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Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 1
REFERENCES
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 2
I. REFERENCES:
1. Allison SD, Manning MC, Randolph TW, (2000), Optimization of storage stability of
lyophilized actin using combinations of disaccharides and dextran. Journal of
Pharmaceutical Sciences. 89:199-214
2. Andersson MM, Breccia JD, Hatti-Kaul R, (2000), Stabilizing effect of chemical
additives against oxidation of lactate dehydrogenase, Biotechnology and Applied
Biochemistry, 32:145-53
3. Andreas Abend and Allen Templeton, (2010), The Impact of Stopper Drying for
Lyophilized Drug Products, American pharmaceutical review, 25(6), 201-206.
4. Anhorn MG, Mahler HC, Langer K, (2008), Freeze drying of human serum albumin
(HSA) nanoparticles with different excipients, International Journal of
Pharmaceutics, 363:162-9
5. Ankit Baheti, Lokesh Kumar, Arvind K. Bansal,(2010), Excipients used in
lyophilization of small molecules, Journal of Excipients and Food Chemicals,. 1;1
6. Arakawa T, Prestrelski SJ, Kenney WC, Carpenter JF, (2001), Factors affecting short-
term and long-term stabilities of proteins. Advanced Drug Delivery Reviews. 46:307-
26
7. Bam NB, Cleland JL, Yang J, (1998), Tween protects recombinant human growth
hormone against agitation-induced damage via hydrophobic interactions. Journal of
Pharmaceutical Sciences, 87:1554-9
8. Bemporad, F., Calloni, G., Camponi, S., Plakoutsi, G., Taddei, N., and Chiti, F.
(2006), Sequence and structural determinants of amyloid fibril formation, American
Chemical Society Publications. 39: 620–627.
9. Bitan, G., Vollers, S. S., and Teplow, D. B. (2003), Elucidation of primary structure
elements controlling early amyloid beta-protein oliogomerization, Journal of
Biological Chemistry. 278: 34882–34889.
10. Brange J, Andersen L, Laursen ED, (1997), Toward understanding insulin fibrillation.
Journal of Pharmaceutical Sciences,. 86:517-25
11. Broering JM and Bommarius AS, (2005), Evaluation of Hofmeister effects on the
kinetic stability of proteins, The Journal of Physical Chemistry B, 109:206, 12-19.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 3
12. Buettner GR and Jurkiewicz BA, (1996), Catalytic metals, ascorbate and free
radicals: combinations to avoid. Radiation Research, 145:532-41
13. Caflisch, A. (2006), Computational models for the prediction of polypeptide
aggregation propensity, Current Opinion in Chemical Biology. 10: 437–444.
14. Carpenter, J. F., Pikal, M. J., Randolph, T. W. (1997), Rational design of stable
lyophilized protein formulations: some practical advice, Pharmaceutical Research. 14:
969–975.
15. Carpenter, J., Chang, B., Rodriguez, W., Randolph, T., Carpenter, J. F. and Manning,
M. C., (2002), Vol. 13, Rational Design of Stable lyophilized Protein Formulations:
Theory and Practice, Kluwer Academic/Plenum Publishers, New York, pp. 109–127.
16. Castellanos IJ, Flores G, Griebenow K, (2005), Effect of the molecular weight of
poly(ethylene glycol) used as emulsifier on alpha-chymotrypsin stability upon
encapsulation in PLGA microspheres. Journal of Pharmacy and Pharmacology,
57:1261-9
17. Chanasattru W, Decker EA, McClements DJ, (2008), Impact of cosolvents (polyols)
on globular protein functionality: Ultrasonic velocity, density, surface tension and
solubility study. Food Hydrocolloids, 22:1475-84
18. Chang LQ, Shepherd D, Sun J, (2005), Effect of sorbitol and residual moisture on the
stability of lyophilized antibodies: implications for the mechanism of protein
stabilization in the solid state. Journal of Pharmaceutical Sciences, 94:1445-55
19. Chou DK, Krishnamurthy R, Randolph TW, (2005), Effects of Tween 20 (R) and
Tween 80 (R) on the stability of albutropin during agitation. Journal of
Pharmaceutical Sciences, 94:1368-81
20. Christopher C. DeMerlis, Jay M. Goldring, Ranga Velagaleti, William Brock, Robert
Osterberg (2009), Regulatory Update: The IPEC Novel Excipient Safety Evaluation
Procedure, Pharmaceutical Technology, 33,11, 72-82.
21. Cruciani, G., Baroni, M., Carosati, E., Clementi, M., Valigi, R., and Clementi, S.
(2004), Peptide studies by means of principal properties of amino acids derived from
MIF descriptors, Journal of Chemometrics. 18: 146–155.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 4
22. David S. Pearson and Geoff Smith (1998), Dielectric analysis as a tool for
investigating the lyophilization of proteins; PSTT Vol. 1, No. 3 June.
23. Day JN and Stacey GN (2007), Methods in Molecular Biology, Cryopreservation and
Freeze-Drying Protocols, Second Edition, Humana Press, vol. 368, 15-72.
24. De Boer A.H, Chan H.K, Price R, (2012), A critical view on lactose-based drug
formulation and device studies for dry powder inhalation: Which are relevant and what
interactions to expect?; Advanced Drug Delivery Reviews 64; 257–274.
25. De Rosier, (2011), Method and formulation for stabilization of enzymes; United
States Patent 6294365.
26. Deirdre Murphy Piedmonte and Michael J. Treuheit, (2008), Formulation of
Neulasta® (pegfilgrastim), Advanced Drug Delivery Reviews 60;50–58.
27. Dobson, C. M. (2004), Principles of protein folding, misfolding, and aggregation,
Seminars in Cell and Developmental Biology. 15: 3–16.
