Truth about Vitamin Pills

Report on the
Dissolution of Multi-Vitamin Tablet


Report For Immediate Release

Regency Medical Research, LTD
Report on the Dissolution of Multi-Vitamin Tablets



Abstract:
Absorption is an essential element in determining the efficacy of a multi-vitamin preparation. Historically, vitamin and mineral supplements have been administered as tablets which are swallowed whole. The tablet then travels down the alimentary canal, passing through the esophagus and into the stomach, where it comes into contact with highly acidic digestive juices. The stomach is generally emptied in about 1 hour. From there, it passes to the small intestine, which consists of the duodenum, jejunum and ileum. The jejunum and ileum are the primary sites for absorption of nutrients. As a general rule, if the nutrients have not been absorbed by the time they pass out of the ileum, they will be passed from the body as waste.

The purpose of this study was to examine the breakdown and dissolution of five of the leading brands of multi-vitamin tablets using a "dissolution test" as suggested by the American Medical Association1 and described in detail by Mason et al.2

Materials and Methods:
Five of the leading national brands of multi-vitamin tablet were selected for the study. These were: Brand 1 (for all ages groups), Brand 2 (from the same company, but designed for seniors), and Brands 3, 4, and 5 (each designed for all age groups).
In each test, one tablet of each brand was placed in either water (25 ml at 25C) or white distilled vinegar (25 ml at 25C). The flask was gently shaken at 5 minute intervals over a period of 1 hour. The appearance of the mass of the tablet and the solution were observed and noted throughout the course of the experiment. Tests were repeated 4 - 6 times.

Results:
Tablet appearance:
Brand 1: Pale orange oval; Brand 2: Silver oval; Brand 3: Bright red shiny oval; Brand 4: Pale green oval with dark flecks; Brand 5: Bright red shiny round.

Disintegration in Water:
All test tablets exhibited varying degrees of disintegration, with Brand 1 performing the best, with disintegration occurring within 2 minutes, by which time the solid mass accumulated at the bottom of the reaction vessel was no longer recognizable as an oval tablet. All other Brands, while partially disintegrated, still retained evidence of their original "tablet outline" after 30 minutes, with the order of recognition being, Brand 3 most recognizable to Brand 4 to Brand 2 to Brand 5 - which was almost unrecognizable as a tablet. The disintegration of ALL tablets in the water was accompanied by the liberation of varying amounts of a gas (effervescence) - most likely carbon dioxide. After 1 hour the bottom of each vessel contained a thick precipitate. The water above the precipitate was milky white for brands 1 and 2, clear for brand 3, pale yellow solution for brand 4, and thick red suspension for brand 5.

Disintegration in Vinegar:
Again, all tablets exhibited varying degrees of disintegration, and again Brand 1 performed the best, although slower than in water. Disintegration occurred within 3 minutes. All other Brands had disintegrated within 60 minutes. The effervescence liberated from Brand 4 was extreme, leading to foaming on the surface of the liquid. The effervescence from Brand 2 and 5 was also moderately vigorous. After 1 hour the bottom of each reaction vessel contained a thick precipitate. The vinegar above the precipitate was milky yellow for brands 2 and 4, almost clear, milky white for Brand 1, clear for Brand 3, and thick red for Brand 5. The precipitates at the bottom of the reaction vessels were primarily chalky white with, as for the water test, flecks of reds and browns.

Discussion:
The purpose of this study was to examine the breakdown of five leading brands of multi-vitamin tablet, using the well-known "vinegar test"1, 2, which mimics the acidic environment of the human stomach. Detailed practical procedures for testing the bioavailability of nutritional components of multi-vitamin formulations have been described by Srinivasan5.
Numerous reports have recently appeared describing the fact that some tablets can pass through the entire human digestive system without either dissolving or disintegrating. In fact, un-dissolved tablets are frequently observed on x-rays of the human body3, which can lead to complications in the diagnosis of certain ailments unless the physician is fully aware of the potential for this to occur.
In addition, serious concerns have been voiced over the fact that essential nutrients and medications may not be fully bioavailable to the user due to failures of dissolution. This failure to dissolve can have serious and far-reaching consequences6,7.
The primary function of the digestive system is to break down the complex molecules present in food into small nutrient molecules that are then absorbed and utilized by the body. This process is achieved through the action of digestive juices which can be acidic or enzymatic in nature. Once absorbed by this route, nutrients are rapidly transported to the liver, where they can undergo metabolism and destruction before ever reaching their site of action (so-call "first pass metabolism")4.
The ingredient listings for the test tablets included such non-nutrient ingredients (excipients) as calcium carbonate (the chemical name for chalk), cellulose (wood fiber), acacia gum, colorings (FD&C Blue No 2 Lake, FD&C Red No 40 Lake, FD&C Yellow No 6 Lake), lactose (which can cause severe problems for those that are lactose intolerant), and carnauba wax (which is the same material found in high quality car polishes), to name but a few. The purpose of these materials is to provide substance to the tablet and help it to stick together and look good. Materials such as the colorants will most likely pass through your body unchanged, which can lead to the false belief that the product is working. These materials serve no nutritional function and it has even been suggested that they can cause allergic reaction. We also noted that one sample of a leading brand was manufactured in China, while two others did not mention their country of origin.
When placed in vinegar, three of the samples exhibited extreme effervescence (liberation of carbon dioxide). This is probably due to the reaction of a material such as bicarbonate with the acidic vinegar, and is probably the means the tablet makers use in order to ensure that the tablet disintegrates. This effect would also occur in the human body, most likely resulting in severe discomfort as gas builds up in the stomach. The observation of effervescence may help to explain the stomach pain felt by many people after swallowing multi-vitamin tablets.

