Efficient throughput method for hygroscopicity classification of active and inactive pharmaceutical ingredients by water vapor sorption analysis

References

• Zografi G. States of water associated with solids. Drug Dev Ind Pharm 1988;14:1905–26
   Web of Science ®Google Scholar
• Kontny M, Zografi G. Sorption of water by solids. In: Brittain H, editor. Physical characterization of pharmaceutical solids. New York: Marcel Dekker; 1995.386–418.
   Google Scholar
• Reutzel-Edens S, Newman A. The physical characterization of hygroscopicity in 17 pharmaceutical solids. In: Hilfiker R, editor. Polymorphism in the pharmaceutical industry. Weinheim: Wiley-VCH; 2006. 235–58.
   Google Scholar
• Fassihi A, Persicaner P. Solid state interaction of bromazepam with poly (vinylpyrrolidone) in the presence of moisture. Int J Pharm 1987; 37:167–70.
   Web of Science ®Google Scholar
• Padmadisastra Y, Kennedy R, Stewart P. Solid bridge formation in sulfonamide-28 29 Emdex interactive systems. Int J Pharm 1994; 112:55–63.
   Web of Science ®Google Scholar
• Schmitt E, Davis CW, Long ST. Moisture-dependent crystallization of amorphous lamotrigine mesylate. J Pharm Sci 1996;85:1215–1219.
   PubMed Web of Science ®Google Scholar
• Koizumi N, Kouji M, Itai S. Effect of water content and temperature on the stability of lornoxicam tablets. Drug Stability 1997; 1:202–8.
   Google Scholar
• Rohrs BR, Thamann TJ, Gao P, Stelzer DJ, Bergren MS, Chao RS. Tablet dissolution affected by a moisture mediated solid-state interaction between drug and disintegrant. Pharm Res 1999;16:1850–1856.
   PubMed Web of Science ®Google Scholar
• Cleaver J, Karatzas G, Louis S, Hayati I. Moisture-induced caking of boric acid powder. Powder Technol 2004; 146:93–101.
   Web of Science ®Google Scholar
• Listiohadi Y, Hourigan J, Sleigh R, Steele R. Properties of lactose and its caking behavior. Aust J Dairy Technol. 2005; 60:33–52.
   Web of Science ®Google Scholar
• Nail S. Physical and chemical stability considerations in the development and stress testing of freeze-dried pharmaceuticals. Drugs Pharm Sci 2005; 153:261–91.
   Google Scholar
• Faqih AM, Mehrotra A, Hammond SV, Muzzio FJ. Effect of moisture and magnesium stearate concentration on flow properties of cohesive granular materials. Int J Pharm 2007;336:338–345.
   PubMed Web of Science ®Google Scholar
• Sun CC. Mechanism of moisture induced variations in true density and compaction properties of microcrystalline cellulose. Int J Pharm 2008;346:93–101.
   PubMed Web of Science ®Google Scholar
• Newman A, Reutzel-Edens S, Zografi G. Characterization of the “hygroscopic” properties of active pharmaceutical ingredients. J Pharm Sci 2008; 97(3):1047–1059.
   PubMedGoogle Scholar
• Huang LF, Tong WQ. Impact of solid state properties on developability assessment of drug candidates. Adv Drug Deliv Rev 2004;56:321–334.
   PubMed Web of Science ®Google Scholar
• Narurkar A, Purkaystha AR, Sheen P-C, Augustine MA. Hygroscopicity of Celiprolol hydrochloride polymorphs. Drug Dev Ind Pharm 1988; 14:465–74.
   Web of Science ®Google Scholar
• Kobayashi Y, Ito S, Itai S, Yamamoto K. Physicochemical properties and bioavailability of carbamazepine polymorphs and dihydrate. Int J Pharm 2000;193:137–146.
   PubMed Web of Science ®Google Scholar
• Kojima T, Sugano K, Onoue S, Murase N, Sato M, Kawabata Y et al. Solid form selection of zwitterionic 5-HT4 receptor agonist. Int J Pharm 2008;350:35–42.
