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Stability of Diazepam Enema Extemporaneous Formulation in Manzoni Base

Author(s):  Lopalco Antonio, Lopedota Angela, Aurelio Fiorenza, la Forgia Flavia, Fontana Sergio, Franco Massimo, Denora Nunzio

Issue:  Sep/Oct 2021 - Volume 25, Number 5
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Page(s):  427-430

Stability of Diazepam Enema Extemporaneous Formulation in Manzoni Base Page 1
Stability of Diazepam Enema Extemporaneous Formulation in Manzoni Base Page 2
Stability of Diazepam Enema Extemporaneous Formulation in Manzoni Base Page 3
Stability of Diazepam Enema Extemporaneous Formulation in Manzoni Base Page 4

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Abstract:  The authors provide a report on the preparation of an extemporaneous liquid formulation of diazepam enema using an alcohol-free base solution for use by both pediatric and adult patients. A solubility study using this base and the chemical stability of the drug in this formulation was performed by using a high-pressure liquid chromatography analytical method. Results of this study showed that the intrinsic solubility of the drug in this liquid base was 6.03 mg/mL ± 0.06 mg/mL and that diazepam was chemically stable when the formulation was stored at 25°C over a period of 3 months.

Related Keywords: diazepam, enema, rectal administration, benzodiazepine, anxiety disorders, sedative, muscle spasms, alcohol withdrawal, Manzoni base, chemical stability, alcohol free, epilepsy, seizure disorders, solubility, children

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS, MUSCULOSKELETAL DISORDERS, NEUROLOGY

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