While some companies say they are raising their standards
... at Thorne we set them.
Prior to the introduction of the Thorne line of products in 1984, there were no truly hypoallergenic products available in the marketplace. Products were still produced as excipient-containing tablets or capsules containing potentially allergenic flowing agents and diluents.
Physicians found something remarkable in the Thorne supplements they prescribed. Since they did not contain unnecessary diluents, sensitive patients no longer suffered bloating, nausea, and diarrhea from supplements that contained hidden lactose or other excipients. The offering of a complete product line of Thorne supplements made without magnesium stearate, palmitic acid, or stearic acid as flowing agents revolutionized the way a supplement’s performance was perceived.
Why? By not coating each nutrient particle with a complete layer of saturated fat, nutrients are available to be immediately absorbed by patients who need the nutrients most – the digestive and immune compromised patient. Physicians now realize not only are Thorne Research products best for their “worst case” patients, but they work better for all patients. Find out here what sets THORNE apart from the competition.
In a classic study published in Pharmaceutical Technology, the results of mixing a nutrient with magnesium stearate were demonstrated. After just 10 minutes mixing time with magnesium stearate, the percent dissolution of the nutrient (after 20 minutes in the solution) decreased from 80-90% dissolution without magnesium stearate. When mixing time of the nutrient with stearate was extended to 28 minutes, less than 20% dissolution was obtained, even after 35 minutes in solution. It is crucial that customers realize that whenever they see magnesium stearate or stearic acid on a label that the supplement contains a mixture of saturated fats used as flowing agents. Stearic acid melts at about 156°F, palmitic acid melts at about 146°F - so imagine your nutrients trapped in a sphere of waxy substances similar to candle wax.
Ascorbyl palmitate, a compound of ascorbic acid and palmitic acid, is a waxy, soapy, slippery substance utilized by some companies as a flowing agent, but labeled as a vitamin C source. Interestingly, a manufacturer using ascorbyl palmitate can claim ascorbyl palmitate is included as a therapeutic vitamin C source, or that it antioxidant actively protects the integrity of the other ingredients in the capsule. The physician's question to such statement should be: "Why isn't the ascorbyl palmitate added to that company's bulk powder with the same ingredient?"
At Thorne, our manufacturing process is considerably more difficult, since no product-compromising flowing agents are utilized. To produce the same number of bottles as the competitor who utilizes magnesium stearate or stearate/palmitic acid, Thorne literally needs to have more than twice the number of comparable encapsulating machines, since most products will only run at a greatly reduced speed without flowing agents. More manufacturing rooms are necessary, more employees, and more support equipment, such as compressors and air removal systems. Manufacturing Thorne products to our rigid standards requires much more effort than any other method. It is Thorne's commitment to our customers.
The addition of any stearic/palmitic acid during the manufacturing process of any dietary supplement product can have an adverse impact on both solubility and bioavailablity of the nutrients in the supplement being manufactured. The result? In patients with compromised digestion or absorption, the presence of stearic/palmitic acid in their dietary supplement can possibly jeopardize utilization by the patient of the intended nutrients. On the other hand, supplements manufactured without these lubricants or additives demonstrate rapid dissolution in the stomach and unimpeded absorption in the intestinal tract, resulting in the most efficient nutrient delivery possible.
Why is stearic/palmitic acid added? Most supplement products are manufactured by "jobbers", who have large production facilities that churn out a multitude of formulas for various companies. Jobbers work on a given profit margin and if a product does not run on specific machinery at optimum speed, then various lubricants, such as stearic/palmitic acid are added to ensure tablet or capsule production meets schedule.
Many companies talk about purity and superior raw materials, but have not managed to solve the problem of flowing agents. Companies have tried to duplicate the Thorne Research manufacturing process, but none have been successful. When Thorne fills additional space in a capsule, only those hypoallergenic ingredients we have utilized for the past 18 yaers are added: magnesium citrate, aspartic acid, leucine or silicon dioxid.
Standards are used throughout many industries. When you purchase a light bulb, it has a standard base which fits your standard socket.A standard piece of paper is 8 ½“ X 11". You would not like to purchase pair of shoes that were made for two left feet (unless, of course, you sold Sago Palm Vitamin C). Throughout the nutritional industry, certain standards are maintained by raw material suppliers to ensure the same potency from batch to batch. As an example, let us look a pancreatin. U.S.P. pancreatin must have an amylase activity not less than 25 U.S.P. units per mg., a lipase activity not less than 2 U.S.P. units per mg. This is “standardized pancreatin” which started out at a much higher potency. Pure, undiluted pancreatin may have an activity of amylase 225+, lipase 38+, and protease 205+ U.S.P. units per mg, but will be diluted to “3X,” “8X or other potencies using the diluents called for, by law, in the “U.S.A. Pharmacopoeia.” Raw material manufacturers must use SUCROSE, LACTOSE, or pancreatin of lower potency as a diluent. The cost of sucrose is about 75 cents per kilo, lactose about $ 1.20 per kilo, and pancreatin $30 to $40 per kilo in lower potency, undiluted form. There is about as much possibility that the pancreatin in the products you use has been diluted without using lactose or sucrose, as the likelihood that your ascorbic acid actually came from “sago palm.”
