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Stability of gabapentin in extemporaneously compounded oral suspensions

This study reports the stability of extemporaneously prepared gabapentin oral suspensions prepared at 100 mg/mL from bulk drug and capsules in either Oral Mix or Oral Mix SF suspending vehicles. Suspensions were packaged in amber plastic bottles and amber plastic syringes at 25°C / 60%RH for up to 9...

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Detalles Bibliográficos
Autores principales: Friciu, Mihaela, Roullin, V. Gaëlle, Leclair, Grégoire
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5393583/
https://www.ncbi.nlm.nih.gov/pubmed/28414771
http://dx.doi.org/10.1371/journal.pone.0175208
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author Friciu, Mihaela
Roullin, V. Gaëlle
Leclair, Grégoire
author_facet Friciu, Mihaela
Roullin, V. Gaëlle
Leclair, Grégoire
author_sort Friciu, Mihaela
collection PubMed
description This study reports the stability of extemporaneously prepared gabapentin oral suspensions prepared at 100 mg/mL from bulk drug and capsules in either Oral Mix or Oral Mix SF suspending vehicles. Suspensions were packaged in amber plastic bottles and amber plastic syringes at 25°C / 60%RH for up to 90 days. Throughout the study period, the following tests were performed to evaluate the stability of the preparations: organoleptic inspection to detect homogeneity, color or odor changes; pH measurements; and gabapentin assay using a stability-indicating HPLC-UV method. As crystallization was observed at 5°C, storage at this temperature condition is not recommended. All preparations stored at 25°C / 60%RH remained stable for the whole study duration of 90 days.
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spelling pubmed-53935832017-05-04 Stability of gabapentin in extemporaneously compounded oral suspensions Friciu, Mihaela Roullin, V. Gaëlle Leclair, Grégoire PLoS One Research Article This study reports the stability of extemporaneously prepared gabapentin oral suspensions prepared at 100 mg/mL from bulk drug and capsules in either Oral Mix or Oral Mix SF suspending vehicles. Suspensions were packaged in amber plastic bottles and amber plastic syringes at 25°C / 60%RH for up to 90 days. Throughout the study period, the following tests were performed to evaluate the stability of the preparations: organoleptic inspection to detect homogeneity, color or odor changes; pH measurements; and gabapentin assay using a stability-indicating HPLC-UV method. As crystallization was observed at 5°C, storage at this temperature condition is not recommended. All preparations stored at 25°C / 60%RH remained stable for the whole study duration of 90 days. Public Library of Science 2017-04-17 /pmc/articles/PMC5393583/ /pubmed/28414771 http://dx.doi.org/10.1371/journal.pone.0175208 Text en © 2017 Friciu et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Friciu, Mihaela
Roullin, V. Gaëlle
Leclair, Grégoire
Stability of gabapentin in extemporaneously compounded oral suspensions
title Stability of gabapentin in extemporaneously compounded oral suspensions
title_full Stability of gabapentin in extemporaneously compounded oral suspensions
title_fullStr Stability of gabapentin in extemporaneously compounded oral suspensions
title_full_unstemmed Stability of gabapentin in extemporaneously compounded oral suspensions
title_short Stability of gabapentin in extemporaneously compounded oral suspensions
title_sort stability of gabapentin in extemporaneously compounded oral suspensions
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5393583/
https://www.ncbi.nlm.nih.gov/pubmed/28414771
http://dx.doi.org/10.1371/journal.pone.0175208
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