Assessment of the Safety Profile of Purified <i>Pentadesma butyracea (Clusiaceae)</i> Gum Intended as a Pharmaceutical Excipient.

Abstract

<i>Pentadesma butyracea</i> (family <i>Clusiaceae</i>) bark is widely used in traditional medicine across sub-Saharan Africa. However, the investigation of the safety profile of the gum exudate obtained from the stem bark of the plant is undocumented. This study evaluated the acute and subacute toxicity of the purified <i>Pentadesma butyracea</i> gum (PBG) in 36 male Sprague Dawley rats (8-10 weeks old; 100-182.08 g) to determine its safety profile for potential use as a pharmaceutical excipient. Acute toxicity was assessed using a single oral dose of 2000 mg/kg PBG, while subacute toxicity involved daily administration of 250, 500, and 1000 mg/kg PBG for 28 days. In the acute toxicity study, no mortality or significant adverse effects on behavior, body weight, relative organ weight, or histological features were observed, suggesting an LD₅₀ greater than 2000 mg/kg PBG. Hematological and biochemical analyses revealed no harmful deviations, supporting the safety of PBG in acute exposure. In the subacute study, no mortality occurred across all doses, and body weight changes were minimal. Relative organ weights of the kidneys, heart, and lungs increased at higher doses, indicating potential dose-dependent effects. Biochemical analyses revealed no significant alterations in liver enzymes (AST, ALT, and ALP) or markers of kidney function (urea and creatinine) at lower doses; however, slight elevations in bilirubin and creatinine were observed at 1000 mg/kg PBG, suggesting mild hepatic and renal stress. Histopathological analysis confirmed the absence of severe pathological changes, with only mild and reversible alterations at higher doses. Overall, PBG demonstrated a favorable safety profile at doses below 1000 mg/kg, supporting its potential use as a pharmaceutical excipient. The preliminary phytochemical screening also showed the presence of tannins, glycosides, coumarins, sterols, and triterpenoids. Further studies, including chronic toxicity and pharmacokinetic assessments, are recommended to establish the long-term safety of PBG.