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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第一行主标题 请输入要描述的内容进行内容补充请输入 - Non-destructive reverse engineering of advanced formulations Identification of unknown excipients 第一行主标题 请输入要描述的内容进行内容补充请输入 - Crystallization process and product online monitoring |
Non-destructive Reverse Engineering of Advanced Formulations In original formulation development, accurately determining the presence of certain very low-level components becomes a critical point in reverse engineering analysis. Raman imaging is applied for real-time spectral results, which can be transformed into chemical images through various mathematical operations. The simplest method to identify each component in the formulation involves comparing all Raman spectra obtained from the formulation with the characteristic spectra of each individual component. If a characteristic peak of a component, which does not overlap with peaks of other components, can be detected, the presence of that component can be confirmed. However, such cases are rare in practical situations. Typically, formulations consist of active pharmaceutical ingredients (APIs) and excipients from different chemical classes, and these components are finely dispersed and well-mixed. Therefore, Raman imaging spectra of such formulations often exhibit overlapping signals from multiple components. Multivariate analysis methods such as Principal Component Analysis (PCA) and Direct Classical Least Squares (DCLS) can effectively distinguish characteristic peaks of different components and extract valuable information for analysis. Reverse analysis in the development process of high-end generic drugs Case Study The application of Raman microspectroscopy as a non-destructive analysis technique for solid dosage forms in the pharmaceutical field originated in the 1990s. Compared to traditional methods, the major advantage of Raman microspectroscopy lies in its ability to analyze the chemical composition of solid dosage forms without damaging their spatial structure. It can characterize different cross-sections to analyze internal information of samples with varying specifications and shapes, revealing the distribution of APIs and excipients across different regions of the formulation. While non-destructive analysis may not appear inherently attractive, the surface analysis information it provides can sometimes be indispensable and cannot be achieved or replaced by conventional destructive analytical techniques such as High-Performance Liquid Chromatography (HPLC), Thin-Layer Chromatography (TLC), or Size-Exclusion Chromatography. For complex formulations with multilayers or coatings, differences in the distribution of APIs among different manufacturers of the same product may indicate variations in production processes. These differences in distribution and preparation processes can directly imply differences in dissolution behavior among formulations from different manufacturers. In the illustration on the right, the capsules of the same API from different manufacturers are shown. In Product A, the API is predominantly concentrated in the middle layer (red represents API, other colors represent excipients), whereas in Product B, the API is mainly mixed in the core of the capsule. Comparing the dissolution profiles of these two products would likely reveal differences. Conversely, understanding the distribution of APIs and excipients and the stratification of the formulation can facilitate reverse engineering efforts to replicate the approximate production processes of Products A or B. This approach significantly streamlines the process of formulation replication, enhances efficiency, and reduces workload. |
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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