Solubility, Polymorphism, Crystallinity, Crystal Habit, and Drying Scheme of (R, S)-(±)-Sodium Ibuprofen Dihydrate - Pharmaceutical Technology

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Solubility, Polymorphism, Crystallinity, Crystal Habit, and Drying Scheme of (R, S)-(±)-Sodium Ibuprofen Dihydrate
The racemic compound (R, S)-()-ibuprofen is a popular and well understood active pharmaceutical ingredient, but it has several disadvantageous formulation properties such as poor solubility, low melting point, and potential esterification with excipients containing an hydroxyl group. The authors investigate the use of an (R, S)-()-ibuprofen salt to evaluate these problems using various analytical methods to determine the polymorphism, crystallinity, and drying scheme.

Pharmaceutical Technology

17. R.A. Granberg and A.C. Rasmuson, "Solubility of Paracetamol in Binary and Ternary Mixtures of Water + Acetone + Toluene," J. Chem. Eng. Data 45 (3), 478–483 (2000).

18. L. Peterson et al., "Interactive High-Throughput Polymorphism Studies on Acetaminophen and An experimentally Derived Structure for Form III," J. Am. Chem. Soc. 124 (37), 10958–10959 (2002).

19. J.S. Drury, "Miscibility of Organic Solvent Pairs," Ind. Eng. Chem. 44 (11), 2744 (1952).

20. W.M. Jackson and J. S. Drury, "Miscibility of Organic Solvent Pairs," Ind. Eng. Chem. 51 (12), 1491–1493 (1959).

21. P. Bustamante, M.A. Pena, and J. Barra, "The Modified Extended Hansen Method to Determine Partial Solubility Parameters of Drugs Containing a Single Hydrogen Bonding Group and their Sodium Derivatives: Benzoic Acid/Na and Ibuprofen/Na," Int. J. Pharm. 194 (1), 117–124 (2000).

22. W.L. Archer, "Hansen Solubility Parameters for Selected Cellulose Ether Derivatives and Their Use in the Pharmaceutical Industry," Drug Dev. Ind. Pharm. 18 (5), 599–616 (1992).

23. L.R. Chen, and D.J W. Grant, "Extension of Clausius-Clapeyron Equation to Predict Hydrate Stability at Different Temperature," Pharm. Dev. Tech. 3 (4), 487–494 (1988).

24. G.G.Z. Zhang et al., "Racemic Species of Sodium Ibuprofen: Characterization and Polymorphic Relationships," J. Pharm. Sci. 92 (7), 1356–1366 (2003).

25. P.J. Haines, "Differential Thermal Analysis and Differential Scanning Calorimetry," in Thermal Methods of Analysis: Principles, Applications and Problems (Blackie Academic & Professional, New York, 1997), p.28.

26. J.M.E. Bunyan, N. Shankland, and D.B. Sheen, "Solvent Effects on the Morphology of Ibuprofen," AIChE Symp. Ser. 87 (284), 44–57 (1991).


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