28. Dubay, K. F., Pawar, A. P., Chiti, F., Zurdo, J., Dobson, C. M., and Vendruscolo, M.
(2004), Prediction of the absolute aggregation rates of amyloidogenic polypeptide
chains, Journal of Molecular Biology, 341: 1317–1326.
29. Edward T. Maggio, (2008), Novel Excipients Prevent Aggregation in Manufacturing
and Formulation of Protein and Peptide Therapeutics; BioProcess International,
November.
30. EMA, scientific guideline for Novel excipient, (2003), from website,
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/0
9/WC500003388.pdf).
31. Fan HH, Li HN, Zhang MY, Middaugh CR, (2007), Effects of solutes on empirical
phase diagrams of human fibroblast growth factor Journal of Pharmaceutical
Sciences, 96:1490-503
32. Fan HH, Ralston J, Dibiase M, (2005), Solution behaviour of IFN-beta-1a: an
empirical phase diagram based approach. Journal of Pharmaceutical Sciences,
94:1893-911
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 5
33. Faria TQ, Mingote A, Siopa F, (2008), Design of new enzyme stabilizers inspired by
glycosides of hyperthermophilic microorganisms. Carbohydrate Research, 343:3025-
33
34. Fei L, Perrett S, (2009), Effect of nanoparticles on protein folding and fibrillogenesis.
International Journal of Molecular Sciences, 10:646-55
35. Fernandez-Escamilla, A., Rousseau, F., Schymkowitz, J., and Serrano, L. (2004),
Predictionof sequence-dependent and mutational effects on the aggregation of peptides
and proteins, Nature Biotechnology. 22: 1302–1306.
36. Fink, A. L. (1998), Protein aggregation: Folding aggregates, inclusion bodies and
amyloid, Folding and Design, 3(1): R9–R23.
37. Fotsing G, Fillet M, Bechet I, Ph. Hubert J, Crommen J, (1997), Determination of six
water-soluble vitamins in a pharmaceutical formulation by capillary electrophoresis;
Journal of Pharmaceutical and Biomedical Analysis 15; 1113-1123
38. Fowler, S. B., Poon, S., Muff, R., Chiti, F., Dobson, C. M., and Zurdo, J. (2005),
Rational design of aggregation-resistant bioactive peptides: Reengineering human
calcitonin, Proceedings of the National Academy of Sciences USA, 102: 10105–10110.
39. Francesco M.Veronese and Gianfranco Pasut (2005), PEGylation,successful approach
to drug delivery, DDT,10, 21, 1-8
40. Franks, F., Hatley, R. H. M., and Mathias, S. F. (1991), Materials science and the
production of shelf-stable biologicals, BioPharm international, 4(9): 38–55, pages 38,
40–42, 55.
41. Frokjaer S, Otzen DE, (2005), Protein drug stability: a formulation challenge. Nature
Reviews Drug Discovery, 4:298-306
42. Galzitskaya, O. V. (2006), Identification of β-aggregate sites in protein chains,
Journal of Molecular Biology, 40: 839–843.
43. Galzitskaya, O. V., Garbuzinskiy, S. A., and Lobanov, M. Y. (2006), Prediction of
amyloidogenic and disordered regions in protein chains, PLOS Computational
Biology. 2: 1639–1648.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 6
44. Galzitskaya, O. V., Garbuzinskiy, S. A., and Lobanov, M. Y. (2006), Search for
amyloidogenic regions of the protein chain, Journal of Molecular Biology. 40: 910–
918.
45. Galzitskaya, O. V., Ivankov, D. N., and Finkelstein, A. V. (2001), Folding nuclei in
proteins, Journal of Molecular Biology, 35: 708–717.
46. Gangadhara, Kumar P, Prakash V, (2008), Influence of polyols on the stability and
kinetic parameters of invertase from candida utilis: correlation with the conformational
stability and activity. Journal of Protein Chemistry, 27:440-9
47. Garbuzynskiy, O. V., Finkelstein, A. V., and Galzitskaya, O. V. (2005), On the
prediction of folding nuclei in globular proteins, Journal of Molecular Biology. 39:
906–914.
48. Gazit, E. (2002), A possible role for π-stacking in the self-assembly of amyloid
fibrils, FASEB J. 16: 77–83.
49. Giorgio Pifferi and Patrizia Restani, (2003), The safety of pharmaceutical excipients,
II Farmaco 58, 541- 550
50. Giorgio Pifferi, (2003), The safety of pharmaceutical excipients, II Farmaco Volume
58, Issue 8, Pages 541-550
51. Girish K Jania, Dhiren P Shahb, Vipul D Prajapatia, Vineet C Jainb, (2009), Gums
and mucilages: versatile excipients for pharmaceutical formulations, Gums and
mucilages, Asian Journal of Pharmaceutical Sciences, 4 (5), 309-323.
52. Glomme A, März J and Dressman J.B. (2005), Comparison of a miniaturized shake-
flask solubility method with automated potentiometric acid/base titrations and
calculated solubilities, Journal of Pharmaceutical sciences, vol 94, No.1.
53. Goldsbury, C., Goldie, K., Pellaud, J., Seelig, J., Frey, P., Muller, S. A., Kistler, J.,
Cooper, G. J. S., and Aebi, U. (2000), Amyloid fibril formation from full-length and
fragments of amylin, Journal of Structural Biology. 130: 352–362.
54. Golovanov AP, Hautbergue GM, Wilson SA, Lian LY, (2004), A simple method for
improving protein solubility and long-term stability. Journal of the American
Chemical Society, 126:8933-9
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 7
55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer
composition on pH changes during far-from-equilibrium freezing of sodium phosphate
buffer solutions. Pharmaceutical Research, 18:90-7
56. Govardhan C, Khalaf N, Jung CW, (2005), Novel long-acting crystal formulation of
human growth hormone. Pharmaceutical Research,, 22:1461-70
57. Grover, A., Dugar, D., and Kundu, B. (2005), Predicting alternate structure
attainment and amyloidogenesis: A non-linear signal analysis approach, Biochemical
and Biophysical Research Communications, 338: 1410–1416.
