Abstract 356P
Background
Abiraterone acetate(AA) is available as various generic brands in Indian market. Data on active pharmacological ingredient (API) is not available. We aim to develop a robust, efficient method for characterizing generic drug formulations. We performed comparative analysis by using orthogonal biophysical techniques.
Methods
AA manufactured by three different companies (coded as B1, B2 and B3) were taken in the study. No changes were made in the formulation conditions. High Performance Liquid Chromatography (HPLC) was performed to check the API concentration. Differential scanning calorimetry (DSC) analysis was performed to characterize the physical and thermodynamic properties, temperature stability and degree of crystallinity. A Solid-state Cross-Polarization Magic Angle Spinning Carbon-13 Nuclear Magnetic Resonance (13C CPMAS solid-state NMR) experiment with variable contact time was performed to elucidate the structural integrity and crystalline packing. For unit crystal lattice information, an x-ray powder diffraction was performed.
Results
From the HPLC experiment, it was quantified that the API concentration is highly varied among samples (Table) and in one sample it was 80.3%. Samples were found to be temperature stable with a similar melting point (Tm). The degree of crystallinity is varied which was confirmed from DH (area under the melting endotherm). From the ssNMR experiment, the atomic dynamicity of all samples was validated, which corroborated the DSC data. But the changes in the intensity of XRPD experiment suggests the difference in the crystal length (short oder or long order crystal). Table: 356P
API content of all samples (B1, B2, B3) calculated and compared from HPLC data
| Samples | API concentration (mg/10ml) | API sample content (%) |
| API | 6 | 100 |
| B1 | 5.88 | 98 |
| B2 | 5.66 | 94.3 |
| B3 | 4.94 | 82.3 |
Conclusions
AA API is varied among available generics. In industry, these methods can establish batch-to-batch variation, if any, with atomic resolution and high reproducibility and check on quality.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
A. Patel and A. Kumar.
Funding
IIT Bombay.
Disclosure
All authors have declared no conflicts of interest.