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Published Online, 8 December 2004, www.theannals.com, DOI 10.1345/aph.1E299.
 The Annals of Pharmacotherapy: Vol. 39, No. 1, pp. 63-67. DOI 10.1345/aph.1E299
© 2005 Harvey Whitney Books Company.
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CLINICAL PHARMACEUTICS

Extemporaneous Procedures for Dissolving Risedronate Tablets for Oral Administration and for Feeding Tubes

Richard J Dansereau, PhD

Research Fellow, Procter & Gamble Pharmaceuticals, Mason, OH

Debbie J Crail

Research Scientist, Procter & Gamble Pharmaceuticals

Reprints: Dr. Dansereau, Procter & Gamble Pharmaceuticals, 8700 Mason-Montgomery Rd., Mason, OH 45040-9462, fax 513/622-3898, dansereau.rj{at}pg.com

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.

Key Words: Actonel, compatibility, feeding tubes, risedronate sodium

Published Online, December 8, 2004. www.theannals.com, DOI 10.1345/aph.1E299




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