inactive ingredient


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inactive ingredient

Additive, Excipient Clinical pharmacology A substance regarded by the FDA as having no effect on a drug's absorption or metabolism, which is added for manufacturer expediency. Cf GRAS substances.
References in periodicals archive ?
For the study, published in the journal Science Translational Medicine, the team analysed data on inactive ingredients in more than 42,000 oral medications that contained more than 350,000 inactive ingredients.
We wanted to understand the problem and drill down to characterize the entire universe of inactive ingredients across thousands of drugs."
Zohydro ER with BeadTek is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate containing technology that contains an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents.
Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions.
* Different generic formations may have different inert ingredients, which may cause problems if patients are allergic to a specific inactive ingredient.
Scientific sessions, workshops and short courses will address topics including: stem cell derived cell lines, Inactive ingredient database and novel excipients, drug product manufacturing, global CMC challenges for break-through designated products, continuous manufacturing, peptide and biologic topics, and more.
Many substances listed in the FDA's Inactive Ingredient Guide (For drugs) (http://www.fda.gov/cder/drug/iig/default.htm) are permitted for use in foods, but not all, and if not permitted for use in food, it cannot be used in a supplement.
Sodium: An "inactive ingredient" (i.e., it has nothing to do with the pharmaceutical action of the product), sodium is ubiquitous in over-the-counter preparations, as well as processed food of all kinds.
In this drug product example, the Ti02 must be considered to be an inactive ingredient in compliance with 21 CFR 330.1(e).
Food and Drug Administration (FDA) Inactive Ingredient Search for Approved Drug Products website to determine the maximum concentration already employed in an approved drug product (4).
While drug manufacturers have been investigating a number of available technologies to make replication of their drug products more difficult, one approach being considered involves the addition of trace amounts of an inactive ingredient or ingredients to an existing section (a discrete contained solid or a layer in a solid oral dosage form) of the dosage form.

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