58. Guidance for Industry (2005): Nonclinical Studies for the Safety Evaluation of
Pharmaceutical Excipients. U.S. Department of Health and Human Services Food and
Drug Administration, Center for Drug Evaluation and Research (CDER), and Center
for Biologics Evaluation and Research (CBER)
59. Guideline on Excipients in the Dossier for Application for Marketing Authorization
of a Medicinal Product, EMEA/CHMP/QWP/396951/2006. European Medicines
Agency. 2007. Available from:
ttp://www.emea.europa.eu/pdfs/human/qwp/39695106enfin.pdf [Last accessed 6 July
2009]• Regulatory insight into the choice of excipients.
60. Guideline on Excipients in the Dossier for Application for Marketing Authorization
of a Medicinal Product, EMEA/CHMP/QWP/396951/2006. European Medicines
Agency. 2007.
61. Haikala R, Eerola R, Tanninen VP, Yliruusi J, (1997), Polymorphic changes of
mannitol during freeze-drying: effect of surface-active agents. PDA Journal of
Pharmaceutical Science and Technology, 51:96-101
62. Hawe A and Friess W, (2007), Formulation development for hydrophobic therapeutic
proteins. Pharmaceutical development and technology, 12:223-37
63. Hedoux A, Willart JF, Paccou L, (2009), Thermostabilization mechanism of
bovine serum albumin by Trehalose. The Journal of Physical Chemistry, 113:6119-26
64. Hellberg, S., Sjostrim, M., Skakerberg, B., and Wold, S. (1987), Peptide quantitative
structure-activity relationships, a multivariate approach, European Journal of
Medicinal Chemistry. 30: 1126–1135.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 8
65. Hillgren A, Lindgren J, Alden M, (2002), Protection mechanism of Tween 80 during
freeze-thawing of a model protein, LDH. International Journal of Pharmaceutics,
237:57-69
66. Hlinak, A. and Clark, B. (2002), Drying and dryers, in Encyclopedia of
Pharmaceutical Technology, 2nd ed., Vol. 1, Swarbrick, J. and Boylan, J. C., eds.,
Marcel Dekker, New York, pp. 1018–1032.
67. Hong Zhao, Elizabeth M. Topp, (2008), Recent U.S. Patents on Protein Drug
Formulation: 2000-2007; Recent Patents on Drug Delivery & Formulation, 2, 200-
208.
68. Houchin ML, Neuenswander SA, Topp EM, (2007), Effect of excipients on PLGA
film degradation and the stability of an incorporated peptide. Journal of Control
Release, 117:413-20
69. Hsu, Chung C, Nguyen, Hoc M, Wu, Sylvia S, (1993), Reconstitutable lyophilized
protein formulation; United States Patent 5192743.
70. Hulse WL, Forbes RT, Bonner MC, Getrost M, (2008), Do co-spray dried excipients
offer better lysozyme stabilisation than single excipients? European Journal of
Pharmaceutical Sciences, 33:294-305
71. Huus K, Havelund S, Olsen HB, (2006), Ligand binding and thermostability of
different allosteric states of the insulin zinc-hexamer. Biochemistry, 45:4014-24
72. Ignatova Z, Gierasch LM, (2006), Inhibition of protein aggregation in vitro and in
vivo by a natural osmoprotectant. Proceedings of the National Academy of
Sciences,103:13357-61
73. Inactive Ingredient Search for Approved Drug Products. FDA Center for Drug
Evaluation and Research, Office of Generic Drugs. 2009.
74. Ingrid J. Castellanos, Ruben Crespo, Kai Griebenow, (2003), Poly(ethylene glycol) as
stabilizer and emulsifying agent: a novel stabilization approach preventing aggregation
and inactivation of proteins upon encapsulation in bio erodible polyester microspheres;
Journal of Controlled Release 88, 135–145.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 9
75. Izutsu K, Kojima S, (2002), Excipient crystallinity and its protein-structure-
stabilizing effect during freeze-drying, Journal of Pharmacy and Pharmacology,
54:1033-9
76. Jain NK, Roy I, (2008), Role of trehalose in moisture-induced aggregation of bovine
serum albumin. European Journal of Pharmaceutics and Biopharmaceutics, 69:824-
34
77. Jain NK, Roy I, (2009), Effect of trehalose on protein structure. Protein Sci, 18:24-36
78. James Taylor, (2006), Current Trends and Challenges in the Excipients Market from
Pharmaceutical Technology, Oct. 1.
79. Jannin V, Musakhanian J, Marchaud D, (2008), Approaches for the development of
solid and semi-solid lipid-based formulations, Advanced Drug Delivery Reviews, 60,
734–746.
80. Jay Goldring, (2009) Novel Excipients: The Next Pharmaceutical Frontier? Drug
Delivery, American pharmaceutical review
81. Jennings, T. A. (1999). Lyophilization: Introduction and Basic Principles, Interpharm
Press, Edition 1, 87-118.
82. Johnson PJ, Skornia SL, Stabenfeldt SE, Willits RK, (2008), Maintaining bioactivity
of NGF for controlled release from PLGA using PEG. Journal of Biomedical
Materials Research, Part A, 86:420-7
83. Johnson RE, Kirchhoff CF, Gaud HT, (2002), Mannitol-sucrose mixtures – Versatile
formulations for protein lyophilization. Journal of Pharmaceutical Sciences, 91:914-
22
84. Jones, S., Manning, J., Kad, N. M., and Radford, S. E. (2003), Amyloid-forming
peptides from β2-microglobulin- insights into the mechanism of fibril formation in
vitro, Journal of Molecular Biology. 325: 249–257.
