NIPTE-FDA Excipient Risk Assessment Database

As is well established, excipients play a critical role in ensuring manufacturability and clinical performance of dosage forms. It is unfortunate that these materials are commonly referred to as "inactive ingredients" thus creating a blind-spot in our collective attention to their selection, characterization and use. We propose to develop a risk assessment system for the evaluation of risks associated with excipient use. The excipient risk analysis database will be a valuable excipient resource and help guide reviewers through the evaluation of excipients in the applications they are reviewing.

When evaluating regulatory filings, knowledge of excipient properties and functionality/performance is critical to the assessment of a proposed product for quality and safety. One of the difficulties in carrying out a review is that for each excipient there can be a significant number of functional and performance properties that could possibly affect product quality and safety. Knowing which of these properties are critical can be difficult to judge, and having risk analysis tools that can systematically help one determine which attributes are critical for a given excipient in a given dosage form with a particular manufacturing process would be very beneficial, and help reviewers to conduct systematic risk assessments and consequently produce better and more consistent reviews.

The assessment of risk depends on the choice of excipient, functionality, grade, dosage form type, manufacturing method and drug class. Our risk assessment tools will classify an excipient that is to be used in a given dosage form with a given manufacturing method into low, medium and high risk. As part of the risk analysis we will identify the attributes that are primarily responsible for the risk profile of an excipient in a given dosage form type. The risk profile will be accompanied by literature documentation, when available, justification for how the rating was obtained, and a description of possible risk mitigation. The development of these risk profiles will be done with regular consultation with FDA personnel.

Using Decision Tools to Assess Excipient Risk in the Manufacture of Tablets

• Magnesium Stearate Decision Flow
• Hydroxy Propyl Celluluse (HPC) Decsion Flow

Investigating Risk Profiles and Excipient Risk Attributes

• Exploration of Risk Profiles

Researchers should cite this work as follows:

• Stephen W. Hoag; Ann Christine Catlin; Chandima Hewanadungodage; Andres Bejarano; Shikhar Singh (2017), "Animations to Demonstrate Excipient Risk Assessment," https://pharmahub.org/resources/731.

  BibTex | EndNote

1. Excipients database
2. fda
3. NIPTE
4. Risk assessment