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Stability of Venlafaxine Hydrochloride Liquid Formulations Suitable for Administration via Enteral Feeding Tubes
Author(s) -
Rosa Nicholas F De,
Sharley Nicholas A
Publication year - 2008
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/j.2055-2335.2008.tb00841.x
Subject(s) - chromatography , venlafaxine hydrochloride , pellets , venlafaxine , enteral administration , medicine , high performance liquid chromatography , chemistry , materials science , surgery , parenteral nutrition , composite material , hippocampus , antidepressant
Background Venlafaxine hydrochloride tablets have been discontinued and the extended‐release capsules are the only formulation available in Australia. The extended‐release capsule releases venlafaxine from pellets within the capsule. These pellets cannot be flushed through a syringe or enteral feeding tube as they adhere to the plastic. Aim To develop a liquid formulation of venlafaxine hydrochloride suitable for enteral feeding and to determine an evidence‐based shelf‐life for the formulation. Method High performance liquid chromatography was used for the analytical procedure. Venlafaxine hydrochloride was subjected to forced degradation at elevated temperatures under acidic, basic and oxidative conditions. Degradation products and formulation excipients were analysed with high performance liquid chromatography to verify the presence of any interfering peaks. Two venlafaxine liquid formulations were prepared in triplicate using Efexor‐XR capsules. Each sample, a blank, and a quality control sample were analysed in duplicate on each study day. Four calibration standards were used and sample venlafaxine hydrochloride concentrations were calculated from the linear regression equation derived from the calibration set. Results The chromatogram exhibited appropriate separation of the respective peaks for venlafaxine, degradation product, and formulation excipients, and can be considered stability indicating. All samples retained above 94% of the original venlafaxine content throughout the 30‐day study period. Conclusion Venlafaxine hydrochloride liquid formulations can be prepared from Efexor‐XR capsules that is stable for 30 days when stored at room temperature.