Crystallization Process Development​

Developing a robust crystallization process offers multiple benefits for pharmaceutical development: 

• Enhanced drug performance: Consistent particle size and crystal habit improve drug dissolution and bioavailability. 

• Improved manufacturability: Scalable processes ensure reproducibility and streamline production. 

• Greater purity and yield: Achieving high-quality crystalline forms reduces impurities and maximizes API production. 

• Reduced drug formulation challenges: Controlling particle attributes to facilitate the development and manufacturing of optimal drug formulations to improve therapeutic outcomes. 

• Risk mitigation: Identifies and addresses potential challenges during scale-up and manufacturing. 

At Solitek, we leverage state-of-the-art tools to optimize every stage of the crystallization process: 

• Particle Size Distribution Control: Precise tuning of nucleation and growth parameters to ensure uniform particle attributes. 

• Polymorphic Stability Assessment: Identifying stable crystalline forms, including monotropic and enantiotropic polymorphs. 

• Seeding Optimization: Adjusting seeding temperatures and conditions, sometimes by just a few degrees, to improve reproducibility and achieve desired crystal morphology. 

• Process Analytical Technology (PAT): Real-time monitoring for in-process control and reduced variability. 

• Solvent System Selection: Optimizing the solubility curve and metastable zone width for efficient crystallization. 

• Anti-solvent Addition: Controlled rates to achieve desired supersaturation levels without unwanted agglomerates. 

Our Crystallization process development services are critical at various stages of drug development: 

• API Development: Optimizing the purity and scalability of active pharmaceutical ingredients. 

• Formulation Design: Controlling particle attributes to facilitate the development and manufacturing of optimal drug formulations for improved therapeutic outcomes.  

• Manufacturing Scalability: Ensuring consistent performance during production scale-up. 

• Regulatory Compliance: Producing data-driven processes that meet stringent pharmaceutical standards. 

At Solitek, we pride ourselves on our ability to adapt to the unique needs of each client. Our client-focused approach ensures that every project benefits from tailored solutions and expert insights: 

• Customized strategies: Designed to meet specific development and manufacturing goals. 

• Innovative techniques: Incorporating predictive models and real-time analytics for superior outcomes. 

• Comprehensive support: From early-stage development to full-scale manufacturing. 

Partnering with Solitek means access to: 

• Expertise in Crystallization Science: Decades of experience in delivering successful outcomes for challenging projects. 

• State-of-the-Art Technology: Advanced tools to monitor and optimize every stage of crystallization. 

• Commitment to Quality: Ensuring consistent and reliable processes that meet regulatory standards. 

• Formulation Optimization: Supporting the development of optimal drug delivery systems by ensuring consistency of crystalline form and particle attributes.