Bibliography

Solubility enhancement of BCS Class II/IV drugs 287

Aakeroy,C.B., ‘Crystal engineering: strategies and architecture’,Acta Cryst.B.,53(1997),569-

586.

Adel,M., Soliva,M., Speiser,P.,‘Hot extruded dosage forms’, Pharm, Acta

Helv.,46,(1971),31-52.

Adhiyaman,R.,Basu,S.K., ‘Crystal modification of dipyridamol using different sovents and

crystallization conditions’,Int.J.Pharm.,321,1-1,(2006),27-34.

Aguiar,A.J.,KRC Jr.,Kinkel,A.W.,Samyn,J.C., ‘Effect of polymorphism on the absorption of

chloramphenicol from chlorophenicol palmitate’, J.Pharm.Sci.,56,7,(1967),847-853.

Almarsson,A.,Zaworotko,M.J., ‘Crystal engineering of the composition of pharmaceutical

phases’,Chem.Comm.,(2004),1889-1896.

Amdidouche,D.,Darrouzet,H.,Duchenne,D.,‘Inclusion of retinoic acid in β-

cyclodextrin’,Int.J.Pharm.,58,(1),(1990),19-24.

Amidon G.L., Lennernas H., Shah V.P., Crison J.R.A., ‘A Theoretical Basis For a

Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution

and In Vivo Bioavailability’ Pharm. Res. 12 (1995),413-420.

Amin, K.,Dannenfesler,R.M.,Zielinski,J.,Wang,B., ‘Lyophilization of polyethylene glycol

mixtures’,J.Pharm.Sci.,93,9(2004),2244-2249.

Babbar AK, Singh AK, Goel HC, Chauhan UPS, Sharma RK., ‘Evaluation of 99m

Tc-labeled

photosan-3, as a hematoporphyrin derivative, as a potential radiopharmaceutical for tumor

scintigraphy’, Nucl Med Biol.,(2000),27:419-426

Beyssac E and J. Lavigne., ‘Dissolution Study of Active Pharmaceutical Ingredients Using

the Flow Through Apparatus USP 4’,Dissolution Technologies,MAY 2005,23-25.

Bisrat M et.al.,‘Physicochemical aspects of drug release XV.Investigation of diffusional

transport in dissolution of suspended, sparingly soluble drugs’, Int J Pharm.,80 (1992),191-

201.

Blagden, N.,de Matas M.,Gavan,P.T.,York,P., ‘Crystal engineering of active pharmaceutical

ingredients to improve solubility and dissolution rates’ Adv.Drug Del.Rev.,59 (2007),617-

630.

Bond FC., ‘Crushing and Grinding Calculations.’Canadian Mining and Metallurgical

Bulletin , 47( 507), Tmns Vol .LV l I, (1954),286-292.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 288

Bohm,K., ‘Production and characterization of nanosuspension as a new medicament form

for medicament materials with low bioavailability’, PhD thesis for University of Berlin,

Germany (1999),55-58.

Borin MT, Hughes GS, et.al., ‘Pharmacokinetics and tolerance studies of cefpodoxime after

single and multiple dose oral administration of cefpodoxime proxetil’, J Clin Pharmacol.,

31,(1991),1137 1145.

Borin MT, ‘A review of the pharmacokinetics of cefpodoxime proxetil’, Drugs, 42(suppl

3),(1991), 13-21.

British Pharmacopoeia, 2009, Published by the Stationary Office on behalf of the Medicines

and Healthcare Products Regulatory Agency (MHRA).

Brouwers,J., Tack,J., Augustijns,P., ‘In vitro behavior of a phosphate ester prodrug of

amprenavir in human intestinal fluids and in caco-2 system’,

Int.J.Pharm.,366,(2),(2007),302-309.

Burstein,A.H.,Cox,D.,Mistry,B., ‘Phenytoin pharmacokinetics following oral administration

of phenytoin suspension and fosphenytoin solution to rats’,Epilepsy Res.,34(1999),129-133.

Calderon, F. L., Schmitt,V., Bibette, J.,. Emulsion Science Basic Principles, In: Calderon, F.

L. (Ed),2nd

Edition.(2007),Springer, 11-13.

Cappucino, J. G.; Sherman, N. Microbiology–A Laboratory Manual; Addison Wesley:

California,(1999),263-265.

Cartensen J. ICH Guidelines. In: Drug Stability Principles and Practices,2nd

ed. New York:

Marcel Dekker, Inc.68,(1995),514-546.

