Package selection for moisture protection for solid, oral drug products

Journal of Pharmaceutical Sciences

Volumn 99, Issue 11, 2010, Pages 4437-4452

  Waterman, Kenneth C ^a   MacDonald, Bruce C ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Accelerated aging; Desiccants; Drug packaging; Drug stability; Moisture transfer

Indexed keywords

DESICCANT; EXCIPIENT; KETOCONAZOLE;

DRUG DOSAGE FORM; DRUG PACKAGING; DRUG STABILITY; DRUG STORAGE; GRAVIMETRY; HUMIDITY; MOISTURE; REVIEW; TABLET FRIABILITY; TABLET HARDNESS; TEMPERATURE MEASUREMENT; VAPOR;

EID: 78149350575     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22161     Document Type: Review

References (59)

1. Allinson JG, Dansereau RJ, Sakr A. 2001. The effects of packaging on the stability of a moisture sensitive compound. Int J Pharm 221: 49-56.
2. Badawy SIF, Gawronski AJ, Alvarez FJ. 2001. Application of sorption-desorption mositure transfer modeling to the study of chemical stability of a moisture sensitive drug product in different packaging configurations. Int J Pharm 223: 1-13.
3. Chen Y, Li Y. 2003. A new model for predicting moisture uptake by packaged solid pharmaceuticals. Int J Pharm 225: 217-225.
4. Naveršnik K, Bohanec S. 2008. Predicting drug hydrolysis based on moisture uptake in various packaging designs. Eur J Pharm Sci 35: 447-456.
5. Guidance for Industry Q3A Impurities in New Drug Substances (ICH), 2008.
6. Guidance for Industry Q3B Impurities in New Drug Products (ICH), 2006.
7. Decagon Devices, Inc., Application Note 2001. (accessed October 21, 2009).
8. Derived from the following calculator: (accessed October 22, 2009).
9. Mauer LJ, Taylor LS. 2009. Deliquescence of pharmaceutical systems. Pharm Dev, Tech electronic publication PMD 19895256.
10. Kontny MJ, Zografi G. 1995. Sorption of water by solids. Drugs Pharm Sci 70: 387-418.
11. Waterman KC, Adami RC. 2005. Accelerated aging: Prediction of chemical stability of pharmaceuticals. Int J Pharm 293: 101-125.
12. Wexler AS, Seinfeld JH. 1991. Second generation inorganic aerosol model. Atmos Environ 25A: 2731-2748.
13. Salameh AK, Taylor LS. 2005. Deliquescence in binary mixtures. Pharm Res 22: 318-324.
14. Waterman KC. 2009. Understanding and predicting pharmaceutical product shelf-life. In: Huynh-Ba K, editor. Handbook of stability testing in pharmaceutical development. New York: Springer. pp 115-135.
15. Waterman KC, Carella AJ, Gumkowski MJ, Lukulay P, MacDonald BC, Roy MC, Shamblin SL. 2007. Improved protocol and data analysis for accelerated shelf-life estimation of solid dosage forms. Pharm Res 24: 780-790.
16. Waterman KC, Colgan ST. 2008. A science-based approach to setting expiry dating for solid drug products. Reg Rapp 5: 9-14.
17. Quadir A, Kotter K. 2006. A comparative study of current superdisintegrants. Pharm Tech (accessed October 22, 2009).
18. Young PM, Edge S, Staniforth JN, Steele DF, Price R. 2005. Dynamic vapor sorption properties of sodium starch glycolate disintegrants. Pharm Dev Tech 10: 249-259.
19. Faroongsarng D, Peck GE. 1994. The swelling & water uptake of tablets III: Moisture sorption behavior of tablet disintegrants. Drug Dev Ind Pharm 20: 779-798.
20. Hersen-Delesalle C, Leclerc B, Couarraze G, Busignies V, Tchoreloff P. 2007. The effects of relative humidity and super-disintegrant concentrations on the mechanical properties of pharmaceutical compacts. Drug Dev Ind Pharm 33: 1297-1307.
21. Akbuga J, Ermantas K. 1992. Role of disintegrants in temperature- and moisture-related physical changes of ketoconazole tablets. Pharmazie 47: 644-645.
22. Uhumwangho MU, Okor RS. 2005. Effect of humidity on the disintegrant property of α-Cellulose. Acta Pol Pharm 62: 39-44.
23. Berggren J, Alderborn G. 2003. Effect of polymer content and molecular weight on the morphology and heat- and moisture-induced transformation of spray-dried composite particles of amorphous lactose and poly(vinylpyrrollidone). Pharm Res 20: 1039-1046.
24. Roos YH. 2001. Water activity and plasticization. In: Eskin NAM, Robinson RS, editors. Food shelf life stability. Boca Raton, Florida: CRC Press LLC. pp 3-36.
25. Fitzpatrick S, McCabe JF, Petts CR, Booth SW. 2002. Effect of moisture on polyvinylpyrrolidone in accelerated stability testing. Int J Pharm 246: 143-151.
26. Kontny MJ, Mulski CA. 1989. Gelatin capsule brittleness as a function of relative humidity at room temperature. Int J Pharm 54: 79-85.
27. Chang R-K, Raghavan KS, Hussain MA. 1998. A study on gelatin capsule brittleness: Moisture transfer between the capsule shell and its content. J Pharm Sci 87: 556-558.
28. Digenis GA, Gold TB, Shah VP. 1994. Cross-linking of gelatin capsules and its relevance to their in vitro-in vivo performance. J Pharm Sci 83: 915-921.
29. Ofner CM III, Zhang YE, Jobeck VC, Bowman BJ. 2001. Crosslinking studies in gelatin capsules treated with formaldehyde and in capsules exposed to elevated temperature and humidity. J Pharm Sci 90: 79-88.
