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Development of two stable oral suspensions for gabapentin
1College of Pharmacy, Ohio State University, Columbus 43210, USA.
Pediatric Neurology
|April 20, 1999
Summary
Stable oral gabapentin suspensions can be prepared from capsules. These suspensions maintain drug integrity for up to 91 days refrigerated or 56 days at room temperature.
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation
- Stability Studies
Background:
- Gabapentin lacks an approved liquid dosage form for clinical administration.
- The need for stable, accessible liquid gabapentin formulations is critical for patient compliance and dosing flexibility.
Purpose of the Study:
- To develop and assess the stability of two extemporaneously prepared oral gabapentin suspensions.
- To determine optimal storage conditions (refrigeration vs. room temperature) for these gabapentin suspensions.
Main Methods:
- Two gabapentin oral suspensions (100 mg/mL) were formulated using methylcellulose/syrup and Ora Plus/Ora Sweet.
- Suspensions were stored in plastic bottles at 4°C and 25°C, with samples analyzed via stability-indicating HPLC on days 0-91.
Main Results:
- Both gabapentin suspensions maintained over 90% of initial concentration for 91 days at 4°C and 56 days at 25°C.
- No significant changes in pH, odor, or physical appearance were noted during the study period.
Conclusions:
- Stable oral gabapentin suspensions can be successfully prepared extemporaneously.
- These formulations are suitable for storage for up to 91 days under refrigeration or 56 days at room temperature, offering a viable alternative to capsules.