Effect of Environmental Humidity on the Transformation Pathway of Nitrofurantoin Modifications During Grinding and the Physicochemical Properties of Ground Products

Author:

Otsuka Makoto1,Matsuda Yoshihisa1

Affiliation:

1. Kobe Women’s College of Pharmacy, Moloyama-Kitamachi 4–19–1, Higashi-Nada, Kobe 658, Japan

Abstract

Abstract The effect of humidity on the physicochemical properties of nitrofurantoin anhydrate and monohydrate during grinding in a humidity-controlled system was investigated using X-ray diffraction analysis, IR spectroscopy, thermal analysis and scanning electron microscopy. Anhydrate and monohydrate were transformed into a noncrystalline solid and a stable monohydrate, respectively, during grinding in a closed system. During grinding in an open system, in which the humidity level of the air was controlled (5, 50 and 75% r.h.), the anhydrate absorbed moisture from the supplied air and water content was increased at 75% r.h.; thereafter the compound was transformed into monohydrate II. The anhydrate did not absorb at 5 or 50% r.h. and was transformed into a noncrystalline solid. Monohydrate I desorbed crystal water during grinding at 5% r.h. and was transformed into a noncrystalline solid. However, monohydrate I was transformed into monohydrate II at 50 and 75% r.h. without desorption of crystal water. These results suggest that the solid-state transformation of nitrofurantoin during grinding depends upon the environmental humidity.

Publisher

Oxford University Press (OUP)

Subject

Pharmaceutical Science,Pharmacology

Reference18 articles.

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2. Nitrofurantoin I. Effect of aging at different relative humidities and higher temperatures on the drug release and the physical properties of tablets;Ebian;Egypt. J. Pharm. Sci.,1985

3. Nitrofurantoin II. Correlation of in vivo bioavailability to in vitro dissolution of nitrofurantoin tablets aged at different relative humidities and elevated temperatures;Ebian;Egypt. J. Pharm. Sci.,1986

4. Guideline: Manufacturing and Controls for INDs and NDAs;FDA Paper;Pharm. Tech. Japan,1985

5. Effect of storage on nitrofurantoin solid dosage forms;Gouda;Int. J. Pharm.,1984

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