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Question

Posted on: March 6 2013

We have a prescription for: Pravastatin 40mg/5ml FAC 3 x 200ml

This preparation should be made on the basis of Pravastatin Sandoz.

Answer

The following text discusses the stability of such preparation. I would rather opt for the ability to pulverize the CLI ë NT a tablet itself and then mix the obtained powder with yogurt or flat cheese, to facilitate the intake issue.
Stability of Pravastatin in two extemporaneously prepared oral dosage forms stored under refrigeration and at room temperature.

Nahata, MC. Morosco, RS. Boster, EA. Zaucha, YEAH.
Ashp Midyear Clinical Meeting. 40: P-101E. 2005.

Pravastatin is used in infants and young children. However, it is not commercially available as a liquid. Little is known about the stability of pravastatin in extemporaneously prepared oral liquid dosage forms. The objective of our study was to determine the stability of pravastatin in two oral suspensions stored at 4 and 25 degrees centigrade in plastic prescription bottles. Methods: Five bottles contained one percent methyl cellulose: simple syrup NF (1:10) and five additional bottles had Ora PIus: Ora Sweet (1:1), at a pravastatin concentration of 10 milligrams per milliliter. Three samples were collected from each bottle on days 0, and 7; These were analyzed by a stability indicating HPLC analytical method (N of 15). Forced degradation was performed with heat, acid and base hydrolysis; There was no interference with the pravastatin quantification. The chromatographic analysis was accomplished using a Zorbax C18 150x3 millimeter internal diameter column. The Mobile phase consisted of acetonitrile and 50 millimolar ammonium phosphate (25:75). The correlation coefficient was greater than 0.9997 with a coefficient of variation less than 1.0 percent intraday and 2.6 percent interday. The pH was measured with a digital pH meter on each study day. Physical appearance was determined on each study day by observing the samples against black and white backgrounds. Results: The mean concentration of pravastatin was above 94.7 Plus/minus 2.1 percent of the original concentration for 7 days at 25 degrees Centigrade and 98.2 plus/minus 1.9 percent for 7 days at 4 degrees centigrade in both formulations. No changes in pH or physical appearance were seen in the refrigerated bottles during this period. At room temperature, contents appeared darker yellow by day 7 and the pH was 0.4 units lower. Conclusion: Pravastatin can be prepared in each of two liquid dosage forms and stored for 7 days under refrigeration and at room temperature, without substantial loss of potency.