Solid Form Screening & Selection
We tailor our screens function of drug substance physchem properties, available time frame, and customer budget. Our main goal is to create value for our customers.
All our screening programs are supported by an analytical package that includes:
- X-Ray Powder Diffraction (XRPD)
- Differential Scanning Calorimetry (DSC)
- Thermo-Gravimetric Analysis (TGA)
- Fourier Transformed Infrared (FT-IR) and Raman Spectroscopy
- High Performance Liquid Chromatography (HPLC)
- Nuclear Magnetic Resonance (NMR), and many others
All these techniques are employed to select the most optimum solid form of the drug substance to be considered for development.
SARA Pharm Solutions offers polymorph screening programs that aim to identify a stable crystalline form of the API. Tailored to customer needs, our designs include a considerable high number of crystallization experiments and target to deliver a robust crystallization process that can be easily transferred to larger scale.
The bio-pharmaceutical properties of each crystalline form are established using several advanced solid-state characterization techniques available in our labs. The benefits of using our approach are:
- polymorph screens are rationally design
- all crystallization modes are tailored to the phys-chem properties of the drug under study
- HT-XRPD is used to identify and locate (new) crystalline forms
- a limited amount of drug substance is required
- expert understanding of generated data is available
A new polymorph of your API with enhanced bio-pharmaceutical properties may be considered to strengthen the Intellectual Property (IP) portfolio of your company.
We offer tailored salt screening and selection programs focused on meeting the customer expectations and needs. Considering the salt formation process we screen a high number of counter ions selected based on:
- experimental pKa values of the free form
- market precedence of counter ions (“Orange Book”)
- known toxicology data of each counter ion and solvent system (ICH guideline)
The aim is to locate a high number of stable crystalline acceptable salts that meet the pharmaceutical property requirements. Once evaluated, the most acceptable salt forms are scaled-up and then fully characterized. Such an investigation is carried out for all salt forms, allowing SARA Pharm Solutions’s scientists to rank the salt forms with respect to their crystallinity, stability, solubility, purity, reproducibility, etc.
A salt form with enhanced bio-pharmaceutical properties may be considered to strengthen the Intellectual Property (IP) portfolio of your company.
Co-crystallization is a crystal-engineering technique employed in case of non-ionizable organic molecules that are unable to form salts. The aim of such a process is to obtain a new solid form with acceptable bio-pharmaceutical properties.
Our approach in co-crystallization is custom made and offers several advantages such as:
- co-crystallize ability is theoretically (via modeling) and experimentally assessed
- we employ tailored co-crystallization techniques such as dry- and solvent-drop grinding, slurry, sonication, cooling co-crystallization
- we carry out process optimization of the co-crystallization scaling-up process
- we investigate co-crystals physchem stability (ICH guidelines)
The identification of most suitable co-crystal form is supported by single-crystal data analysis, and solid state NMR data. A co-crystal form with enhanced physchem properties may be considered to strengthen your Intellectual Property (IP) portfolio.
Amorphous Solid Dispersions Screening
Amorphous phase plays a key role in the solid-state pharmaceuticals field. This is due its greater solubility in comparison to any crystalline form of the same API. Our scientists focus on the following aspects:
- preparation of amorphous phases using solid and solution-based methods
- characterization and quantification of the amorphous phases
- stabilization of amorphous phase (eg. via amorphous solid dispersions, ASDs)
Advantages of using our approach:
- quick and easy production of amorphous phase
- full characterization of amorphous phase
- quantification of amorphous content via different methods
- rational design of ASD screen
- ICH guidelines stability studies for Am phase and ASDs
The experience of our scientists in the field of amorphous phase stabilization ensures the success of your research program with us.