Developing a new formulation of sodium phenylbutyrate

Abstract

In vitro dissolution, in vitro and in vivo taste profiles support the view that the newly developed granules can be swallowed before release of the bitter active substance, thus avoiding stimulation of taste receptors. Moreover, Luc 01 was shown to be bioequivalent to the licensed product. The availability of a taste-masked form should improve compliance which is critical to the efficacy of NaPB treatment in patients with UCD.

Design, development andin-vitroevaluation of diclofenac taste-masked orodispersible tablet formulations

“…Tastemasked microgranules have already been introduced in the development of different types of oral solid formulations and have been in the late past also described in the production of chewable and rapidly disintegrating tablets 28,[30][31][32] . Applying particular excipients and technologies, lower effective surface area of the drug exposed to the human tongue after oral intake can be achieved.…”

A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

“…The electronic tongue is a device which detects an electronic signal in a given formulation; the goal is to achieve an electronic signal of the formulation containing the active drug which is similar to formulation containing a placebo (25)(26)(27). A recent paper describes the use of the electronic tongue in formulating a palatable sodium phenylbutyrate preparation, an extremely difficult task (28). In certain cases, the API may have no aversive sensory attributes.…”

One Year Experience of Pheburane® (Sodium Phenylbutyrate) Treatment in a Patient with Argininosuccinate Lyase Deficiency

“…Pheburane ® (granules) consists of small spherical sugar cores which are then coated with NaPB and ethylcellulose sequentially in two separate layers. Ethylcellulose is a well-known taste-masking agent for active substances (Guffon et al 2012). …”