Salt Screening Studies – A Simple Path to the Clinic
For orally dosed compounds, the dissolution rate enhancement that can be achieved using a salt strategy can markedly improve bioavailability and remove the need for enabling formulation approaches, simplifying the path to the clinic. Selection of appropriate counterions can also be used to fine-tune dissolution rates, an approach that has been used to successfully improve lung retention for dry powder inhaled dosing.
Formulation Studies – Where Should I Begin?
Answer a few quick questions to learn next steps, how much material you will need, and process workflow and timing as well as considerations to achieve success.
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When the free form of a drug is difficult to crystallise or has challenging handling properties, a salt screening drug development strategy gives an opportunity to identify a solid form that is easier to work with, simplifying material supply planning and reducing the risk of delays to your pre-clinical program.
Salt Screening Studies and Intellectual Property (IP)
Novel salt forms are also patentable and can therefore can add value to your program by strengthening your IP position.
Combining a salt screening drug development strategy with thorough polymorphism screening puts you in the best possible position to identify the optimum solid form of your drug. Our experts have extensive experience in these areas and are ideally placed to guide you through the process.
Frequently Asked Questions (FAQs) About Salt Screening
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What is salt screening?
Salt screening is the process of co-crystallising a compound in the presence of counter-ions, with the aim of identifying novel solid forms that display improved performance characteristics.
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What kind of molecules are suitable for salt screening?
Salt screening can be applied to any molecule with one or more basic or acidic center.
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What are the main advantages of using a salt form?
Salt forms often display improved performance characteristics over their free-form equivalent; dissolution rate, stability, and hygroscopicity can often be improved by employing a salt screening drug development strategy.
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Do salts have polymorphs?
Salt forms display polymorphism in the same way as free APIs. Performing polymorph screening is recommended on any novel salt forms, in order to fully understand their solid-form behavior.
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How much material is needed to conduct salt screening?
Typically, around 5 g is needed to perform a comprehensive salt screen, although a more focused screen can be performed with as little as 1 g.
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How long does salt screening take?
A comprehensive salt screen typically takes around eight weeks to perform.