2011LamPharmacotherapyFormulationsoralantineoplastic

EXTEMPORANEOUS PREPARATION OF ORAL LIQUID ANTICANCER DRUGS Lam17Table 1. (continued)Storage and Stability, and Label Information Codes a CommentsNo dataANo data A, C, J Bioavailability of oral tablets is equal to that of solutionNo dataMethod 1: 0 days at room temperature andunder refrigeration at 5°CShake well, protect from lightMethod 2: 5 days at room temperature,84 days when refrigeratedShake well, refrigerateAA, C, FNo data; drink the liquid immediately, then A, F, H, J Oral suspension and oral swallowed capsules arerinse glass with half a glass of water andbioequivalentconsume to ensure administration of full doseDo not disperse capsules or drink the suspension withgrapefruit juiceNo dataAMethod 1: 30 days when stored under A, C, F, J When stored at room temperature, stability is only 2 daysrefrigerationat which only 95.7% of the drug remains, and after 3 days,Shake well, refrigerateonly 90.8% remainsMethod 2: No dataDrug monitoring and individual dosage adjustment shouldbe considered because of the variability in busulfanbioavailability and wide interpatient variability regardlessof what oral formulation is usedNo data; drink the liquid immediately, then A, D, F Bitter taste of the solution can be flavored with fruit juicerinse the glass with half a glass of water andor squash, but grapefruit juice should not be used; theconsume to ensure administration of full dosesolution may also be administered through a nasogastrictube or other enteral feeding tube7 days when refrigerated A, C, F Potency dropped < 90% in less than 24 hrs at roomShake well, refrigerate, protect from lighttemperatureMethod 1: 14 days when refrigerated A, C, F Tablets can be crushed but manufacturer recommends to useShake well, refrigerateinjection powder for reconstitution for making oral liquidMethod 2: At least 5 days in both simple syrupMethods 2 and 3 may be preferred due to their simplicity inand Ora-Plus when refrigerated; 8 days inpreparation and longer stability, and aromatic elixir is nosimple syrup at room temperature and 3 dayslonger commercially availablein Ora-Plus at room temperatureShake well, refrigerateThe rate of degradation was not studied withrespect to light conditions; the authorssuggested storing the suspension in the darkor using amber syringesPhysical stability (odor, color, and consistencyof the suspension) remained unchanged at theend of the studyThere was no evidence of microbial growthMethod 3: Storage at room temperature resultedin 10% degradation of the drug in 10. days insimple syrup and in .0 days in Ora-Plus