Embed Size (px)
Citation preview
REFFERENCE
292
REFFERENCE
1. www.pharmatimes.com/WorldNews/article.aspx?id=17655
2. “Solution for Poorly water-Soluble Drugs”: Solid Dispersion by Fuji Chemical
Industry’s CSD Technology, Technical Newsletter, at www.
Fujichemical.co.jp/English.
3. Peter LD, Michael DM, Wildfong: Aqueous solubility enhancement through
engineering of binary solid composites – Pharmaceutical applications, J. Pharm.
Innov, 2009; 4: 36-49.
4. Suess, Wolfgang: Physicochemical and pharmacological aspects of the use of
surface - active agents in medicinal technology, Pharmazeutische Zentralhalle
fuer Deutschland, 1967; 106(10): 669-681.
5. Lima, Adley AN, Sobrinho, Jose LS, Correa, Roberto AC, Rolim Neto, Pedro J:
Alternative technologies to improve solubility of poorly water soluble drugs,
Latin American Journal of Pharmacy, 2008; 27(5): 789-797.
6. Alexanian C, Papademou H, Vertzoni M, Archontaki H, Valsami G: Effect of
pH and water-soluble polymers on the aqueous solubility of nimesulide in the
absence and presence of cyclodextrin derivatives, Journal of Pharmacy and
Pharmacology, 2008; 60(11): 1433-1439.
7. Chiou WL, Riegelman S: Pharmaceutical Applications of Solid Dispersion
Systems, J. Pharm. Sci, 1971; 60(9): 1281-1302.
8. Modi A, Tayade P: Enhancement of Dissolution Profile by Solid Dispersion
(Kneading) Technique, AAPS Pharm. Sci. Tech. 2006; 7(3): E1-E6.
9. Trivedi JS, Wells ML: Solubilization using cosolvent approach, Water-Insoluble
Drug Formulation, 2000; 141-168.
REFFERENCE
293
10. Good DJ, Rodriguez HN: Solubility - advantage of Pharmaceutical Co crystals,
Cryst. Growth Des, 2009; 9(5): 2252–2264.
11. Dong Y, Shen S, Kim S, Tan RB: Preparation and characterization of
spironolactone nanoparticles by antisolvent precipitation, Int. J. Pharm, 2009;
375: 84–88.
12. Sheng JJ, Kasim NA, Chandrasekharan R, Amidon GL, Solubilization and
dissolution of insoluble weak acid, ketoprofen: effects of pH combined with
surfactant, Eur. J. Pharm. Sci, 2006; 29: 306–314.
13. Shah JC, Chen JR, Chow D, Metastable polymorph of etoposide with higher
Dissolution rate, Drug Dev. Ind. Pharm, 2006; 25: 63–67.
14. Biswal S, Sahoo J, Murthy PN, Giradkar RP, Avari JG, Enhancement of
dissolution rate of gliclazide using solid dispersions with polyethylene glycol
6000, AAPS Pharm. Sci. Tech., 2008; 9: 563–570.
15. Hancock BC, Zografi G, Characteristics and significance of the amorphous state
in pharmaceutical systems, J. Pharm. Sci, 1997; 86: 1–12.
16. Grau MJ, Kayser O, Mu¨ ller RH, Nanosuspensions of poorly soluble drugs –
reproducibility of small scale production, Int. J. Pharm, 2000; 196: 155–157.
17. Kakkar P, Singh M, Mendiratta A, Isolation and characterization of
ciprofloxacin. HCL crystals, Drug Dev. Ind. Pharm, 1997; 23: 1063.
18. Tiwary K, Modification of crystal habit and its role in dosage form performance,
Drug Dev. Ind. Pharm, 2001; 27: 699.
19. S. Agatonovic-Kustrin BD, Glass, Mangan M, Analysing the crystal purity of
mebendazole raw material and its stability in a suspension formulation, Int. J.
Pharm, 2008; 361: 245.
REFFERENCE
294
20. Aulton ME, Pharmaceutics the science of dosage form design, Churchill and
Livingstone, New York, 1998; 343-350.
21. Zhang X, Chen Y, Sanmingli, Investigation and physicochemical
characterization of clarithromycine-citric acid-cyclodextrins ternary complexes,
Drug Dev. Ind. Pharm, 2007; 33: 163-171.
22. Mackellar J, The controlled crystallization of a model powder: the effects of
altering the stirring rate and the supersaturation profile, and the incorporation of
surfactants, Int. J. Pharm, 1994; 112: 65-78.
23. Kato F, Otsuba M, Kinetic study of the transformation of mefenamic acid
polymorphs in various solvents and under high humidity conditions, Int. J.
Pharm, 2006; 321: 18-26.
24. Kawashima Y, Development of spherical crystallization technique and its
application to pharmaceutical systems, Arch. Pharm. Res, 1984; 7(2): 145-151.
25. Yang M, Velaga S, Yamamoto H, Takeuchi H. Characterisation of salmon
calcitonin in spray-dried powder for inhalation: effect of chitosan, Int. J. Pharm,
2007; 331: 176–181.
