How Does FDgard Work?

FDgard – an advance in the management of FD in the United States.

FDgard is a medical food specially formulated for the dietary management of Functional Dyspepsia. The combination of caraway oil (primary components: d-Carvone and d-Limonene) and peppermint oil (primary component: l-Menthol) has been shown in several double-blind, randomized, placebo-controlled studies1 to be effective for people with FD and can help to:

  • Normalize the digestion of food and absorption of nutrients which have been compromised by FD.2
  • Reduce the accompanying and often distressing symptoms of FD, which can include epigastric pain, discomfort, cramping, postprandial fullness, early satiety, nausea, bloating and belching.3

FDgard capsules deliver individually triple-coated, targeted-release, solid-state microspheres of caraway oil (d-Carvone and d-Limonene) and l-Menthol, quickly and reliably to where they are needed most in FD – the gastro-duodenal region.

FDgard has been engineered specifically to allow release of the caraway oil and l-Menthol from microspheres into the duodenum, for optimal delivery.

Until now, targeted delivery to the duodenum— the site of the disturbance in FD— has posed a challenge. Each capsule contains tiny microspheres (≈1.2mm), that can pass easily from the stomach to the duodenum, without relying on gastric emptying. Instead, these microspheres move quickly through the pylorus to the duodenum.

Site Specific Targeting technology pill spill

SST® (Site Specific Targeting) Technology

SST (Site Specific Targeting) technology is a breakthrough in targeted delivery science. Each individual microsphere in the FDgard capsule has three layers of coating, which cover a unique solid-state inner core (as a opposed to a liquid-filled product).

  1. The outermost layer is a non muco-adhesive layer. This layer allows the microspheres to travel easily through the esophagus and prevents their muco-adhesion to the stomach wall and large food particles.
  2. The second layer contains a pH triggered coating that rapidly dissolves, as it passes through the pylorus at a pH of 5.5.
  3. The third layer provides protein (via a gelatin seal coat) in order to prevent the loss of caraway oil and l-Menthol from the core of the microspheres.
  4. The core of the microspheres contains a fiber matrix that entraps the caraway oil and l-Menthol in a solid state. The core also contains a super disintegrant that enables rapid release once the microspheres have entered the duodenum.

FDgard® Delivery Technology

Diagram of triple-coated, sustained-release microsphere

FDgard Advantage

FD symptoms frequently occur during and after eating. FDgard has been formulated so that patients can have dosing flexibility by taking FDgard before or after a meal. Note: Many physicians are now recommending taking FDgard before a meal, as it enables the supportive effect of FDgard to start as early as possible. 

The microspheres in FDgard move quickly and reliably, irrespective of the interdigestive phase of the stomach. This allows for the rapid normalization of the digestive and absorptive processes that have been disrupted by FD.

Among patients taking a fixed combination of caraway oil and peppermint oil, 67% reported a significant global improvement (“very much improved” or “much improved”) in symptoms, compared to 22% for placebo.3

FDgard helps restore normal digestion, absorption, and motility disrupted by FD.

 

1 Thompson Coon, J, and E Ernst. 2002. “Systematic Review: Herbal Medicinal Products for Non-Ulcer Dyspepsia.” Alimentary Pharmacology & Therapeutics 16 (10): 1689–99. doi:10.1046/j.0269-2813.2002.01339.x.

2 Goerg, K. J., and Th Spilker. 2003. “Effect of Peppermint Oil and Caraway Oil on Gastrointestinal Motility in Healthy Volunteers: A Pharmacodynamic Study Using Simultaneous Determination of Gastric and Gall-Bladder Emptying and Orocaecal Transit Time.” Alimentary Pharmacology and Therapeutics. doi:10.1046/j.1365-2036.2003.01421.x.

3 May, B., S. Köhler, and B. Schneider. 2000. “Efficacy and Tolerability of a Fixed Combination of Peppermint Oil and Caraway Oil in Patients Suffering from Functional Dyspepsia.” Alimentary Pharmacology and Therapeutics 14: 1671–77. doi:10.1046/j.1365-2036.2000.00873.x.