Development and validation of an intrinsic dissolution method for nimodipine polymorphs

• Authors: Manoela Riekes , Gislaine Kuminek , Gabriela Rauber , Silvia Cuffini , Hellen Stulzer
• Languages of publication: EN

Abstracts

EN

The polymorphs of nimodipine, Modification I (Mod I), the metastable racemate, and Modification II (Mod II), the stable conglomerate, were evaluated by means of the intrinsic dissolution procedure. For this purpose, a hydro alcoholic solution (ethanol:water, 50:50, v/v) was selected as the dissolution medium, maintained at 37±0.5°C. Different rotation speeds were tested (50, 75 and 100 rpm) and the lower one was chosen for the test validation. Although the sample initially characterized as polymorph Mod I presented higher intrinsic dissolution rates in all the conditions tested, no statistical differences were noticed between the two polymorphs. This result can be attributed to the partial solution-mediated phase transformation from Mod I to Mod II, detected through X-ray powder diffraction and differential scanning calorimetry. Also, reliable intrinsic dissolution rate data were acquired for the polymorph Mod II. The dissolution method was validated, being considered stable, specific, linear, sensible, accurate and precise.

Keywords

EN

Nimodipine; Polymorphism; Intrinsic dissolution rate

• Publisher: De Gruyter Open
• Journal: Open Chemistry
• Year: 2014
• Volume: 12
• Issue: 5
• Pages: 549-556

Dates

published

1 - 5 - 2014

online

21 - 2 - 2014

Contributors

author

Manoela Riekes

• Federal University of Santa Catarina

author

Gislaine Kuminek

• Federal University of Santa Catarina

author

Gabriela Rauber

• Federal University of Santa Catarina

author

Silvia Cuffini

• Federal University of São Paulo

author

Hellen Stulzer

• Federal University of Santa Catarina

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Identifiers

DOI

10.2478/s11532-014-0511-9