182
O. D. Putra and H. Uekusa
29. Baghel, S., Cathcart, H., O’Reilly, N.J.: Polymeric amorphous solid dispersions: a review of
amorphization, crystallization, stabilization, solid-state characterization, and aqueous solubilization of biopharmaceutical classification system class II drugs. J. Pharm. Sci. 105, 2527–2544
(2016)
30. Almarsson, O., Vadas, E.B.: Molecules, materials, medicines (M3): linking molecules to
medicines through pharmaceutical material science. Cryst. Growth. Des. 15, 5645–5647 (2015)
31. Daousani, C., Macheras, P.: Biopharmaceutic classification of drugs revisited. Eur. J. Pharm.
Sci. 82–87, 82–87 (2016)
32. Butler, J.M., Dressman, J.B.: The developability classification system: application of biopharmaceutics concepts to formulation development. J. Pharm. Sci. 99, 4940–4954 (2010)
33. Khadka, P., Ro, J., Kim, H., Kim, I., Kim, J.T., Kim, H., Cho, J.M., Lee, J.: Pharmaceutical
particle technologies: an approach to improve drug solubility, dissolution and bioavailability.
Asian J. Pharm. Sci. 9, 304–316 (2014)
34. Kawabata, Y., Wada, K., Nakatani, M., Yamada, S., Onoue, S.: Formulation design for poorly
water-soluble drugs based on biopharmaceutics classification system: basic approaches and
practical applications. Int. J. Pharm. 420, 1–10 (2011)
35. Onoue, S., Yamada, S., Chan, H.K.: Nanodrugs: pharmacokinetics and safety. Int. J. Nanomed.
9, 1025–1037 (2014)
36. Newman, A.W., Reutzel-Edens, S.M., Zografi, G.: Characterization of the “hygroscopic”
properties of active pharmaceutical ingredients. J. Pharm. Sci. 97, 1047–1059 (2008)
37. Sun, C.C., Grant, D.J.W.: Improved tableting properties of p-hydroxybenzoic acid by aater of
crystallization: a molecular insight. Pharm. Res. 21, 382–386 (2004)
38. Zu, B., Wang, J., Zhang, Q., Zu, B., Wang, J., Zhang, Q., Mei, X.: Improving dissolution
and photostability of vitamin K3 via cocrystallization with naphthoic acids and sulfamerazine.
Cryst. Growth Des. 16, 483–492 (2016)
39. Song, J.X., Yan, Y., Yao, J., Chen, J.M., Lu, T.B.: Improving the solubility of lenalidomide via
cocrystals. Cryst. Growth Des. 14, 3069–3077 (2014)
40. Geng, N., Chen, J.M., Li, Z.J., Jiang, L., Lu, T.B.: Approach of cocrystallization to improve
the solubility and photostability of tranilast. Cryst. Growth Des. 13, 3546–3553 (2013)
41. Good, D.J., Rodríguez-Hornedo, N.: Solubility advantage of pharmaceutical cocrystals. Cryst.
Growth Des. 9, 2252–2264 (2009)
42. Visalakshi, N.A., Mariappan, T.T., Bhutani, H., Singh, S.: Behavior of moisture gain and equilibrium moisture contents (EMC) of various drug substances and correlation with compendial
information on hygroscopicity and loss on drying. Pharm. Dev. Tech. 10, 489–497s (2005)
43. Sun, C.C., Grant, D.J.W.: Influence of crystal structure on the tableting properties of
sulfamerazine polymorphs. Pharm. Res. 18, 274–280 (2001)
44. Gupta, D., Bhatia, D., Dave, B., Sutariya, V., Gupta, S.V.: Salts of therapeutic agents: chemical,
physicochemical, and biological considerations. Molecules 23, 1719 (2018)
45. Putra, O.D., Yoshida, T., Umeda, D., Gunji, M., Uekusa, H., Yonemochi, E.: Crystallographic
analysis of phase dissociation related to anomalous solubility of irsogladine maleate. Cryst.
Growth Des. 16, 6714–6718 (2016)
46. Tovey, G.D.: Pharmaceutical Formulation: The Science and Technology of Dosage Forms. The
Royal Society of Chemistry, Croydon (2018)
47. Iacocca, R.G., Burcham, C.L., Hilden, L.R.: Particle engineering: a strategy for establishing
drug substance physical property specifications during small molecule development. J. Pharm.