26. Li DX, Oh YK, Lim SJ, Kim JO, Yang HJ, Sung JH, Yong CS, Choi HG, Novel
gelatin microcapsule with bioavailability enhancement of ibuprofen using spray-
drying technique, Int. J. Pharm, 2008; 355: 277-284.
27. Billon B, Bataille G, Cassanas M, Jacob, Development of spray-dried
acetaminophen microparticles using experimental designs, Int. J. Pharm, 2000;
203: 159– 168.
28. Muller CR, Bassani VL, Pohlmann AR, Preparation and characterization of
spray-dried polymeric nanocapsiles, Drug Dev. Ind. Pharm, 2000; 26: 343–347.
REFFERENCE
295
29. Schwarz C, Mehnert W, Freeze-drying of drug-free and drugloaded solid lipid
nanoparticles, Int. J. Pharm, 1997; 157: 171–179.
30. Nazik E, Kadria E, Abdallah M, Ahmed E, Lyophilization monophase solution
technique for improvement of the physicochemical properties of an anticancer
drug, flutamide, Eur. J. Pharma. Bio, 2010; 74: 397–405.
31. Remington‟s Pharmaceutical Sciences, 17th Edition, Mack Publishing
Company, Easton, Pennesylvania, 1985: 1119.
32. Cordero JA, Alarcon L, Escribano F, Obach R, Domenech J, Comparative study
of transdermal penetration of a series of nonsteroidal antiinflammatory drugs, J.
Pharm. Sci, 1997; 86: 503–507.
33. Physicians’ Desk reference, 56th ed, Medical Economics Company, Inc,
Montvale, NJ, 2002: 2685.
34. Amidon GL, Lennernäs H, Shah VP, Crison JR, A theoretical basis for a
biopharmaceutic drug classification: The correlation of in vitro drug product
dissolution and in vivo bioavailability, Pharm. Res, 1995; 12: 413–420.
35. Subramanian S, Zaworotko MJ, Manifestations of noncovalent bonding in the
solid-state. 6. H-4(cyclam) (4+) (cyclam = 1,4,8,11-tetraazacyclotetra-decane)
as a template for crystal engineering of network hydrogenbonded solids, Can. J.
Chem, 1995; 73: 414–424.
36. Lehn JM, Supramolecular chemistry — scope and perspectives molecules,
supermolecules, and molecular devices, Angew. Chem., Int.Ed. Engl, 1988; 27:
89–112.
37. Von Hippel AR, Molecular designing of materials, Science, 1963; 138: 91.
REFFERENCE
296
38. Schmidt GMJ, Topochemistry. Part III. The crystal chemistry of some trans-
cinnamic acids, J. Chem. Soc, 1964; 2014.
39. Steed JW, Atwood JL, Supramolecular Chemistry, John Wiley & Sons, Ltd,
2000.
40. Desiraju GR, Supramolecular synthons in crystal engineering — a new organic-
synthesis, Angew. Chem., Int. Ed. Engl, 1995; 34: 2311–2327.
41. Allen FH, The Cambridge structural database: a quarter of a million crystal
structures and rising, Acta Cryst, 2002; 58: 380–388.
42. Bruno IJ, Cole JC, Edgington PR, Kessler MK, Macrae CF, McCabe P, New
software for searching the Cambridge structural database and visualising crystal
structures, Acta Cryst, 2002; 58: 389–397.
43. Cabrerra N, Vermilea DA, Growth Perfection of Crystals, Chapman and Hall,
London, 1958; 393.
44. Burton WK, Cabrera N, Frank FC, The growth of crystals, Philos.Trans. R. Soc,
1951; 243: 299–358.
45. Κato Y, Okamoto Y, Nagasawa S, Ishihara I, Relationship between
polymorphism and bioavailability of drug. IV. New polymorphic forms of
phenobarbital, Chem. Pharm. Bull, 1984; 32(10): 4170–4174.
46. Salole EG, Al-Sarraj FA, Spiranolactone crystal forms, Drug Dev. Ind. Pharm,
1984; 11 (4): 855–864.
47. Kobayashi Y, Ito S, Itai S, Yamamoto K, Physicochemical properties and
bioavailability of carbamazepine polymorphs and dihydrate, Int. J. Pharm, 2000;
193: 137–146.
REFFERENCE
297
48. Chow AHL, Hsia CK, Gordon GD, Young JWM, Vargha-Butler EI, Assessment
of wettability and its relationship to the intrinsic dissolution rate of doped
phenytoin crystals, Int. J. Pharm, 1995; 126 (1,2): 21–28.
49. Singhal D, Curatolo W, Drug polymorphism and dosage form design: a practical
perspective, Adv. Drug Deliv. Rev, 2004; 56: 335–347.
50. Pandit JK, Gupta SK, Gode KD, Mishra B, Effect of crystal form on the oral
absorption of phenylbutazone, Int. J. Pharm, 1984; 21: 129–132.
51. Human HJ, van der Eerden JP, Jetten LAMJ, Oderkerken JGM, On the surface
roughening transition of faceted to non faceted growth of diphenyl for different
organic solvents and the melt, J. Cryst. Growth, 1981; 51: 598–600.
