Case Study - Crystal Pharmatech Co., Ltd.

Case Study

How can physiologically-based pharmacokinetic (PBPK) modeling maximize ADME performance and identify a path forward for GLP Tox and FIH formulations?GastroPlus incorporates in-vivo and in-vitro data t...

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Case Study

Assessment of CQA in mRNA-LNP Modality

“Figure 1. mRNA encapsulated with LNP typically composed of encapture nucleic acids such as mRNA, siRNA, etc. as shown in the blue curve line by lipid nanoparticle, LNP as ionized, pegylated, phosph...

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Case Study

Case Study 6: Oxybutynin- Crystalline Change From Salt to Free Base

Oxybutynin HCl (Fig. 14) has been recognized as a BDDCS I compound exhibiting high solubility and permeability (Benet et al. 2011). It has been used in a variety of marketed products for the treatment...

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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...

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Case Study 3: Atorvastatin - Crystalline Form Change In Late Development

Atorvastatin (CI-981) is an HMG CoA reductase inhibitor marketed as Lipitor® (Fig. 8). As a BCS II drug, it has exhibited poor solubility and high permeability (Wu and Benet 2005). The compound was o...

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Case Study 4: Gatifloxacin - Crystalline Form Changes With A Licensed Compound

Gatifloxacin (also known as AM-1155, CG5501, and BMS-206584) has been established as a fluoroquinoline broad-spectrum antibiotic (Fukuda et al. 1998) (Fig. 10). It was originally discovered by Kyorin ...

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Case Study 2: DPC 961 – Form Change On A Fast Track Compound

DPC 961 (Fig. 6) was a development compound indicated for the treatment of HIV infections and was developed as a neutral molecule (Staszewski et al. 1999). The compound was designated as Biopharmaceut...

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Case Study

Case Study 1: Indinavir - Early Salt Form Change

BackgroundIt has been reported that the solid form of active pharmaceutical ingredients (APIs) has significantly impacted quality and consistency of the final dosage form for drug development compound...

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