Comprehensive Solutions for Formulation Development
In the entire process of pharmaceutical research and quality control, analytical instruments are efficient tools that drive innovation and ensure drug safety. Advanced and user-friendly instruments have been developed to evaluate drug dissolution and absorption in vivo, to screen and verify the physicochemical properties of formulations, or conduct real-time monitoring in quality testing. Amerigo Scientific offers a series of comprehensive solutions, accelerating the process of new drug discovery and development.
With advanced in situ monitoring technologies, simulation platforms, and high-throughput screening methods, our analysis instruments can:
- Accelerate drug development: shorten experimental cycles and reduce sample consumption
- Enhance data quality: achieve real-time monitoring and high-precision measurements
- Strengthen quality control: ensure compliance and consistency across R&D and manufacturing stages
Compound Screening Solutions
Amerigo Scientific offers SiriusT3 compound screening solution for the physicochemical characterization of single-component organic chemicals and their salts. This instrument can be seamlessly integrated with the analytical workflow of drug discovery to quickly and effectively identify the most promising small molecule candidates, reducing the risk of failure in drug development.
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Product | Application |
|---|---|---|
| SiriusT3 PhysChem Compound Screening Instrument | Early drug screening and lead compound optimization |
Features
- Ultra-low sample requirements: Sub-milligram sample quantities are required, and single titrations take < 6 minutes.
- High-throughput pKa determination: Up to 80 tests can be performed per day.
- Dual pKa technology: Spectrophotometric (for UV-active compounds) + potentiometric (for non-UV-active compounds).
- Fast log P/D determination: Potentiometric, complete in < 2 hours, replacing traditional shake-flask methods.
- Patented CheqSol technology: Determine kinetics and intrinsic solubility in under 2 hours.
- In-depth solubility analysis: Provide solubility versus pH curves, revealing the extent and duration of supersaturation.
Configurations
| Configuration | Application |
| DTAu | Fully automated with pKa high throughput screening SiriusT3 system with both spectroscopic and potentiometric assay capabilities. |
| DTu | A single vial system for one assay at a time with both spectroscopic and potentiometric assay capabilities. |
| DTA | A fully automated system with only potentiometric assay capabilities. |
| Lite | A single vial system for one assay at a time with only potentiometric assay capabilities. |
Concentration Monitoring Solutions
Amerigo Scientific offers the Rainbow R6 for monitoring concentration of compounds. It is based on in-situ fiber UV-VIS spectroscopy technology and features a deuterium lamp light source and photodiode array detection. Rainbow R6 can be applied to accurately measure dissolution in real-time, specifically for pharmaceutical R&D and quality control.
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Product | Application |
|---|---|---|
| Rainbow R6 for QC and R&D - In Situ Fiber Optic UV-Vis Spectrometer | Early formulation development, formulation optimization, and regulatory quality testing |
Features
- Equipped with up to 8 independent fiber-optic channels. it enables high-precision and repeatable concentration measurements.
- There are no delays between sample draw and analysis, providing concentration measurement in real-time.
- Samples are measured within less than 5 seconds, enabling extremely short sampling intervals required for measuring immediately released formulations.
- Unattended, extended assays are possible as concentration measurement is performed directly in assay media.
Configurations
The Rainbow R6 features a highly modular and scalable design to meet the diverse needs. It can be seamlessly integrated with a variety of dissolution testing platforms and supporting equipment for real-time concentration monitoring for dissolution, absorption, and solubility studies, enabling automated data acquisition and analysis. Whether in low-volume R&D or large-volume quality control experiments compliant with USP standards, the Rainbow R6's modular configuration delivers highly accurate, reproducible, and traceable data.
| Application | System | Test Volume | Component |
| Dissolution Testing for Small Volumes | MiniDISS Profiler In Situ Fiber Optic UV Monitoring System | 2-20mL Dissolution Assays | R6 and a low-volume dissolution bath |
| MicroDISS In Situ Fiber Optic UV Monitoring System | 100-250mL Dissolution Assays | R6 and a miniDT small volume tester | |
| Dissolution and Absorption | Miniflux In Vitro Analytical Platform for Dissolution and Flux Measurements | 130-250mL Dissolution and Absorption | R6 coupled with the miniDT 250 mL volume dissolution bath and a submerging acceptor chamber |
| Bioflux In-Situ UV Probe-Based Dissolution System | 500mL Dissolution and Absorption | R6 coupled with a compendial dissolution apparatus | |
| Macroflux In-Vitro Assessment of Dissolution-Absorption Processes | 900mL Dissolution and Absorption | R6 coupled with a compendial dissolution apparatus and submerging Flux acceptor chambers | |
| Injection Site Monitoring | Scissor N3 In Vitro Subcutaneous Injection Site Simulator | In vitro subcutaneous injection site simulator | |
| Compendial Dissolution Testing | DissoSpec QC Dissolution Monitoring System | Integrated, in situ UV-VIS dissolution testing system | |
Injection Site Simulating Solutions
The SCISSOR N3 is a subcutaneous injection site simulator with advanced in vitro model capability for investigating the release performance of subcutaneous formulations under simulated physiological conditions. It can be applied to assess the risk and performance of subcutaneously administered drugs including biologics, peptides and small molecules.
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Product | Application |
|---|---|---|
| Scissor N3 In Vitro Subcutaneous Injection Site Simulator | Formulation development: rank ordering formulations and excipient screening |
Features
The SCISSOR N3 is the solution that bridges the gap between standard dissolution and solubility results and in vivo Pharmacokinetics (PK) studies.
- Run up to 3 independent assays on a single SCISSOR N3, simultaneously.
- Optional automated sample fraction collector for unattended operation, with programmable sampling volumes and times, 240 vial capacity, and media refill after sampling.
- Integrated camera and turbidity sensors for effective detection of turbidity and assessment of precipitation or dissolution of particles in suspension.
- Fiber Optic probe port for use with Rainbow R6 Concentration monitor to generate concentration profiles in real-time.
- Physiologically relevant temperatures and buffer environments maintained during assays.
- Monitors pH change upon injection in the extracellular matrix (ECM), by using a hyaluronic acid-based viscous liquid.
- Optimized extracellular matrix options provide accurate simulation of the extracellular matrix, by using a hydrogel containing hyaluronic acid.
Application
SCISSOR N3 allows investigation of the API interaction with the extracellular matrix, monitors the pH change upon injection, and identifies optimal excipient conditions.
- Excipient screening during formulation development
- Formulation comparison
- Rank ordering formulations for candidate selection
- Investigation of drug stability upon and after injection
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