Abstract
AbstractObjectivesDrugs are developed for adults, making it difficult to find suitable treatments for children. Hospital pharmacy has developed alternatives to respond to this medical need. The objective of this study is to present a new liquid formulation of ursodeoxycholic acid (UDCA) at a concentration suitable for treatment of neonatal jaundice, and to introduce a novel high pressure liquid chromatography (HPLC) assay method.MethodsFour formulations have been developed using suspension vehicles due to the low solubility of the active ingredient, and different concentrations of excipient, xanthan gum, needed to facilitate resuspension. An HPLC method coupled to a diode array detector (DAD) has been developed. This method was used to analyze chemical and microbiologic stabilities, as well as physicochemical properties and palatability.ResultsAfter formulation was chosen, our new HPLC method assay was developed and validated for the quantification of chemical and microbiological stabilities of our product. Both parameters were stable over three months. Palatability has been improved thanks to the addition of universal suspension adjuvants. Odor, appearance and taste were judged pleasant despite a bitter aftertaste, with a persistence of the UDCA resuspension after one month.ConclusionsThree months after informing neonatal department about the availability of the drug, patients and caregivers are satisfied, and production campaigns are routinely planned.
Highlights
Due to financial constraints and trial design challenges, most drugs are developed for adults and are administered to children empirically using fractions of adult dosing
The objective of this study is to present a new liquid formulation of ursodeoxycholic acid (UDCA) at a concentration suitable for treatment of neonatal jaundice, and to introduce a novel high pressure liquid chromatography (HPLC) assay method
An HPLC method coupled to a diode array detector (DAD) has been developed
Summary
Due to financial constraints and trial design challenges, most drugs are developed for adults and are administered to children empirically using fractions of adult dosing. Ursodeoxycholic acid (UDCA) is a natural bile acid present in very small quantities in humans It is currently used for the treatment of neonatal jaundice. This disease, caused by an immaturity of the biliary production, affects 1 out of 2,500 births [1]. UDCA acts on the enterohepatic circulation of endogenous bile acids by increasing their biliary secretion, inhibiting their active reabsorption by the intestine and lowering their concentration in the blood. It reduces the saturation of bile in cholesterol by reducing its intestinal absorption, increasing its hepatic catabolism, and maintaining it in its soluble form in the bile [2]
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