Particle size of active pharmaceutical ingredient (API) directly correlates to bioavailability and drug effectiveness. For all respiratory drugs with topical semisolid formulations,
the API particle size distribution correlates to biological performance. The API particle size distribution should be stable to ensure reproducible bioavailability within the storage period. FDA recommends a thorough characterization of particle size distributions when the performance of a drug product depends on particle size. rap.ID provides fast, detailed and highly reproducible particle characterization services.
Particle size distribution of a suspended API in topical formulation can be easily investigated. The level of agglomeration, the presence of lumps and the occurrence of amorphous or polymorphous material are a giveaway.
rap.ID provides on a GMP level, data on a particle size distribution for the API, even in a mixture. A plot for the low concentration of 0.1% active ingredient, as well as the high concentration, ensures API is determined. The amounts of aggregates, polymorphs and amorphous material is reported.
With the reliable results from the chemical specific particle size distribution analysis, (even for low API concentrations) quality control over agglomerates and polymorphs are provided by the streamlined GMP contract testing services. For an ANDA you can easily show that the particle size distribution of drug substance PSD in each product are identical. This is useful information to show bioequivalence and help reverse engineering of originators products.