title: Compatibility studies of nateglinide with excipients in immediate release tablets.
abstract: 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.
authors.affiliation: Department of Pharmaceutical Technology, Gayatri College of Pharmacy, Sambalpur, Odisha-768200, India. niharpani@gmail.com
authors.forename: Nihar Ranjan
authors.initials: NR
authors.lastname: Pani
authors.forename: Lila Kanta
authors.initials: LK
authors.lastname: Nath
authors.forename: Sujata
authors.initials: S
authors.lastname: Acharya
mesh_terms: D002152:Calorimetry, Differential Scanning; D055598:Chemical Phenomena; D003510:Cyclohexanes / Q000008:administration & dosage / Q000032:analysis / Q000737:chemistry*; D004339:Drug Compounding; D004344:Drug Incompatibility; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry*; D006244:Hardness; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000032:analysis / Q000737:chemistry*; D007700:Kinetics; D055595:Mechanical Phenomena; D000077715:Nateglinide; D010649:Phenylalanine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D012995:Solubility; D017550:Spectroscopy, Fourier Transform Infrared; D013229:Stearic Acids / Q000737:chemistry; D013607:Tablets; D013696:Temperature
chemical_list: D003510:Cyclohexanes; D005079:Excipients; D007004:Hypoglycemic Agents; D013229:Stearic Acids; D013607:Tablets; D000077715:Nateglinide; D010649:Phenylalanine; C031183:stearic acid