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.
Highlights
We report a comprehensive evaluation of the stability of gabapentin compounded preparations (100 mg/mL) using a validated stability-indicating HPLC-UV method
We studied the effect of the following variables: (1) time: up to 90 days; (2) temperature: 25 ̊C; (3) gabapentin source: bulk drug and capsules; (4) vehicle: Oral Mix and Oral Mix SF; and (5) packaging: amber PET bottles and oral plastic syringes
When gabapentin liquid preparations were produced in these vehicles, there was little or no change in appearance suggesting that most of the drug was in the dissolved state
Summary
Gabapentin binds to voltageoperated N and P/Q calcium channels causing the inhibition of voltage-dependent calcium current [1] This mechanism of action is different from other classes of antiepileptic drugs that increase GABA-mediated events, block sodium channels or inhibit glutamate mediated event. According to product label of Neurontin in the USA, this drug is indicated for the treatment of post-herpetic neuralgia in adults as well as an adjunctive treatment of partial onset seizures in adults and patients 3 years and older [2]. This drug need to be titrated over a period of three days up to a maintenance dose of 600 mg three time a day for patient of 12 years and older [2]. The maintenance dose in children of 3 to 12 years of age is 10 to 15 mg/kg/day divided in three equal doses per day [2]
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