SARA Pharm Solutions

Transcription

1 SARA Pharm Solutions

2 Who we are? Sara Pharm Solutions European Innovative R&D-based Solid state pharmaceutical CRO 2

3 Company Background Incorporated in Bucharest, Romania Contract Research Organization Quality Management System - ISO 9001:2008 Approved laboratory for the quality control of medicines according to GMP (Romanian Medicine Agency) 3

4 Business Model Material Science API Solid Form Screening & Selection Solid dosage form preclinical formulation 4

5 Drug development strategy Discovery Antisolvent Addition Pre-formulation Formulation partner Formulation development PLM_SPS1911_AS16_4x PLM_SPS1911_AS28d_4x PLM_SPS1911_AS41w_10x Patient benefit Formulation testing Improved Drug Product Development Proof of Concept Licensing

6 Solid state research in drug development 6

7 Work flow: Screening Solubility Starting Material Characterization Solubility assessment (with characterization of residual solids) Starting Material Characterization: HPLC, XRPD, DSC, TGA, PLM 7

8 Work flow: Screening Solubility Starting Material Characterization Design of screen experiments Rational design based on diversity of crystallization methods & conditions Evaporation crystallization Cooling crystallization Crash crystallization with anti-solvent addition Slurry experiments Vapor diffusion Dry and solvent-drop grinding Combined slurry / cooling / evaporation in one experiment 8

9 Work flow: Screening Solubility Starting Material Characterization Design of screen experiments Screening µl or ml scale experiments Polymorph, salt, co-crystal, etc. 9

10 Work flow: Screening Solubility Starting Material Characterization Design of screen experiments Screening XRPD PLM State of the art High-throughput XRPD technology and Polarized Light Microscopy 10

11 Work flow: Screening Solubility Starting Material Characterization Design of screen experiments Screening XRPD PLM Data Analysis XRPD classification 11

12 Work flow: Screening Solubility Starting Material Characterization Design of screen experiments Screening XRPD PLM Data Analysis Follow up Analysis DSC, TGA, HPLC, single-crystal, IR, Raman, NMR, SS-NMR 12

13 Work flow: Screening Solubility Design of Experiments Screening XRPD PLM Data Analysis Starting Material Characterization Follow up Analysis Data analysis Interpretation Conclusions Recommendations Report 13

14 Process Development Solubility assessment in process solvents Evaluate polymorphism Solvates formation Estimate metastable zone width (MSZW) Select best solvent Run unseeded process with HPLC, XRPD, DLS etc. analysis 14

15 General Conclusions Solid state research is essential in drug development Solvents play a major role from screening to the end process Rational design is recommended Special tools are needed for high-throughput experimentation and analysis 15

16 Solid state services Optimal solid form selection Polymorph screening Salt screening Co-crystal screening Stabilizing amorphous Crystallization process support Process selection Process development Pre formulation services Physical & chemical stability studies Phase transition studies Particle size distribution Excipient compatibility studies Solubility, dissolution rate and supersaturation assay profiling Early formulation development Solid form IP consultancy and projects Building patent portfolio for IP protection 16

17 Packages Pre-IND screens Phase 3 & IP screens Process optimization & Scale-Up Solubilizing agents for poor soluble compounds Advanced analytics Stability studies (ICH) Solving complex problems: particle size, crystal habit, crystallization/polymorphs, amorphous stabilization of ASDs, stability 17

18 Collaboration opportunities Proficiency in solid-state pharmaceuticals State-of-art equipment & lab facilities Quality Management System (ISO9001: 2008) Competitive pricing & timelines Flexibility - all time zones 18

19 Contact Calea Rahovei - Bucharest - Romania TEL: FAX: info@sara-pharm.com 19