| By Larry Payton, Biochemist Myalganex System |
| Monday, 30 March 2009 |
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Whether via prescription medications, dietary supplements, or even processed foods, most fibromyalgia patients regularly ingest the often misunderstood chemical compounds known as excipients. Excipients are substances other than the active ingredient which are included in the manufacturing process or are
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contained in a finished dosage form. Many of us have read the fine print on our vitamin label and having found ingredients like magnesium stearate, EDTA, and hydroxy-propyl-methylcellulose, wondered, "What are these things, really? And, do they really need to be in my fibromyalgia supplements?"
It turns out that defining the purpose of a given excipient is a lot easier than determining whether or not it needs to be in your vitamins. This is due primarily to the broad range of purposes served by excipients. Some excipients, like disintegrants, are an essential part of a dosage form. Others, like sweeteners and shellacs, are intended solely to make a dosage form more palatable and the perceived value of these excipients likely would vary from patient to patient.
More controversial still are excipients such as lubricants and glidants whose lone purpose is to aid in the manufacturing process. These additives ensure the smooth functioning of the manufacturing machinery, ultimately leading to a lower market price, but they provide no real health benefit.
Many fibromyalgia patients, especially those who experience extreme chemical sensitivities, choose to minimize exposure to these "nonessential" excipients.
Finally, there are excipients that are used as marketing aids. These are things like artificial colors and printing inks which are intended to help the manufacturer sell more product. Most fibromyalgia patients try to avoid these types of excipients. Let's look in more detail at the |
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classifications of excipients, categorize them by how "essential" they are, and examine some of the more commonly used compounds.
Essential: Excipients Integral to Dosage Formulation
* Binders hold the tablet ingredients together in a stable form which makes them essential for obvious reasons.
* Disintegrants, conversely, are used to break apart tablets in the digestive tract thereby releasing the active ingredients for absorption into the blood stream.
* Fillers (diluents) are used to add volume to the dosage form so that it can be handled by the patient. Without fillers, some dosage forms would be too tiny to see!
* Suspensing/dispersing agents are used to prevent settling or clumping in suspensions and are necessary to ensure that each dose has the proper amount of active ingredient.
Cellulose, hydroxypropyl cellulose, methylcellulose, sodium starch glycolate, and crosscarmellose are commonly used examples of this category.
Optional: Excipients Based On Personal Preference
* Sweeteners are used to make ingredients more palatable, typically in liquid dosage forms.
* Preservatives are used to prolong the shelf life of the ingredients.
* Film formers/coatings are used to prolong shelf life and make large or unpleasant-tasting tablets easier to swallow.
* Flavors are used to mask unpleasant tasting active ingredients
Methyl paraben, propyl paraben, sugar and sodium citrate are typically used excipients in this category.
Questionable: Excipients Used To Improve The Manufacturing Process
* Lubricants are used to prevent powders from adhering to manufacturing machinery. They are usually used in conjunction with glidants.
* Glidants (flow enhancers) are also
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used to promote powder flow through manufacturing machinery, this time by reducing interparticle friction.
* Compression aids are used to compact ingredients prior to tableting.
Talc, magnesium stearate, and stearic acid are examples of this category of excipient.
Avoidable: Excipients Used For Marketing Purposes
* Printing inks are used for identification purposes as well as marketing. Since identifying marks are required on prescription medications, it may not always be possible to avoid ink.
* Colors, likewise, are used for identification and marketing purposes.
The FD&C dyes are the primary excipients in this category.
Because many fibromyalgia patients experience extreme chemical sensitivities they are understandably concerned about the effect pharmaceutical excipients may have on them. A rational strategy for these patients would be to exclude those excipients in the Questionable and Avoidable categories, select only those excipients necessary to ensure compliance from the Optional category, and accept that the excipients in the Essential category are required for the active ingredient to have the desired effect.
About the Author
Larry Payton is a biochemist and pharmacist with over 10 years of practical experience. His current passion involves developing the Myalganex System, nutritional supplements targeted specifically for the fibromyalgia patient.
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