An enhanced ginger product for nausea and vomiting related to taking medications, pregnancy, surgery, motion sickness, overeating, and flatulence*
Zindol® DS [US Patent No. 8,436,575] is a highly purified ginger product that is standardized by the bioactive constituents, gingerols and shogaol, of ginger (Zingiber officinale, Roscoe). This product recently completed a successful Phase II/III clinical trial for nausea and vomiting in cancer patients undergoing chemotherapy (Ryan et al., 2011).
Zindol® DS Standardization and Manufacturing
Aphios’ scientists and engineers utilize polarity-guided SuperFluids™ CXF fractionation technology to establish conditions for the isolation of the active ingredients of Zindol® DS [US Patent Nos. 5,854,064 and 6,569,640]. The technology is then scaled-up to manufacture the active pharmaceutical ingredients utilizing patented SuperFluids™ CXP manufacturing technologies [US Patent Nos. 5,440,055 and 5,750,709].
We use organically grown ginger and SuperFluids™ carbon dioxide to selectively extract and concentrate gingerols and shogaol. These extracts are thus free of potentially toxic organic solvents and are tested and certified to be free of pesticides, herbicides, and other contaminants.
This product is manufactured following current Good Manufacturing Practices (GMP) of the U.S. Food and Drug Administration (FDA).
Zindol® DS Formulation and Encapsulation
The enhanced ginger concentrate is then formulated to achieve a specific concentration of gingerols and shogaol with all-natural liquid excipients designed to maximize the stability and bioavailability of the bioactive constituents [US Patent, 2013]. The golden-brown formulation is then encapsulated into gel capsules (LiCaps™) with a nitrogen head by Capsugel, Inc. (a former subsidiary of Pfizer) following cGMP guidelines.
Zindol® Clinical Testing
Zindol® DS’ (Patent, 2013) sister product Zindol® was recently evaluated in a multi-center, 644-patient, dose-finding, placebo-controlled, randomized Phase II/III clinical trial as an adjunctive therapy to conventional 5-HT3 antiemetics for nausea in cancer patients undergoing chemotherapy. This successful clinical trial was managed by the University of Rochester Medical School, Rochester, NY.
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.
Zindol® is a Registered Trademark of Aphios CorporationLicaps® is a Registered Trademark of Capsugel, Inc.