   PubMed Web of Science ®Google Scholar
• Aaltonen J, Allesø M, Mirza S, Koradia V, Gordon KC, Rantanen J. Solid form screening–a review. Eur J Pharm Biopharm 2009;71:23–37.
   PubMed Web of Science ®Google Scholar
• Katrincic LM, Sun YT, Carlton RA, Diederich AM, Mueller RL, Vogt FG. Characterization, selection, and development of an orally dosed drug polymorph from an enantiotropically related system. Int J Pharm 2009;366:1–13.
   PubMedGoogle Scholar
• Morris KR, Fakes MG, Thakur AB, Newman AW, Singh AK, Venit JJ, et al. An integrated approach to the selection of optimal salt form for a new drug candidate Int J. Pharm 1994; 105:209–17.
   Google Scholar
• Bastin R, Bowker M, Slater B. Salt selection and optimization procedures for pharmaceutical new chemical entities. Org Process Res Dev 2000; 4:427–435.
   Web of Science ®Google Scholar
• Machatha SG, Sanghvi T, Yalkowsky SH. Structure determination and characterization of carbendazim hydrochloride dihydrate. AAPS PharmSciTech 2005;6:E115–E119.
   Google Scholar
• Guerrieri P, Jarring K, Taylor L. Impact of counter ion on the chemical stability of crystalline salts of procaine. J Pharm Sci 2010; 99:3719–30.
   PubMed Web of Science ®Google Scholar
• Kumar L, Amin A, Bansal AK. An overview of automated systems relevant in pharmaceutical salt screening. Drug Discov Today 2007;12:1046–1053.
   PubMed Web of Science ®Google Scholar
• Callahan J, Cleary G, Elefant M, Kaplan G, Kensler T, Nash R. Equilibrium moisture content of pharmaceutical excipients. Drug Dev Ind Pharm 1982; 8:355–69.
   Web of Science ®Google Scholar
• Visalakshi NA, Mariappan TT, 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 Technol 2005;10:489–497.
   PubMed Web of Science ®Google Scholar
• Roskar R, Kmetec V. Evaluation of the moisture sorption behaviour of several excipients by BET, GAB and microcalorimetric approaches. Chem Pharm Bull 2005;53:662–665.
   PubMedGoogle Scholar
• Anonymous. Characters section in monographs. European Pharmacopoeia 6, version 6.8, Section 5.11 ed2010.
   Google Scholar
• Hilfiker R, Blatter F, Raumer M. Relevance of solid-state properties for pharmaceutical products. In: Hilfiker R, ed. Polymorphism: in the Pharmaceutical Industry. Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA; 2006. 1–19.
   Google Scholar
• Petit S, Coquerel G. The amorphous state. In: Hilfiker R, editor. Polymorphism in the Pharmaceutical Industry. Weinheim: Wiley-VCH; 2006.259–285.
   Google Scholar
• Yoshinari T, Forbes RT, York P, Kawashima Y. Moisture induced polymorphic transition of mannitol and its morphological transformation. Int J Pharm 2002;247:69–77.
   PubMed Web of Science ®Google Scholar
• Balbach S, Korn C. Pharmaceutical evaluation of early development candidates “the 100 mg-approach”. Int J Pharm 2004;275:1–12.
   PubMed Web of Science ®Google Scholar
• Umprayn K, Mendes R. Hygroscopicity and moisture adsorption kinetics of pharmaceutical solids: A review. Drug Dev Ind Pharm 1987; 13:653–693.
   Web of Science ®Google Scholar
• Jain A, Adeyeye M. Hygroscopicity, phase solubility and dissolution of various 6789 substituted sulfobutylether β-cyclodextrins (SBE) and danazol-SBE inclusion complexes. Int J Pharm 2001; 212:177–186.
   PubMedGoogle Scholar
• van Drooge DJ, Hinrichs WL, Visser MR, Frijlink HW. Characterization of the molecular distribution of drugs in glassy solid dispersions at the nano-meter scale, using differential scanning calorimetry and gravimetric water vapour sorption techniques. Int J Pharm 2006;310:220–229.
   PubMed Web of Science ®Google Scholar