52. Heng JYY, Thielmann F, Williams DR, The effects of milling on the surface
properties of form I paracetamol crystals, Pharm. Res, 2006; 23 (8): 1918–1927.
53. Adhiyaman R, Basu SK, Crystal modification of dipyridamole using different
solvents and crystallisation conditions, Int. J. Pharm, 2006; 321 (1–2): 27–34.
54. Nokhodchi A, Bolourtchian N, Dinarvand R, Crystal modification of phenytoin
using different solvents and crystallisation conditions, Int. J. Pharm, 2003; 250
(1): 85–97.
55. Kobayashi Y, Ito S, Itai S, Yamamoto K, Physicochemical properties and
bioavailability of carbamazepine polymorphs and dihydrate, Int. J. Pharm, 2000;
193: 137–146.
56. Pandit JK, Gupta SK, Gode KD, Mishra B, Effect of crystal form on the oral
absorption of phenylbutazone, Int. J. Pharm, 1984; 21: 129–132.
REFFERENCE
298
57. Garekani HA, Sadeghi F, Badiee A, Mostafa SA, Rajabi-Siahboomi AR, Crystal
Habit Modifications of Ibuprofen and Their Physicomechanical Characteristics,
Drug Development and Industrial Pharmacy, 2001; 27(8): 803–809.
58. Sugawara M, Kadomura S, Xin H, Takekuma Y, Khori N, Miyazaki K, The use
of an in vitro dissolution and absorption system to evaluate oral absorption of
two weak bases in pH independent controlled-release formulations, Eur. J.
Pharm Sci, 2005; 26: 1-8.
59. Subhashis C, Dali S, Achint J, Brahmeshwar M, Sanjay S, Assessment of
solubilization characteristics of different surfactants for carvedilol phosphate as
a function of pH, J. Coll. Inter. Sci, 2009; 335: 242–249.
60. Lieberman H A, Lachman L, Schwartz JB, Marcel D, In pharmaceutical dosage
forms: Tablets New Yark, 1989; 1: 1-73.
61. Mohanachandran PS, Sindhumo PG, Kiran TS, enhancement of solubility and
dissolution rate: an overview, Pharmacie Globale, 2010; 4 (11): 765-774.
62. Rasool AA, Hussain AA, Dittert LW, Solubility enhancement of some water-
insoluble drugs in the presence of nicotinamide and related compounds, J.
Pharma. Sci, 1991; 80(4): 387–393.
63. Badwan AA, El Khordagui LK, Saleh AM, Khalil SA, The solubility of
benzodiazepines in sodium salicylate solution and a proposed mechanism for
hydrotropic solubilization, Inter. J. Pharm, 1983; 13(1): 67–74.
64. Muller RH, Jacobs C, Kayer O, Nanosuspensions for the formulation of poorly
soluble drugs, in Pharmaceutical Emulsion and Suspension, Marcel Dekker,
New York, NY, USA, 2000; 383–407.
REFFERENCE
299
65. Nash RA, Suspensions,” in Encyclopedia of Pharmaceutical Technology, J.
Swarbrick, J. C, Boylan, Eds., Marcel Dekker, New York, NY, USA, 2nd
edition, 2002; 3:2045–3032.
66. Sunkara G, Kompella UB, Drug delivery applications of supercritical fluid
technology, Drug Delivery Technology, 2002; 2: 44–50.
67. Manna L, Banchero M, Sola D, Ferri A, Ronchetti S, Sicardi S, Impregnation of
PVP microparticles with Ketoprofen in the presence of supercritical CO2,
Journal of Supercritical Fluids, 2007; 42(3) 378–384.
68. Edward KH, Li D, Solubility,” in Drug like Properties: Concept, Structure,
Design and Methods, from ADME to Toxicity Optimization Elsevier, 2008; 56.
69. Martin A, Physical Pharmacy, Willaims and Wilkins, Baltimore, Md, USA, 4th
edition, 1993.
70. Rangel-Yagui CD, Pessoa A, Tavares LC, Micellar solubilization of drugs, J.
Pharma. Pharma. Sci, 2005; 8(2): 147–163..
71. Masters K, Spray Drying—An Introduction to Principles, Operational Practice
and Applications, Leonard Hill, London, 2007.
72. Wassim A, Ghania D, Serge S, Hatem F, Freeze-drying of nanoparticles:
Formulation, process and storage considerations, Advanced Drug Delivery
Reviews, 2006; 58:1688–1713.
73. Kawashima Y, Development of spherical crystallization technique and its
application to pharmaceutical systems, Arch. Pharm. Res, 1984; 7(2): 145-151.
74. Mehrotra VP, Sastry KVS, Morey, Review of oil agglomeration technique for
processing of fine coals, Int. J. Mineral. Proc, 1983; 11: 175-201.
REFFERENCE
300
75. Smith HM, Puddington IE, Spherical agglomeration of Barium sulphate, Can. J.
Chem 1960; 35: 1911-1913.
76. Muthuswamy V, Tadimethi R, Kinetic study of agglomerates growth in coal-oil
agglomeration process Fuel, 1984; 63, 738-743.
