references - shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. ·...

22
Reference 2012 Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 1 REFERENCES

Upload: others

Post on 02-Nov-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

Reference 2012

Lyophilized Formulation Development with Novel Excipients Derived from Cassia Roxburghiifor a PEGylated Therapeutic Protein Page 1

REFERENCES

Page 2: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 3: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 4: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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

Page 5: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 6: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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

Page 7: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 8: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 9: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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

Page 10: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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

Page 11: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 12: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 13: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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

Page 14: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 15: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 16: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 17: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 18: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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

Page 19: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 20: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.

Page 21: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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

Page 22: REFERENCES - Shodhgangashodhganga.inflibnet.ac.in/.../13225/15/15_reference.pdf · 2015. 12. 4. · 55. Gomez G, Pikal MJ, Rodriguez-Hornedo N, (2001), Effect of initial buffer composition

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.