About FDgard®

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 Meal-Triggered Indigestion or 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 intake and the uptake (i.e., digestion of food and absorption) of nutrients, which have been compromised by FD2.
  • Reduce the accompanying and often distressing symptoms of FD, which can include epigastric pain, discomfort, cramping, postprandial fullness, early satiety, nausea, bloating and belching3.

FDgard® capsules deliver solid-state, triple-coated, targeted-release 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 targeted delivery.

Until 2016, targeted delivery to the duodenum— the site of the disturbance in FD— had posed a challenge. FDgard® answered this challenge. Each FDgard® capsule contains tiny microspheres (≈1.2mm), that can pass easily from the stomach to the duodenum without relying on gastric emptying. Instead, these microspheres are designed to stay intact and move quickly through the stomach and through the pylorus and release fast in the duodenum.

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 opposed to a liquid-filled product).

  • 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 to large food particles.
  • The second layer contains' a pH triggered coating that rapidly dissolves as it passes through the pylorus into a pH of 6.64.
  • 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.
  • 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® Advantage

FD symptoms frequently occur during and after eating. FDgard® has been formulated to be taken 30-60 minutes before a meal. If this pre-meal dosage is missed, the patients have dosing flexibility to take FDgard® during 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 inter-digestive phase of the stomach. This helps toward 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 placebo3.

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

References

  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.
  4. Evans DF, Pye G, Bramley R, Clark AG, Dyson TJ, Hardcastle JD. Measurement of gastrointestinal pH profiles in normal ambulant human subjects. Gut. 1988;29(8):1035-1041. doi:10.1136/gut.29.8.1035.

Testimonials

Dr. Arai

“What I like about FDgard® is it’s very safe, very easy to access...It’s very effective, and I find that it works early on.”

Dr. Shanmugam

“FDgard® [has] very minimal side effects and is easily accessible over the counter.”

Consumer

“One will do anything to feel better, so my husband and I went to CVS/pharmacy and luckily found one remaining box on the shelf, I bought it, took it that afternoon and again the next morning. To my surprise and amazement, I felt great within a short time, and continued feeling wonderful.”

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