77. Capes CE, Darcovich K, A survey of oil agglomeration in wet fine coals
processing, Powder Technol, 1984; 40: 43-52.
78. Vangamudi, Rao TC, Prediction of the size distribution of agglomerates in the
coal-oil agglomeration process, Powder Technol, 1984; 21: 29-32.
79. Paradkar AR, Pawar AP, Mahadik KR, Kadam SS, Spherical crystallization: A
novel particle design technique, Indian Drugs, 1994; 31: 229-233.
80. Kawashima Y, Spherical crystallization: Direct spherical agglomeration of
salicylic acid crystals during crystallization, Science, 1982; 216: 1127-28.
81. Gupta VK. Jayaswal SB, Srivastava AK, Kumar MV, Controlled release
microspheres of diclofenac sodium prepared by spherical crystallization
technique, Pharmazie, 1994; 49: 692-693.
82. Paradkar AR, Pawar AP, Chordiya J K, Patil VB, Ketkar AR, Spherical
crystallization of celecoxib, Drug Dev. Ind. Pharm, 2002; 28(10): 1213-1220.
83. Espitalier F, Biscans B, Laguerie, Deleuil M, Spherical crystallization: modeling
of the emulsion solvent diffusion technique, KONA, 1997; 15: 159-168.
84. Anja A. Leopold S, Peter C, Schmidl, Some physicochemical properties of
Mefenamic acid, Drug Dev. Ind. Pharm, 2000; 26(5): 477-487.
85. Kawashima Y, Spherical crystallization: Direct spherical agglomeration of
salicylic acid crystals during crystallization, Science, 1982; 216: 1127-28.
REFFERENCE
301
86. Kawashima Y. Shan YL, Masafumi N, Hideo T, Direct agglomeration of
Sodium theophylline crystal produced by salting out in liquid,
Chem.Pharm.Bull. 1982; 30(8): 1837-1843.
87. Puechagut HG, Bianchotti J, Chiale CA, Preparation of norfloxacin spherical
agglomerates using the ammonia diffusion system, J. Pharm. Sci, 1998; 87: 519-
523.
88. Masters K, Spray Drying—An Introduction to Principles, Operational Practice
and Applications, Leonard Hill, London, 2007.
89. Broadhead J, Edmond RSK, Rhodes CT, The spray drying of pharmaceuticals,
Drug Dev. Ind. Pharm, 1992; 18: 1169–1206.
90. http://www.niroinc.com/html/drying/fdspraychem.html/ accessed on November
11, 2008.
91. Tong HHY, Chow AHL, Control of physical forms of drug particles for
pulmonary delivery by spray drying and supercritical fluid processing. KONA,
2006; 24:27–40.
92. Hirofumi, Takehiko, Tomoaki, Hiromitsu, Yoshiaki, Spray-dried composite
particles of lactose and sodium alginate for direct tabletting and controlled
releasing, Int. J. Pharma,1998; 174: 91-100.
93. Ameye D, Musa D, Foreman P, Remon J, Spray-dried Amioca® starch/
Carbopol® 974P mixtures as buccal bioadhesive carriers, Int. J. Pharma, 2005;
301: 170-180.
94. Tanino H, Danjo K, Asada M, Takahashi H, Okamoto H. Theophylline particle
design using chitosan by the spray drying, Int. J. Pharma, 2004; 270: 167-174.
REFFERENCE
302
95. Chawla A, Taylor K, Newton J, Johnson M, Production of spray dried
Salbutamol Sulphate for use in dry powder aerosol formulation, 233-240.
96. Lin JC, Gentry JW, Spray drying drop morphology: experimental study,
Aerosol. Sci. Tech, 2003; 37: 15–32.
97. Sweeney L, Wang Z, Loebenberg R, Wong J, Lange C, Finlay W, Spray-freeze-
dried liposomal ciprofloxacin powder for inhaled aerosol drug delivery, Int. J.
Pharma, 2009; 305: 180–185.
98. Palmieri G, Wenrle P, Stamm A, Evaluation of spray-drying as a method to
prepare micro particles for controlled drug release, Drug Development and
Industrial Pharmacy, 1994; 20(18): 2859-2879.
99. Espositoa E, Cervellatib F, Menegattia E, Nastruzzic C, Cortesia R, Spray dried
Eudragit micro particles as encapsulation devices for vitamin C, Int. J. Pharma,
2002; 242: 329-334.
100. Palmieri G, Bonacucina G, Martino P, Sante Martelli, Spray-Drying as a
Method for Microparticulate Controlled Release Systems Preparation:
Advantages and Limits. I. Water-Soluble Drugs, Drug Development and
Industrial Pharmacy, 2009; 27(3): 195-204.
101. Franks F, Freeze-drying of bioproducts: putting principles into practice, Eur. J.
Pharm. Biopharm. 1998; 45: 221–229.
102. Chang BS, Kendrick BS, Carpenter JF, Surface-induced denaturation of proteins
during freezing and its inhibition by surfactants, J. Pharm. Sci, 1996; 85: 1325–
1330.
