2011LamPharmacotherapyFormulationsoralantineoplastic

EXTEMPORANEOUS PREPARATION OF ORAL LIQUID ANTICANCER DRUGS Lam175Table 1. (continued)Storage and Stability, and Label Information Codes a CommentsMethods 1, 2, and 3: No data; administer A, B, F, H To enhance absorption, some clinicians recommendimmediately after preparationadministering with a fatty mealMethod 4: 24 hrs at room temperatureMust not be administered in combination with vitamin AMethod 5: No data; administer immediatelyafter preparationsince symptoms of hypervitaminosis A could be aggravatedNo bioavailability data comparing oral capsules and oralliquid are available, but one pharmacokinetic studysuggests that absorption is highly variable among patients2 wks at room temperature (does not require A, B, F, Irefrigeration)prepared oral solution from the solid dosageforms were found for only seven oral anticanceragents.Major Factors Involved in Extemporaneous OralLiquid PreparationBefore an oral liquid formulation is preparedextemporaneously, it is essential to have anadequate understanding of the pharmacokineticcharacteristics of the drug, the chemical compatibilityof an active drug with excipients, as well asstability, palatability of the final solution, ease ofadministration, and safety concerns. 140–143 With athorough understanding of these basic scientificprinciples, pharmacists will be able to design aformula for extempo-raneous preparation of oralliquid formulations if no suitable formula isavailable in the literature.ExcipientsExcipients used for preparation of oral liquidformulations include suspending agents, vehicles(syrup or flavors to enhance taste), coloradditives, and preservatives. 140–143 Since mostdrugs are not completely soluble in water, a suspendingagent is required to prepare an extemporaneousoral liquid from tablets or capsules. 140Carboxymethylcellulose and methylcellulose arethe most common suspending agents to enhancedose uniformity and physical stability. 140–142Concentrated syrup usually serves as a vehiclebecause it not only improves the taste due to itshigh content of sugar or sucrose, but alsoprovides a preservative effect resulting from its140, 143high osmolality. The most commonly used,commercially available suspending agent andvehicle are Ora-Plus (Paddock Laboratories, Inc.,Minneapolis, MN) and Ora-Sweet (PaddockLaboratories, Inc.), respectively. Ora-Plus, whichis buffered to an acidic pH of 4–4.5 and containspreservatives, is designed to meet the widest142, 144range of potential uses. Ora-Sweet is acitrus-berry–flavored syrup with a buffered pH of4–4.5. 144 For patients with diabetes mellitus, asugar-free product (Ora-Sweet SF [Paddock