Compatibility studies of camptothecin with various pharmaceutical excipients used in the development of nanoparticle formulation

摘要: Objective: For the design and development of any novel formulation, assessment of drug-excipients compatibility using different techniques such as thermal and isothermal stress testing, represents an important phase in preformulation stage. The potential physical and chemical interactions between the drug and excipients can affect the chemical nature, stability, bioavailability of drugs and subsequently, affects their therapeutic efficacy and safety.Method: To assess the drug–excipients compatibility, the analytical techniques like Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR) and Isothermal Stress Testing (IST) were adopted. In the present study, the possible interaction between the Camptothecin with Eudragit S 100, β Cyclodextrin and Poloxamer 188 were evaluated initially by DSC. The drug and each excipient (1: 1 w/w) were stored at 40±2oC and 75±5% RH for 1 month.Results: The FTIR spectrum of pure drug, excipients and drug-excipients mixtures were compared to find out the possible interaction. Stressed binary mixtures (stored at 50 C for 2 weeks) were periodically examined for any change in colour and the drug content was determined quantitatively using HPLC. No concrete evidence of interaction was observed between drug and the excipients.Conclusion: On the basis of the results obtained from DSC, FTIR and IST studies, all the excipients used were found to be compatible with the drug and can be used for the development of Nanoparticles formulation.