Development and Physical Stability Assessment of an Extemporaneous Formulation of Gabapentin Lozenges.

Abstract

Background: Lozenge formulations are typically used for local effects on mouth and throat tissue or for systemic drug delivery, which is particularly beneficial for elderly patients with dysphagia. Given that gabapentin is a widely prescribed medication, especially among older adults, an extemporaneous formulation of gabapentin lozenges would offer a valuable alternative for these patients.

Objective: To formulate gabapentin lozenges in three different bases and evaluate which base provides a physically stable extemporaneous compounded formulation.

Method: An experimental design was employed. Three gabapentin lozenge formulations were prepared using different bases: sorbitol, PEG, and gelatin, representing hard, soft, and chewable lozenges, respectively. The resulting formulations were tested for physical stability, including appearance, weight variation, and dissolution, at different temperatures (4°C and 25°C) over a period of 8 consecutive weeks. Retention of original physical properties during the testing period was indicative of physical stability.

Results: The results obtained show that gabapentin is physically stable in soft (PEG) and chewable (gelatin) lozenge bases at room temperature (25 ± 2 °C) and in hard (sorbitol) and soft (PEG) bases at refrigerator temperature (4 ± 2 °C).

Conclusion: The findings suggest that the physically stable gabapentin lozenge formulations obtained in this study: soft and chewable at room temperature, and hard and soft at refrigerator temperature, can be considered viable new dosage forms.