Solid State characterization
Seqens has the industrial experience to manufacture API polymorphs in a stable and reproducible manner and offers the convenience of partnering with you to customize particle size distribution to your specifications.
In addition, Seqens has significant expertise in developing chiral pure APIs from its existing catalogue of racemic APIs and can apply our processes to racemic molecules produced by other manufacturers.
Solid state science drug development track record:
- Cinacalcet synthesis
- Esomeprazole trihydrate/dehydrate
Why choose Seqens’Lab for Solid State Services ?
Seqens’Lab possesses a comprehensive State of the art equipment allowing high capacity and fast turn-around, supporting development, stability and batch release.
Our experts develop in-house generic methods for a variety of techniques to eliminate the need to develop a method from scratch.
We can transfer compendial or client-provided methods, per cGMP, as well as develop new methods when no current method exists.
Our state-of-the-art PAT (Process Analytical Technology) supports process optimization and scale-up (Blaze 900 in situ probe which provide chord length distribution, high resolution imaging and Raman characterization).
Low aqueous solubility of active pharmaceutical ingredients (APIs) often translates to poor bioavailability that can be a cause of failure during drug development. As such, improved aqueous solubility is a primary objective of formulation development, especially for oral, inhaled, and topical drug treatments.
Spray drying is an established particle engineering technology that involves producing dry powders from a fluid material through atomization into a hot drying gas medium, usually air or nitrogen. It offers several advantages over other particle engineering technologies, not least the capacity for continuous operation that removes any limitations on batch size. Other benefits of spray drying include rapid, scalable, cost-effective operation, and implicit compatibility with process analytical technology to safeguard highly reproducible drug production.
Spray drying is also more controllable, especially in the hands of an experienced API CDMO.
The micronization of APIs is increasingly becoming a key capability for Contract Development and Manufacturing Organizations (CDMOs) as demand for semi-solid drugs, creams and gels continues to grow, as well as the use of APIs in foodstuff ingredients.
Micronization is a process for reducing the diameter of a solid material’s particles to enable the solubility of Active Pharmaceutical Ingredients (APIs). Whether administered orally or topically, this solubility is a key factor in bioavailability, and ultimately, the effectiveness of a drug.
Pre-formulation testing capabilities
- Allows for precise pH control and monitoring, enabling you to study dissolution under conditions that mimic in vivo conditions more closely that other systems.
- Provide biorelevant dissolution and solubility data (IDR, pKa, etc.)
- Determine characteristic absorption patterns of raw materials
- Empyrean Serie III Malvern-Panalytical XRPD and CHC chamber (resolved temperature and relative humidity control)
- NMR Bruker Avance III 400 Mhz
- Mettler DSC3
- Mettler TGA/DSC3+
- FP-80 HT Hot-stage microscope, Mettler
- Malvern-Panalytical Particle Size Analyzer (LDPSD) Mastersizer 3000 (wet & dry)
- Malvern-Panalytical Morpho-analyzer Morpholo M4 ID with Raman spectrocopy
- Hosokawa Alpine Air jet Siever
- Malvern-Panalytical DLS Zetasizer Pro Red
- Microtrac BET Belsorp-Mini X
- DVS Intrinsic (SMS)
- Optical Light Microscopy
- Hitachi TM-1000 Scanning Electron Microscopy
- Perkin-Elmer FTIR Spectrocopy
- Agilent Ultraviolet (UV) Spectroscopy
- Sotax Powder Flow Tester