Nycrist Pharmatech Limited

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Solid Form Screen
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◆ Polymorph and salt screening ◆Cocrystal screening ◆ IP support ◆ Crystallization method development

▶ 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 assure...

▶ 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 pharm...

▶ 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, crys...

▶ 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.
Solid State Understanding
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◆ Full analytical services and competent interpretation ◆ Crystal structure identification ◆Impurity quantification ◆Trouble shooting

▶ 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 differen...

▶ 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, ...

▶ Impurity quantification

Quantification of extremely low levels of impurity can be difficult. The detection limit and sensitivity provided by each technique also vary with solid properties. We have developed a comprehensive experience of effectively combining different technologies with proper data processing methods, which allows an accurate quantification even for samples with very low levels of impurity.

▶ Trouble shooting

It is critical to utilize existing data and plan an efficient pathway to identify the root-cause of pharmaceutical failures. No matter if they are early preclinical issues regarding pure substances, excipients, or complex processing and formulation problems, we can offer immediate assistance, deliver relevant and useful suggestions in close collaborations with our customer. Just name a few examples where the key to solving challenging problems actually resides in the solid state aspects, for in...
Formulation Development
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◆ Amorphous materials ◆Excipient compatibility screening ◆Solid Dispersions Screening

▶ Amorphous materials

Preparation of amorphous Depending on the chemical nature of each model compound, we offer service and suggestions on selecting suitable methods for ‘destroying’ crystalline into amorphous with high stability and chemical/physical purity. Commonly utilized techniques including: (1) From liquid phase to amorphous solid – freezing-in disorder ◆ Spraying drying ◆ Quench cooling ◆ Melt extrusion ◆ Super critical fluids ◆ Co-precipitation (2) From crystalline solid to amorphous solid – inducing disor...

▶ Excipient compatibility screening

Excipients are indispensible for a tablet formulation. There are numerous excipients with different chemical functionalities and diverse physiochemical properties that may be selected for a given compound. It is important to carefully evaluate the potential of different excipients, and rationally choose compound combinations that represent a safe way forward in terms of chemical compatibility and/or physical stability. Based on our extensive experience, main areas listed as follows can be evalua...

▶ Solid dispersion screening

We provide service for an effective solid dispersion screen focusing on the aspects as below: ◆ Rational excipient screen ◆ Formulation design and optimization ◆ Solubility testing while monitoring solid state of API ◆ Stability tests and behavior prediction
Raman&PAT
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◆ Raman and polymorphic analysis ◆ Raman analysis in aqueous environments ◆Raman and process monitoring

▶ Raman and polymorphic analysis

Raman spectroscopy has only recently arisen as one of the commonly used molecular motion probing techniques. The invention of Raman spectroscopy goes back to 1928 when the Indian physicist C.V. Raman first found that the wavelength of a small fraction of the radiation scattered by certain molecules differs from that of the incident beam. This discovery led Raman to be awarded the Nobel Prize in Physics in 1931. Chandrasekhara Venkata RAMAN, 1928 The energy levels explored by Raman spectroscopy a...

▶ Raman analysis in aqueous environments

a. Effect of water on Raman spectra One of the major advantages of Raman is that water has very weak Raman scattering. Therefore, Raman can be utilized in various aqueous formulations without the influence of the presence of water. The suspensions were measured directly by Raman without the need of any sample preparation. Because of the weak Raman scattering of water, the chemical composition as well as the polymorphic form of API can be easily identified by Raman. Further reading：Sandler N et a...

▶ Raman and process monitoring

Raman could help generate valuable process data to ensure optimal process control, comprehensive process understanding at a molecular level and maximum efficiency in pharmaceutical production. Various factors can possibly induce solid state changes during pharmaceutical processing, as illustrated below. To ensure a robust processing, a key aspect of FDA's process analytical technology (PAT) philosophy is that every stage of the manufacturing process should be monitored and understood so that...

News

Pharmaceutical Solid State Research Cluster (PSSRC) Annual Meeting

Pharmaceutical Solid State Research Cluster (PSSRC) Annual Meeting

September 18th 2015 Pharmaceutical Solid State Research Cluster (PSSRC) Annual Meeting Ghent University, Belgium http://www.pssrc.org/news/114/pssrc-annual-meeting-2015-in-ghent

[ 2015 - 09 - 25 ]

9th Annual Symposium of Pharmaceutical Solid State Research Cluster (PSSRC)

9th Annual Symposium of Pharmaceutical Solid State Research Cluster (PSSRC)

September 16th 2015 - September 17th 2015 9th Annual Symposium of Pharmaceutical Solid State Research Cluster (PSSRC) Ghent University, Belgium http://www.pssrc.org/news/110/9th-annual-symposium-of-pharmaceutical-solid-state-research-cluster-pssrc

[ 2015 - 09 - 25 ]

IWPCPS® - 17 Seventeenth International Workshop on Physical Characterization of Pharmaceutical

IWPCPS® - 17 Seventeenth International Workshop on Physical Characterization of Pharmaceutical

IWPCPS® - 17 Seventeenth International Workshop on Physical Characterization of Pharmaceutical Solids Fernandina Beach, Florida, USA http://www.assainternational.com/workshops/iwpcps-17/

[ 2015 - 09 - 25 ]

Pharmaceutical Solid State Research Cluster (PSSRC) Annual Meeting

Pharmaceutical Solid State Research Cluster (PSSRC) Annual Meeting

September 18th 2015 Pharmaceutical Solid State Research Cluster (PSSRC) Annual Meeting Ghent University, Belgium http://www.pssrc.org/news/114/pssrc-annual-meeting-2015-in-ghent

[ 2015 - 09 - 25 ]

9th Annual Symposium of Pharmaceutical Solid State Research Cluster (PSSRC)

9th Annual Symposium of Pharmaceutical Solid State Research Cluster (PSSRC)

September 16th 2015 - September 17th 2015 9th Annual Symposium of Pharmaceutical Solid State Research Cluster (PSSRC) Ghent University, Belgium http://www.pssrc.org/news/110/9th-annual-symposium-of-pharmaceutical-solid-state-research-cluster-pssrc

[ 2015 - 09 - 25 ]

IWPCPS® - 17 Seventeenth International Workshop on Physical Characterization of Pharmaceutical

IWPCPS® - 17 Seventeenth International Workshop on Physical Characterization of Pharmaceutical

IWPCPS® - 17 Seventeenth International Workshop on Physical Characterization of Pharmaceutical Solids Fernandina Beach, Florida, USA http://www.assainternational.com/workshops/iwpcps-17/

[ 2015 - 09 - 25 ]

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