap and reliable cream and ointment ot be used topically as and efficient medicament for use in CL treatment without side effects. Four per cent Balanites and six percent of Lupin were formulated in different bases wich are hydrous wool fat (HWF) ointment polyethylene glycol (PEG) ointment in different concentrations of different blends, aqueous cream and gel. Dimethyt sulfoxide (DMSO), 0.5 percent W/W, was used in all the formulations as penetration enhancer. In order to select stable and suitable base for Balanites and Lupin in usage and storage in hot climate countries, pharmaceutical, studies were performed for the different bases; these studies included physical characteristics experiments which are the specific gravity, conjealing properties, drop point and weight variation. On the other hand consistency and penetration using different techniques as penetrometer, extrusion and extensometer sliding were performed. To determine the base stability on storage at penetration using dfferent techniques as penetrometer, extrusion a dnextensometer sliging were performed. To determine the base stability on storage at temperatures between 35-45 C, the oil number and rheological studies which include plastic viscosity, yield values and hysteresis loop area were done for all the basese. Also, the in vitro release of 4 percent Balanites and 6 percent Lupin was performed using different methods in order to select the base of suitable onset of action. Also. Their antimicrobial activity and their toxicological action on biological organs of chicks. Four per cent Balanites and and six per cent Lupin formulations were compared from pharmaceutical point of view to chooose the suitable base for CL treatment. On the other hand the suitable base was compared clinically with the conventional and nonconventional medicaments currently used in the treatment of CL in Sudan. In conclusion, from the different experimental and clinical dinndinges concerning stability and efficacy, 4 percent Balanites and 6 percent Lupin with 0.5 percent dimethl sulphoxide in aqueous cream formulations were found to be most suitable and best formulations for CL in tropical and subtropical countries.