Bromelain and Papain are also standardized with lactose or sucrose from their undiluted form. Bromelain in the undiluted form is about 1800 to 2400 MCU (milk clotting units) of activity per gram. One MCU of activity is equal to about 0.6 GDU (gelatin digestive units). Thus Bromelain 2000 MCU is approximately equivalent to Bromelain 1200 GDU. Most Bromelain is supplied in the standardized dilutions of 75, 150, 300, 600,1200, and 1600 MCU, diluted from pure form with lactose. Papain in the undiluted form has about 1350 MCU of activity minimum. One thousand MCU activity of Papain approximately equivalent to 30,000 FCC (Food Chemical Codex units) or 500 Wallerstein units. Standard Papain N.F. is 70 MCU while other dilutions are 100, 150, 200, 300, 400, and 600 MCU, again usually diluted with lactose.
Vitamin A capsules which are “natural source” cod, halibut or fish liver oils have most likely been standardized. There are few fish swimming around that have the foresight to standardize their own livers so that exactly 10,000 IU of Vitamin A will fit perfectly in a #3 oval soft gelatin capsule. Pure Vitamin A Palmitate (possibly stabilized) is used to standardize the product. DI-alpha tocopheryl is used diluted in some case to standardize natural source “ Vitamin E capsules.
Herbal extract concentrates, which are sold in powder form, have been placed on a carrier, usually lactose or dextrin, since solid extracts themselves have the consistency of tar. Hence, a “4X” concentrate of an herb in a tablet product most likely contains lactose or dextrin.
Many other substances are sold as “standardized dilutions” by raw material supplier, such as acerola Powder, Rose Hips Powder, Hesperidin, and the Citrus Bioflavonoids. It is very easy for a manufacturer to put on a label 100 mg of Citrus Bioflavonoid complex and, in fact, put in the product 100 mg of a complex purchased from a raw material supplier which is in actuality only 30% pure bioflavonoids and 70% lactose. They are somewhat correct in their labeling, albeit not totally truthful, since they have used a standardized 30% complex.
Let us look at some of the raw material manufacturers that supply U.S.P. grade vitamin products to the industry. As you will see, there are many choices for your finished product manufacturer to choose from.
BASF (Germany) produces many products, including the pure form of the B vitamins, thiamine, riboflavin, pyridoxine, and calcium pantothenate, and pure as well as coated Vitamin C products. The dry Vitamin E products include free-flowing powder in a matrix of
gelatin, lactose, sodium caseinate, mono- and diglycerides, free-flowing powder with silicic acid adsorbates and crystalline E, all in the “dI”-form. The dry Vitamin A products, both acetate and palmitate, which are suitable for tableting contain BHT as a stabilizer and are embedded in a gelatin carbohydrate matrix which gives the product the ability to flow. The liquid Vitamin A products are in a peanut oil base and usually are stabilized with tocopherol or BHT. The liquid products which are not stabilized have had their concentration adjusted by “use of suitable food grade vegetable oils,” again a standardized product. BASF beta-carotene is a liquid 30% suspension in peanut oil. Liquid E is also available as “dI-.”
DANOCHEMO (Denmark) produces B1, B2 and B12 in a matrix of gelatin, carbohydrate, and modified starch only. The dry Vitamin E products are also provided in a matrix of gelatin, carbohydrate and modified starch only, all in the “dI-“ form. This company stabilizes its Vitamin A and D products with the same gelatin, carbohydrate and starch matrix used in the other products. Although there is a loss of potency slightly less than 1% per month, this process eliminates the use of BHT and other stabilizers (if you don´t mind sugar and starch). Their dry Vitamin A products are very suitable for direct compression; however, in granulation a high solvent to water ration must be used to prevent swelling and dissolution of the gelatin matrix. They provide Vitamin A in liquid form as oil, with a peanut oil diluent, and in water soluble form. However, no mention is made in the technical data of the agent utilized to make the product “miscible with water in any proportion.” Liquid E is also available as “dI-.”
DORMAR provides many products such as enzymes, vegetable powders, and vitamin granulations. B-12 is offered in triturations of dicalcium phosphate, gelatin, and mannitol. Vitamin E is “dI-“ as a spry-dried form. Vitamin A is offered from “fish liver oils or lemongrass,” in some cases with Vitamin D. The B vitamins are offered as “direct compression vitamins that are 95% active.” The technical sheet states that they are “sugar and starch free.” However, it does not state from what the other 5% is composed, and several attempts to find what makes the product “compressible” have produced no result.
