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 generics drug development since a generic drug formulation must have the same ingredients (Q1), the same quantities (Q2) and the same physical and chemical properties (Q3) as the brand name drug (i.e., Reference Listed Drug) for which the generic is to be substituted.
LATITUDE has successfully deformulated many Reference Listed Drugs and subsequently developed FDA-accepted generic formulations, even for the most complex drug formats 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 generics formulation development services including patent research, deformulation, and generics formulation development with Q1, Q2 and Q3 qualifications. To learn more, contact us.