Acta Pharm. 61 (2011) 237-247

full paper

Short communication

Compatibility studies of nateglinide with excipients in immediate release tablets

NIHAR RANJAN PANI, LILA KANTA NATH and SUJATA ACHARYA

niharpani@gmail.com

¹ Department of Pharmaceutical Technology, Gayatri College of Pharmacy, Sambalpur, Odisha-768200, India

² Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh Assam-786004, India

³ University Department of Pharmaceutical Sciences, Utkal University, Bhubaneswar, Orissa, India

Accepted May 5, 2011

Experiments were done to assess the compatibility of nateglinide with selected excipients in the development of immediate release tablets of nateglinide by thermal and isothermal stress testing (IST) techniques. To evaluate the drug-excipient compatibility, different techniques such as differential scanning calorimetric (DSC) study, infra-red (IR) spectrophotometric study and isothermal stress testing were adopted. The results of DSC study showed that magnesium stearate exhibited some interaction with nateglinide. However, the results of IR, and IST studies showed that all the excipients used in the formula were compatible with nateglinide. Optimized formulations developed using the compatible excipients were found to be stable over 3 months of accelerated stability studies (40 ± 2 °C and 75 ± 5 % RH). Overall, compatibility of excipients with nateglinide was successfully evaluated using a combination of thermal and IST methods and the formulations developed using the compatible excipients were found to be stable.

Keywords: nateglinide, immediate release tablet, drug-excipient interaction