Polymorph Screening

We offer unique polymorph screening workflows designed for early stage and late stage development. Whether your objective is to find the most stable and viable solid form for development or to provide a comprehensive polymorphic landscape for NDA submission and also extended IP coverage to further block generic entry. We will recommend the most phase appropriate service for you. 

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Salt Screening

Salt screening is crucial step in the early phases of development for potential drug candidates, whether for IP protection or to improve upon specific properties. The best time for such screening is pre-GLP Tox batch. All our workflows are tailored to the specific molecular structure of the drug substance.

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Co-Crystal Screening

Co-crystals have gained tremendous attention due to their potentials for improving the bioavailability or physicochemical properties of API. Solid State Pharma’s co-crystal screening workflow is on the basis of scientific and rational selection of co-formers.

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Amorphous to Crystalline

Some API molecules might not easily form a crystalline solid due to higher molecular weight, steric hinderance or simply the conditions at which it is isolated. This workflow is scientifically designed to help formation of long range arrangement of molecules to promote crystal formation.

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Crystallization Development

Depending on your stage of development, we have workflows designed to engineer and optimize the crystallization of your API. Our scientists are experienced in efficiently resolving crystallization challenges for early phase APIs and providing a deep understanding of the impact of various process parameters on the quality of late phase APIs.

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Solid State Characterization

Solid State Pharma offers an extensive list of characterization services to understand the solid state aspects of your API. 

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pKa, Log P/D Determination

Drug candidates show a tendency to exhibit low water solubility; as a result, present with issues measuring pKa by a traditional aqueous methods. Solid State Pharma is capable of measuring compounds with low water solubility by using an organic co-solvent. Log P and log D are simultaneously measured.

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Chiral Resolution

This service is specifically designed for chiral resolution of pharmaceutical APIs and intermediates through salt screening using chiral counter ions as resolving agents. Diastereomeric salt formation provide the opportunity of forming salt of diastereomer as crystalline solid while leaving the other one in the mother liquor. 

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Particle Engineering

Particle engineering is key in the development of a desired product profile. With the continued discovery of low solubility drugs particle engineering becomes a crucial aspect for drug development. The drug substance particle size distribution and morphology can not only influence downstream processes such as filtration, drying and drug flowability but also the bioavailability of the compound. 

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Ternary Phase Diagram Development

Solid phases are identified using analytical techniques such as X-ray powder diffraction while concentration of API and co-former are typically assessed by chromatography. The data are used to define phase stability boundaries, eutectic compositions, and develop a TPD which can be leveraged in co-crystallization process development. SSPI can not only help you screen for a co-crystal that may improve physiochemical properties and strengthen the IP of your drug, but we can also develop a process to allow the co-crystal to be scaled-up successfully.

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