85. Kang J, Schwendeman SP, (2002), Comparison of the effects of Mg(OH)2 and
sucrose on the stability of bovine serum albumin encapsulated in injectable poly(D,L-
lactide-co-glycolide) implants. Biomaterials, 23:239-45
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 10
86. Katakam M, Bell LN, Banga AK, (1995), Effect of surfactants on the physical
stability of recombinant human growth hormone. Journal of Pharmaceutical Sciences,
84:713-16
87. Katayama DS, Nayar R, Chou DK, (2006), Effect of buffer species on the thermally
induced aggregation of interferon-tau. Journal of Pharmaceutical Sciences, 95:1212-
26
88. Kate Denton, (2010), Regulatory challenges are hindering the use of novel excipients,
from Pharmaceutical Technology, July 2010.
89. Katharina Woertz, Corinna Tissen, Peter Kleinebudde, Jörg Breitkreutz, (2011)
comparative study on two electronic tongues for pharmaceutical formulation
development Journal of Pharmaceutical and Biomedical Analysis 55 272–281
90. Kerwin BA, (2008), Polysorbates 20 and 80 used in the formulation of protein
biotherapeutics: structure and degradation pathways. Journal of Pharmaceutical
Sciences, 97:2924-35
91. Kerwin BA, Heller MC, Levin SH, Randolph TW, (1998), Effects of Tween 80 and
sucrose on acute short-term stability and long-term storage at -20 degrees C of a
recombinant hemoglobin. Journal of Pharmaceutical Sciences, 87:1062-8
92. Kett V, McMahon D, Ward K, (2004), Freeze-drying of protein pharmaceuticals – the
application of thermal analysis. Cryo Letters, 25:389-404
93. Kikuchi T, Kubota S, Asaumi K, (2008), Promotion of bone regeneration by CCN2
incorporated into gelatin hydrogel. Tissue Engineering, Part A, 14:1089-98
94. Kim AI, Akers MJ, Nail SL, (1998), The physical state of mannitol after freeze-
drying: Effects of mannitol concentration, freezing rate, and a noncrystallizing
cosolute. Journal of Pharmaceutical Sciences, 87:931-5
95. Kohn WD, Kay CM, Hodges RS, (1997), Salt effects on protein stability: two-
stranded alpha-helical coiled-coils containing inter- or intrahelical ion pairs. Journal of
Molecular Biology, 267:1039-52
96. Kokate CK, (1994),Practical Pharmacognosy, 4th Edition, Nirali Publication, Page
No: 107-111
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 11
97. Kolp S, Pietsch M, Galinski EA, Gutschow M, (2006), Compatible solutes as
protectants for zymogens against proteolysis. Biochimica et Biophysica Acta,
1764:1234-42
98. Kowalski, S. J., ed. (2003), Characterization of drying processes, Thermomechanics
of Drying Processes, Vol. 8, Springer, Heidelberg, Germany, pp. 24–30.
99. Krebs, M. R. H., Devlin, G. L., and Donald, A. M. (2007), Protein particulates:
Another generic form of protein aggregation? Biophysical Journal. 97: 1336–1342.
100. Krielgaard, L., Jones, L. S., Randolph, T. W., Frokjaer, S., Flink, J. M., Manning,
M. C., and Carpenter, J. F. (1998), Effect of tween 20 on freeze-thawing- and
agitation-induced aggregation of recombinant human factor XIII, Journal of
Pharmaceutical Sciences. 87(12): 1593–1603.
101. Kumar V, Sharma VK, Kalonia DS, (2009), Effect of polyols on polyethylene
glycol (PEG)-induced precipitation of proteins: Impact on solubility, stability and
conformation. International Journal of Pharmaceutics, 366:38-43
102. Kundlik Girhepunje, Arulkumaran, Ranju Pal, Nitin Maski, N Thirumoorthy,
(2009), A Novel Binding agent for pharmaceutical formulation from Cassia
roxburghii seeds, International Journal Of Pharmaceutical Sciences, Vol.1, 1-6
103. Kundu, B. and Gluptasarma, P. (1999), Hydrophobic dye inhibits aggregation of
molten carbonic anhydrase during thermal unfolding and refolding, Proteins:
Structure, Function, and Bioinformatics, 37: 321–324.
104. Kwak HH, Shim WS, Choi MK, Son MK, Kim YJ, Yang HC, Kim TH, Lee GI,
Kim GM, Kang SH, Shim CK, (2009), Development of a sustained-release
recombinant human growth hormone formulation, Journal of Controlled Release 137,
160–165.
105. Lakshmi K Narasimha Rao, Krishnaiah Ch, Sudheer Babu K, Padmaja Reddy K,
(2012), Development and validation of a stability-indicating LC method for
simultaneous determination of related compounds of guaifenesin, terbutaline sulfate
and ambroxol HCl in cough syrup formulation, Journal of Saudi Chemical Society,
12.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 12
106. Lei Yu, Alona Vizel, Mary Beth Huff, Meagan Young, Richard L. Remmele Jr.,
Bing He, (2006), Investigation of N-terminal glutamate cyclization of recombinant
monoclonal antibody in formulation development; Journal of Pharmaceutical and
Biomedical Analysis 42; 455–463.
107. Lene Jorgensen, Susanne Hostrup, Eva Horn Moeller, and Holger Grohganz (2009),
Recent trends in stabilising peptides and proteins in pharmaceutical formulation –
considerations in the choice of excipients; Expert Opinion on Drug Delivery, Vol. 6,
No. 11 : Pages 1219-1230.
