Extemporaneous procedures for dissolving risedronate tablets for oral administration and for feeding tubes.
BACKGROUND
Risedronate (Actonel, Procter & Gamble Pharmaceuticals) is commercially available only as film-coated tablets. Extemporaneous procedures for dissolving tablets for feeding tubes and for preparation of an oral liquid have not previously been evaluated.


OBJECTIVE
To evaluate procedures for dissolving risedronate sodium tablets for administration in liquid form and drug recovery following dissolution in cups and following passage through different types of feeding tubes.


METHODS
Tablets (5 and 35 mg) were individually dispersed in 2 oz of water. After 2 minutes, the solution was stirred for 30 seconds, dispensed, and rinsed with an additional 4 oz of water. The sample was filtered and analyzed by HPLC. Ten replicates were performed using the various cups. Gastrostomy and nasoenteric tubes were flushed with 1 oz of water. Individual tablets were dispersed in 2 oz of water; after 2 minutes, the solution was stirred for 30 seconds and poured through the tube and flushed with 1 oz of water. Samples were filtered and analyzed by HPLC. Ten replicates were performed for each type of feeding tube.


RESULTS
For cups, the mean amount of drug recovered ranged from 95.7% to 100.5% of the label claim, with a relative standard deviation (RSD) range of 1.1-6.3%. For gastrostomy and nasoenteric tubes, the mean amount of drug recovered ranged from 98.3% to 101.9% of label claim, with an RSD range of 0.9-3.3%.


CONCLUSIONS
A simple and accurate procedure was developed for dissolving risedronate tablets in water to prepare a liquid formulation for administration orally or through feeding tubes.
Dansereau
Richard J
RJ
Procter & Gamble Pharmaceuticals, Mason, OH 45040-9462, USA. dansereau.rj@pg.com
Crail
Debbie J
DJ
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D004750:Enteral Nutrition; D012968:Etidronic Acid / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000737:chemistry; D019999:Pharmaceutical Solutions; D000068296:Risedronic Acid; D012995:Solubility; D013607:Tablets / Q000737:chemistry
D019999:Pharmaceutical Solutions; D013607:Tablets; D000068296:Risedronic Acid; D012968:Etidronic Acid