Abstract:
Cilazapril is a
drug commonly used in management of
heart failure in pediatric population. On
pharmaceutical market it is available only in inconvenient for pediatric use
tablet dosage forms. Until now, no oral liquid formulation containing
cilazapril has been evaluated. Therefore, the aim of this study was to prepare easy to made and palatable 1 mg/mL oral liquid formulation with
cilazapril (with consideration of original and generic
cilazapril tablet and different packages) and subsequent investigation of physicochemical stability of these
suspensions. Formulations were compounded using
cilazapril obtained from original or generic
cilazapril marketed
tablet formulations and Ora-Blend"
suspending agent. Stability of prepared
suspensions stored in closed
amber glass or
amber plastic PET bottles in the temperature of 298 K was estimated throughout 28 day shelf-life period. Chemical stability was assessed by HPLC
cilazapril stability indicating method. Physical stability was evaluated by appearance, taste, smell, pH and theological assessments.
Cilazapril oral
suspensions at concentration of 1 mg/mL demonstrated satisfactory stability over 28 day long storage at room temperature.
Cilazapril concentrations remained within acceptable limit (+/- 10%) stored in closed
amber bottles made of glass or PET material. Moreover,
suspensions physical properties remained unaffected.
Cilazapril - Ora-Blend* pediatric oral liquid is easy to made, palatable and stable when stored at room temperature for 28 days. Stability of
cilazapril oral liquid remains unchanged while using
cilazapril tablets produced by different manufacturers and bottles made of
amber glass or PET material.