108. Li SH, Nguyen TH, Schoneich C, Borchardt RT, (1995), Aggregation and
precipitation of human relaxin induced by metal-catalyzed oxidation. Biochemistry,
34:5762-72
109. Li SH, Schoneich C, Wilson GS, Borchardt RT, (1993), Chemical pathways of
peptide degradation .5. ascorbic-acid promotes rather than inhibits the oxidation of
methionine to methionine sulfoxide in small model peptides. Pharmaceutical
Research, 10:1572-9.
110. Linding, R., Schymkowitz, J., Rousseau, F., Diella, F., and Serrano, L. (2004), A
comparative study of the relationship between protein structure and β-aggregation in
globular and intrinsically disordered proteins, Journal of Molecular Biology. 342:
345–353.
111. Lopez de la Paz, M. and Serrano, L. (2004), Sequence determinants of amyloid
fibril formation, Proceedings of the National Academy of Sciences, 101: 87–92.
112. Lu J, Wang XJ, Liu YX, Ching CB, (2007), Thermal and FTIR investigation of
freeze-dried protein-excipient mixtures. Journal of Thermal Analysis and Calorimetry,
89:913-19
113. Luthra S, Obert JP, Kalcinia DS, Pikal MJ, (2007), Impact of critical process and
formulation parameters affecting in-process stability of lactate dehydrogenase during
the secondary drying stage of lyophilization: a mini freeze dryer study. Journal of
Pharmaceutical Sciences, 96:2242-50
114. Magee GA, Halbert GW, Wilmott N, (1995), Effect of process variables on the in
vitro degradation of protein microspheres; Journal of Controlled Release 37, 11-19.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 13
115. Mahesh V. Chaubal, (2004), Application of formulation technologies in lead
candidate selection and optimization, DDT Vol. 9, No. 14.
116. Manning, M. C., Patel, K., and Borchardt, R. T. (1989), Stability of protein
pharmaceuticals, Pharmaceutical Research. 6: 903–917
117. Martı n-Alfonso JE, Valencia C, Sanchez MC, Franco JM, Gallegos C, (2007),
Development of new lubricating grease formulations using recycled LDPE as rheology
modifier additive, European Polymer Journal 43; 139–149.
118. Matthews B, (2002), Excipients for non-oral routes of administration. Regulatory
insight into the choice of excipients, Clinical Research and Regulatory Affairs ;897-
908
119. Matthews B, (2002), Excipients used in products approved through the EU central
procedure. Clinical Research and Regulatory Affairs, 1036-44
120. Mattos C, Clark AC. (2008), Minimizing frustration by folding in an aqueous
environment,. Archives of Biochemistry and Biophysics, 469:118-31
121. McGaughey, G. B., Gagn´e, M., and Rapp´e, A. K. (1998), π-stacking interactions.
Alive and well in proteins, Journal of Biological Chemistry. 273: 15458–15463.
122. Meinhardt, J., Tartaglia, G. G., Pawar, A., Christopeit, T., Hortschansky, P.,
Schroeckh, V., Dobson, C. M., Vendruscolo, M., and F¨andrich, M. (2007),
Similarities in the thermodynamics and kinetics of aggregation of disease-related
Aβ(1–40) peptides, Protein Sciences. 16: 1214–1222.
123. Middaugh, R. C. (1994), The analysis of protein pharmaceuticals: Near Future
advances, Cytotechnology 15: 187–194.
124. Mohl S, Winter G, (2006), Continuous release of Rh-interferon (alpha-2a) from
triglyceride implants: storage stability of the dosage forms. Pharmaceutical
Development and Technology, 11:103-10
125. Mollmann SH, Elofsson U, Bukrinsky JT, Frokjaer S,(2005), Displacement of
adsorbed insulin by tween 80 monitored using total internal refelction fluorescence
and ellipsometry. Pharmaceutical Research, 22:1931-41
126. Monsellier, E., Ramazzotti, M., de Laureto, P. P., Tartaglia, G. G., Taddei, N.,
Fontana, A., Vendruscolo, M., and Chiti, F. (2007), The distribution of residues in a
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 14
polypeptide sequence is a determinant of aggregation optimized by evolution,
Biophysical Journal, 93: 4382–4391.
127. Mujumdar, A. S., (2007), Principles, classification and selection of dryers,
Handbook of Industrial Drying, 3rd ed., CRC Press, Boca Raton, FL, pp. 3–32.
128. Nageswara Rao R, Kumar Talluri MVM, Narasa Raju A, Dhananjay D. Shinde,
G.S. Ramanjaneyulu, (2008), Development of a validated RP-LC/ESI-MS–MS
method for separation, identification and determination of related substances of
tamsulosin in bulk drugs and formulations, Journal of Pharmaceutical and
Biomedical Analysis 46, 94–103.
129. Nandhakumar L, Rameshkumar S, Dharmamoorthy G, Dinesh M, (2011),
Lyophillization formulation development with novel excipients for Pegylated
therapeutic proteins: A case study, Journal of Pharmacy Research, 4(12), 4754-4759.
130. Nayar, R. and Manning, M. C. (2002), High throughput formulation: Strategies for
rapid development of stable protein products, Pharmaceutical Biotechnology. 13: 177–
198.
131. Nema S, Washkuhn RJ, Brendel RJ, (1997), Excipients and their use in injectable
products. PDA Journal of Pharmaceutical Science and Technology, 51:166-71
132. Pancera SM, Itri R, Petri DFS, (2004), The effect of poly(ethylene glycol) on the
activity, structural conformation and stability of yeast hexokinase. Progr Colloid
Journal of Polymer Science, 128:178-83
133. Parkins DA and Lashmar UT, (2000),The formulation of biopharmaceutical
products, Pharmaceutical Science & Technology Today, Apr; 3(4), 129-137.
