Gabapentin stability and shelf life
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Gabapentin Stability in Oral Suspensions and Solid Dosage Forms
Stability of Gabapentin Oral Suspensions
Multiple studies have shown that gabapentin oral suspensions can remain stable for extended periods under various storage conditions. Suspensions prepared at 100 mg/mL using different vehicles (such as Oral Mix, Oral Mix SF, methylcellulose in syrup, and commercial suspending agents) and stored at room temperature (25°C) maintained over 90% of their initial concentration for up to 90 days, with no significant changes in pH, odor, or appearance. However, refrigeration at 4°C is not always recommended, as crystallization can occur in some formulations, though others remained stable for up to 91 days under refrigeration or 56 days at room temperature, depending on the vehicle used 235.
Stability of Gabapentin in SyrSpend SF
Gabapentin compounded in SyrSpend SF, a suspending agent free of alcohol and sorbitol, was found to be stable for at least 90 days when stored in low actinic bottles at both room temperature and refrigerated conditions, provided the product is protected from light. The concentration remained within 90% to 110% of the initial value throughout the study period, suggesting a beyond-use date of at least 90 days .
Stability of Gabapentin Capsules and Repackaged Forms
Gabapentin 300-mg capsules stored in their original containers or repackaged in unit dose blister strips remained stable for up to one year under long-term storage conditions (25°C, 60% relative humidity) and for up to three months under accelerated conditions (40°C, 75% relative humidity). Potency remained above 95–97%, and any detected degradation products were within acceptable limits. However, repackaged capsules showed some weight increase, but this did not affect potency or stability .
Physical Stability in Topical Formulations
Gabapentin compounded in Pluronic lecithin organogel for topical use was physically stable for at least 14 days, with consistent organoleptic properties and only slight pH changes. The stability and drug release profile depended on the specific formulation, especially when combined with other drugs. More complex combinations showed some instability and altered physical properties .
Manufacturing and Shelf Life Risk Assessment
A model-based risk assessment approach using Bayesian estimation and Monte Carlo simulations has been applied to gabapentin tablet formulations to predict the probability of meeting end-of-expiry stability criteria. This approach links manufacturing controls with shelf life stability, allowing for better prediction and management of stability risks during production and storage .
Conclusion
Gabapentin is generally stable in both oral suspension and solid dosage forms under recommended storage conditions, with shelf lives ranging from 56 to 91 days for suspensions and up to one year for capsules. The choice of suspending agent, storage temperature, and packaging can influence stability, and advanced modeling can help predict and manage shelf life risks. Proper formulation and storage are key to maintaining gabapentin’s potency and safety over time 123456.
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