Pharmaceutical deformulation, the reverse engineering of a product’s formulation, is a necessary process to create generic drugs. Even before patent expiration, skilled chemists must perform a detailed analysis to identify, quantify, and characterize the original formula’s active pharmaceutical ingredients (APIs) and its excipients, whether it’s a drug or supplement.
Successful generics companies are the first to market after patent expiration, bringing bioequivalent products to pharmacies as quickly as possible. They achieve this through having solid reverse engineering programs and by utilizing outside labs when necessary to help in the process. Learn more about the pharmaceutical reverse engineering process and why it’s necessary below.
What is Pharmaceutical Deformulation?
Deformulation is the analysis of a product where a lab breaks down a material or product to determine the identity and quantity of its components. Sometimes known as “chemical reverse engineering,” this process enables scientists to take a medication and discover the contents of its core and coatings. This is the method necessary to create a generic version of a medication and requires various chemical processes to discover the exact contents of a formula.
Why Do Generics Companies Need to Reverse Engineer Medications?
Just because a medication’s patents expire doesn’t mean the original patent holders have to divulge the formulas. For a generics company to obtain approval under ANDA (Abbreviated New Drug Application), it must demonstrate a bioequivalent product. The blood levels of the active ingredient must be highly similar in the generic composition to the original product. The FDA, however, considers the innovator’s formula proprietary, and won’t give it out to any generics company. This lack of guidance creates the need for pharmaceutical reverse engineering to prove bioequivalence and discover a manufacturing method for the new medication.
How Does Reverse Engineering Work?
Pharmaceutical deformulation can be a complex process and will differ depending on the composition of the drug in question. The first step begins with 1st level deformulation, which identifies and quantifies the major ingredients. In this step, quantitation is not performed. This level of analysis is only used to verify label claims and assist a chemist with the formulation. 2nd and 3rd level deformulation quantitate the components of the formulation, including coating systems and agents used to mask the taste, and will ensure the ANDA is approved by the FDA quickly.
Once you’ve decoded the quantitative formula, the components need to be separated and individually quantified using gravimetric or other detection tools, like UV light. It’s important that the new generic formula uses the same polymorphic form as the RLD (Reference Listed Drug) to ensure similar stability and dissolution profile, as well as to pass the ANDA. After you’ve got the formula down, it’s necessary to decide on a manufacturing method, such as wet or dry granulation, direct compression, or other methods, based on the properties of the drug.
FDA Approval for a New Generic Product
Once you’ve achieved bioequivalence to the original product, it’s time to submit your ANDA to the FDA. Compilation and filing of this application take 2-3 months. Although it’s called the Abbreviated New Drug Application, the FDA still generally takes 18-24 months to approve a new generic and allow a company to bring it to market. It’s important to reverse engineer your desired drug several years before the patent expires so you’re ready to launch as soon as you can. The total timeline can easily take three or more years from when you begin reverse engineering.
Avomeen and Pharmaceutical Reverse Engineering
Contact Avomeen today for a free quote on deformulation services or call (800) 930-5450 to learn more. Our expert Ph.D. chemists know all about the pharmaceutical and supplement industry and can help you with your reverse engineering needs.