Welcome to Solid State Pharma Inc.

Solid State Pharma Inc. (SSPI) is a crystallization engineering and solid state science company founded on the basis of scientific knowledge, hands-on experience and advanced characterization technologies utilization. SSPI is the partner to pharmaceutical and natural product companies to bring value through understanding the solid state of the drug candidates, extending the patent life of the drug and also developing crystallization processes that will lead to optimal physical properties, morphology and particle size distribution through crystallization engineering.
The majority of pharmaceutical intermediates or APIs exhibit polymorphism. Different polymorphs of a drug can have different solubility, dissolution rate and therefore different bioavailability in the body and ultimately different therapeutic effects. The FDA and other regulatory agencies require all pharmaceutical companies to perform polymorph screening before submitting a new drug application (NDA). Therefore, control of API polymorphism has become a critical part of the drug development. SSPI offers a unique workflow that finds all possible polymorphs and identifies the most viable one for drug development.
In addition to pharmaceuticals, SSPI is involved with natural health products. The use of these products has been steadily increasing in recent years. When natural products are used as or defined as a drug, purification to meet the regulatory requirements becomes mandatory. In many cases the primary purification method is chromatography, which is expensive compared with crystallization techniques. Applying solid state science and crystal engineering, cost effective crystallization procedures could be developed which may significantly reduce the manufacturing costs and make natural products more competitive.

SSPI Screening and Crystallization Services

SSPI workflows have been developed by combining fundamentals of crystallization and solid form science with years of experience and high throughput techniques. For more details on workflows, please contact us.
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FAST-MORPHTM

Identifies the most stable and most viable polymorph for development as a drug candidate.

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FAST-SALTTM

Rapidly identifies a viable salt with minimum number of experiments. This helps discovery scientists to produce a workable salt in precilinical phases where the lead candidate has not been selected.

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OPTIM-SALTTM

Identifies the most viable salt for development as a drug candidate. This in-depth workflow is specificto the molecular structure of the drug substance.

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CRYSTAL-ITTM

Finds a crystalline state for drug substances which are amorphous and difficult to crystallize.

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Publications

If you would like to receive a hard copy of any of the following articles, please contact us.

Stavudine

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Mahmoud Mirmehrabi et. al.
Acta Crystallographica, Section C: Crystal Structure Communications, C61(12), 695-698

Abstract

The crystal structure of the title compound (systematic name: 2′,3′-didehydro-2′,3′-deoxythymidine), C10H12N2O4, consists of two molecules in the asymmetric unit bound together by hydrogen bonds. The conformational geometry differentiates this form of stavudine from its two previously published polymorphs. In addition, a different hydrogen-bonding scheme is observed compared with the previous two structures. This polymorph is the thermodynamically most stable form of the antiviral drug, as evidenced by differential scanning calorimetry (DSC) and IR data.

Characterization of Tautomeric Forms of Ranitidine Hydrochloride: Thermal Analysis, Solid-State NMR, X-ray

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Mahmoud Mirmehrabi, et. al. Journal of Crystal Growth, 260, 517-526

Abstract

The molecular structure of ranitidine hydrochloride (RAN-HCl) has an important influence on the growth of individual crystals and consequently the physical properties such as bulk solid density. This paper suggests that the correct structure of the nitroethenediamine moiety in the Form 2 RAN-HCl is a mixture of enamine and nitronic acid tautomers. Thermal analysis showed that the difference between the two forms Read More

Thermodynamic Modeling of Activity Coefficient and Prediction of Solubility: Part 2. Semi-Predictive or Semi-Empirical Models.

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Mahmoud Mirmehrabi et. al.
Journal of Pharmaceutical Sciences, 95(4), 798-809

Abstract

The solubility of stearic acid, ranitidine hydrochloride, and stavudine were predicted in selected organic solvents. The experimental solubility data of stearic acid and ranitidine hydrochloride were reported in previous work of the authors and stavudine’s solubility was measured in this work. Equilibrium aqueous solubility of crystalline stauvudine was determined at controlled Read More

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