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`Lisinopril as a liquid dosage form intended for pediatric use
`Abstract:
`Purpose The U.S. Na៝onal Ins៝tute of Health (NIH) funded the Pediatric Trials Network to design, in
`part, pediatric liquid dosage forms of drugs for commercial produc៝on. The goal of this project is to
`develop a diluent for lisinopril and study the stability and palatability proper៝es of the formula៝on.
`This study will inves៝gate the stability of the drug as a func៝on of pH, temperature, and presence of
`amino acids as stabilizing agents; as well as the presences of different flavorings. Methods Lisinopril
`solu៝ons (10mg/10ml) were prepared under the following condi៝ons: four solu៝ons were prepared
`in a pH 4.66 buffer solu៝on and stored at different temperatures (4, 25, 35, 45&[deg]C). Three
`separate solu៝ons were prepared with buffer adjusted to pH 4.16, 5.15, 5.7 and stored at room
`temperature (25&[deg]C). The remaining three solu៝ons were prepared with a 3:2 mol ra៝o of
`amino acid (glycine, alanine and 50/50 glycine/alanine to lisinopril. The lisinopril solu៝ons were
`assayed over ៝me using HPLC (UV Detec៝on and 20% (v/v) acetonitrile/buffer mobile phase). In
`addi៝on, five flavors were tested with Ora‐Sweet/Ora‐Plus solu៝ons in order to determine a
`palatable diluent to mask the taste of the lisinopril solu៝on. The diluents were first tested alone to
`op៝mize the product for sweetness, flavor, and consistency. The selected diluent mixtures were then
`tested with lisinopril. The diluent with lisinopril was then assayed using the same HPLC system as
`stated above. Results The goal is to prepare a palatable and stable lisinopril mixture with a shelf life
`of 18‐24 months that can be scaled for commercial produc៝on. Stability tes៝ng as a func៝on of
`buffer and temperature are ongoing. Once the most stable buffer (pH) solu៝on is iden៝fied, stability
`tes៝ng will include lisinopril with the selected flavoring/diluent. To date, a diluent ra៝o of 1 drop
`flavoring:10mL Ora‐Sweet: 10mL Ora‐Plus) mixed in equal parts with a 2mg/ml solu៝on of lisinopril
`yields a palatable dosage form. Conclusion The final prepara៝on will be one that offers the greatest
`stability and palatability for inclusion in clinical trials outlined by the Pediatric Trials Network (PTN).
`Authors:
`Kibbe, Arthur, VanWert, Adam, Jacobs, Harvey, Bohan, Jefferson, Beidel, Ben
`Affilia៝ons: Wilkes University
`Poster
`Number: W5015
`AAPS2011‐002534.pdf
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` © Mira Conference 1997 ‐ 2017
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