134. Passot S, Fonseca F, Alarcon-Lorca M, (2005), Physical characterisation of
formulations for the development of two stable freeze-dried proteins during both dried
and liquid storage. European Journal of Pharmaceutics and Biopharmaceutics,
60:335-48
135. Pastor, M. T., Esteras-Chopo, A., and Lopez de la Paz, M. (2005), Design of model
systems for amyloid formation: Lessons for prediction and inhibition, Current Opinion
in Structural Biology, 15: 57–63.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 15
136. Patro SY, Freund E, Chang BS, (2002), Protein formulation and fill-finish
operations. Biotechnology Annual Review, 8:55-84
137. Pedro E. Cruz, Ana Carina Silva, Anto´nio Rolda˜o, Marlene Carmo, Manuel J. T.
Carrondo and Paula M. Alves, (2006), Screening of Novel Excipients for Improving
the Stability of Retroviral and Adenoviral Vectors, Biotechnology Progress. 22, 568-
576.
138. Perez C, Griebenow K, (2003), Effect of salts on lysozyme stability at the water-oil
interface and upon encapsulation in poly(lactic-co-glycolic) acid microspheres.
Biotechnology and Bioengineering, 82:825-32
139. Pikal MJ, Rigsbee D, Roy ML, (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. Journal of Pharmaceutical Sciences,
2008;97:5106-21
140. Pikal, M. J. Koval, R. L, Marcel Dekker (2004), Mechanisms of protein
stabilization during freeze-drying and storage: The relative importance of
thermodynamic stabilization and glassy state relaxation dynamics, in Drugs and the
Pharmaceutical Sciences: Freeze-Drying/Lyophilization of Pharmaceutical and
Biological Products, Vol. 137, New York, pp. 63–107.
141. Poddar NK, Ansari ZA, Singh RKB, (2008), Effect of monomeric and oligomeric
sugar osmolytes on Delta G(D), the Gibbs energy of stabilization of the protein at
different pH values: is the sum effect of monosaccharide individually additive in a
mixture? Biophys Chem, 138:120-9
142. Pyne A, Chatterjee K, Suryanarayanan R, (2003), Solute crystallization in mannitol-
glycine systems - Implications on protein stabilization in freeze-dried formulations.
Journal of Pharmaceutical Sciences, 92:2272-83
143. Rajan K. Verma1, Sanjay Garg, (2004), Compatibility studies between isosorbide
mononitrate and selected excipients used in the development of extended release
formulations, Journal of Pharmaceutical and Biomedical Analysis 35;449–458.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 16
144. Rathore N, Rajan RS, (2008), Current perspectives on stability of protein drug
products during formulation, fill and finish operations. Biotechnology Progress,
24:504-14
145. Remmele RL, Stushnoff C, Carpenter JF, (1997), Real-time in situ monitoring of
lysozyme during lyophilization using infrared spectroscopy: dehydration stress in the
presence of sucrose. Pharmaceutical Research, 14:1548-55
146. Richard S. Brody, Ada S. Cowan, (2011), Protein Stabilization; Patent application
number: 20110014676.
147. Richard S. Kaye, Tarlochan S. Purewal Oya H. Alpar, (2009), Development and
testing of particulate formulations for the nasal delivery of antibodies, Journal of
Controlled Release 135; 127–135
148. Rousseau, F, Serrano, L., and Schymkowitz, J. W. H. (2006), How evolutionary
pressure against protein aggregation shaped chaperone specificity, Journal of
Molecular Biology. 355: 1037–1047.
149. Rousseau, F., Schymkowitz, J., and Serrano, L. (2006), Protein aggregation and
amyloidosis: Confusion of the kinds? Current Opinion in Structural Biology. 16: 118–
126.
150. Sadeghi, M., Naderi-Manesh, H., Zarrabi, M., and Ranjbar, B. (2006), Effective
factors in thermostability of thermophilic proteins, Biophysical Chemistry. 119: 256–
270.
151. Saiki, M., Konokahara, T., and Morii, H. (2006), Interaction-based evaluation of the
propensity for amyloid formation with cross-β structure, Biochemical and Biophysical
Research Communications, 343: 1262–1271.
152. Sampath Krishnan, Wenjin Cao, Joseph Phillips, (2009), Applying Raman
Spectroscopy to Design of Lyophilization Cycles for Protein Formulation
Development; American Pharmaceutical Review, September, October.
153. Sandberg, M., Eriksson, L., Jonsson, J., Sjostrom, M., and Wold, S. (1998), New
chemical descriptors relevant for the design of biologically active peptides. A
multivariate characterization of 87 amino acids, European Journal of Medicinal
Chemistry. 41: 2481–2491.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 17
154. Sandeep Nema and Ronald J. Brendel, (2011), Excipients and Their Role in
Approved Injectable Products: Current Usage and Future Directions, PDA Journal of
Pharmaceutical Science and Technology,Vol.65, No.3.
155. Sanjay Garg, Rajan K. Verma, Divi Murali Krishna, (2002), Formulation aspects in
the development of osmotically controlled oral drug delivery systems, Journal of
Controlled Release 79, 7–27.
156. Sarciaux JM, Mansour S, Hageman MJ, Nail SL, (1999), Effects of buffer
composition and processing conditions on aggregation of bovine IgG during freeze-
drying. European Journal of Pharmaceutical Sciences, 88:1354-61
157. Sathish HA, Kumar PR, Prakash V, (2007), Mechanism of solvent induced thermal
stabilization of papain. International Journal of Biological Macromolecules, 41:383-
90
158. Schoubben A, Blasi P, Giovagnoli S, (2009), Novel composite microparticles for
protein stabilization and delivery. European Journal of Pharmaceutical Sciences,
36:226-34
159. Schwegman JJ, Carpenter JF, Nail SL, (2007), Infrared microscopy for in situ
measurement of protein secondary structure during freezing and freeze-drying.