103. Jiang S, Nail SL, Effect of process conditions on recovery of protein activity
after freezing and freeze-drying, Eur. J. Pharm. Biopharm, 1998; 45: 249–257.
REFFERENCE
303
104. Searles JA, Carpenter JF, Randolph TW, The ice nucleation temperature
determines the primary drying rate of lyophilization for samples frozen on a
temperature-controlled shelf, J.Pharm. Sci, 90: 860–871.
105. Pikal MJ, Freeze-drying of proteins. Part I: process design. BioPharm, 1990; 3:
18–28.
106. Pikal MJ, Freeze-drying of proteins part II: formulation selection. BioPharm,
1990; 3: 26–30.
107. Pikal MJ, Shah S, Senior D, Lang JE, Physical chemistry of freeze-drying:
easurement of sublimation rates for frozen aqueous solutions by a microbalance
technique, J. Pharm. Sci, 1983; 2: 635–650.
108. Pikal MJ, Shah S, Roy ML, Putman R, The secondary drying stage of freeze
drying: drying kinetics as a function of temperature and chamber pressure, Int. J.
Pharm, 1990; 60: 203–217.
109. Pikal MJ, Dellerman KM, Roy ML, Formulation and stability of freeze-dried
proteins: effects of moisture and oxygen on the stability of freeze-dried
formulations of human growth hormone, Develop. Bio. Standard, 1991; 74: 21–
38.
110. Hageman MJ, The role of moisture in protein stability, Drug Dev. Ind. Pharm,
1988; 14: 2047–2070.
111. Abdelwahed W, Degobert G, Fessi H, Investigation of nanocapsules
stabilization by amorphous excipients during freeze-drying and storage, Eur. J.
Pharm. Biopharm, 2006; 63: 87–94.
REFFERENCE
304
112. Roy D, Guillon X, Lescure F, Couvreur P, Bru N, Breton P, On shelf stability of
freeze-dried poly(methylidene malonate 2.1.2) nanoparticles, Int. J. Pharm,
1997; 148: 165–175.
113. Dulieu C, Bazile D, Influence of lipid nanocapsules composition on their
aptness to freeze-drying, Pharm. Res, 2005; 22: 285–292.
114. Fourage M, Dewulf M, Couvreur P, Roland M, Vranckx Z, Development of
dehydroemetine nanoparticles for the treatment of visceral leishmaniasis, J.
Microencapul, 1989; 6: 29–34.
115. Heiati H, Tawashi R, Phillips NC, Drug retention and stability of solid lipid
nanoparticles containing azidothymidine palmitate after autoclaving, storage and
lyophilization, J. Microencapsul, 1998; 15: 173–184.
116. Alonso M, Losa C, Calvo P, Vila-Jato JL, Approaches to improve the
association of amikacin sulphate to poly (alkylcyanoacrylate) nanoparticles, Int.
J. Pharm, 1991; 68: 69–76.
117. Chasteigner SD, Fessi H, Cavé G, Devissaguet JP, Puisieux F, Gastro-intestinal
tolerance study of a freeze-dried oral dosage form of indomethacin-loaded
nanocapsules, STP Pharma Sci, 1995; 5: 242–246.
118. Oh KS, Lee KE, Han SS, Cho SH, Kim D, Yuk SH, Formation of core/shell
nanoparticles with a lipid core and their application as a drug delivery system,
Biomacromolecules, 2005; 6: 1062–1067.
119. Vij DR, Neena J, Hand Book of Applied Solid State Spectroscopy, Springer US,
2006, pp 411-446.
120. www.ericweisstein.com.
REFFERENCE
305
121. Joseph B, Lambert, Herbert E, Shurvell, David A, Lightner and Graham Cooks:
Organic structural spectroscopy, Prentice Hall, 1998, 152-174.
122. Brittain, H.: Physical Characterization of pharmaceutical solids, M. Dekker,
New York, (1995), pp 1-8.
123. Brittain H, Physical characterization of Pharmaceutical Solids, M. Dekker, New
York, 1995, 188-195.
124. Skoog DA, Donald M, West: Principles of Instrumental Analysis, California,
1971, 358.
125. Skoog DA, Holler FJ, Nieman TA, Principles of Instrumental analysis, 5th
edition USA: Thomson Learning Inc, 1998, 295.
126. Cullity B, Elements of X-Ray Diffraction, Addison-Wesley, Reading, Mass,
1978.
127. William Bragg, An introduction to crystal analysis, G. Bell and Sons, London,
1993, 12-21.
128. Klug H, Alexander L, X-Ray Diffraction Procedure for Polycrystalline and
Amorphous Materials, Wiley, New York, 1974.
129. http://www.nightlase.com.au/education/optics/diffraction.htm
130. Shechtman D, Quasiperiodic Crystals – Experimental Evidence, Journal de
Physique, 1986, 1.
131. Brittain H, Physical characterization of Pharmaceutical Solids, M Dekker, New
York 1995; 13-18.
132. Crompton TR, Analysis of Polymer, Pergamon, New York, 1989; 208.
133. Lever TJ, Hardy MJ, Barnes AF, A review of the application of thermal
methods in the pharmaceutical industry, J.Therm.Anal, 1993; 4: 499.