Cavalli R, Trotta F, Tumiatti W., ‘Cyclodextrin-based Nanosponges for Drug Delivery’, J

Incl Phenom Macro Chem., 56,(2006),209–213.

Chada.R .,Kashid.N,.Saini.A., ‘Account of analytical techniques employed for the

determination of thermodynamics of inclusion complexation of drugs with

cyclodextrins’,J.Sci.Ind.Res., Vol.63,(2004),211-229.

Chattopadhyay,P.,Gupta,R.B., ‘Production of griseofulvin nanoparticles using supercritical

CO2 antisolvent with enhanced mass transfer’, Int.J.Pharm.,228(2001),19-31.

Charoenchaitrakool,M.,Dehgani,F.,Foster,N.R., ‘Micronization by rapid expansion of

supercritical solutions to enhance the dissolution rates of poorly water-soluble

pharmaceuticals’,Ind.Eng.Chem.Res.,39(2000),4794-4802.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 289

Chiou,W.L.,Riegelmen,S., ‘Preparation and dissolution characteristics of several fast-release

solid dispersions of griseofulvin’, J.Pharm.Sci.,58,(1969),1505-1510.

Chiou,W.L.,Riegelmen,S., ‘Pharmaceutical applications of solid dispersion systems’,

J.Pharm.Sci.,60,(1971),1281-1302.

Colin W. Pouton, ‘Formulation of poorly water-soluble drugs for oral administration:

Physicochemical and physiological issues and the lipid formulation classification

System’, Eur.J.Pharm.Biopharm.Sci.,29, (3-4), (2006),173-334.

Collnot EM, Baldes C, Wempe MF, Kappl R, et.al., ‘Mechanism of inhibition of P-

glycoprotein mediated efflux by vitamin E TPGS: influence on ATPase activity and

membrane fluidity’,Mol Pharm., 4(3) (2007),465-474.

Constantinides PP., ‘Lipid microemulsion for improving drugs dissolution and oral

absorption: physical and biopharmaceutical aspects’, Pharm Res. 12,(1995),1561-1572.

Cornaire,G.,Woodley,J.,Hermann,P., ‘Impact of excipients on the absorption of P-

glycoprotein substrates in vitro and in vivo’,Int.J.Pharm.,278,(2004),4022-4031.

Crauste-Manciet, S., Huneau, J.F., Decroix, M.O., Tome, D., Chaumeil, J.C., ‘Cefpodoxime

proxetil esterase activity in rabbit small intestine: role in the partial cefpodoxime

absorption’, Int. J. Pharm.,149,(1997),241–249.

Croft,A.P.,Bartxh,R.A., ‘Synthesis of chemically modified cyclodextrins’,

Tetrahedron,39(9),(1983),1417-1474.

Dai,L., Li,W.,Hou,X., ‘Colloids surface’ Physicochem. Engg. Aspects,125(1997),27-32.

Davis,M.E., Brewster,M.E., ‘Cyclodextrin based pharmaceutics: past, present, future’

Nat.Rev.Drug Discov.,3(2004),1023-1035.

Dhumal,R.S.,Biradar,S.V.,Shigeo,Y.,Paradkar,A.R.,York,P., ‘Preparation of amorphous

cefuroxime axetil nanoparticles by sonoprecipitation for enhancement of bioavailability’,

Eur.J.Pharm.Biopharm.,70 (2008),109-115.

Dittgen,M.,Fricke,S.,Gerecke,H.,Osterwald,H., ‘Hot spin mixing: a new technology to

manufacture solid dispersions-part 1:testosterone’,Pharmazie,50,(1995),225-226.

Dittgen,M.,Fricke,S.,Gerecke,H.,Osterwald,H., ‘Hot spin mixing: a new technology to

manufacture solid dispersions-part 3:progesterone’,Pharmazie,50,(1995),507-508.

Dong, Y.,Kiong,W.N.,Shen,S.,Sanggu,K., ‘Preparation and characterization of

spironolactone nanoparticles by antisolvent precipitation’, Int.J.Pharm.,375(2009),84-88.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 290

Drooge,D.J.V.,Hinrichs,W.L.J.,Frijlink,H.W., ‘Anomalous dissolution behavior of tablets

prepared from sugar glass-based solid dispersions’ J.Contr. Rel., 97 (2004),441-452.

Dressman J, B., G.L. Amidon, C. Reppas, V.P. Shah., ‘Dissolution testing as a

prognostic tool for oral drug absorption- immediate release dosage forms’, Pharm.

