After more than 12 years in various pharmacist roles, Melissa King, PharmD, brought her expertise to Epicur® Pharma. Over the last three years, she has led Epicur’s manufacturing processes and operations and helped the company raise the standard of care in veterinary drugs. We met with Melissa to learn about what her team is focusing on next and the importance of dosage knowledge within veterinary practices.
Tell us a bit about your work at Epicur.
I am a pharmacist by training, and the Director of Manufacturing at Epicur. I oversee nonsterile and sterile manufacturing operations and supply chain operations, including procurement, receiving, fulfillment, and shipping. Most recently, we completed an FDA facility inspection, which yielded favorable results.
What’s the FDA inspection process like?
Every two years, the FDA comes out to our facility to ensure that our practices are following current good manufacturing practices, or cGMPs. It can be tricky because manufacturers are given a template or overview of what is expected at a minimum (Code of Federal Regulations Parts 210 and 211), but we are not told exactly what should be done to remain in compliance as this is process-specific from manufacturer to manufacturer. Significant research and planning need to be done by the company to ensure that we are in compliance with cGMPs. If a company’s manufacturing process is seen to have any deficiencies, a 483 form is issued, and this gets reported for the public to see. The length of the audit can be related to the number of deficiencies a company has. The audit at Epicur only lasted 8 days, which is very quick.
Do you have any new processes or products that you are currently working on?
Yes, we are really excited about our new FMB-210 automated ophthalmic filling machine, which will fill and cap eye drops with minimal human intervention. This will enable us to make larger batches of product. It also allows for quicker changeover between one liquid product to another without contamination. We have just developed our first ophthalmic ointment, which I believe is the first of its kind in 503B manufacturing. We also have begun manufacturing oil-based oral suspensions. These can be made into various flavors for different animals’ preferences and can also mask bitter tastes. For example, savory chicken flavor is preferred by dogs and cats, while ferrets and birds favor a sweeter flavor, like marshmallow. This allows the animal to enjoy the medications that they might have resisted taking before, which makes them easier to dose.
At Epicur, you’re working to expand standard medications like tablets. How do these formulations differ from traditional capsules?
The main difference between these two forms of medication is how tablets and capsules are made. Capsules are made manually; therefore, there can be a lot more room for variability. Especially in 503A pharmacies, capsules can range significantly as potency results are not required. Capsules are easier to make but leave more room for error from a dosage standpoint. Tablets are machine-made, which makes them more accurate. With tablets, the entire process is validated, and potencies are consistent within each batch as well as between different batches.
Which medications are particularly problematic when dosage is inexact? What are potential side effects?
Drugs that have a narrow therapeutic range are the most problematic when incorrect dosage occurs. Examples of this are thyroid or antiseizure medications. The side effects are dependent on the condition because if the drug is underdosed, then it will not be effective toward what it is supposed to be treating. If the dosage is well above the prescribed amount, it could potentially lead to toxic levels of the drug within the animal. This could be harmful to the animal and is not helpful towards treating the specific condition.