Abstract

FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF DOXORUBICIN SUSTAINED RELEASE PALANOSETRON IMMEDIATE RELEASE BILYER TABLETS

*Kontham Raghu Ram Reddy, Kondru Divya, Laxmi Saranya Venkateshwarlu, Kolanu Shivnath Reddy

ABSTRACT

Background: Acute Chemotherapy induced nausea and vomiting is inescapable issue faced by every patient undergoing cancer treatment in order to mitigate this 5HT3 palonosetron was been added to chemotherapy present article was made with an aim to formulate and evaluate an ideal formulation for bi layer tablet of doxorubicin anthracylcine antibiotic (antineoplastic agent) and palonosetron to mitigate the nausea and vomiting caused by doxorubicin. Materials and Methods: Materials like super disintegrant sodium starch glycolate was employed for making palonosetron immediate release layer and binders like PVP K 30 was employed for making doxorubicin sustained release layer along with other excipients like MCC, HPMC etc. Different formulations were prepared with varying weights of excipients by employing wet granulation method for tablet compression. The Tablets are evaluated both during pre compression and post compression. Results: An ideal formulation of doxorubicin sustained release and palonosetron immediate release bi layer tablet was formulated and evaluated. The bi layer tablet had average thickness 450±1.25mg Hardness 6.2±0.042 Thickness 5.9±0.018 and 2 min 18 sec disintegration time for immediate release and 86.22 drug release of sustained release layer after 12 hours. Conclusion: The doxorubicin sustained release and palonosetron immediate release bi layer tablets were compressed and were in the limits of all acceptance criteria and may mitigate the Chemotherapy induced nausea and vomiting.

Keywords: Doxorubicin; Palonosetron; Bi layer tablets; wet granulation method; Chemotherapy induced nausea and vomiting.