Wednesday, February 16, 2011

How can a soft gel equal two ounces of Essiac?

Our biggest challenge was how to convert this age old formula from brewing a tea into a 21st century method of simply taking a pill and obtain the same results.

As many of you may know, pharmaceutical contractors do this every single day and it is really quite a simple math formula to determine the conversion rate from liquid to solid. It goes something like this:

1 ounce of raw Essiac powder diluted into 32 ounces of water equals 28.349 grams of solid powder divided by 32 ounces of liquid water. This equals .886 milligrams of solid powder. This simply means if you took .886 milligrams of the Essiac powder, by itself, and injested it (hard to do without water) however if you managed to ge it down, it would be equal to one ounce of tea.

Now the challenge really begins because the milligram capacity of a soft gel (the amount of stuff you can fit inside the soft gel) is .583 mg. So, how do we fit .886 mg of Essiac powder inside a soft gel that only holds .583 mg?

The answer is extracts. Through testing and research we determined that we could use the powder form of 5 of the herbs needed for the 8 herb formula. We then take the remaining 3 herbs and convert them to an extract form, such as a 4-1 ratio to the powder. As you all know, an extract is simply a condensed form of a product, like frozen orange juice. When you add the water back to the frozen orange juice, it becomes whole again.

Mechanically the production works like this:
  1. Our herbs are orderded from our various suppliers of organic herb growers. The growers send us a sample from their on hand inventory for testing.
  2. Since we manufacture our product to FDA standards of cGMP regulations (compliant to good manufacturing practices) we are required to test every herb for microbiological limits, such as E. Coli, Salmonella and also for heavy metal limits such as lead, mercury, cadmium, et
  3. After receipt of the herb inventory needed for production, we are required by cGMP regulations to test the actual inventory a second time and record that. There is always the possibility that the original test samples could be different than the actual inventory shipped.
  4. Upon approval of the herbs they are then compounded. The compounding process is a series of mixing the 5 herbs and the 3 extracts to the exact formula and adding inactive ingredients such as deionized water, sunflower lecithin which becomes a loose paste and it is forced through various filters, each filtering system finer than the next. This process eventually creates a fine grit that can be mechanically forced through insertion tubes. The grit of this herb paste needs to be a fine as possible as to not pierce the skin of the soft gel, causing it to leak.
  5. The production process is fully automated and the soft gel machine begins to form the soft gels into a mold, which is heated. The actual soft gel is simply made of inactive ingredients such as Rice Bran Oil, Gelatin, Glycerin, Beeswax, which disloves in the stomach in about 12 to 20 minutes. As the machine fills the mold to create the soft gel, the insertion tube measures out the amount of paste needed to fill the soft gel and inserts it into a cavity of the soft gel.
  6. After the production, the soft gels are left on drying racks on top of absorbtion paper for up to a week. The paper absorbs any "leakers" and these are removed during the sorting process. While the soft gels are being dried, we are required once more to test the soft gels to be certain that during the manufacturing process, there was no contamination to the product.
  7. This soft gel, now becomes a 398 mg product once the filling and herbs are added and it is bottled ready for human consumption.
So, taking 2 soft gels in the morning and 2 soft gels in the evening would equal taking 2 ounces of Essiac tea in the AM and 2 ounces in the PM. The soft gel method is not only the easy way to go, withhout any storage, mixing, brewing, and being totally portable but it is the most accurate way to take your Essiac. Each dose is 100% exact, as opposed to adding too much water to your brew or drinking less or more when you are trying to measure your ounces.

Essiac is finally 21st century!

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