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

• Published in: The Annals of pharmacotherapy 2005-01, Vol.39 (1), p.63-67
• Main Authors: Dansereau, Richard J, Crail, Debbie J
• Format: Article
• Language: English
• Subjects: Administration, Oral; Biological and medical sciences; Chemistry, Pharmaceutical; Drug Compounding; Enteral Nutrition; Etidronic Acid - administration & dosage; Etidronic Acid - analogs & derivatives; Etidronic Acid - chemistry; General pharmacology; Medical sciences; Pharmaceutical Solutions; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Risedronate Sodium; Solubility; Tablets - chemistry
• ISSN: 1060-0280; 1542-6270
• DOI: 10.1345/aph.1E299

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.