Stability of gabapentin in extemporaneously compounded oral suspensions

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.

Acute post-injury blockade of α2δ-1 calcium channel subunits prevents pathological autonomic plasticity after spinal cord injury

“…We first tested different routes of GBP administration to determine the optimal method to achieve consistent, neuroactive concentrations of GBP within the spinal cord. GBP saturates in pure H 2 O at 100 mg/ml (Friciu et al, 2017), and we determined it saturates in saline at 133 mg/ml. Therefore, for initial dosing studies we first administered 133 mg/ml GBP via an implanted mini-pump with a delivery rate of 6 ml/day (800 mg total GBP/day or 40 mg/kg), which was the maximum volume possible with the mini-pump.…”

Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method

“…Even though the sample preparation presented in this article is complex and involves a multi-step preparation, results and variations observed are within the acceptable range for the stability evaluation of compounded preparation [ 23 – 27 ]. The advantage of this method is the opportunity to concentrate the analyte to facilitate its detection and to drastically reduce the quantity of excipients injected in the HPLC system.…”

Beyond-Use Dates Assignment for Pharmaceutical Preparations: Example of Low-Dose Amiodarone Capsules

“…Total aerobic microbial count and total combined yeasts and mold count were performed only on the 5 mg capsules at time zero (3 batches tested), 1 week (batch 1), 1 month (batch 2), 2 months (batch 3), 3 months (batch 1), 4 months (batch 2), 6 months (batch 3), and 1 year (3 batches tested). As reported in several publications, a significant change in the active pharmaceutical ingredient content was defined as a “10% change in assay from its initial value.” 17-22…”