Core Excipients: Why They Are Critical to Pharma Brands
When it comes to solid oral dosage pharmaceutical drugs, core pharmaceutical excipients are extremely important. They help to create robust and stable pharmaceutical products and can make the drug more effective through solubility enhancement and modify the release profile of the drug.
This guide will help you understand what core excipients are and why they matter to pharmaceutical brands – as well as what your options are if you are in the market for a tablet or capsule core excipient solution.
Need advice on an excipient solution for a pharma product? Colorcon has over 60 years of experience, so contact us today for a consultation. Learn more about our pharmaceutical excipient products here.
What Are Excipients?
Oral excipients are inactive substances that act as the delivery vehicle for a drug’s active pharmaceutical ingredient (API). While excipient ingredients are considered the inactive part of pharmaceutical products, excipients perform important functions: in the core they act as binder, lubricant and filler/diluent and as a film coating provide protection for the tablet as well as color for recognition and branding.
Pharmaceutical tablet coating systems protect the active ingredient, support stability of the product, and can be used to tailor delivery of the active. Excipients do not provide any direct treatment benefits, but they help with the API's limitations: manufacturability, stability, and drug delivery.
Excipients are used in many applications outside of pharmaceuticals, such as in dietary supplements, nutritional and animal health applications. There are also many types of excipients, from binders to pigments to solvents. This article deals specifically with core excipients for oral solid dosage forms.
What Are Core Excipients?
Core excipients are the primary delivery vehicle of the drug. Most people focus on the active ingredient in a drug, but the core excipients are vital to manufacturing the product and the therapeutic activity of the drug.
Benefits of Core Excipients
There are three key benefits that make core excipients essential in the pharmaceutical industry.
Drug Absorption
Pharma excipients can help with the absorption of drugs. For example, some APIs do not dissolve easily in liquid, and core excipients can to improve solubility. Another example is that lipid-based excipients can enhance the absorption of drugs by affecting physiological processes in the body, like stimulating bile flow and pancreatic juice secretion.
Drug Delivery (Pharmacokinetics)
Another benefit of core excipients is that they can modify drug pharmacokinetics, or the delivery of the drug to the body. For example, rate controlling polymers can modify release (MR) of the drug, either through sustained (SR), delayed (DR) or extended release (ER). It can also help with targeting specific locations for drug release.
The excipient can make sure that a drug’s active ingredient gets to the right place in the body at the right time so that it works as intended. If a pharmaceutical drug includes an inconsistent excipient, the drug treatment may not be effective despite the right ingredients and dosage. In some cases, it may even be harmful to the patient.
Drug Stability
Finally, pharma excipients can help with increasing the stability of a drug. Dr. Ali Rajabi-Siahboomi, a pharmaceutical excipients expert who is vice president at Colorcon, says that core excipients are capable of:
- Preventing the degradation of the API
- Reducing oxidative degradation with antioxidants
- Sequestering oxidation-inducing metal ions via chelating agents
- Promoting degradation if the wrong excipient is chosen
These factors tell us why choosing the right core excipient is so important.
Colorcon Excipient Solutions
Want to learn more? Colorcon can help. We’ve been serving the pharma excipients market with core excipient solutions for over 60 years. As one of the leading pharmaceutical excipients manufacturers, we are experts in finding the right excipient solution for pharmaceutical companies around the world.
Our experts will consult with pharma companies on their needs and use their extensive pharmaceutical excipients knowledge to recommend a tailored solution that will help to reduce development time while providing robust manufacturing of the final product.
Contact us today for a consultation to learn more about our tablet and capsule excipients, or visit one of our product pages below:
