Report on the Dissolution of Multi-Vitamin Tablets
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.
Vitamist nano sprays, are distributed by:
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