PREFORMULATION STUDIES FOR A
PARENTERAL SOLUTION OF MEMANTINE
MARCELA ACHIM1*, LAURIAN VLASE1, IOAN TOMUŢĂ1, DANA
MUNTEAN1, CRISTINA IUGA2, RADU GEORGESCU3, SORIN
LEUCUŢA1
1Department of Pharmaceutical Technology and Biopharmaceutics,
University of Medicine and Pharmacy “Iuliu Haţieganu”, Cluj-Napoca, 8
V.Babeş, 400012, Romania;
2Department of Drug Analysis, University of Medicine and Pharmacy
“Iuliu Haţieganu”, Cluj-Napoca, 8 V.Babeş, 400012, Romania;
3Department of Pharmacology, University of Medicine and Pharmacy
“Iuliu Haţieganu”, Cluj-Napoca, 8 V.Babeş, 400012, Romania
*corresponding author: machim@umfcluj.ro
Download Full Article

Abstract:

Preformulation studies regarding a physico-chemical evaluation of memantine, a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, are presented in this work. This characterization of memantine is pre-required for the formulation of a parenteral
solution. The water solubility, the thermal behavior and the chemical stability in aqueous solution, depending on the pH, temperature, UV light and the presence of oxidizing or isotonising agents were determined.
A LC/MS/MS analytical method for memantine hydrochloride quantification
was developed and validated. It was determined that memantine hydrochloride has a water solubility of 47.035 mg/mL (20oC). Thermal analysis revealed that it is an anhydrous substance, presenting a crystalline form, with the melting point at 297.16oC. In aqueous
solution memantine hydrochloride is stable at room temperature (20oC), regardless the pH of medium, UV light, isotonising agent or oxidizing agent and at 80ºC, at acidic pH value.
These results indicate that memantine hydrochloride has appropriate physico-chemical properties for a parenteral solution formulation.

Top