Res.,15,(1988),11-22.

Duggan,D.E.,Hooke,K.F.,Hwang,S.S., ‘Kinetics of tissue distribution of sulindac and

metabolites’,Drug Metab.,Dispos.,8(4),1980,241-246.

Dunitz, J.D., ‘Crystal and co-crystal: a second opinion’,Cryst.Eng.Commun.,5,(2003),506.

Eerdenbrugh B.V.et.al.,‘Top-down production of drug nanocrystals: Nanosuspension

stabilization, miniaturization and transformation into solid products’ Int. J Pharm.,

364(2008),64-75.

El-Shabouri,M.H.,‘Nanoparticles for improving the dissolution and oral bioavailability of

spironolactone,a poorly soluble drug’,STP Pharm.SCi.,12(2002),97-101.

FDA, ‘Draft-guidance for industry: waiver of in vivo bioavailability and bioequivalence

studies for immediate release solid oral dosage forms containing certain active

moieties/active ingredient based on a biopharmaceutic classification system’, US department

of health, Food and Drug Administartion, Center for Drug Evaluation and Research

BP2,January 1999.

J.H.,Patel,T.V.,Fischer,P.A., ‘Fosphenytoin:clinical pharmacokinetics and comparative

advantages in the acute treatment of seizures’, Clin.Pharmacokin.,42(1),(2003),33-58.

Forster,A., Rades,T., Hempenstall,J., ‘Selection of suitable drug and excipient candidates to

prepare glass solutions by melt extrusion for immediate release oral

formulations’Pharm.Tech.Eur.,14(2001),27-37.

Gassmann P,List,A.,Schweitzer,H.,Sucker,H., ‘Hydrosols-alternatives for the parenteral

application of poorly soluble drugs,Eur.J.Pharm.Biopharm.,40 (1994),64-72.

Goldberg,A.H.,Gibaldi,M,Kanig,J.L., ‘Increasing dissolution rates and gastrointestinal

absorption of drugs via solid solutions and eutectic mixtures II-experimental evaluation of a

eutectic mixture’,J.Pharm.Sci.,55,(1966),482-487.

Goldberg,A.H.,Gibaldi,M,Kanig,J.L.,Mayersohn,M., ‘Increasing dissolution rates and

gastrointestinal absorption of drugs via solid solutions and eutectic mixtures IV-

experimental evaluation of a eutectic mixture’,J.Pharm.Sci.,55,(1966),581-583

Bibliography

Solubility enhancement of BCS Class II/IV drugs 291

Goldblatt, P. J. The Goldblatt experiment: a conceptual paradigm. In: Hypertension:

Pathophysiology, Diagnosis and Management, edited by J. H. Laragh and B. M. Brenner.

New York: Raven, 1995, p. 23–35.

Gupta,R.B.,Kompella,U.B.,Nanoparticle Technology for Drug Delivery,First

ed.,(2006),Taylor & Francis Group.,New York,23-36.

Gursoy,R.N.,Benita,S., ‘Self-emulsifying drug delivery systems (SEDDS) for improved oral

delivery of lipophilic drugs’,Biomed.Pharmacother.58 (3),(2004),173-182.

Hamamura, T., Kusai, A., Nishimura, K., ‘Gel formation of cefpodoxime proxetil’, S.T.P.

Pharm. Sci. 5,(1995a),324–331.

Hamamura, T., Ohtani, T., Kusai, A., Nishimura, K., ‘Unusual dissolution behavior of

cefpodoxime proxetil: effect of pH and ionic factors’, S.T.P. Pharm. Sci. 5,(1995b),332–338.

Hamamura, T., Terashima, H., Ohtani, T., Mori, Y., Seta, Y., Kusai, A., Sasahara,K.,

Nishimura, K., ‘Decrease in dissolution of cefpodoxime proxetil tablets by gel formation and

its improvement’, Yakuzaigaku 55,(1995c),175–182.

Hauss,D.J.,Fogal,S.E.,Ficorilli,J.V.,Price,C.A., ‘Lipid-based delivery systems for improving

bioavailability and lymphatic transport of a poorly water-soluble LTB4 inhibitor’,

J.Pharm.Sci.,87,(1998),164-169.

Hauss,D.J., ‘Oral lipid-based formulations’, Adv.Drug Del.Rev.,59,(2007),667-676.

Harada A, Furue M, Nozakura S. Catalysis and Binding with Cyclodextrin-Containing

Polymers. Macromolecules 1976;9(5):705-710.

