Injectable biodegradable
polymer poly(sebacic-co-
ricinoleic acid),
P(SA-RA) is currently under development for intratumoral (IT) delivery of drugs for treating solid
tumors. This study presents formulation development, pharmacokinetic and efficacy studies of two anticancer drugs (
cisplatin and
paclitaxel) formulated with
P(SA-RA)
polymer. In pharmacokinetic study, systemic exposure and pharmacokinetic parameters of
cisplatin/
paclitaxel following single intravenous (IV) or subcutaneous (SC) doses of
cisplatin/
paclitaxel was compared with intramuscular (IM) or SC doses of
cisplatin/
paclitaxel formulated with
P(SA-RA)
polymer in male CD rat. Simultaneously, the
tumor reduction effect and toxicity for these formulations were evaluated in human FaDu head and neck
tumor xenograft subcutaneous nude mouse model. Pharmacokinetic data reflect the lower maximal concentrations and sustained release of
polymer-
cisplatin/
paclitaxel formulations compared to standard
cisplatin/
paclitaxel administration. Regarding efficacy study, a single IT or near the
tumor injection (NT) of
polymer-
paclitaxel or
polymer-
cisplatin formulation significantly reduced the
tumor size, compared to the standard
paclitaxel or
cisplatin treatments. No death or toxicity and no effect on
body weight as well as macroscopic and/or microscopic changes in or near the injected area were observed, proving biocompatibility and acceptability of
polymer-formulations. In conclusion, the developed formulation demonstrated controlled release and significant efficacy in delivering these agents and exhibit potential for further clinical development.