Polymorphy 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 - Establishing of quality standards for Polymorphy content limits 第一行主标题 请输入要描述的内容进行内容补充请输入 -Development of Methods for Controlling Particle Size and Crystal Habit 第一行主标题 请输入要描述的内容进行内容补充请输入 - Single Crystal Growth and Structural Identification |
Solid-state stability studies and prediction In preclinical drug research, the crystalline form of a compound can undergo polymorphic transformation due to various environmental factors such as temperature, humidity, light exposure, and pressure. These transformations can lead to changes in the properties of the drug. Throughout the multiple processing steps from drug raw materials to the final solid dosage form (including refining, grinding, granulation, drying, compression, etc.), these processes may alter the crystalline form of the drug. The stability of the pharmaceutical crystalline form directly impacts the drug's efficacy and safety, necessitating research into its stability. This includes: The Interrelationship between Formulation Processes and Crystalline Forms ■ Stability of the crystalline form of active pharmaceutical ingredients (APIs).
■ Compatibility of API crystalline forms with various excipients in formulation.
■ Influence of formulation processes such as granulation, compaction, drying, etc., on the crystalline form of APIs. ■ Stability testing under conditions such as high temperature, high humidity, and light exposure, examining factors affecting the crystalline form's stability. ■ Evaluation of the crystalline form's stability under pressure conditions to observe any polymorphic transformations. Studying the stability of crystalline forms provides scientific basis for selecting advantageous drug crystalline states, optimizing drug formulations, controlling manufacturing processes, and determining storage conditions. In pharmaceutical development, various issues often arise, such as tablets made from the same process and formulation exhibiting different crystalline forms in the finished product. This discrepancy indicates that the API crystalline form has undergone polymorphic transformation under external influences. Therefore, detailed quantitative analysis of the crystalline form is essential to confirm the occurrence of polymorphism and identify whether it has transformed into another known type of crystal or a new crystalline form. Different crystalline forms of drugs can vary significantly in their efficacy, necessitating thorough research to understand and clarify the contributing factors. The study of crystalline forms aims to identify the factors causing polymorphic transitions and to design formulation and processing protocols accordingly. Several common reasons in formulation processes that are believed to cause polymorphic transformations include: ■ Purification of APIs before formulation processing, such as recrystallization, where changes in crystallization solvents, cooling methods, or temperature variations can alter the drug's crystalline form. ■ Mechanical grinding of drugs can generate heat in particles, leading to crystalline form changes. ■ Humidity and drying conditions can also influence crystalline form changes. Polymorphic drugs melted at high temperatures and crystallized differently upon cooling can yield different crystalline forms. Polymorphic drugs also commonly undergo polymorphic transformations during drying. ■ Polymorphic unstable types and stable types typically transform under pressure, with the extent of polymorphic transformation varying at different pressures and locations. |
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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19145082504（Mr.lee）
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