FORMULATION AND IN-VITRO EVALUATION OF ORAL CAPSULES CONTAINING AN ETHANOL EXTRACT OF XIMENIA AMERICANA: A MEDICINAL PLANTS USED FOR BREAST CANCER MANAGEMENT

Abstract

Ximenia americana stem (XA) bark extract is widely used by several Africa traditional medical practitioners for
the treatment of breast cancer and other neoplastic diseases due to its effectiveness, safety and availability. This
study was aimed at formulating the extract as a solid pharmaceutical product. The stem bark extract of Ximenia
americana was obtained by maceration technique and thereafter screened for its phytochemical contents and in-
vitro cytotoxicity. Five different batches of XA granules were prepared by wet granulation technique and their
flow properties investigated via standard pharmaceutical methods. Subsequently the granules batches were
formulated as capsules. Uniformity of capsule weight, the capsule crushing strength as well as the drug release
profiles of each batch were determined. The crude extract yield was 23% w/w and revealed the presence of
cardiac glycosides, flavonoids, saponins, and tannin. All the batches of XA granules were fairly free flowing
with ranking order of flowability: XA2 ≤ XA4 ≤ XA 5 ≤ XA 1 ≤ XA 3. The capsule weight was uniform as none of
the batch deviated from the mean by 5%. All the batches disintegrated to release the active medicament with the
pharmacopeia stipulated time of 15 minutes and the capsules crushing strength were well above the official limit
of 4.5KgF. The cumulative amount of XA in solution at 45 minutes were above 75%, indicating compliance
with the United States Pharmacopeia (USP) standards. There is however the need for the optimization these XA
formulations before commercial scale up.