REFFERENCE
306
134. Skoog DA, Leary JJ, Principles of instrumental analysis; Saunder‟s College
Publishing, 4th Edition, 1971; USA.
135. Groenewoud WM, Characterization of Polymers by Thermal Analysis, First
edition, 2001; Netherland.
136. Zhou, Weilie,Wang, Zhong Lin, Scanning Microscopy for Nanotechnology:
Techniques and Applications, Springer New York, 2007; V.1.
137. http://serc.carleton.edu/research/education/geochemsheets/techniques/SEM.html
138. Argast, Anne, Tennis, Clarence F, III: A web resource for the study of alkali
feldspars and perthitic textures using light microscopy, scanning electron
microscopy and energy dispersive X-ray spectroscopy, Journal of Geoscience
Education 52, 2004; 3:213-217.
139. Goldstein J, Scanning electron microscopy and x-ray microanalysis, Kluwer
Adacemic, Plenum Pulbishers, 2003; 689-702.
140. Egerton RF, Physical principles of electron microscopy : An introduction to
TEM, SEM, and AEM; Springer, 2005; 202.
141. Skoog, Principles of Instrumental Analysis. 6th ed. Thomson Brooks/Cole.
2007; 169-173.
142. http://www.chemistry.adelaide.edu.au/external/soc-rel/content/uv-vis.htm
143. Hansen W, Handbook of Dissolution Testing, Pharmaceutical technology
publications, 1982; 1-2: 28-31.
144. Hansen W, Handbook of Dissolution Testing, Aster Publishing Corporation, 2nd
edition, 1991; 1-2.
145. Leeson L, Cartensen J, Dissolution technology, Washington D.C., Academy of
Pharmaceutical sciences, 1974.
REFFERENCE
307
146. Albert H, Chow L, Molly WM, Leung, A study of the mechanism of wet
spherical agglomeration of pharmaceutical powders. Drug Dev. Ind. Pharm,
1996; 22(4): 357-371.
147. The Merck Index (10th ed.). Rahway, NJ: Merck & Co, 1983; 749.
148. Morrison, Robert T, Boyd, Robert N, Organic Chemistry, 2nd ed., Allyn and
Bacon 1972; 569.
149. http://en.wikipedia.org/wiki/Dimethylformamide
150. Rossberg M, Chlorinated Hydrocarbons” in Ullmann’s Encyclopedia of
Industrial Chemistry, 2006; Wiley-VCH, Weinheim.
151. http://en.wikipedia.org/wiki/Isopropyl_acetate
152. http://en.wikipedia.org/wiki/Dichloromethane
153. http://en.wikipedia.org/wiki/Toluene
154. Indian pharmacopoeia, Controller of publication, New Delhi 1996. Vol. 1. 387-
388
155. Indian pharmacopoeia, Controller of publication, New Delhi 1996; Vol. 1: 459-
460.
156. Unite States Pharmacopoeia 24/NF19, Rockvill; United State Pharmacopoeial
Convention 1999;1147-1148.
157. USP/NF 19, Rockvill; United State Pharmacopoeial Convention 1999.
158. USP24/NF19, Rockvill; United State Pharmacopoeial Convention 1999.
159. Shechtman D, Quasiperiodic Crystals – Experimental Evidence, Journal de
Physique, 1986; 1.
160. Rawlinson CF, Williams AC, Timmins P, Grimsey I, Polymer-mediated
disruption of drug crystallinity, Int. J. Pharm, 1997; 336: 42–48.
REFFERENCE
308
161. Vij DR, Neena J, Hand Book of Applied Solid State Spectroscopy, Springer US,
2006; 411-446.
162. Brittain H, Physical characterization of Pharmaceutical Solids, M. Dekker, New
York, 1995; 188-195.
163. Zhou, Weilie, Wang, Zhong L, Scanning Microscopy for Nanotechnology :
Techniques and Applications, Springer New York, 2007; 1.
164. Kulkarni PK, Nagavi BG, Spherical Crystallization-a review, Indian J. Pharma.
Edu, 2002; 36: 66-73.
165. Shangraw RF, Compressed tablets by direct compression. In: Lieberman HA,
Lachman L, Schwartz JB. Pharmaceutical Dosage Form: Tablets, Vol 1. Marcel
Dekker, New York. 1989; 195–246.
166. Venkadari RG, Srinivas M, Madhobhai M, Patel Vice Chancellor, Girish KJ,
Department of Pharmaceutics, N. E. T. Pharmacy College, Navodaya Nagar,
Mantralayam Road Raichur-584103, India.
167. Kawashima Y, Development of spherical crystallization technique and its
application to pharmaceutical systems, Arch. Pharm. Res, 1984; 7(2): 145-151.
168. Parthasarathi PK, Mudit D, Achin J, Spherical Agglomeration Of Naproxan By
Solvent Change Method, Stam. J. pharma. Sci, 2011; 4(1): 01-08.
