Evaluation of manometric temperature measurement, a process analytical technology tool for freeze-drying: Part II measurement of dry-layer resistance

AAPS PharmSciTech

Volumn 7, Issue 4, 2006, Pages

  Tang, Xiaolin Charlie ^a,c   Nail, Steven L ^b,d   Pikal, Michael J ^a  

^a UNIVERSITY OF CONNECTICUT   (United States)

^b PURDUE UNIVERSITY   (United States)

^c CENTOCOR INC   (United States)

^d ELI LILLY AND COMPANY   (United States)

Author keywords

Dry layer resistance; Freeze drying; Heterogeneity; Manometric temperature measurement; Process analytical technology; Product temperature

Indexed keywords

ACCURACY; ANALYTICAL EQUIPMENT; ANALYTICAL ERROR; ARTICLE; COMPUTER PROGRAM; CONTROLLED STUDY; CORRELATION ANALYSIS; FREEZE DRYING; INTERMETHOD COMPARISON; LOW TEMPERATURE; MANOMETER; MANOMETRY; REFERENCE VALUE; TEMPERATURE MEASUREMENT; THERMAL CONDUCTIVITY; THERMOSTABILITY; VAPOR PRESSURE; CHEMICAL MODEL; CHEMISTRY; COMPUTER SIMULATION; EVALUATION; MATERIALS TESTING; METHODOLOGY; PHARMACEUTICS; PRESSURE; TEMPERATURE; THERMOGRAPHY;

DRUG; WATER;

COMPUTER SIMULATION; FREEZE DRYING; MANOMETRY; MATERIALS TESTING; MODELS, CHEMICAL; PHARMACEUTICAL PREPARATIONS; PRESSURE; SOFTWARE; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; THERMOGRAPHY; WATER;

EID: 33845643122     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/pt070493     Document Type: Article

References (16)

1. Pikal MJ. Lyophilization. In: Dekker M, ed. Encyclopedia of Pharmaceutical Technology. 2001:1299-1326.
2. Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res. 1997;14:969-975.
3. Tang X, Pikal MJ. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm Res. 2004;21:191-200.
4. Milton N, Pikal MJ, Roy ML, Nail SL. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization. PDA J Pharm Sci Technol. 1997; 51:7-16.
5. Overcashier DE, Patapoff TW, Hsu CC. Lyophilization of protein formulations in vials: investigation of the relationship between resistance to vapor flow during primary drying and small-scale product collapse. J Pharm Sci. 1999;88:688-695.
6. Pikal MJ, Shah S, Senior D, Lang JE. Physical chemistry of freeze-drying: measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. J Pharm Sci. 1983;72: 635-650.
7. Searles JA, Carpenter JF, Randolph TW. Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine Tg' in pharmaceutical lyophilization. J Pharm Sci. 2001;90:872-887.
8. Lu X, Pikal MJ. Freeze-drying of mannitol-trehalose-sodium chloride-based formulations: the impact of annealing on dry-layer resistance to mass transfer and cake structure. Pharm Dev Technol. 2004;9:85-95.
9. Pikal MJ, Roy ML, Shah S. Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial. J Pharm Sci. 1984;73:1224-1237.
10. Pikal MJ. Use of laboratory data in freeze drying process design: heat and mass transfer coefficients and the computer simulation of freeze drying. J Parenter Sci Technol. 1985;39:115-139.
11. Tang XC, Nail SL, Pikal MJ. Mass Transfer in Freeze Drying: Measurement of Dry-layer Resistance by a Non-Steady State Method (the MTM Procedure). Paper presented at: AAPS Annual Meeting; November 14-18; New Orleans, LA. 1999.
12. Jancso G, Pupezin J, Van Hook WA. The vapor pressure of ice between 0.01 and -100 C. J Phys Chem. 1970;74:2984-2989.
13. Chang L, Tang X, Pikal MJ, Milton N, Thomas L. The Origin of Multiple Glass Transitions in Frozen Aqueous Solutions. Proceeding NATAS Annual Conference Thermal Analysis and Applications. Bowling Green, NY, NATAS. 1999:624-628.
14. Shamblin SL, Tang X, Chang L, Hancock BC, Pikal MJ. Characterization of the time scales of molecular motion in pharmaceutically important glasses. J Phys Chem B. 1999;103: 4113-4121.
15. Tang X, Nail SL, Pikal MJ. Evaluation of manometric temperature measurement (MTM) in freeze drying. Part I: product temperature measurement [serial online]. AAPS PharmSciTech. 2006;7:E14.
16. Nail SL. The effect of chamber pressure on heat transfer in the freeze drying of parenteral solutions. J Parenter Drug Assoc. 1980;34:358-368.