Harada A, Takahashi S. Preparation and properties of cyclodextrin–ferrocene inclusion

complexes. J Chem.Soc.Chem.Comm. (1984), 645-646.

Harada A, Kamachi M. Complex Formation between Poly (ethy1ene glycol) and a-

Cyclodextrin. Macromolecules,23,(1990)2821-2823.

Hassan,M.A.,Suleiman,M.S.,Najib,N.M., ‘Improvement of the in vitro dissolution

characteristics of famotidine by inclusion in β-cyclodextrin ’,Int.J.Pharm.,58,(1),(1990),19-

24.

Heng,J.Y.Y.,Thielman,F.,Williams,D.R., ‘The effects of milling on the surface properties of

formI paracetamol crystals’ Pharm.Res.,23,8,(2006),1918-1927.

Higuchi W.I., ‘Diffusional models useful in biopharmaceutics’,J Pharm.Sci., 56(1967),315-

324.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 292

Higuchi,T.,Lach,J.L., ‘Investigation of some complexes formed in solution by caffeine. IV.

Interactions between caffeine and sulfathiazole, sulfadiazine, p-aminobenzoic acid,

benzocaine, phenobarbital, and barbital ’,J.Am.Pharm.Assoc.Sci.,43(1954),349-54.

Higuchi T, Connors K. Phase solubility techniques. In: Reilly, C. (ed.) Advances in

Analytical Chemistry and Instrumentation. Wiley Interscience: NewYork 1965:117–212.

Higuchi W., Swarbick, J., Ho, N., Simonelli A.P., Martin A., In Gennaro,A.R.(Ed),

Remington’s Pharmaceutical Sciences, Mack,Easton,PA,1985,301-329.

Hixson A.W.,Crowell J.H., ‘Dependence of reaction velocity upon surface and agitation’,

Ind.Engg.Chem.,23(1931),923-931.

Humberstone,A.J.,Charman,W.N., ‘Lipid-based vehicles for the oral delivery of poorly

water soluble drugs’,Adv.Drug Del.Rev.,25,(1997),103-128.

Indian Pharmacopoeia, 2007, Government of India, Ministry of health & Family Welfare,

Published by The Indian Pharmacopoeia Commission, Ghaziabad

Javadzadeh,Y., Navimipur,B.J., Nokodchi,A., ‘Liquisolid technique for dissolution rate

enhancement of a high-dose water-insluble drug(carbamazepine)’, Int.J.Pharm.,

341,(2007),26-34.

Ja Y. Kim, Young S. Ku, ‘Enhanced absorption of indomethacin after oral or rectal

administration of a self-emulsifying system containing indomethacin to rats’, Int.J of

Pharm.,194 (2000),81–89.

Jani,P., Halbert G., Langridge J., Florence A.T., ‘Nanoparticle uptake by the rat

gastrointestinal mucosa: quantitation and particle size dependency’, J.Pharm.Pharmacol.,

42(1990),821-826.

Jiang,Z.T., Li,R., Zhang,J., ‘Effect of hydrophilic polymer on solubilization of fenofibrate by

cyclodextrin complexation’, J Food Drug Anal., 12,(2004),183.

Jochem A.,Kansy M., ‘High throughput solubility measurement in drug discovery and

development’, Adv.Drug Del.Rev.,59,(2007),546-567.

Johnson ,B.K., Prudhome,R.K.,Polym. Mater. Sci.Eng., 89(2003),283-284.

Kakumanu VK, Arora V, Bansal AK, Investigation of factors responsible for low oral

bioavailability of cefpodoxime proxetil, Int. J.Pharm. 317,(2006),155–160.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 293

Kang,K.B.,Lee,J.S.,Chon,S.K.,Jeong,S.Y., ‘Development of self-microemulsifying drug

delivery systems (SMEDDS) for oral bioavailability enhancement of simvastatin in beagle

dogs’, Int.J.Pharm.,274,(2004),65-73.

Kanig,J.L., ‘Properties of fused mannitol in compressed tablets’J.Pharm.Sci.,53,(1964),188-

192.

Kawakami,K.,Oda,N.,Miyoshi,K., ‘Solubilization behaviuor of a poorly soluble drug

under combined use of surfactants and cosolvents’,Eur.J.Pharm.Sci.,28,(2006),7-14.

Karavas,E.,Geoegarakis.E.,Sigalas,M.P., ‘Investigation of the release mechanism of a

sparingly water-soluble drug from solid dispersions in hydrophilic carriers based on physical

state of drug’,Eur.J Pharm.Biopharm., 66 (2007),334-347.

