Allergic to Commercial Products?

We all need to take medicine sometimes. If you are allergic or sensitive to a certain component of a drug that is available commercially, you may need to have your medication compounded without that ingredient or with a substitute.

What are excipients?

Excipients are also known as inactive ingredients in a drug formula. In any drug (excluding supplements), there will always be an active pharmaceutical agent (API) and a list of inactive ingredients also included in the tablet, capsule, liquid, suppository, etc. Different excipients play different roles in a drug formula.

Common uses of excipients are to

  1. Enhance stability of the formulation: Often times, the API is not stable for very long in its pure form. In order to provide added stability, various excipients may added to prolong shelf life.
  2. Bulk up the formulation: Most of the time, the physical amount of active ingredient required for a dose of solid medication is so small that there is no way to mold it into a tablet or punch it into a capsule by itself. For example, bumetanide is a well-known diuretic used for high blood pressure. Normally it comes in 0.5mg to 1mg tablets. 5mg of powder is about the size of a nail head. Trying to mold a quantity this small into a tablet formulation without adding anything else would be impossible, because there is simply not enough physical matter to work with. Therefore, most medications, even compounded ones, will include a filler in the formulation for added weight.
  3. Improve taste: Certain drugs have a bitter taste in its pure form. For liquids or tablets meant to dissolve in the mouth, often times a sweetener or flavor is added to mask the unpleasant taste of the active ingredient.

 Excipients used in compounded products

  1. Avicel (capsule filler, synthetic)
  2. Loxoral (capsule filler, synthetic)
  3. Tapioca powder (capsule filler, natural)
  4. Rice flour (capsule filler, natural)
  5. Potato starch (capsule filler, natural)
  6. Methocel (suspending agent for liquids, synthetic)
  7. Plain water (suspending agent for liquids)

Common allergens found in commercial drug products

Corn syrup: Because corn syrup is found in almost all food products, including medications, someone with severe allergies to corn products will likely need to review the inactive ingredients in a commercial drug tablet or capsule prior to having a prescription filled at a regular pharmacy. What they can do instead is have that medication compounded using allergen-free fillers and veggie-based capsules.

Lactose: For those who are allergic to dairy products, effort may be required to avoid lactose-containing medications. Because most commercially-made tablets and capsules use lactose as a filler for added weight, some people may require their medications compounded using alternate fillers. In compounding, we are able to create capsules using a variety of synthetic fillers that do not contain allergens, such as Avicel and Loxoral.

Dyes: Since many drug products come with a dye, it may be necessary for someone with a dye allergy to have their medication compounded without any color. In fact, it is possible for many commercially-available tablets to be compounded into clear capsules. Furthermore, if someone needs a drug made without dyes in a liquid form, we may be able to compound the medication into a syrup or suspension using various bases, like regular water, Methocel, Orasweet/Oraplus, and even oil. As long as our pharmacy can source the drug in its powdered form, there is likely a way to create an allergen-free drug product that is effective for each individual patient.

Gluten: For those with celiac disease, it is important to know what exactly goes into the products they consume. Commercially-available medications often have wheat, barley, and rye-based inactive ingredients. Examples of potential gluten-containing excipients are: modified starch, pregelatinized starch, dextrates, dextrin, dextrimaltose, and carmel coloring (when barley malt is used). Although quantities of gluten are relatively small in drug products, it may still be an area of caution. Therefore, for those who prefer gluten-free medications, we are able to compound capsules using a substitute fillers like Avicel (synthetic), potato starch, or rice flour, to name a few.

Gelatin: Almost all commercial drug capsules are made using gelatin. For those with severe gelatin allergies, we are able to compound commercial drugs into a capsule form using vegetable-based capsules, or “veggie caps”. This removes the potential for gelatin-related allergic reactions.

Signs of an allergic reaction

Hives, skin rashes, swelling of the face, and/or difficulty breathing are all common symptoms of an allergic reaction. Because these symptoms can lead to anaphylaxis and can be fatal, care must be taken to seek immediate medical attention if any of these occur.

For many people, allergies pose a serious concern to healthcare decisions. It is everyone’s right to be offered medication that is safe for them to take. Compounded drugs provide safety and a sense of comfort to those who have allergies to various excipients found in commercially-available drugs. Here at Miller’s, we recognize that each individual patient has unique requirements for their medications. We are happy to work with new and existing customers around the nation to provide high-quality and customized care to all.

References:

Bumetanide Epocrates

Compounding and the FDA: Questions and Answers FDA

Gluten in Medications Beyond Celiac

Loxoral PCCA

Pharmaceutical Excipients: A Review INTERNATIONAL JOURNAL OF ADVANCES IN PHARMACY,

BIOLOGY AND CHEMISTRY

 


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