49 Drug Discovery & Pharmaceuticals


Table 2. Crystalline Polymorphisms as identifi ed by XRD analysis. No.


Solvent


1 2 3 4 5 6 7 8 9


10 11 12


13 14 16 17 18 20 21


Dichloromethane


Tertiary Butyl Methyl Ether Acetone


Methyl Acetate Chloroform


Tetrahydrofuran Hexane


Methanol


Cyclo Hexane Ethyl Acetate


Methyl Ethyl Ketone Acetonitrile


1,2-Dimethoxy Ethane Ethanol Heptane


Isopropyl Alcohol Toluene


1,4-Dioxane Benzene


Conclusion


Crystal Polymorph Form I & II I I I


III I I I I


Not identifi ed Not identifi ed I


Not identifi ed II I I I I I


Exalt Controlled Crystallisation allows the quick and easy screening of an API with minimal compound (6mg per vial). Piroxicam was screened using 20 solvents, identifying three polymorphic forms, utilising just 150mg of compound. In addition the method is non- destructive meaning, where crystals are not formed, the compound may be re-dissolved for further use.


New compounds purifi ed by reverse phase chromatography and dried by centrifugal evaporation are usually amorphous. Crystallisation changes properties such dissolution rate and biologically active so ideally polymorphisms should be identifi ed before the compound is taken forward. In reality initial screening is often performed on amorphous compound. Erroneous results derived from amorphous compound may mean a candidate API is needlessly rejected, or is further developed only for the crystalline form to be found unsuitable at a later stage. Opportunity to obtain crystals easily at an early stage of drug discovery, with minimal compound, provides the ability to identify polymorphisms, work up potential hits more effi ciently, and provide seed crystals / solvent data for scale up.


References


1. Vrecer F, Vrbinc M, Moden A (2003). Characterization of Piroxicam Crystal Modifi cations. International Journal of Pharmaceutics, Vol.256(1-2), 3–15.


2. Darrington R (2014). New technology for pharma small-molecule crystallisation. Lab Product News, http://www.labcanada.com/features/pharmaceutical-small-molecule- crystallization/.


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New Series of ‘How to’ Videos Released Silverson Machines Ltd have recently released a series of ‘How to’ videos on their YouTube channel intended to demonstrate how to get the best results from various key ingredients in the pharmaceutical industry.


The series includes ‘How to’ information on applications such as Mixing Xanthan Gum and Dispersing Titanium Dioxide.


With more people turning to video for information Silverson began producing video content to demonstrate and instruct how to get the best results in various applications when using a high shear mixer. Although Silverson have previously produced videos focusing on the capabilities and range of their mixing equipment, the new series of videos is intended to reach out to those who aren’t aware of Silverson and their mixing technology, to help them improve their processes and get the best yield from their ingredients with the help of a Silverson High Shear mixer. With over 70 years’ experience, Silverson are hoping to help a new set of customers with their mixing requirements.


By focusing on what people are searching for online, ‘How to disperse Titanium Dioxide’ for example, Silverson’s new videos target a


new audience while showing how versatile and useful their mixing equipment is in these applications. Harold Rothman, Managing Director of Silverson said: “Videos are very demonstration friendly allowing the viewer to quickly understand the benefits of Silverson Mixers.“


More ‘How to’ videos are currently being filmed including videos on emulsions and High Active Surfactants. Additional videos will be released over the year covering a range of applications over the food, chemical, cosmetic and pharmaceutical industries.


To view the videos, please visit: www.youtube.com/silversonmachines and subscribe to the channel to get updates on the newest content. The videos are also available to view alongside the corresponding application reports on the Silverson website at www.silverson.co.uk.


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EDXRF Spectrometer Enables Data-Safe Process and Quality Control of APIs and Inorganic Impurities


The S2 PUMA energy dispersive X-ray fluorescence spectrometer (EDXRF) now comes with the 21 CFR Part 11-compliant software package enabling users to integrate the instrument seamlessly into pharmaceutical laboratory environments for process and quality control. Applications include the analysis of active pharmaceutical ingredients (APIs), product safety measures such as the quantification of inorganic impurities, and the analysis of residual compounds from metallic process catalysts.


The new software guarantees complete data integrity and authenticity with features such as electronic record keeping, electronic signatures, and automatic audit trails. The complementing instrument qualification and operational qualification package (IQ/OQ) further supports users in the pharmaceutical industry.


Based on its HighSenseTM


technology, the S2 PUMA easily performs the identification and analysis of hazardous toxic trace elements and contaminants from production processes according to Pharmacopeia regulation. No matter if samples are presented as pressed pellets or in powder form, the instrument can be configured for measurements in vacuum or under helium to perfectly suit any application.


Especially in combination with the TouchControlTM interface and its unique ease-of-use for failsafe operation, the S2 PUMA becomes a vital tool for the pharmaceutical industry.


For higher workloads the compact benchtop instrument is available with an exclusive 20 position sample tray and an automatic sample grabber. The S2 PUMA is also available for integration into automated laboratory environments.


EDXRF is a reliable technology used worldwide in many industrial quality control applications and stands for high analytical accuracy and precision, simple sample preparation, fast analysis-to-results times, easy instrument operation, and lowest cost of ownership. The S2 PUMA combines all of this into one high-performing instrument.


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