Deformulation, or reverse engineering, is the separation, identification and quantitation of individual components or ingredients in a drug product. Deformulation generates the most critical information needed for generic drug development since a generic drug formulation must have the same ingredients (Q1) and the same quantities (Q2) as the brand name drug (i.e., Reference Listed Drug) for which the generic is to be substituted. Moreover, the generic formulation must also have the same physical and chemical properties as the Reference Listed Drug (Q3).
LATITUDE has successfully deformulated Reference Listed Drugs, and subsequently developed generic formulations, for even the most complex drugs, such as injectable liposome drugs, injectable PLGA microsphere drugs, injectable nanoparticle drugs, ophthalmic suspension drugs, oral suspension drugs and topical drugs.
To deformulate, our experienced analytical scientists apply an array of analytical instruments to determine and measure the Q1, Q2 and Q3 related properties. Our formulation scientists also have a wide range of lab scale or pilot scale manufacturing equipment to use for the development of simple as well as complex formulations.
LATITUDE offers generic formulation development services including patent research, deformulation, and generic formulation development with Q1, Q2 and Q3 qualifications. To learn more, contact us.