HENKEL produces natural Vitamin E as d-alpha tocopherol, d-alpha tocopheryl, and mixed tocopherols. They are considered by many to be the best in the industry for natural source E. Although some products are manufactured with flowing agents such as cellulose gum and sodium silico-aluminate, they do manufacture pure liquid E as d-alpha tocopheryl acetate (Covitol 1360) and pure crystalline E as d-alpha tocopheryl acid succinate (Cpvotp; 1210) Their technical assistance is very efficient, and they provide volumes of information on Vitamin E upon request (perhaps I shouldn´t make that public; they may bill me for future printing costs).
EM INDUSTRIES, U.S. (MERCK, Germany) manufactures pure B1, B2, B6 and folic acid, as well as various pure Vitamin C products and one “compressible C” coated with 1.5% ethyl cellulose. Their dry Vitamin E powder is spray-dried, benzoates are used as well as sorbic acid. The E is in the “dl-“ form. The company provides biotin in two forms, pure and 1% titration with calcium phosphate as the diluent. Merck is also a source for pyridoxal hydrochloride, pyridoxal-5-phosphate, Vitamin K, and some of the ascorbate products, all in pure form. Liquid E is also available as “dl-“.
HOFFMANN-LaROCHE (U.S.). There could very well be a philosophical joke bantered around at Roche: „If a Sago Palm falls in the Roche forest and no one is there to hear it, does it have any validity?“ The answer, of course, would be “no,” since there would be no validity even if someone were present. Roche is the giant in Vitamin C production. In a given year, China will produce 600 metric tons of ascorbic acid; Plevia (Italy), 800; Pfizer, 2,600; BASF, 3,600; EM (Merck), 5,000; Takeda (the “sago palm people,” Japan), 8,000; and Roche alone will produce 33,000 metric tons, more than all the others combined. Roche produces the B vitamins in pure form, as well as B-1, B-2, niacinamide and B-6 in coated form, called Rocoats. The coated materials are worked with more easily. The flavour of B vitamins in products such as chewable multi-vitamin combinations is masked by the coatings. Mono-and diglycerides of “edible fatty acids” as well as stearic acid are employed in Rocoats.
About 20 different Vitamin A products are offered for use in the nutritional industry. All but one (Trans-Retinoic, which is still investigational) contain stabilizing agents such as BHT, BHA, “edible vegetable oils,” sodium benzoate, sorbic acid, dl-alpha tocopherol, methylparaben, prophyl-paraben and potassium sorbate. Many also contain modified food starch, sugar, acacia, lactose, fractionated coconut oil, etc. However, there is hope. Roche is the only domestic supplier of pure, crystalline beta-carotene in unstabilized form. It is difficult to work with, and most of it is sold for research purposes, not to the nutritional industry. The popular forms of beta-carotene are stabilized in much the same manner as the Vitamin A products.
Roche provides about 15 different Vitamin C products. Many are pure (of different density and characteristics), as well as some that are “compressible” such as C-90 (90% ascorbic acid, 10% modified food starch). Biotin and B12 are provided in pure as well as triturated form. Vitamin D is provided in stabilized form or in mixtures with stabilized Vitamin A. E is provided in “dl-“ form only.
As with Henkel, one gets a very good feeling working with Roche. The products are of excellent quality, and the technical assistance is the best in the industry. One does not deal with an importer or manufacturer´s representative; one deals directly with Roche. The technical data state directly in the first paragraph what the product contains (including preservatives, stabilizers, etc.). Information from other manufacturers is buried in an obscure sentence near the end of a nondescript report. If there are any questions about Roche products, one receives an immediate, detailed response from the technical director.
VITAMINS, Inc., provides the B vitamins in pure form as well as Vitamin C, folic acid, and biotin. Vitamin D is provided on a dextrin carrier, and although the technical sheet makes no mention of stabilizers on the product is stabilized with BHT and BHA. Vitamin A is provided in liquid form, standardized in corn oil, with no mention of stabilizers on the technical sheet. Beta-carotene is provided in a carrier of “food grade vegetable oils (partially hydrogenated cottonseed and vegetable oils), “ again with no mention of stabilizers by technical report.
Just as the physician has numerous choices of nutritional suppliers, the suppliers have numerous raw material manufacturers from which to choose. (The aforementioned is only a partial listing.)
As you can see, the choice of raw material and suppliers can become very important to the physician as well as the patient. By questioning the raw materials utilized in the manufacture of supplements, you can upgrade the quality of products you use.
References
1. Technical and sales literature from various companies
2. Food Chemicals Codex, 3rd Edition, National Academy Press, 1981.
3. U.S.P., XX1, 1985, Mack Printing Co., Easton, PA.
Thorne manufactures to GMP (Good Manufacturing Practices) standards that exceed those currently proposed by the industry. These internal GMPs include written, stringent, standard operating procedures for every step of the manufacturing process, including (but not limited to) receiving raw materials, cleaning the manufacturing facility, material storage, product encapsulation, shipping, and quality control procedures. And since January 2000 our GMPs have been approved by the Australian Therapeutic Goods Association, the most stringent governmental health organization in the world.