European Journal of Pharmaceutical Sciences, 96:179-95
160. Schwendeman SP, (2002), Recent advances in the stabilization of proteins
encapsulated in injectable PLGA delivery systems. Critical Reviews in Therapeutic
Drug Carrier Systems, 19:73-98
161. Sebastian Vonhoff, Jamie Condliffe, Heiko Schiffter, (2010), Implementation of an
FTIR calibration curve for fast and objective determination of changes in protein
secondary structure during formulation development, Journal of Pharmaceutical and
Biomedical Analysis 51,39–45.
162. Sedlak E, Stagg L, Wittung-Stafshede P, (2008), Role of cations in stability of
acidic protein Desulfovibrio desulfuricans apoflavodoxin. Archives of Biochemistry
and Biophysics, 474:128-35
163. Sharma, B. (2007), Immunogenicity of therapeutic proteins. Part 2: Impact of
container closures, Biotechnology Advances. 25: 318–324.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 18
164. Shengmin Sua, Yunqiu Yua, Wei Mob, Yanling Zhang, Houyan Song, Qinfen
Chenc, Yi Xie, (2008), A development of LC–MS method combining ultrafiltration
and lyophilization for determination of r-RGD-Hirudin in human serum; Journal of
Chromatography B, 870, 27–31.
165. Shireesh P.Apte , (2003) Emerging Excipients in Parenteral Medications from
Pharmaceutical Technology
166. Shireesh P.Apte and Sydney O. Ugwu, (2003), A Review and Classification of
Emerging Excipients in Parenteral Medications, Pharmaceutical Technology, March,
1-8.
167. Shnek DR, Hostettler DL, Bell MA, (1998), Physical stress testing of insulin
suspensions and solutions. European Journal of Pharmaceutical Sciences, 87:1459-65
168. Short, Robert E and Los Gatos, (1999), a novel excipient for the lyophilization of
aqueous suspensions of microparticles; WO 2000/006124.
169. Sikkink LA, Ramirez-Alvarado M, (2008), Salts enhance both protein stability and
amyloid formation of an immunoglobulin light chain. Biophysical Chemistry,135:25-
31
170. Snowman, John W (1988), Downstream Processes: Equipment and Techniques,
Binary - Computing in Microbiology, 6: pages 315-351.
171. Sosabowski JK, Lee M, Dekker BA, (2007) Formulation development and
manufacturing of a gastrin/CCK-2 receptor targeting peptide as an intermediate drug
product for a clinical imaging study. European Journal of Pharmaceutical Sciences,
31:102-11
172. Sun, S. and Bernstein, E. R. (1996), Aromatic van der Waals clusters: Structure
and nonrigidity, The Journal of Physical Chemistry A, 100: 13348–13366.
173. Taluja A, Bae YH, (2007), Role of a novel excipient poly(ethylene glycol)-b-
poly(L-histidine) in retention of physical stability of insulin at aqueous/organic
interface. Molecular Pharmacology, 4:561-70
174. Tamilvanan S, Venkatesh BR, Kannan K, (2008), Manufacturing techniques and
excipients used during the design of biodegradable polymer-based microspheres
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 19
containing therapeutic peptide/protein for parenteral controlled drug delivery. PDA
Journal of Pharmaceutical Science and Technology, 62:125-54
175. Tartaglia, G. G., Cavalli, A., Pellarin, R., and Caflisch, A. (2005), Prediction of
aggregation rate and aggregation-prone segments in polypeptide sequences, Protein
Science. 14: 2723–2734.
176. Tavornvipas S, Hirayama F, Takeda S, (2006), Effects of cyclodextrins on
chemically and thermally induced unfolding and aggregation of lysozyme and basic
fibroblast growth factor. Journal of Pharmaceutical Sciences, 95:2722-9
177. Tavornvipas S, Tajiri S, Hirayama F, (2004), Effects of hydrophilic cyclodextrins
on aggregation of recombinant human growth hormone. Pharmaceutical Research,
21:2369-76
178. Telang C, Yu L, Suryanarayanan R, (2003), Effective inhibition of mannitol
crystallization in frozen solutions by sodium chloride. Pharmaceutical Research,
20:660-7
179. Thanaset Senawong (2008), Biochemistry, Science KKU, 318-711.
180. Thomas J. Anchordoquy, S. Dean Allison, Marion d.C. Molina, Lorinda G.
Girouard and Taylor K. Carson (2001), Physical stabilization of DNA-based
therapeutic; DDT Vol. 6, No. 9 May.
181. Thompson, M. J., Sievers, S. A., Karanicolas, J., Ivanova, M. I., Baker, D., and
Eisenberg, D. (2006), The 3D profile method for identifying fibril-forming segments
of proteins. Proceedings of the National Academy of Sciences, 103: 4074–4078.
182. Thyagarajapuram N, Olsen D, Middaugh CR. Stabilization of proteins by
recombinant human gelatins. Journal of Pharmaceutical Sciences, 2007;96:3304-15
183. Tim J. Kamerzell, Reza Esfandiary, Sangeeta B. Joshi, C. Russell Middaugh, David
B. Volkin, (2011), Protein–excipient interactions: Mechanisms and biophysical
characterization applied to protein formulation development, Advanced Drug
Delivery Reviews 63, 1118–1159.