169. Tetsuya O, Shuji B, Takuto M, Yuuki T, Hiroshi Y, Hiroaki O, Preparation of
two-drug composite microparticles to improve the dissolution of insoluble drug
in water for use with a 4-fluid nozzle spray drier, J. Cont. Rele, 2005; 107: 387–
394.
REFFERENCE
309
170. JingXia C, ChunLei L, YingJie D, YongLi W, Wei W, Freeze-drying of
liposomes using tertiary butyl alcohol/water cosolvent systems, Int. J. Pharma,
2006; 312: 131–136.
171. Kamble R, Maheshwari M, Paradkar AR and Kadam S, Melt solidification
technique: Incorporation of higher wax content in ibuprofen beads. AAPS
PharmSciTech, 2004; 5(4).
172. Paradkar AR, Maheshwari M, Ketkar AR and Chauhan B. Preparation and
evaluation of ibuprofen beads by melt solidification technique, Int. J. Pharm,
2003; 255: 33-42.
173. Amal A, Elkordy, Ebtessam AE, Dissolution of ibuprofen from spray dried and
spray chilled particles, Pak. J. Pharm. Sci, 2010; 23(3): 284-290.
174. Maa YF, Nguyen PA, Sit K, Hsu CC, Spray drying performance of bench-top
spray dryer for protein aerosol powder preparation, Biotech. Bioeng, 1998; 60:
301-309.
175. Maury M, Murphy K, Kumar S, Shi L, Lee G, Effects of process variables on
the powder yield of spray-dried trehalose on a laboratory spray-dryer, Eur. J.
Pharm. Biopharm, 2005; 59: 565-573.
176. ICH Topic Q 6 A, Specifications: Test Procedures and Acceptance Criteria for
New Drug Substances and New Drug Products: Chemical Substances.
(CPMP/ICH/367/96).
177. Amoore JE, Hautala E, Odor as an aid to chemical safety: odor thresholds
compared with threshold limit values and volatilities for 214 industrial
chemicals in air and water dilution. J of App Tox, 1983; 3: 272- 290.
178. ICH Topic Q3C (R5) Impurities: Guideline for Residual Solvents.
REFFERENCE
310
179. Brittain H, Physical characterization of Pharmaceutical Solids, M. Dekker, New
York 1995; 13-18.
180. Lever TJ, Hardy MJ, Barnes AF, A review of the application of thermal
methods in the pharmaceutical industry, J. Therm. Anal, 1993; (4): 499.
181. Skoog DA, Leary JJ, Principles of instrumental analysis; Saunder‟s College
Publishing, 4th Edition, 1971; USA.
182. Martin A, Physical Pharmacy, 4. Lea and Febiger, Philadelphia, 1993; 266–272.
183. Remington’s Pharmaceutical Sciences, 17th Edition, Mack Publishing
Company, Easton, Pennesylvania, 1985; 1119.
184. Joseph B, Lambert, Herbert E, Shurvell, David A, Lightner and Graham Cooks:
Organic structural spectroscopy, Prentice Hall, 1998; 152-174.
185. Brittain H, Physical Characterization of pharmaceutical solids, M. Dekker, New
York, 1995, 1-8.
186. Silverstein RM, Webster FX, Kiemle DJ, Spectrometric identification of organic
compounds, State university of New York, John Wiley & Sons Inc, 86-87.
187. http://wwwchem.csustan.edu/Tutorials/infrared.htm
188. Brittain H, Physical characterization of Pharmaceutical Solids, M. Dekker, New
York, 1995; 188-195.
189. Skoog DA, Donald M, West: Principles of Instrumental Analysis, California,
1971; 358.
190. Zhou, Weilie, Wang, Zhong L, Scanning Microscopy for Nanotechnology:
Techniques and Applications, Springer New York, 2007; 1.
191. http://serc.carleton.edu/research_education/geochemsheets/techniques/SEM.htm
l
REFFERENCE
311
192. Argast, Anne, Tennis, Clarence F, III: A web resource for the study of alkali
feldspars and perthitic textures using light microscopy, scanning electron
microscopy and energy dispersive X-ray spectroscopy, Journal of Geoscience
Education 52, 2004; 3: 213-217.
193. Nilüfer Y, Berna T, Aslhan HK, Berrin B. Lubricant Efficiency of Magnesium
Stearate in Direct Compressible Powder Mixtures Comprising Cellactose®80
and Pyridoxine Hydrochloride, FABAD J. Pharm. Sci, 2007; 32: 173-183.
194. ICH Harmonised tripartite guideline stability testing of new drug substances and
products Q1A (R2), Current Step 4 version, dated 6 February 2003.
195. Kulkarni PK, Spherical agglomeration of indomethacin by solvent change
method. Int. Jur. Pharm. Res. Dev, 2010; 2(9): 33.
196. Nazik E, Kadria E, Abdallah M, Ahmed E, Lyophilization monophase solution
technique for improvement of the physicochemical properties of an anticancer
drug, flutamide. Eur. J. Pharma. Biopharma, 2010; 74: 397–405.
197. Tsinontides SC, Rajniak P, Pham D, Hunke WA, Placek, J, Reynolds SD,
Freeze drying- principles and practice for successful scale-up to manufacturing,
Int J Pharm, 2004; 280: 1-16.
