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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...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2017
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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. |
format | Online Article Text |
id | pubmed-5393583 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
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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