Drug Substance: Solid State Services
Solid state services to support your drug substance manufacturing.
Salt Selection
Poor bioavailability or instability of a drug substance can often be solved/improved by screening different salt forms. The selection of the most appropriate salt can not only improve the physicochemical properties but identify all developable salts that can strengthen the intellectual property of the drug substance. The choice of counterions is typically based on the pKa of the drug substance, the relevance of the expected dosage form, and the know-how of our experts
Polymorph Screening
To meet regulatory requirements, the polymorphic behaviour of a drug substance needs to be assessed and the polymorph chosen for development needs to be fully identified/characterized. Identifying the polymorph landscape can also strengthen the intellectual property
Amorphous Dispersions
Amorphous forms can have increased solubility and bioavailability in comparison with their crystalline form. However, crystalline materials tend to be more stable and amorphous material can recrystallize over time but can be stabilized as an amorphous solid dispersion. Whether it's spray-dried dispersions (SDDs) or hot melt extrusion (HME), our team of experts can support the enhancement needs of your molecule.
Crystallization Development
Supporting the drug substance development team, purification steps can be improved and drug substance manufacturing yield, throughput, and purity can be increased by integrating a solid-state approach to recrystallization processes.
Solid-State Characterization
We offer a wide range of analytical techniques to fully characterize solid-state forms, including dissolution/disintegration testing and X-ray powder diffraction (XRPD) as well as:
- Thermal analysis: differential scanning calorimetry (DSC), thermogravimetric analysis (TGA)
- Hygroscopy: dynamic vapor sorption (DVS)
- Hot-stage microscopy
- Particle size distribution and particle enumeration
- Surface area
- Solution and solid-state nuclear magnetic resonance (NMR) spectroscopy
- Fourier-transform infrared spectroscopy (FT-IR)
Pre-formulation and Material Science
Our experienced material scientists can support your pre-formulation screening to allow selection of your drug candidate for pre-clinical evaluation and identification of your drug product in early clinical evaluation.
Expanded drug substance manufacturing capabilities in Alnwick, UK
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Info SheetDrug Substance Synthesis and ManufacturingTactical deployment of best-in-class synthesis technologies to minimize chemistry costs and move your drug substance supply off the critical path.
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Case StudiesThermal Rearrangement – Flow Chemistry - Case StudyQuotient Sciences seeking to improve the yield and purity of a US Biotech API intermediate using flow chemistry
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Case StudiesAPI Development Case StudyRapid development of a scalable route towards an analogue of a new drug substance, with definition of an optimal salt form for formulation
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Case StudiesDrug Substance Salt Selection Case StudyUS Biopharmaceutical seeking drug substance and salt screen selection for their molecule.