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First-Time-Right Formulation, Built with Full Lifecycle Intent How early formulation decisions shape the entire drug development lifecycle and why getting it right the first time matters more than ever.
Peptide Crystallization Process Development: A Practical CMC Guide for Peptide APIs Peptide crystallization process development can transform peptide API stability, filtration, and downstream manufacturability. Learn high-throughput screening, salt and polymorph screening, seeding, a...
Chiral Separation More than 70% of drug candidates worldwide are chiral. Typically, for chiral API, only one enantiomer or diasteromer is biologically active or desirable. Therefore, the production of enantiopure compounds or diastereomers is imperative. In the production of small molecule drugs with desired chirality, separation via crystallization can be much more economical and environmentally favorable than chromatography.
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Case Study 5: Lifecycle Management - Olanzapine - Crystalline Change From Free Acid to Salt Olanzapine (Fig. 12), a Biopharmaceutics Drug Disposition Classification System (BDDCS) 2 drug (Benet et al. 2011) with poor solubility and high permeability, has been marketed towards treating schizo...
Presentation
In-Silico PBPK Modeling and Simulation Crystal Pharmatech now provides Physiologically Based Pharmacokinetics (PBPK) simulation capability.
Crystallization Development Services Based on in-depth research on the properties of the crystal form itself and the transformation relationship between crystal forms, Crystal Pharmatech can offer a robust and scalable crystallization process that yields a reproducible high-quality solid form.
Excipient Selection and Compatibility Studies Excipients play an important role in drug release, drug stability and manufacture of drug product. We help customers select the appropriate excipients in early formulation development through screenin...
Dr. LianFeng Huang Joins Crystal Pharmatech as Chief Scientist Crystal Pharmatech is pleased to announce the appointment of Dr. LianFeng Huang as Chief Scientist. Dr. Huang is an accomplished R&D leader with over 30 years of experien...
Development and Production Application Cases of Amorphous Solid Dispersion Formulations (II) - Spray Drying In the preceding article, we discussed the application of hot-melt extrusion technology in developing amorphous solid dispersions (ASD) for pharmaceutical formulations. The process involves dispersing...
Utilizing Compaction Simulation for Advancing Oral Dosage Formulation Design Speaker: Feng Li, Ph.D., CSO, Crystal Formulation Services