Stability of gabapentin in extemporaneously compounded oral suspensions

PLoS One. 2017 Apr 17;12(4):e0175208. doi: 10.1371/journal.pone.0175208. eCollection 2017.

Abstract

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.

Publication types

  • Validation Study

MeSH terms

  • Administration, Oral
  • Amines / administration & dosage*
  • Amines / chemistry*
  • Anticonvulsants / administration & dosage*
  • Anticonvulsants / chemistry*
  • Capsules
  • Chromatography, High Pressure Liquid
  • Cold Temperature
  • Cyclohexanecarboxylic Acids / administration & dosage*
  • Cyclohexanecarboxylic Acids / chemistry*
  • Drug Compounding
  • Drug Stability
  • Drug Storage
  • Gabapentin
  • Humans
  • Powders
  • Suspensions
  • gamma-Aminobutyric Acid / administration & dosage*
  • gamma-Aminobutyric Acid / chemistry*

Substances

  • Amines
  • Anticonvulsants
  • Capsules
  • Cyclohexanecarboxylic Acids
  • Powders
  • Suspensions
  • gamma-Aminobutyric Acid
  • Gabapentin

Grants and funding

This study was supported by an unrestricted grant from Medisca Pharmaceutique Inc. In compliance with Pr. Leclair's standard protocol, this study was conducted to evaluate the stability of extemporaneously compounded diazoxide suspensions prepared from bulk drug and commercial capsules in Oral Mix and Oral Mix SF vehicles and stored in plastic bottles and oral syringes. Oral Mix and Oral Mix SF are proprietary vehicles of Medisca Pharmaceutique Inc. Funding for this project was only conditional to the execution of the study and no commitments were taken regarding the outcome results of this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. If accepted for publication in PLOS One, the publication costs will be covered by Medisca Pharmaceutique Inc.