Kato,Y.,Okamoto,Y.,Nagasawa,S.,Ishihara,I., ‘Relationship between polymorphism and

bioavailability of drug.IV.New polymorphic forms of phenobarbital’

Chem.Pharm.Bull.32,10,(1984),4170-4174.

Keck,C.M., Müller,R.H., ‘Drug nanocrystals of poorly soluble drugs produced by high

pressure homogenisation’ Eur.J.Pharm.Biopharm.,62 (2006),3-16.

Kedzierewicz,F.,Hoffman,M.,Maincent,P., ‘Comparison of tolbutamide β-cyclodextrin

inclusion compounds and solid dispersions: Physicochemical characteristics and dissolution

studies’, Int.J.Pharm.,58,(3),(1990),221.

Khaled,K.A.,Asiri,Y.A.,Sayed,M.E., ‘In vivo evaluation of hydrochlorthiazide liquisolid

tablet in beagle dogs’, Int.J.Pharm., 222,(2001),1-6.

Kharb,V.,Bhatia,M.,Dureja,H.,Kaushik, D., ‘Nanoparticle technology for the delivery of

poorly water-soluble drugs’ Pharm.Technol.,2(2006),82-92.

Khoo SM. et al., "Formulation design and bioavailability assessment of lipidic self-

emulsifying formulation of halofanitrine," Int.J Pharm.167, (1998),155–164.

Kim,C.,Park,J., ‘Solubility enhancement for oral drug delivery:can chemical structure

modification be avoided’ Am.J.Drug Deliv.,2(2004),113-130.

Kim CK, Hong J, Kim J, Song Y, Park J. A new self emulsifying formulation of itraconazole

with improved dissolution and oral absorption, J Cont.Rel., 110,(2006),332-338.

Kipp,J.E., Wong,J.C.T., Doty,M.J., Rebbeck,C.L., ‘Microprecipitation method for preparing

submicron suspensions’, United States Patent 6,607,784,Baxter International Inc.,(Deerfield,

IL),USA,2003.

Kobayashi,Y.,Ito,S.,Itai,S.,Yamamoto,K., ‘Physicochemical properties and bioavailability of

carbamazepine polymorphs and dihydrate’,Int.J.Pharm.,193,(2000),137-146.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 294

Kocbek P., S. Baumgartner and J. Kristl, ‘Preparation and evaluation of nanosuspensions for

enhancing the dissolution of poorly soluble drugs’, Int.J.Pharm.,312 (1-2) (2006),179-186.

Kommuru TR., Gurley B, Khan MA, Reddy IK, ‘Self-emulsifying drug delivery systems

(SEDDS) of coenzyme Q10: formulation development and bioavailability assessment’ Int.J

Pharm.,212,(2001),233–246.

Langguth,P.,Hanafy,A.,Frenzel,D., ‘Nanosuspension formulation for low soluble

drugs:pharmacokinetic evaluation using spironolactone as model compound’ Drug

dev.Ind.Pharm.,31(2005),319-329.

Lach,J.L., Cohen,J., ‘Interaction of pharmaceuticals with schardinger dextrins I. Interaction

with hydroxybenzoic acids and p-hydroxybenzoates’,J.Pharm.Sci.,52(1963),132-136.

Law,D.,Krill,S.L.,Schmitt,E.A., ‘Physicochemical considerations in the preparation of

amorphous ritonavir-poly(ethylene glycol)8000 solid

dispersions’,J.Pharm.Sci.,90,(2001),1015-1025.

Lawence, MJ., Rees, GD., ‘Microemulsion-based media as novel drug delivery systems’,

Adv.Drug Deliv.Rev., 2000,45,89-121.

Leuner,C.,Dressman,J., ‘Improving drug solubility for oral delivery using solid dispersions’,

Eur.J.Pharm.Biopharm.,50 (2000),47-60.

Lipinsky,C.A., Lombardo,F., Dominy,B.W., Feeney,P.J., ‘Experimental and computational

approaches to estimate solubility and permeability in drug discovery and development

settings’ Adv. Drug Del.Rev.,23 (1997),3-25.

Lipinsky, C.A., ‘Avoiding investment in doomed drugs’ Curr. Drug Discov.,1,(2001),17-19.

Liversidge,G.G., Cundy,K.C.,Bishop,J., Czekai,D., 1991, ‘Surface modified drug

nanoparticles’, US Patent No.5145684.

