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▶ Polymorph screening
Guided by the initial crystallization knowledge, we design the relevant experimental space including solvent, temperature, humidity (water activity) etc, systematically employing the highest possible diversity of the screening methods and dimensions to ensure a maximum probability in finding all solid forms. Specific areas including: ◆ Screen all possible solid forms of a new chemical entity ◆ Select the optimum solid form early in drug development ◆ Develop a crystallization process that assures control of solid form ◆ Produce a drug product with stable solid form through expiration Besides commonly utilized crystallization methods, other screening approaches might also be applied, for instance: (1) Dry and solvent-drop grinding (2) Spray drying and freeze drying (3) Lyophilization (4) Crystallization from the melt (5) Compression (6) Sonication (7) Supercritical antisolvent (SAS) Further reading: Allesø M, Tian F, Cornett C, Rantanen J, Journal of Pharmaceutical Sciences ...
▶ Cocrystal screening
Pharmaceutical co-crystals are multi-component crystalline structures made of neutral APIs and co-crystal formers that are solid at ambient conditions and that are bound via non-covalent interactions. The co-crystallization of APIs with pharmaceutically acceptable co-crystal formers is nowadays a recognized technique in pharmaceutical science for improving the drug physico-chemical properties leading to an enhanced oral bioavailability. Additionally, co-crystals have great potential in the pharmaceutical industry by creating intellectual property (IP) protection and extending the life cycles of the APIs. Taking an integrated approach in searching for the right conformer and crystallization method, we offer effective and comprehensive cocrystal screening services.
▶ Crystallization development
Building on a comprehensive crystallization experiences, we are capable of offering direct support on how to develop robust, reproducible, and scalable crystallization processes that generate the solid with desired crystalline form, size, and shape. Providing strategic crystallization suggestions on how to crystallize out ‘non-crystalline form’ is also one major focus of our crystallization services. Although amorphous form has advantages of greatly enhanced dissolution rate and solubility, crystalline form may still be the preferred form in most cases. Persuading non-crystalline form to crystallize out however can be challenging sometimes. Further reading:Qu H, Munk T, Cornett C, Wu J X, Bøtker JP, Christensen L P, Rantanen J, Tian F, Pharmaceutical Research 2010, 28, 364-373.
▶ IP support
Protecting intellectual property rights is one of the most critical tasks in pharmaceutical R&D. Patent generation formulating an important part of business strategies for both innovative and generic companies. Our services include evaluating all suitable data, determining whether your invention is patentable, and providing suggestions on the scope of protection for potential patent rights.
▶ Full analytical services
Polymorphism can influence every aspect of the properties of a solid including the shelf life, dissolution rate, solubility, formulation properties and processing properties of a solid drug. A deeper understanding of polymorphism and related solid state properties would ensure an improved quality of the materials used throughout drug preparation, dosage form formulation and clinical trials. Therefore, determination of the existence of polymorphs and pseudopolymorphs, characterization of different solid state forms and their respective properties, and controlling the existing form in the resulting formulation all form part of a rapidly growing field within pharmaceutical research and industry. Based on our extensive experiences in solid state research, we can assist with performing accurate solid state characterization, and also competent interpretation of the characterization results. Although it is vital to explore the solid state features of the representative form, an accurate unde...
▶ Crystal structure identification
When discovering the ‘true’ identity of each solid form, single crystal X-ray crystallography has been accepted as one of the definitive approaches. Utilizing our crystallization knowledge and experiences, we offer direct guidance and service on crystallization of perfectly grown and pure single crystals. Morphology of a typical CBZ single crystal and Miller indices of three faces (A), and position of the crystals mounted on the sample holder (B). Further reading: Tian F, Sandler N, Gordon KC, McGoverin CM, Reay A, Strachan CJ, Saville DJ, Rades T, European Journal of Pharmaceutics and Biopharmaceutics 2006,64: 326-335
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广东省深圳市宝安区西乡街道办航城大道光电研发大厦二楼
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nycrist@nycrist.com
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