Traditionally, pharmaceutical excipients are known for being non-medicinal components of a pharmaceutical product. Although they aren’t typically supposed to cause a reaction of any kind, they are a necessary part of a pharmaceutical product’s manufacturing phase. Excipients also help with breaking the product down in the user’s stomach, binding ingredients together, and stabilizing the product.
As a student in regulatory affairs, you can learn how to ensure any pharmaceutical product adheres to federal and/or provincial regulations, and how to know when pharmaceutical excipients cause an adverse reaction. Here’s what students interested in regulatory affairs courses should know about pharmaceutical excipients.
A Primer on Pharmaceutical Excipients for Students in Regulatory Affairs Programs
Rooted in the Latin word “excipere” (to except), an excipient is any substance found in pharmaceutical products that is not the active ingredient. Excipients are also known as pharmaceutical additives. Pharmaceutical excipients can appear in a variety of dosage forms, including:
Excipients can be multipurpose in nature (which can limit how many excipients are included in the product), and types of excipients include:
- Colouring agents
- Flavouring agents
- Viscosity agents
Although they have traditionally been considered inert substances (and this is what they are supposed to be), there have been examples of excipients triggering adverse reactions.
Why Pharmaceutical Products Contain Excipients, and Why They’re Used
Not only are excipients used for manufacturing purposes, but they are also meant to improve their overall stability and dispersion during use. Students in regulatory affairs courses should remember that, although excipients are not typically supposed to produce effects of their own, side effects can happen on occasion. However, there are certain properties that each excipient should have, including:
- Ability to reproduce
- Handling feasibility
- Inertia (though this is no longer a guarantee)
- No side effects/unfavourable interactions with product
- Produces desired effect
- Stabilizes the product
Depending on the excipient present in the product, they can serve a variety of purposes. For example, disintegrants can be used to expedite the process of a pill breaking down within the user’s digestive system. A diluent is used to increase the weight of products such as tablets, while a binder is meant to bind ingredients together. In any formulation, an excipient can have numerous other uses, including aiding its delivery, effectiveness, bioavailability, processing, and maintenance of product integrity.
Pharmaceutical Excipients and Regulatory Affairs: What You Need to Know
Those enrolled in regulatory affairs programs should remember that any pharmaceutical excipient present in a product needs to have its safety level evaluated before the product can receive approval. This is where regulatory factors enter the equation.
A case study regarding regulatory considerations for excipients, released by Health Canada, says that clinical lots for testing and the resulting commercial lots must be similar in order to ensure that the pharmaceutical product is safe and effective. Should there be any changes, the two would possibly not be reflective of each other if there are differences with the product’s formulation.
Health Canada assesses the excipients present in pharmaceutical products in several different ways:
- Inhalation products: the properties and efficacy of excipients are extremely important
- Modified-release products: different types of excipients are thoroughly examined
- Nasal and topical products: evaluated case-by-case
- Ophthalmic (eye) products: confirmation of excipients potentially affecting efficacy of the products is necessary
- Products for immediate release: grading of excipients are not crucial in most situations
While assessing the excipients, Health Canada first evaluates whether or not studies on these excipients were undertaken prior to the review process.
Before these products are distributed, the properties of excipients are examined and subsequently compared to their previous lots, and various strategies (such as teleconferencing and consultations regarding the clinical relevance of the differing properties) can then be undertaken to correct any issues with differences caused by excipients.
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