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Vraag

Gepost op: 6 maart 2013

Wij hebben een voorschrift voor: Pravastatine 40mg/5ml fac 3 x 200ml


Deze bereiding moet gemaakt worden op basis van Pravastatine Sandoz.

Antwoord

In de hierop volgende tekst wordt de stabiliteit van dergelijk preparaat besproken. Ik zou eerder opteren voor de mogelijkheid de cliënt een tablet zelf te doen verpulveren en vervolgens het verkregen poeder te mengen met yoghurt of platte kaas, kwestie van de inname te vergemakkelijken.
Stability of pravastatin in two extemporaneously prepared oral dosage forms stored under refrigeration and at room temperature.

Nahata, MC. Morosco, RS. Boster, EA. Zaucha, JA.
Ashp Midyear Clinical Meeting. 40: p 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 methylcellulose: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.