A novel hypromellose capsule, with acid resistance properties, permits the targeted delivery of acid-sensitive products to the intestine

The delivery of acid sensitive actives in the gastrointestinal tract (GIT) requires specific formulation technology that can act as protection against harsh physiological conditions. Recently, vegetarian capsules based on hypromellose have become commercially available (for example, Vcaps (R), Vcaps (R) plus and DRcaps (TM)). Among them, DRcaps (TM) shows a dissolution profile that is resistant at low pH (1.2). The objective of this study is to assess the efficacy the DRcaps (TM) in protecting and delivering pure probiotic and enzymatic activities under gastrointestinal relevant conditions such as fasted and fed status, using the Simulator of the Human Intestinal Microbial Ecosystem (SHIME (R)) technology platform. When compared with other formulations, DRcaps (TM) show - especially under fasted conditions - an increased ability to protect both probiotic microorganisms (at least an increase of 1 Log) and acid-sensitive enzymes, i.e. lipase and amylase (at least an activity increase of 1.5 times over the other formulations) during gastrointestinal digestion. Additional trials with DRcaps (TM) also show a 100% residual viability for probiotic bacteria in a 24-month shelf-life test (temperature of 25 degrees C and 30 degrees C/13.8 and 18.2 g/m(3) relative humidity, respectively). Finally, customers perceive that this new type of capsule has a superior organoleptic performance, assessed by the reduction or absence of an aftertaste, when compared with compressed tablets. (C) 2014 Elsevier Ltd. All rights reserved.