Don’t be so sensitive: Fillers, Dyes and other Excipients

Don’t be so sensitive: Fillers, Dyes and other Excipients

Don’t be so sensitive: Fillers, Dyes and other ExcipientsThe process seems simple. A patient makes an appointment with their doctor and usually leaves with a prescription. Within a short period of time, they pick up medications from a pharmacy and start their therapy soon after. Although commercially available prescription medications may be fitting for most patients, there are select patients that wish to avoid them simply due to specific inactive ingredients found in the product.

These inactive ingredients or excipients (inactive substances that serve as the vehicle or medium of a drug or other active substance), should be taken seriously. Despite being present in minute amounts, they can still cause a serious allergic reaction, trigger an intolerance, worsen a health condition or go against one’s religious or dietary beliefs. The excipients most patients are concerned with and look for include fillers and dyes. Certain groups are also concerned with capsules derived from gelatin sources due to religious or dietary reasons. Fortunately, compounding pharmacies offer medications specifically tailored to each patient and can be made free of any ingredients a patient wishes to avoid.

It is first imperative to understand the difference between intolerances and allergies. In general, food intolerance symptoms are less serious and often limited to digestive system issues. They can even be controlled by consuming small amounts of the food or taking certain steps to make the food tolerable (e.g. taking lactaid for lactose intolerant patients). However, a true food allergy causes an immune system reaction and is far more serious and dangerous than intolerances.

At times these allergic reactions can cause an anaphylactic reaction and become life-threatening. Trace amounts of an ingredient or allergen found in commercially available products can have a significant effect on patients with certain health conditions. For example, many patients diagnosed with Celiac disease must follow strict limitations on what they consume such as products containing egg, milk, soy, peanuts and fish. Other patients, such as those with Crohn’s Disease may hope to avoid gluten, wheat starch or corn starch. Many compounding pharmacies, such as American Integrative Pharmacy in Lomita, California can make customized medications free of such allergens and chemicals.

Fillers are defined as inactive substances used in pharmaceutical compounding to give size to finished products and ease in the processing of a product. They are inert (inactive) and do not have any direct therapeutical effect but this does not mean everyone is unaffected by their consumption. In commercially available products made from pharmaceutical companies, typical fillers for capsules and tablets include starch, calcium salts and sugars like lactose. In pharmacy compounding, medications are made from scratch and filler options usually include lactose, acidophilus and Avicel (microcrystalline cellulose). Some compounding pharmacies, like American Integrative Pharmacy, do not use lactose when creating compounded products since many patients may be lactose intolerant or may have the intolerance but are unaware of it. Acidophilus lactobacillus, the bacteria naturally found in our stomach and small intestines, is a filler used by American Integrative Pharmacy in powder form due to its great tolerability. Avicel, a microcrystalline cellulose powder, is another tolerable filler requested by prescribers and patients.

Dyes are synthetic, chemical compounds that, when dissolved in a solvent, exhibit a coloring power or tinctoral strength. They are used in the production of many pharmaceutical products for many reasons. These may include coating tablets for drug identification or to promote acceptability to children. Some dyes that could be used include Red No. 3 (Erythrosine), Yellow No. 6 (Sunset yellow), Yellow No. 5 (tartrazine), Green No. 3 (Fast Green FCF) and Blue No. 2 (Indigotine). In recent years, there has been a growing trend among adults concerned with dyes that are present in medications. Although several dyes have been banned by the Food and Drug Administration (FDA), several of the chemicals mentioned above are still FDA approved and used. This is true despite some studies proving toxicity.  Tartrazine (Yellow No.5) is of particular concern. One study from 2004 showed how Yellow No. 5 can damage nerve cells and hinder their ability to send and receive signals. In another toxicology study in 2005, Dr. Karen Lau, researcher and professor at University of Liverpool showed that combining yellow No. 5 and aspartame in amounts relative to a single snack, was toxic to developing neurons at a level far beyond that expected from the toxicity of each alone.

One area of particular concern for years is the effect artificial food color has on behavioral disorders in children. This area has been studied for over 35 years with accumulating evidence from imperfect studies. Reviewing all the literature currently available, the authors of Artificial Food Colors and Attention-Deficit/Hyperactivity Symptoms: Conclusions to Dye for stated that the current status of evidence is inconclusive “but too substantial to dismiss”. Often times, warnings for certain products for children’s health will not be limited to that specific age group, leading adults to be concerned about their own. Dyes are used in very dilute and minuscule amounts in pharmacy compounding to show even mixing and blending of powders in some compounding pharmacies,  American Integrative Pharmacy currently creates several products such as T3, Progesterone, Naltrexone, T4/T3 and cortisol in “dye-free” form for their patients.

All other chemicals that can be used in pharmaceutical manufacturing are coatings, disintegrants, lubricants (such as calcium/magnesium stearate and polyethylene glycol), sweeteners, flavoring agents and preservatives (benzalkonium chloride). At times, these ingredients are needed to create the dosage form required. Compounding pharmacies can make medications free of such ingredients per prescriber’s request or offer alternative, more natural/botanical, options. Gelatin is still used to create the capsules that surround the medications we find commercially available. Often times, patients wish to avoid gelatin due to religious reasons or since they are strict vegetarians since gelatin is a pork derivative. American Integrative Pharmacy uses only pure vegetarian capsules derived from plant sources.

Although considered “inactive”, fillers, dyes and other excipients found in commercially available medications could, for some patients, affect their health and overall well-being. Patients with true allergies should read labels carefully to avoid hypersensivity reactions. Other patients with strict diets, such as those diagnosed with celiac, should also be cautious.  Although current literature regarding the effects of dyes, fillers and excipients may still remain inconclusive, patients, prescribers and pharmacists should be receptive to ingredients used in pharmaceutical manufacturing that could harm certain patient populations. This also goes for patients that wish to have their medication personalized through compounding for personal reasons. Compounding pharmacists can assist patients and prescribers by identifying ingredients found in commercially available products and offering solutions with customized compounded products.

For more information on compound pharmacy medications available or to make an online prescription purchase, please click here or call Toll Free 1-855-247-7948.

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American Integrative Pharmacy is located in Lomita, CA serving residents in and around Orange County, Los Angeles, Long Beach, Torrance and surrounding areas. Online prescription sales are available across the US.

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Torrance, CA 90505

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