High-precision absolute (true) density measurements on hygroscopic powders by gas pycnometry: Application to determining effects of formulation and process on free volume of lyophilized products

Journal of Pharmaceutical Sciences

Volumn 100, Issue 7, 2011, Pages 2945-2951

  Kikuchi, Takayuki ^a,b   Wang, Bingquan Stuart ^a,c   Pikal, Michael J ^a  

^a UNIVERSITY OF CONNECTICUT   (United States)

^b DAIICHI SANKYO CO   (Japan)

^c GENZYME CORPORATION   (United States)

Author keywords

Annealing; Density; Free volume; Heat treatment; Lyophilized solids; Stability

Indexed keywords

DEXTRAN;

ARTICLE; ATMOSPHERIC MOISTURE; FREEZE DRYING; LYOPHILISATE; MEASUREMENT; MOLECULAR WEIGHT; WETTABILITY;

EID: 79955605752     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22521     Document Type: Article

References (14)

1. Chang LL, Shepherd D, Sun J, Ouellette D, Grant KL, Tang XC, Pikal MJ. 2005. Mechanism of protein stabilization by sugars during freeze drying and storage: Native structure preservation, specific interaction and/or immobilization in a glassy matrix? J Pharm Sci 94(7):1427-1444.
2. Shamblin S, Hancock BC, Pikal MJ. 2006. Coupling between chemical reactivity and structural relaxation in pharmaceutical glasses. Pharm Res 23:2254-2268.
3. Abdul-Fattah AM, Truong-Le V, Yee L, Nguyen L, Kalonia DS, Cicerone MT, Pikal MJ. 2007. Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on stability (I): Stability of a monoclonal antibody. J Pharm Sci 96(8):1983-2008.
4. Pikal MJ, Rigsbee D, Roy ML, Galreath D, Kovach KJ, Wang B, Carpenter JF, Cicerone MT. 2008. Solid state chemistry of proteins: II. The correlation of storage stability of freeze-dried human growth hormone (hGH) with structure and dynamics in the glassy solid. J Pharm Sci 97(12):5106-5121.
5. Luthra SA, Hodge IM, Utz M, Pikal MJ. 2008. Correlation of annealing with chemical stability in lyophilized pharmaceutical glasses. J Pharm Sci 97(12).
6. Wang B, Tchessalov S, Cicerone MT, Warne NW, Pikal MJ. 2009. Impact of sucrose level on storage stability of proteins in freeze-dried solids: II. Correlation of aggregation rate with protein structure and molecular mobility. J Pharm Sci 98:3145-3166.
7. Wang B, Pikal MJ. 2010. The impact of thermal treatment on the stability of freeze dried amorphous pharmaceuticals: I. Dimer formation in sodium ethacrynate. J Pharm Sci 99:663-682.
8. Duncan-Hewitt WC, Grant DJW. 1986. True density and thermal expansivity of pharmaceutical solids: Comparison of methods and assessment of crystallinity. Int J Pharm 28(1):75-84.
9. Cao X, Leyva N, Anderson SR, Hancock BC. 2008. Use of prediction methods to estimate true density of active pharmaceutical ingredients. Int J Pharm 355:231-237.
10. Viana M, Jouannin P, Pontier C, Chulia D. 2002. About pycnometric density measurements. Talanta 57:583-593.
11. Kriesten U, Hutchinson JM. 1992. On the use of density gradient column to monitor the physical aging of polystyrene. Polymer 33:4875-4877.
12. Ramiah MV, Goring DAI. 1965. The thermal expansion coefficients for cellulose, hemicellulose, and lignin. J Polymer Sci part C: Polymer Symposia 11(1):27-48.
13. Imamura K, Maruyama Y, Tanaka K, Yokoyama T, Imanaka H, Nakanishi K. 2008. J Pharm Sci 97(7):2789-2797.
14. Pikal M. 2002. Lyophilization, encyclopedia of pharmaceutical technology; Swarbrick J and Boylan JC, Eds. Vol VI. Marcel Dekker New York, NY, pp 1299-1326.