In all tests, the tablets failed to dissolve. The residues were generally gray/white with globules of other colored material interspersed. These globules were most likely oil soluble material such as beta-carotene. All samples, both in water and vinegar, exhibited a scum on the top of the liquid. The liquid above the solid mass varied in color and composition from almost clear (Brand 3, vinegar and water), through a pale yellow solution (Brand 4, water) to a thick red emulsion (Brand 5, vinegar and water).


Summary and Conclusions:

Nutrient molecules must be in solution, i.e. fully dissolved, in order for absorption to occur. All tests performed with leading brands of multi-vitamin supplement tablets demonstrated that the tablets disintegrated to varying degrees, but they did not dissolve. The disintegration resulted in the appearance of a thick, chalky precipitate. The AMA suggests that if a tablet does not dissolve after 30 minutes, then it is probably not dissolving in the stomach and is not being absorbed1.

Further Information

Additional Study performed by Brookson and Associates


Based on the above results, an independent laboratory analyzed the elapsed time from ingestion to breakdown and release of active and waste ingredients in the three leading multivitamin pills. After two hours the pH level was increased to simulate the pills' passage from the stomach into the digestive tract.
In this study the independent testing laboratory identified the number and type of waste materials in the top three competitive vitamin pills which must be flushed from the body.
Waste/filler-type ingredients ranged between 45.5% and 69% of each pill/gel in the top 3 brands. The waste/fillers that were found:
· Milk/sugar fillers
· Gum
· Coating
· Glue
· Lubricants
· Wax
· Plasticizer
· Sand
· Yellow and red dye
After 2 hours in the system, pills and gels become ineffective. The undissolved waste portions of the pills are then flushed from the system. Note that the elapsed time for breakdown of the top three brands was a minimum of two hours or more.
One product did stand out and it had none of the waste/fillers that have been listed. It also had none of the problems with dissolving and absorption because of its one-of-a-kind delivery system. The product is VitaMist spray vitamins.

References:

1. Understanding Osteoporosis. American Medical Association Web Site (www.ama-assn.org).

2. Mason, N.A., Patel, J.D., Dressman, J.B., Shimp, L.A. 1992 Consumer vinegar test for determining calcium disintegration. American Journal of Hospital Pharmacy 49:2218-2222.

3. Yochum, T.R. and Rowe, L.J. 1996. Essentials of Skeletal Radiology. Second Edition. Williams & Wilkins, Baltimore, MD, USA.

4. Shojaei, A.H. 1998. Buccal mucosa as a route for systemic drug delivery: A review. J. Pharm. Pharmaceut. Sci. 1:15-30.

5. Srinivasan, V.S. 2001. Bioavailability of Nutrients: A Practical Approach to In Vitro Demonstration of the Availability of Nutrients in Multivitamin-Mineral Combination Products. J. Nutr. 131:1349S-1350S.

6. Hoag, S.W., Ramachandruni, H. and Shargraw, R.F. 1997. Failure of Prescription Prenatal Vitamin Products to Meet USP Standards for Folic Acid Dissolution. J. Am. Pharm Assoc. 37:397-400.

7. Stamatakis, M.K. and Meyer-Stout, P.J. 1999. Disintegration Performance of Renal Multivitamin Supplements. J.Renal Nutr. 9:78-83.

Test it yourself Vitamin Test

This simple test allows you to test the rate at which various brands of vitamin pills dissolve and are absorbed by the body.

Vitamin Pill Absorption Test

1. Place a vitamin pill in a shallow, clear container.

2. Next, pour enough white table vinegar into the container so that the pill is completely covered. (A test standard as set by the American Medical Association.)

3. After you've poured the vinegar into the container, set a timer for one-half hour (30 mins).

4. After one-half hour has passed, check the container and look at the vitamin pill. How much of pill has dissolved? (By dissolved, we mean has the pill disappeared in the vinegar, the way sugar or salt "disappears" in water).

What does the pill look like?

Can you still see the outline of the pill's original shape?

Is the white vinegar still clear, or has it become cloudy from the pill's dyes and fillers?

5. If the vitamin pill hasn't broken down completely and become part of the vinegar solution in thirty minutes, the nutrients it contains are probably not getting absorbed in your digestive tract. The undissolved parts of the pill will be flushed from your system, and the nutrients in it will be wasted

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