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You are here: Home / Dynamic Vapor Sorption (DVS) Analysis / Applications for Dynamic Vapor Sorption / Hydrate formation

Hydrate formation

Many crystalline solids form hydrates in the presence of water. The water molecules can be incorporated into the crystal lattice in stoichiometric or non-stoichiometric proportions. Typically, a hydrate is only stable within a certain temperature and relative humidity range. Upon dehydration, a hydrate may reversible transform into an anhydrous or a less hydrated form. The hydrate form affects the physical and chemical properties of a crystalline solid such as solubility, stability and processing properties. Therefore, the hydrate form of an Active Pharmaceutical Ingredient (API) or excipient plays a significant role in the development of new drugs in connection with the bioavailability and the manufacturing process of the drug. In this context, dynamic water vapor sorption analysis enables the precise characterization of different hydrate states and their stability as a function of temperature and relative humidity. This allows new formulations, manufacturing processes and storage conditions to be adapted to specific requirements.

Application notes

DVS hydrate formation of L-lysin HCl

Hydrate formation of L-lysine HCl

Crystalline active pharmaceutical ingredients (APIs) may be present in an hydrated or, after drying, also in an anhydrous state. In pharma research and quality assurance, the characterization and control of the hydrate state is highly relevant since the properties of the active ingredient are decisively influenced by the state of hydration. This includes in particular properties such as shelf life, dissolution behavior, compressibility and bioavailability of the product. By means of DVS analysis, the different hydrate states as well as their formation kinetics and stability can be characterized as a function of relative humidity and temperature. Applications note 20-06 and white paper 20-06 demonstrate the hydrate formation of L-lysin HCl. Special focus is placed on the necessity of sufficiently long measuring times with regard to hydrate formation kinetics and the resolution of the RH steps.

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DVS hydrate formation of creatine

Hydrate formation of creatine

As a non-essential amino acid, creatine can be can be produced endogenously by the amino acids arginine, glycine and methionine. Due to its involvement in energy metabolism, it is considered to have a positive effect on muscle performance. This makes it one of the most widely used supplements in the field of sports nutrition.
For creatine both an anhydrous and a hydrated state is known. Due to the influence of the hydrate form on, for example, physical properties and bioavailability, knowledge and identification of the respective state is crucial to ensure the efficacy of a substance. In the application note, dynamic water vapor sorption analysis is presented as an effective tool to determine the hydrate states of creatine and to identify critical relative humidity values for phase transition.

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Literature references for hydrate formation analysis with the ProUmid DVS instruments

Feth, Martin P., et al. „Challenges in the development of hydrate phases as active pharmaceutical ingredients–An example.“ European Journal of Pharmaceutical Sciences 42.1 (2011): 116-129. doi:10.1016/j.ejps.2010.11.001

Kachrimanis, Kyriakos, et al. “Effects of moisture and residual solvent on the phase stability of orthorhombic paracetamol.” Pharmaceutical research 25.6 (2008): 1440-1449. doi: 10.1007/s11095-007-9529-4

D.E. Braun, U.J. Griesser, Stoichiometric and Nonstoichiometric Hydrates of Brucine, Cryst. Growth Des. (2016). doi:10.1021/acs.cgd.6b01231.

M.C. Allan, E. Grush, L.J. Mauer, RH-temperature stability diagram of α- and β-anhydrous and monohydrate lactose crystalline forms, Food Res. Int. (2020). doi:10.1016/j.foodres.2019.108717.

M. Allan, M.C. Chamberlain, L.J. Mauer, RH-Temperature Stability Diagram of the Dihydrate, β-Anhydrate, and α-Anhydrate Forms of Crystalline Trehalose, J. Food Sci. 84 (2019) 1465–1476. doi:10.1111/1750-3841.14591.

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Product Vsorp for hydrate formation analysis
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Further reading

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  • Learn more about the Dynamic Vapor Sorption (DVS) method

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              Application Notes

              Food

              AN_20-01 Amorphous lactose in food
              AN_20-02 Amorphous fractions in sucrose and sucrose containing model food systems
              AN_20-03 Deliquescence and deliquescence lowering of food ingredients and blends
              AN_20-04 Dehydration behavior of bread crumb and crust

              Pharma

              AN_20-05 Amorphous lactose in the pharmaceutical industry
              AN_20-06 Hydrate formation of L-lysine HCl
              AN_20-09 Hydrate formation of creatine

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              AN_20-07 Water vapor sorption of plaster

              Permeability of Packaging material and Foils

              AN_12-01 Water vapor permeability of films

              AN_15-01 Water vapor sorption of product packages

              White Papers

              Universal

              WP_20-01 Amorphous content lactose

              Food

              WP_20-02 Amorphous fractions in sucrose and sucrose containing model food systems
              WP_20-03 Deliquescence and deliquescence lowering of food ingredients and blends

              Pharma

              WP_20-06 Hydrate formation of L-lysine HCl

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