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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: Antonio Lopalco, PhD in Pharmaceutical Technology, Angela Lopedota, PhD in Pharmaceutical Technology, Fiorenza Aurelio, Master's Degree in Chemistry and Pharmaceutical Technology, Flavia la Forgia, Master's Degree in Pharmacy, Sergio Fontana, Master's Degree in Pharmacy, Massimo Franco, PhD in Pharmaceutical Technology, Nunzio Denora, PhD in Pharmaceutical Technology, 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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