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Average of 8.8 Inactive Ingredients Found in Oral Medications

Overall, 92.8 percent of oral solid medications contain at least one potential allergen

MONDAY, March 18, 2019 (HealthDay News) — Oral forms of medications contain an average of 8.8 inactive ingredients, many of which could cause adverse reactions, according to a perspective piece published in the March 13 issue of Science Translational Medicine.

Daniel Reker, Ph.D., from the Massachusetts Institute of Technology in Cambridge, and colleagues used data analytics to characterize the abundance and complexity of inactive ingredients in approved medications.

The researchers found that oral solid dosage formulations of the most commonly prescribed medications in the United States consist of 75 ± 26 percent inactive ingredients based on data from the pharmacy at Brigham and Women’s Hospital. According to data from the Pillbox database for 42,052 oral solid dosage formulations, an average tablet or capsule contains 8.8 inactive ingredients. Thirty-eight inactive ingredients have been described that cause allergic symptoms after oral exposure either via direct allergenic potential or through contamination introduced through these ingredients. A total of 92.8 percent of oral solids contain at least one potential allergen. Only 28 percent of active ingredients have at least one available formulation that avoids all potential allergens, and only 12 percent of active pharmaceutical ingredients are free of inactive ingredients reported to cause allergic reactions.

“Recognizing that the inactive portion of a medication, which corresponds on average to two-thirds of the administered material, may be more ‘active’ than previously anticipated, we foresee potential implications for medical protocols, regulatory sciences, and pharmaceutical development of oral medications,” the authors write.

Several authors are named on a provisional patent application encompassing systems and algorithms capable of quantifying and providing inactive ingredient burden in medications.

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