184. Tim Serno, Raimund Geidobler, Gerhard Winter, (2011), Protein stabilization by
cyclodextrins in the liquid and dried state; Advanced Drug Delivery Reviews 63;
1086–1106.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 20
185. Timasheff SN, (2002), Protein hydration, thermodynamic binding, and preferential
hydration. Biochemistry, 41:13473-82
186. Tjernberg, L., Hosia, W., Bark, N., Thyberg, J., and Johansson, J. (2002), Charge
attraction and β propensity are necessary for amyloid fibril formation from
tetrapeptides, Journal of Biological Chemistry. 277: 43243–43246.
187. Tsumoto K, Umetsu M, Kumagai I, (2004), Role of arginine in protein refolding,
solubilization, and purification. Biotechnology Progress, 20:1301-8
188. Tsutomu Arakawaa, Steven J. Prestrelskia, William C. Kenneya, b John F.
Carpenter, (2001), Factors affecting short-term and long-term stabilities of proteins;
Advanced Drug Delivery Reviews 46, 307–326.
189. Turnell, W. G. and Finch, J. T. (1992), Binding of the dye Congo Red to the
amyloid protein pig insulin reveals a novel homology amongst amyloid-forming
peptide sequences, Journal of Molecular Biology. 227: 1205–1223.
190. Van de Weert M, Hennink WE, Jiskoot W, (2000), Protein instability in poly(lactic-
co-glycolic acid) microparticles. Pharmaceutical Research, 17:1159-67
191. Van der Walle CF, Sharma G, Ravi KM, (2009), Current approaches to stabilising
and analysing proteins during microencapsulation in PLGA. Expert Opinion on Drug
Delivery, 6:177-86
192. Venkata R. Garigapati, (2008), Protein stabilization formulations; US
2008/0147077 A1.
193. Volkin, D. B., Sanyal, G., Burke, C. J., and Middaugh, C. R. (2002), Preformulation
studies as an essential guide to formulation development and manufacture of protein
pharmaceuticals, in Development and Manufacture of Protein Pharmaceuticals, Vol.
14 of Pharmaceutical Biotechnology Series, Plenum Press, New York, pp. 1–39.
194. Wang W, (2000), Lyophylization and development of solid protein
pharmaceuticals. International Journal of Pharmaceutics, 203:1-60
195. Wang W, Wang YJ, Wang DQ, (2008), Dual effects of Tween 80 on protein
stability International Journal of Pharmaceutics 2008;347:31-8
196. Wang, W. (1999), Instability, stabilization, and formulation of liquid protein
pharmaceuticals, International Journal of Pharmaceutics. 185(2): 129–188.
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 21
197. Wei-Guo Dai, Crystal Pollock-Dove, Liang C. Dong, Shu Li (2008), Advanced
screening assays to rapidly identify solubility-enhancing formulations; Advanced Drug
Delivery Reviews 60 ; 657–672.
198. Wong D, Parasrampuria J, (1997), Pharmaceutical excipients for the stabilization of
proteins. Pharmaceutical Technology, 34-48
199. Wood, S. J., Wetzel, R., Martin, J. D., and Hurle, M. R. (1995), Prolines and
amyloidogenicity in fragments of the Alzheimer’s peptide beta/A4, Biochemistry 34:
724–730.
200. Yichun Suna, Daniel W. Scruggs, Yingxu Peng, James R. Johnson, Atul J. Shukla,
(2004), Issues and challenges in developing long-acting veterinary antibiotic
formulations, Advanced Drug Delivery Reviews 56, 1481– 1496.
201. Yin DF, Lu Y, Zhang H, (2008), Preparation of glucagon-like peptide-1 loaded
PLGA microspheres: characterizations, release studies and bioactivities in vitro/in
vivo. Chemical and pharmaceutical bulletin (Tokyo), 56:156-61
202. Yon, J. M. (2002), Protein folding in the post-genomic era, Journal of Cellular and
Molecular Medicine. 6: 307–327.
203. Yoon, S. and Welsh, W. J. (2004), Detecting hidden sequences propensity for
amyloid fibril formation, Protein Science. 13: 2149–2160.
204. Yu L, Milton N, Groleau EG, (1999), Existence of a mannitol hydrate during
freeze-drying and practical implications. European Journal of Pharmaceutical
Sciences, 88:196-8
205. Yuan WE, Geng Y, Wu F, (2009), Preparation of polysaccharide glassy
microparticles with stabilization of proteins. International Journal of Pharmaceutics,
366:154-9
206. Yunhui Wu, Filippos Kesisoglou, Santipharp Panmai, , (2007), Nanosizing — Oral
formulation development and biopharmaceutical evaluation, Advanced Drug Delivery
Reviews 59, 631–644..
207. Zhang Y, Deng YJ, Wang XL, (2009), Conformational and bioactivity analysis of
insulin: freeze-drying TBA/water co-solvent system in the presence of surfactant and
sugar, International Journal of Pharmaceutics, 371:71-81
Reference 2012
Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 22
208. Zhang, Z., Chen, H., and Lai, L. (2007), Identification of amyloid fibril-forming
segments based on structure and residue-based statistical potential, Bioinformatics 23:
2218–2225.
209. Zheng K, Middaugh CR, Siahaan TJ, (2009), Evaluation of the physical stability of
the EC5 domain of E-cadherin: effects of pH, temperature, ionic strength, and
disulfide bonds. European Journal of Pharmaceutical Sciences, 98:63-73
210. Zibaee, S., Jakes, R., Fraser, G., Serpell, L. C., Crowther, R. A., and Goedert, M.
(2007), Sequence determinants for amyloid fibrillogenesis of human α-synuclein,
Journal of Molecular Biology. 374: 454–464.
211. Zsuzsanna Kálmán-Szekeres,Marcell Olajos,Katalin Ganzler, (2012), Analytical
aspects of biosimilarity issues of protein drugs, Journal of Pharmaceutical and
Biomedical Analysis, 11.