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¹³C Solid-State NMR Analysis of the Most Common Pharmaceutical Excipients Used in Solid Drug Formulations, Part I: Chemical Shifts Assignment

¹³C Solid-State NMR Analysis of the Most Common Pharmaceutical Excipients Used in Solid Drug Formulations, Part I: Chemical Shifts Assignment

Dariusz Maciej Pisklak, Monika Agnieszka Zielińska-Pisklak, Łukasz Szeleszczuk, Iwona Wawer

J Pharm Biomed Anal. 2016 Apr 15;122:81-9.

PMID: 26845204

Abstract:

Solid-state NMR is an excellent and useful method for analyzing solid-state forms of drugs. In the (13)C CP/MAS NMR spectra of the solid dosage forms many of the signals originate from the excipients and should be distinguished from those of active pharmaceutical ingredient (API). In this work the most common pharmaceutical excipients used in the solid drug formulations: anhydrous α-lactose, α-lactose monohydrate, mannitol, sucrose, sorbitol, sodium starch glycolate type A and B, starch of different origin, microcrystalline cellulose, hypromellose, ethylcellulose, methylcellulose, hydroxyethylcellulose, sodium alginate, magnesium stearate, sodium laurilsulfate and Kollidon(®) were analyzed. Their (13)C CP/MAS NMR spectra were recorded and the signals were assigned, employing the results (R(2): 0.948-0.998) of GIPAW calculations and theoretical chemical shifts. The (13)C ssNMR spectra for some of the studied excipients have not been published before while for the other signals in the spectra they were not properly assigned or the assignments were not correct. The results summarize and complement the data on the (13)C ssNMR analysis of the most common pharmaceutical excipients and are essential for further NMR studies of API-excipient interactions in the pharmaceutical formulations.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP9063381-A	Sodium Starch Glycolate Type A		9063-38-1	Price

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