Carbomers are widely used thickeners, controlled release polymers, suspending agents, stabilizers, and binders that ensure the performance of pharmaceutical products. However, growing competition as a result of globalization is forcing many manufacturers to explore alternative carbomers to minimize production costs and potentially compromise on quality performance. This means many companies may be exploring cheaper excipients. On the surface, this may seem ok, but these carbomers are often lower-cost for a reason – they may be made using materials and techniques that render them toxic, low quality and unsafe for human consumption.
To penetrate the markets, manufacturers must ensure that drug products comply with the local regulations. This means ensuring that none of their products contain toxic solvents or impurities. In an industry where the global regulatory environment is fragmented, developers and manufacturers need to know the standard of their carbomers.
Is your carbomer safe?
A fragmented regulatory environment has led to considerable differences in quality among carbomer manufacturers.
“Traditional” carbomers are synthesized in class I (e.g. benzene, 1,2-dichloroethane) and class II solvents (e.g. methylene chloride) that are likely to become more restricted for use in pharmaceutical applications.
Under USP467(ICH Q3C) guidelines, class I solvents are to be avoided and class II solvents must be limited. Benzene and 1,2-dichloroethane class I solvents should be avoided in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity.
Failing to address the removal of these excipients may:
- Affects consumers' health
- Prevents companies from selling products in global markets
- Result in regulatory action by authorities
- Negatively affects sales and profitability
- Cause global reputational damage that could take years to repair
Ultimately, choosing the wrong carbomer can lead to longer development, processing and manufacturing times and costs, ultimately leading to lower profitability, regulatory challenges and reputational damage.
Are you compromising on quality?
In addition to the safety implications, choosing the wrong carbomer can have a negative impact on quality and on manufacturing efficiency too.
For process and manufacturing, if carbomer properties are not optimal, the product development process will be negatively affected. This may lead to failed analytical testing and increased processing time and issues. Innovative actives and formulations are also often dropped in phase I and III trials as the carbomer chosen cannot support the novel formulation.
Know the carbomer landscape
Critically, there are carbomers available on the market that can address these safety and quality issues, provided you know how to look. In order to find a trusted and reliable supplier, it's important to focus on suppliers that offer the following :
- Comprehensive excipient characterization, including residual solvents and elemental impurities
- Toxicity and stability data
- Manufacturing standards and customer support
Carbomer producers that may not have these available can bring significant risks.
Quality excipients matter
To bypass the risks associated with choosing the wrong carbomer, developers may turn to an experienced carbomer producer who can ensure these resources.
As the original carbomer producer, we pride ourselves on manufacturing high-quality, non-toxic Carbopol polymers.
To find out more about how we can help you find the right carbomer for your product, contact our expert team today.
Disclaimer:
Lubrizol Advanced Materials, Inc makes no warranties, express or implied, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No warranties or guarantees are made as to the suitability of the products for the applications disclosed. Full-scale testing and end product performance are the responsibility of the user. Lubrizol Advanced Materials, Inc. shall not be liable for and the customer assumes all risk and liability of any use or handling of any material beyond Lubrizol Advanced Materials, Inc.'s direct control. The SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Nothing contained herein is to be considered as permission, recommendation, nor as an inducement to practice any patented invention without permission of the patent owner.
