Compatibility study between acetylcysteine and some commonly used tablet excipients

Author:

Kerc̆ J1,Src̆ic̆ S12,Urleb U12,Kanalec A1,Kofler B1,s̆Mid-Korbar J2

Affiliation:

1. Department of Research and Development, Lek Pharmaceutical and Chemical Works, Ljubljana, Slovenia, Yugoslavia

2. Department of Pharmacy, University of Ljubljana, Slovenia, Yugoslavia

Abstract

Abstract Differential scanning calorimetry (DSC), Fourier transform infra-red spectroscopy (FT-IR), HPLC and TLC were used to investigate the interactions between the mucolytic drug acetylcysteine and a number of commonly used tablet and capsule excipients. Acetylcysteine was found to be compatible with micro-crystalline cellulose (Avicel PH 101), sodium carboxymethylcellulose, amorphous silicon dioxide (Aerosil), PVP, cross-linked PVP (Polyplasdone XL), corn starch, saccharose and magnesium stearate. Acetylcysteine thermal stability (onset degradation temperature) was decreased in mixtures with corn starch, magnesium stearate, saccharose and lactose. Interactions of acetylcysteine with lactose, PEG 4000 and 6000, glycine, adipic acid and saccharin sodium were found using DSC and studied in detail with FT-IR, HPLC and TLC. The results suggest that acetylcysteine in mixtures with PEG 4000, glycine or saccharin sodium is degraded during storage at conditions of high temperature and humidity.

Publisher

Oxford University Press (OUP)

Subject

Pharmaceutical Science,Pharmacology

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