Drug solid-state screening

Rapid and precise deciphering of complex formulations

In-depth analysis of solid-state properties

Development and Industrialization of Solid State
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- Polymorphy identification in ultra-low content formulations
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- Non-destructive reverse engineering of advanced formulations
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- Crystallization process and product online monitoring
Identification of Unknown Excipients
Reference formulations typically list the types of excipients they contain. However, critical excipients that are not disclosed in these lists and exist in very low quantities can directly impact the formulation process and dissolution mechanisms of the drug product. Failing to accurately analyze whether the originator includes these critical low-level excipients can significantly increase the workload of the generic drug development process. Conversely, effectively and accurately identifying these excipients, along with understanding their functionalities, can greatly streamline the development of generic drugs, making the process more efficient and effective.
Application Case of Raman Spectroscopy in the Analysis of Low-Content Components
Our company utilizes Raman spectroscopy in the analysis of low-content components.
different substances. For instance, the API content is approximately 3% (magenta), excipient 1 (green), excipient 2 (red), and so on.


Figure 1. Raman Imaging Distribution Map of the Formulation
Figure 2. Comparison of Mapping Spectrum with Component Spectrum in the Formulation
Figure 2 shows the Mapping spectrum of each component in the formulation, as well as spectra of individual components. By directly comparing the spectra, the signal peaks of main components 1-5 can be observed, confirming their presence. However, for components with potentially very low concentrations, their characteristic peaks may not be clearly visible. Therefore, there are two possibilities: either the spectrum of these components is masked or these components may not exist.
Figure 3 employs Principal Component Analysis (PCA) to analyze the entire set of Raman mapping spectra. By comparing the data models, it is evident that the data model of PC6 is similar to the reference spectrum of component X, which is hypothesized to exist (Figure 4). This provides reliable evidence for detecting the low-content excipient X.
Figure 3. Principal Component Data Model of Mapping Spectrum
Figure 4. Comparison of PC6 Data Model with Spectrum of Component X
Summary: Through Raman spectroscopy, we are not only able to detect formulations using Mapping images and gather extensive data for analysis, but also combine point detection methods to obtain the required data more accurately and swiftly, achieving qualitative or quantitative analysis. Additionally, we possesses a vast pharmaceutical excipient database with comprehensive information. We have established an intelligent data retrieval system to enhance data mining and analysis capabilities. By searching and comparing information within the database, we can rapidly and accurately identify unknown excipients, significantly accelerating the drug development process.
Solid State Research

Improving drug absorption through solid-state technology is the foundation of all innovative technologies at Xinyang Weikang.

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Innovative Improved Drugs
Our company strategically focuses on developing high-end formulations, successfully completing numerous advanced oral film formulations, and establishing a systematic approach to formulation development.
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CDMO
We are the only integrated domestic platform specializing in crystalline formulation production, strictly adhering to GMP standards. We specialize in scaling up research and commercial production of various dosage forms including oral films, topical formulations, and solid formulations.
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Nycrist Phamatech Co.,Ltd
Tel:19129598229  
       19129598368(Mr.Lee)
       19926561149(Mrs.Chen)
       19926414326(Mr.Liu)


Headquarters Address: Building A3, Guanming Technology Park, No. 3009 Guangming Avenue, Fenghuang Community, Fenghuang Street, Guangming District, Shenzhen


Production Base Address: Weiguang Life Science Park, Guangming District, Shenzhen


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