30. 1H NMR as a new method to monitor softening of gelatin and HPMC capsule shells. Drug Dev Ind Pharm 32: 1165-1173.
31. Akbuǧa J, Gürsoy A. 1987. The effect of moisture sorption and desorption on furosemide tablet properties. Drug Dev Ind Pharm 13: 1827-1845.
32. Ahmad I, Shaikh RH. 1994. Effect of temperature and humidity on hardness and friability of packaged paracetamol tablet formulations. Pakistan J Pharm Sci 7: 69-78.
33. Krzyzaniak JF, Williams GR, Ni N. 2007. Identification of phase boundaries in anydrate/hydrate systems. J Pharm Sci 96: 1270-1281.
34. Lu J, Rohani S. 2009. Polymorphism and crystallization of active pharmaceutical ingredients. Curr Med Chem 16: 884-905.
35. Urakami K. 2005. Characterization of pharmaceutical polymorphs by isothermal calorimetry. Curr Pharm Biotech 6: 193-203.
36. Murphy DK, Rabel S. 2008. Thermal analysis and calorimetric methods for the characterization of new crystal forms. Drugs Pharm Sci 78: 279-321.
37. Willson RJ, Sokoloski TD. 2004. Ranking of polymorph stability for a pharmaceutical drug using the Noyes-Whitney titration template method. Thermochim Acta 417: 239-243.
38. Yoshinari R, Forbes RT, York P, Kawashima Y. 2002. Moisture induced polymorphic transition of mannitol and its morphological transformation. Int J Pharm 247: 69-77.
39. Durig T, Fassihi AR. 1991. Preformulation study of moisture effect on the physical stability of pyridoxal hydrochloride. Int J Pharm 77: 315-319.
40. Vemuri S, Tracatac C, Skluzacek R. 1985. Color stability of ascorbic acid tablets measured by tristimulus colorimeter. Drug Dev Ind Pharm 11: 207-222.
41. Aulton ME, Travers DN, White PJP. 1973. Strain recovery of compacts on extended storage. J Pharm Pharmac 25: 79P-86P.
42. Roskar R, Kmetec V. 2005. Evaluation of the moisture sorption behavior of several excipients by BET, GAB and microcalorimetric approaches. Chem Pharm Bull 53: 662-665.
43. Blahovec J, Yanniotis S. 2009. Modified classification of sorption isotherms. J Food Eng 91: 72-77.
44. Kontny MJ, Connors JJ. 2002. Water sorption of drugs and dosage forms. In: Swarbick J, Boylan JC, editors. Encyclopedia of pharmaceutical technology. New York: Marcel Dekker, Inc. pp 2970-2987.
45. Dalton CR, Hancock BC. 1997. Processing and storage effects on water vapor sorption by some model pharmaceutical solid dosage formulations. Int J Pharm 156: 143-151.
46. Li Y, Sanzgiri YD, Chen Y. 2003. A study on moisture isotherms of formulations: The use of polynomial equations to predict the moisture isotherms of tablet products. AAPS PharmSciTech 4: 1-8 (article 59).
47. Peng G, Chen C, Wu W, Jiang X. 2007. Modeling of water sorption isotherms for Corn Starch. J Food Eng 80: 562-567.
48. Bronlund J, Paterson T. 2004. Moisture sorption isotherms for crystalline, amorphous and predominantly crystalline lactose powders. Int Dairy J 14: 247-254.
49. Li S, Lin S, Daggy BP, Mirchandani HL, Chien YW. 2003. Effect of HPMC and Carbopol on the release and floating properties of gastric floating drug delivery system using factorial design. Int J Pharm 253: 13-22.
50. Newman AW, Reutzel-Edens SM, Zografi G. 2008. Characterization of the "hygroscopic" properties of active pharmaceutical ingredients. J Pharm Sci 97: 1047-1059.
51. Vrentas JS, Vrentas CM. 1996. Hysteresis effects for sorption in glass polymers. Macromolecules 29: 4391-4396.
52. Price R, Young PM. 2004. Visualization of the crystallization of lactose from the amorphous state. J Pharm Sci 93: 155-164.
53. Bolhuis G, Kussendrager K, Langridge J. 2004. New developments in spray-dried lactose. Pharm Tech (suppl. Excipients Solid Dosage Forms) 26: 28-31.
54. Snider B, Liang P, Pearson N. 2007. Implementation of water-activity testing to replace Karl Fischer water testing. Pharm Tech 31: 56, 58, 60, 62, 64-66, 68, 70-71.
55. Kontny MJ, Koppenal S, Graham ET. 1992. Use of the sorption-desorption moisture transfer model to assess the utility of a desiccant in a solid product. Int J Pharm 84: 261-271.
56. Mwesigwa E, Basit AW, Buckton G. 2008. Moisture sorption and permeability characteristics of polymer films: Implications for their use as barrier coatings for solid dosage forms containing hydrolyzable drug substances. J Pharm Sci 97: 4433-4445.
57. Bley O, Siepmann J, Bodmeier R. 2009. Characterization of moisture-protective polymer coatings using differential scanning calorimetry and dynamic vapor sorption. J Pharm Sci 98: 651-664.
58. Piergiovanni L, Fava P, Siciliano A. 1995. A mathematical model for the prediction of water vapor transmission rate at different temperature and relative humidity combinations. Pack Tech Sci 8: 73-83.
59. Chen Y, Li Y. 2008. Determination of water vapor transmission rate (MVTR) of HDPE bottles for pharmaceutical products. Int J Pharm 358: 137-143.