In the complex tapestry of pharmaceutical product development, the collaboration between APIs and excipients is not merely a combination of components, it's a precise orchestration of chemical interactions. Our company, a distinguished name in the industry with many years of unparalleled experience, stands at the forefront of preformulation studies. We can provide customers with a full range of services of API-excipient compatibility to study the interactions between API and excipients and help customers select the appropriate excipients in early formulation development. In addition, we also provide compatibility research on packaging materials to help customers choose suitable packaging materials. If you have any needs, please feel free to contact us.
Our Services
The API, often the therapeutic nucleus of a pharmaceutical product, is only one facet of the intricate composition of drug formulations. Excipients, on the other hand, play multifaceted roles, enhancing drug quality, stability, and overall performance. Proper selection and assessment of possible incompatibilities between drugs and excipients during preformulation studies is critical to achieving target product characteristics and quality attributes. The types of incompatibilities between drugs and excipients are as follows:
| Physical incompatibility | Involves a change in the physical form of the formulation, including color change, liquefaction, phase separation, or insolubility. |
| Chemical incompatibility | It involves formulation changes due to the formation of new chemical components. |
| Therapeutic incompatibility | This is a type of in vivo compatibility. It involves a change in the therapeutic response of the preparation. |
At our company, we use multiple technologies such as differential scanning calorimetry (DSC) and Fourier-transform infrared spectroscopy to explore the API-excipient interplay. This holistic approach unravels potential incompatibilities, ensuring that the final formulation is devoid of adverse interactions that could jeopardize safety and stability.
Our Methods
| High pressure liquid chromatography | Differential scanning calorimetry | Fourier-transform infrared spectroscopy |
| Differential thermal analysis | Diffuse reflectance spectroscopy | Fluorescence spectroscopy |
| X-ray powder diffraction instrument | Thin layer chromatography | Osmometry |
| Vapor sorption analysis | LC mass spectrophotometer | Nuclear magnetic resonance |
Advantages
- Rapid turnaround, unwavering quality: Our API-excipient compatibility studies adhere to the highest standards, aligning with regulatory requirements and industry best practices. With rapid turnaround times, high-quality reports, and effective communication between our clients and experts, we guarantee accurate and timely results that empower informed decision-making.
- Holistic excipient compatibility studies: Our excipient compatibility studies span a spectrum of excipients, ensuring a thorough evaluation of interactions to ensure the final formulation's safety and stability.
- Cutting-edge technologies: Our company employs advanced technologies. The use of these technologies can help customers analyze and understand the interactions between APIs, excipients, and packaging materials.
Delivery
Complete experimental data are provided, including physical and chemical compatibility data, thermal analysis data, storage conditions, etc.
Please kindly note that our services are for research use only.