198. Betageri GV, Makarla KR, Enhancement of dissolution of Glyburide by solid
dispersion and lyophilization techniques, Int J Pharm, 1995; 126:155-160.
199. Michael M, Crowley, Anke F, Britta S, Shawn K, Suneela P, Michael A, Repka,
James W, The influence of guaifenesin and ketoprofen on the properties of hot-
melt extruded polyethylene oxide films, Eur. J. PharmA. Sci, 2004; 22: 409–
418.
REFFERENCE
312
200. Perrrut M, Jung J, Leboeuf F, Enhancement of dissolution rate of poorly-soluble
active ingredients by supercritical fluid processes. Part I: Micronization of neat
particles, Int. J. Pharm, 2005; 288: 3–10.
201. Byrn SR, Pfeiffer RR, Stephenson G, Grant DJW, Gleason WB, Solid state
pharmaceutical chemistry, Chem. Mater, 1994; 6: 1148.
202. Japan pharmacopeia, XIV, Mefenamic acid, official monograph for part I.
203. International Programme on Chemical Safety (IPCS). Chloroform.
Environmental Health Criteria 163. 1994, WHO: Geneva.
204. Burleight-Flayer H, Garman R, Neptun D, Bevan C, Gardiner T, Kapp R, Tyler
T, Weight G, Isopropyl alcohol vapor inhalation oncogenicity study in Fischer
344 rats and CD-1 mice. Fundam. appl. Toxicol., 1997; 36: 95–111.
205. Indian pharmacopoeia 2010 volumeII page no 1542.
206. Gary G, Liversidge, Analytical profiles of drug substances by Klaus florey. 10:
443-471.
207. Lu WL, Zhang Q, Zhend L, Antipyretic, analgesic and anti-inflammatory
activity of ketoprofen beta-cyclodextrin inclusion complexes in animals. Biol.
Pharm. Bull, 2004; 27: 1515-1520.
208. Leuner C, Dressman J, Improving drug solubility for oral delivery using solid
dispersions, Eur. J. Pharm. Biopharm, 2000; 50: 47–60.
209. Bikiaris D, Physicochemical studies on solid dispersions of poorly water-soluble
drugs: Evaluation of capabilities and limitations of thermal analysis techniques,
Thermochim. Acta, 2005; 439: 58–67.
REFFERENCE
313
210. Karavas E, Effect of hydrogen bonding interactions on the release mechanism of
felodipine from nanodispersions with polyvinylpyrrolidone, Eur. J. Pharm.
Biopharm. 2006; 63: 103–114.
211. Sekiguchi K, Obi N, Studies on Absorption of Eutectic Mixture. Ii. Absorption
of Fused Conglomerates of Chloramphenicol and Urea in Rabbits, Chem.
Pharm. Bull (Tokyo), 1964; 12: 134–144.
212. Mamoru F, Dave A, Miller, Nicholas A, Peppas, James W, McGinity, Influence
of sulfobutyl ether _-cyclodextrin (Captisol®) on the dissolution properties of a
poorly soluble drug from extrudates prepared by hot-melt extrusion. Int. J.
Pharma, 2008; 350: 188–196.
213. Nazik E, Kadria E, Abdallah M, Ahmed E, Lyophilization monophase solution
technique for improvement of the physicochemical properties of an anticancer
drug, flutamide. Eur J. Pharm. Biopharma. 2010; 74:397–405.
214. ICH Harmonised tripartite guideline stability testing of new drug substances and
products Q1A (R2), Current Step 4 version, dated 6 February 2003.
215. Sheng JJ, Kasim NA, Chandrasckaran R, Amidon GL, Solubilization and
dissolution of insoluble weak acid, ketoprofen: effect of pH combined with
surfactant, Eur.J. Pharm. Sci, 2006; 29: 306-314.
216. Verheyen S, Blaton N, Kinget R, Van den MG, Mechanism of increased
dissolution of diazepam temazepam from polyethylene glycol 6000 solid
dispersions, Int. J. Pharma, 2002; 249: 45-58.
217. Arias MJ, Gines JM, Moyamo JR, Perez-Martinez JI, Rabasco AM, Influence of
the preparation method of solid dispersions on their dissolution rate: study of
triameterene- D-mannitol system, Int. J. Pharm, 1995; 123: 25-31.
REFFERENCE
314
218. Amit K, Mahalaxmi R, Srinivas P, Deepak K, Enhancement of solubility and
dissolution of poorly soluble drug, J. Chem. Pharm. Res, 2011;, 3(1): 268-276.
219. Mura P, Moyano JP, Gonzalez RML, Rabasco-Alvarez AM, Cirri M, Maestrelli
F, Drug development and Industrial pharmacy, 2005; 31: 425-434.
220. Mladen M, Hrvoje H, Josip K, Branka K, Vesna C, Franjo K, Nikola B,
Analytical profiles of drug substances by Klaus Florey, 15: 509-531
221. Indian pharmacopoeia, Controller of publication, New Delhi, 2010 volume III,
1926-1927
222. Gudrun F, Drug Information Journal, 2001; 35: 865–874.
