Changing Excipients for Special-needs Patients
Some patients cannot take various drug products (Rx and OTC) because they have allergies or are intolerant to various substances, including:
- Dyes
- Flavorings
- Sweeteners
- Preservatives
- Gelatins
- Milk products
- Gluten
- Corn
- Soy
- Nuts
- Alcohol
- Chocolate
- Animal-derived ingredients
Sometimes the specific allergy or intolerance is difficult to determine. Once known, the compounding pharmacist can work with the patient to circumvent the offending agent and resolve the problem.
Oftentimes, the offending agent is an excipient in a commercial drug product. The source that can be used for compounding of the active drug may be a raw material or possibly an injection or dosage form with minimal excipients and not containing the offending agent. Next, there are numerous excipients in each group that may be substituted for different patients with a little bit of research and asking questions on the Compounders' Network List (CNL), etc.
In some cases, the issue can be resolved by changing brands or even generic manufacturers, as many different generics of the same drug product contain different excipients. The package insert should list the excipients contained in their products. Manufacturers of generics are not required to have identical excipients in their products; this can sometimes be an issue.
Additional reading and resources on special-needs patients can be found at:
Nagel-Edwards KM, Ko JY. Excipient choices for special populations. IJPC 2008; 12(5): 426-430.
Cacace JL. Formulating for the gluten-sensitive individual. IJPC 2005; 9(5): 357-358.
Claycomb J. Pharmacists Must Guard Vulnerable Patients Against Inactive Ingredients in Medications. Pharmaceutical Industry Today June 11, 2015. Available at:
http://drugtopics.modernmedicine.com/drug-topics/news/pharmacists-must-guard-vulnerable-patients-against-inactive-ingredients-medications
www.Glutenfreedrugs.com
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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