Flexible and Creative Approaches to Product Development
As a specialist contract pharmaceutical research organisation, we provide our clients with a comprehensive package of preclinical analytical services and drug delivery technologies to support the development of new and existing active drug substances.
With a particular focus on low solubility, poorly bioavailable compounds, our expertise in oral, parenteral and inhaled drug delivery, combined with state-of-the-art analytical research and development technologies, can help guide you through the complexities of early stage product development and provide quick and cost effective entry into first in man trials.
Our core contract services are grouped into five main categories:
(please click on the relevant link for more details)
Active Substance (AS) / Drug Product (DP) Characterisation
Informed analysis at critical time points during the R&D process is an effective strategy for clarifying decisions and reducing both the overall research time and chances of late-stage product failure.
At Synectix, we have the expertise and facilities to offer efficient, accurate and reliable contract research and cGMP analytical drug substance and product characterisation services, which are able to provide valuable solutions to all your analytical requirements.
Through the integrated application of our technologies and expertise in solid-state physical chemistry, we can rapidly provide a greater insight into the physicochemical and physicomechanical properties of your API and provide cost effective options for both preclinical and clinical formulation product design.
The following is a list of links to specific application areas
- Drug substance and product physico-chemical profiling
- Rapid excipient compatibility screening
- Amorphous content detection, quantification and method validation
- Chemical mapping and imaging
Pharmaceutical Preformulation
At Synectix Pharmaceutical Solutions Ltd, we believe that an adequate understanding of the properties of your drug substance will minimise problems in the later stages of drug development, reduce drug development costs, and decrease your product's time to market.
Preformulation is a branch of pharmaceutical sciences that utilises biopharmaceutical principles in the determination of physicochemical properties of a drug substance. The goals of preformulation studies are to choose the correct form of your drug substance, evaluate its physical properties, and generate a thorough understanding of the material's stability under various conditions, leading to the optimal drug delivery system.
We offer a wide range of analytical technologies and expertise to achieve these goals. These approaches are designed to help move your compound from drug candidate to marketable product.
Product Properties
- Kinetic and equilibrium Solubility (aqueous/buffers/organic solvents)
- Dissociation Constant (pKa)
- Partition Coefficient (log p or log D)
- Salt screening (determination of preferred salt forms)
Solid State Characterisation
- Powder properties (flow/compaction/ density/particle size/surface area)
- Microscopy (morphology, particle characteristics)
- Thermal Analysis (DSC, TGA)
- Molecular Spectroscopy (FTIR, NMR, MS)
- X-ray Diffraction
- High-throughput Excipient compatibility screening (depending on dosage route)
- Stability (heat/light/acid/base/oxidizer)
- Moisture isotherm (formation of hydrates/deliquescence)
The Scientists and Synectix work closely with your own R&D team to design and conduct the relevant preformulation studies. Depending on the nature of your drug candidate, we can conduct special studies expanding the scope of information obtained on the drug molecule.
Monitoring Process Induced Structural Disorder and its Influence on the Functionality and Perfomance of APIs For Inhaled Delivery (AmorFx™ Toolkit)
In conjunction with our strategic partner organisation, NanoPharm Ltd, we have developed a sophisticated suite of novel analytical methodologies combined with advanced particle and surface science characterisation technologies to help improve our understanding of the impact of API mechanical properties on micronisation processing and post-micronisation influences on the characteristic properties and functionality of APIs.
Our expertise and technologies allows for timely analysis to measure the “Cause and Effects” of processing in order to provide a greater scientific and technical understanding of the relationship between materials and processes in the development and manufacturing of robust and stable pharmaceutical products .
To learn more about the novel AmorFx™ Toolkit, please click here
Preclinical Concept Studies: Rapid Screening For Improved Solubility (SOLENT™ Assay)
Developed by the scientists at Synectix, SOLENT™ is a rapid, low-cost, solubility screening platform to help identify options to support preclinical toxicity testing and pharmacokinetic studies. Specifically focussed on low solubility, hydrophobic drug compounds, the process capitalises on skilled manual intervention and laboratory semi-automation controlled through a sophisticated database approach to yield results quickly and cost-efficiently.
Using as little as 50 mg of compound, our researchers screen the specific API against our exclusive pre-formulation matrix, which represents a wide variety of liquid-based GRAS excipients suitable for both oral and IV use. The resulting data drives the direction of our experienced scientists to produce suitable dosing options for pre-clinical and early-phase clinical trials.
To learn more about the SOLENT™ solubility screening platform, please click here
Drug Delivery Technologies
At Synectix, we are dedicated to the continued development and commercialisation of breakthrough products for new chemical entities (NCEs) and commercial compounds requiring reformulation, as well as rescuing potential R&D drop-outs. Our research efforts are focused on the application of bespoke particle processing and drug delivery technologies for liquid and solid dosage forms in order to produce cost-effective products with enhanced solubility / dissolution, bioavailability, stability and more convenient dosing.
Our technologies for preparation of stable intermediates for solubility and bioavailability enhancement include
:
- Rapid drug solubility screening to identify dosing options for preclinical and early phase clinical trials
- Lena™ Nanoceutics particle processing for preparation of nanoparticles and nanosuspensions
- ProRelease™ stabilised amorphous microparticulates for solubility and oral bioavailability enhancement
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