Sci. 99, 51–75 (2010)
48. Chattoraj, S., Sun, C.C.: Crystal and particle engineering strategies for improving powder
compression and flow properties to enable continuous tablet manufacturing by direct compression. J. Pharm. Sci. 107, 968–974 (2018)
49. Ramirez, M.A., Borja, N.L.: Epalrestat: an aldose reductase inhibitor for the treatment of
diabetic neuropathy. Pharmacotherapy 28, 646–655 (2008)
50. Steel, J.W., Faulds, D., Goa, K.L.: Epalrestat. a review of its pharmacology, and therapeutic
potential in late-onset complications of diabetes mellitus. Drugs Aging 3, 532–555 (1993)
O. D. Putra and H. Uekusa
29. Baghel, S., Cathcart, H., O’Reilly, N.J.: Polymeric amorphous solid dispersions: a review of
amorphization, crystallization, stabilization, solid-state characterization, and aqueous solubilization of biopharmaceutical classification system class II drugs. J. Pharm. Sci. 105, 2527–2544
(2016)
30. Almarsson, O., Vadas, E.B.: Molecules, materials, medicines (M3): linking molecules to
medicines through pharmaceutical material science. Cryst. Growth. Des. 15, 5645–5647 (2015)
31. Daousani, C., Macheras, P.: Biopharmaceutic classification of drugs revisited. Eur. J. Pharm.
Sci. 82–87, 82–87 (2016)
32. Butler, J.M., Dressman, J.B.: The developability classification system: application of biopharmaceutics concepts to formulation development. J. Pharm. Sci. 99, 4940–4954 (2010)
33. Khadka, P., Ro, J., Kim, H., Kim, I., Kim, J.T., Kim, H., Cho, J.M., Lee, J.: Pharmaceutical
particle technologies: an approach to improve drug solubility, dissolution and bioavailability.
Asian J. Pharm. Sci. 9, 304–316 (2014)
34. Kawabata, Y., Wada, K., Nakatani, M., Yamada, S., Onoue, S.: Formulation design for poorly
water-soluble drugs based on biopharmaceutics classification system: basic approaches and
practical applications. Int. J. Pharm. 420, 1–10 (2011)
35. Onoue, S., Yamada, S., Chan, H.K.: Nanodrugs: pharmacokinetics and safety. Int. J. Nanomed.
9, 1025–1037 (2014)
36. Newman, A.W., Reutzel-Edens, S.M., Zografi, G.: Characterization of the “hygroscopic”
properties of active pharmaceutical ingredients. J. Pharm. Sci. 97, 1047–1059 (2008)
37. Sun, C.C., Grant, D.J.W.: Improved tableting properties of p-hydroxybenzoic acid by aater of
crystallization: a molecular insight. Pharm. Res. 21, 382–386 (2004)
38. Zu, B., Wang, J., Zhang, Q., Zu, B., Wang, J., Zhang, Q., Mei, X.: Improving dissolution
and photostability of vitamin K3 via cocrystallization with naphthoic acids and sulfamerazine.
Cryst. Growth Des. 16, 483–492 (2016)
39. Song, J.X., Yan, Y., Yao, J., Chen, J.M., Lu, T.B.: Improving the solubility of lenalidomide via
cocrystals. Cryst. Growth Des. 14, 3069–3077 (2014)
40. Geng, N., Chen, J.M., Li, Z.J., Jiang, L., Lu, T.B.: Approach of cocrystallization to improve
the solubility and photostability of tranilast. Cryst. Growth Des. 13, 3546–3553 (2013)
41. Good, D.J., Rodríguez-Hornedo, N.: Solubility advantage of pharmaceutical cocrystals. Cryst.
Growth Des. 9, 2252–2264 (2009)
42. Visalakshi, N.A., Mariappan, T.T., Bhutani, H., Singh, S.: Behavior of moisture gain and equilibrium moisture contents (EMC) of various drug substances and correlation with compendial
information on hygroscopicity and loss on drying. Pharm. Dev. Tech. 10, 489–497s (2005)
43. Sun, C.C., Grant, D.J.W.: Influence of crystal structure on the tableting properties of
sulfamerazine polymorphs. Pharm. Res. 18, 274–280 (2001)
44. Gupta, D., Bhatia, D., Dave, B., Sutariya, V., Gupta, S.V.: Salts of therapeutic agents: chemical,
physicochemical, and biological considerations. Molecules 23, 1719 (2018)
45. Putra, O.D., Yoshida, T., Umeda, D., Gunji, M., Uekusa, H., Yonemochi, E.: Crystallographic
analysis of phase dissociation related to anomalous solubility of irsogladine maleate. Cryst.
Growth Des. 16, 6714–6718 (2016)
46. Tovey, G.D.: Pharmaceutical Formulation: The Science and Technology of Dosage Forms. The
Royal Society of Chemistry, Croydon (2018)
47. Iacocca, R.G., Burcham, C.L., Hilden, L.R.: Particle engineering: a strategy for establishing
drug substance physical property specifications during small molecule development. J. Pharm.
Sci. 99, 51–75 (2010)
48. Chattoraj, S., Sun, C.C.: Crystal and particle engineering strategies for improving powder
compression and flow properties to enable continuous tablet manufacturing by direct compression. J. Pharm. Sci. 107, 968–974 (2018)
49. Ramirez, M.A., Borja, N.L.: Epalrestat: an aldose reductase inhibitor for the treatment of
diabetic neuropathy. Pharmacotherapy 28, 646–655 (2008)
50. Steel, J.W., Faulds, D., Goa, K.L.: Epalrestat. a review of its pharmacology, and therapeutic
potential in late-onset complications of diabetes mellitus. Drugs Aging 3, 532–555 (1993)