Abstract
Negative hedonic sensory qualities of HIV antiretroviral drugs often reduce patient adherence particularly in pediatric populations requiring oral consumption. This study examines the palatability of an innovative delivery mechanism utilizing a freeze-drying-in-blister approach to create fast-dissolving tablets (FDTs) containing a fixed-dose combination of lopinavir and ritonavir (LPV/r). Consumption patterns of solutions during brief-access and long-term testing and baby foodstuff consumption were analyzed to evaluate the orosensory detection and avoidance of placebo FDTs containing no LPV/r (FDT−) and FDTs containing LPV/r (FDT+). Rats showed no change in consumption patterns for the placebo FDT− compared with control solutions. Rats can detect but do not avoid FDT+ at body-weight-adjusted dosages in both brief-access (30-s) and long-term (23 h) consumption tests. There is an aversive response to concentrated doses of FDT+ during brief-access tests that cannot be masked by 25% sucrose. However, the strongest FDT+ concentration was not rejected when mixed with 50 g of applesauce, banana sauce, or rice cereal baby foodstuffs. The averseness of the FDT+ was associated with the presence of LPV/r and not the FDT− formulation itself. The novel FDT formulation appears to be a palatable delivery mechanism for oral antiretroviral pharmaceuticals especially when mixed with baby foodstuffs.
Highlights
As of 2015, there were an estimated 1.8 million children under the age of fourteen living with HIV, and only half of those children were receiving medical treatment [1]
There was a significant main effect (F[5,60] = 664.270, p < .001) of increasing the lopinavir and ritonavir (LPV/r) fast-dissolving tablets (FDTs)+ concentration on the standardized lick ratio during 30-s trials (Figure 1(a)) with post hoc pairwise comparisons revealing no difference between water, the FDT−
Avoidance of LPV/r (FDT+) during brief-access tests demonstrated an aversive orosensory component that was attributed to the LPV/r component and not the FDT formulation (FDT−) and this averseness could not be masked by sucrose
Summary
As of 2015, there were an estimated 1.8 million children under the age of fourteen living with HIV, and only half of those children were receiving medical treatment [1]. One of the most common and successful treatments for HIV is antiretroviral therapy through pharmaceuticals such as the protease inhibitors lopinavir and ritonavir (LPV/r) [2]. LPV/r effectively reduces circulating HIV which in turn has been shown to reduce the risk of opportunistic infections in a pediatric population [3]. The current oral liquid formulation of LPV/r contains 42% ethanol (EtOH) and 15% propylene glycol which elicits an aversive response. In children under the age of four, taste and the inability to swallow were the most commonly reported problems with the adherence for either liquid or minitablet formulations of LPV/r [6, 7]
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