Survival of a probiotic-containing product using capsule-within-capsule technology in an in vitro model of the stomach and small intestine (TIM-1)

Abstract

The aim of the research was to compare the survival of a blend of five probiotic strains (2 bifidobacteria and 3 lactobacilli) in a capsule within capsule (Duocap®) containing Ahiflower® oil, as compared to the strains in the powder (with or without Ahiflower oil), or the strains when present in the inner capsule only. This was tested in a validated, dynamic in vitro model of the stomach and small intestine (TIM-1), simulating human adults. Experiments were performed both in the gastric compartment of the model, as well as in the complete system (stomach + small intestine). Survival of the strains after transit through the gastric compartment in the Duocap capsule was higher by about a factor of 1.5 compared to the other 3 variables. In these gastric experiments, the Ahiflower oil did not seem to have an additional benefit, in the sense that it did not increase survival over the strains alone. After transit through the complete gastrointestinal tract survival was approximately 2-fold higher for the strains within the Duocap capsule, compared to the strains within the inner capsule or the powder. In these experiments, Ahiflower oil did have an additional benefit. The survival of the strains in the combination of powder with Ahiflower oil showed a similar survival as that of the Duocap, although in the first few hours of the experiments survival of both species lagged behind, and only caught up at the end of the test. In conclusion, the developed capsule-in-capsule technology increased the amount of viable cells in the upper gastrointestinal tract, mainly due to the presence of the polyunsaturated fatty acids contained in the outer capsule, which particularly protected the blend of probiotics in the small intestine.

Combined Self-Nanoemulsifying and Solid Dispersion Systems Showed Enhanced Cinnarizine Release in Hypochlorhydria/Achlorhydria Dissolution Model

“…Based on these findings, the claimed hypothesis was proven and the system can be developed so that the drug-free S-SNEDDS would be totally separated from CN loaded SD to minimize drug interaction with the formulation excipients and/or the adsorbent. The developed formulation could be filled using capsule-in-capsule strategy where CN-SD and drug-free S-SNEDDS would be filled in two different capsules [ 36 ]. Alternatively, drug-free S-SNEDDS might be compressed into tablets followed by layering of CN-SD as a separate coating layer on top of the SNEDDS tablet [ 13 ].…”

Effect of Simulated Gastrointestinal Tract Conditions on Survivability of Probiotic Bacteria Present in Commercial Preparations

“…This is, probably, caused by reduced survivability of individual probiotic strains under varying conditions of the alimentary tract. Oral administration of at least 10 7 cells of a probiotic strain per milliliter or gram of food should ensure a positive effect to the host even when some of them do not survive the unfavorable conditions of the gastrointestinal passage [16]. Most of the commercial probiotics are registered as "dietary supplements" and therefore do not have to comply with quality requirements obligatory for drugs [17].…”

In vitro models to evaluate ingestible devices: Present status and current trends

“…The TIM-1 apparatus has been used to evaluate the survival of probiotics in a capsule within capsule (Duocap®) ingested device [146]. The ability to directly observe the disintegration of the capsules within the gastric compartment was noted as a useful feature of the TIM-1 apparatus in this particular study [146].…”

“…The TIM-1 apparatus has been used to evaluate the survival of probiotics in a capsule within capsule (Duocap®) ingested device [146]. The ability to directly observe the disintegration of the capsules within the gastric compartment was noted as a useful feature of the TIM-1 apparatus in this particular study [146]. TIM-1 has also been reported to have been used to optimize the composition of an enteric coating as well as the thickness that should be applied to a probiotic ingested tablet [147].…”