Acta Pharm. 62 (2012) 515-528

 

full paper

Original research paper

 

Influence of different types of commercially available microcrystalline cellulose on degradation of perindopril erbumine and enalapril maleate in binary mixtures

TANJA VEHOVEC, ANDREJ GARTNER, ODON PLANINŠEK and ALEŠ OBREZA

Ales.Obreza@ffa.uni-lj.si

1 Krka d.d. Novo mesto, Stability Testing Department, 8501 Novo mesto, Slovenia

2 University of Ljubljana, Faculty of Pharmacy, 1000 Ljubljana, Slovenia

Accepted September 18, 2012

 

Influence of some commercially available types of microcrystalline cellulose (MCC) on the stability of certain active pharmaceutical ingredients (APIs), when in contact, has been investigated. Two structurally similar APIs, perindopril erbumine (PER) and enalapril maleate (EM), both well-known angiotensin-converting enzyme inhibitors were used. The main properties of an MCC that could determine the stability for each API were measured and correlated to the stability of these two APIs in binary mixtures. The stability of these APIs differed when in contact with different types of MCC. The dominant properties of MCC from one manufacturer were surface features that influenced the stability of PER and acidity that influenced the stability of EM. In the case of MCC from other manufacturers, unbound water was stability determining for both substances.

 

Keywords: microcrystalline cellulose, perindopril erbumine, enalapril maleate, stability study, drug-excipient binary mixtures