Liversidge,G.G., Conzentino P., ‘Drug particle size reduction for decreasing gastric irritancy

and enhancing absorption of naproxen in rats’, Int. J Pharm., 125 (1995), 309-313.

List,M.,Sucker,H., ‘Pharmaceutical colloidal hydrosols for injection GB Patent

2200048,Sandoz LTD.CH,GB,1988.

Löbenberg,R,Amidon,G.L., Modern bioavailability, bioequivalence and biopharmaceutics

classification system. New scientific approaches to international regulatory standards’ Eur.J

Pharm. Biopharm.,50(2000),3-12.

Loftsson T, Cyclodextrin solubilization of the antibacterial agents triclosan and triclocarbon:

formation of aggregates and higher order complexes, Int.J Pharm.,297,(2005),213-222.

Maheshwari,R.K.,Shukla,R.S., ‘Novel method for spectroscopic analysis of

hydrochlorthiazide tablets using niacinamide as hydrotropic agent’,Asian

J.Pharm.,(2008),68-69.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 295

Makhlof,A.,Miyazaki,Y.,Tozuka,Y.,Takeuchi,H., ‘Cyclodextrins as stabilizers for the

preparation of drug nanocrystals by emulsion solvent diffusion method’,

Int.J.Pharm.,357(2008),280-285.

Matteucci,M.E.,Hotze,M.A.,Johnston,K.P.,Williams,R.O., ‘Drug nanoparticles by

antisolvent precipitation:Mixing energy vs surfactant stabilization’,

Langmuir,22,(2006),8951-8959.

Margulis-Goshen K and Magdassi S, ‘Formation of drug nanoparticles form

microemulsions’ ,NSTI-Nanotech 2010,Vol.3.(2010),308-311.

Marques M., Dissolution media Simulating Fasted and Fed State, Dissolution Technol.,

11(2), (May 2004),16.

McCabe,W.L.,Smith,J.C.,Harriott,P., ‘Unit Operations of Chemical Engineering’,6th

ed.,McGraw-Hill,New York.,2001.

McNamara,D.P.,Childs,S.L.,Giordono,J., ‘Use of glutaric acid cocrystal to improve oral

bioavailability of a low solubility API’,Pharm.Res.,23(8),(2006),1888-1897.

Melgardt de Villiers,Daniel P Otto in ‘Physicochemical Principles of Nanosized Drug

Delivery Systems Nanotechnology in Drug Delivery’,Ed:,Pornanong Aramwil, Glen S

Kwon,Springer,2009AAPS.

Meyer,M.C.,Straughn,E.J.,jarvi,G.C.,Wood,G.C., ‘The bioequivalence of carbamazepine

with a history of clinical failures’ Pharm.Res.,9 (1992),1612-1616.

Merisko-Liversidge,E.,Liversidge,G.,Cooper E.,Nanosizing:a formulation approach for

poorly water soluble compounds’,Eur.J.Pharm.Sci.,18,(2003),113-120.

Mocamu G, Vizitiu D Carpo A. Cyclodextrin Polymers. J Bioact Compat Pol 2001;16:315-

342.

Modi,A.,Tayade,P.A., ‘Comparative solubility enhancement profile of valdecoxib with

different solubilization approaches’ Ind.J Pharm.Sci., 69,3,(2007),427-430.

Mosharraf,M.,Nyatröm,C., ‘The effect of particle size and shape on the surface specific

dissolution rate of microsized practically insoluble drugs’ Int.J.Pharm.,122(1995),35-47.

Mu.L.,Feng,S.S., ‘A novel controlled release formulation for the anticancer drug

paclitaxel:PLGA nanoparticles containing vitamin E TPGS’,J.Cont.Rel.,86(2003),33-48.

Müller,R.H.,Peters,K.,Nanosuspensions for the formulation of poorly soluble drugs

I.Preparation by a size reduction technique’Int.J.Pharm.,160(1998),229-237.

Müller,R.H.,Jacobs,C.,Kayser,O., ‘Nanosuspensions as particulate drug formulations in

therapy:Rationale for development and what we can expect for the future’, Adv.Drug

Del.Rev.,47,(2001),3-19.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 296

Müller,R.H.,Becker,R.,Kruss,B.,Peters,K., ‘Pharmaceutical nanosuspensions for medicament

administration as system of increased saturation solubility and rate of solution’, US Patent

No.5858410.

Nakao H, Ide J, Yanagisawa H et al. Cefpodoxime proxetil (CS-807), a new orally active

cephalosporin. Sankyo Kenkyusho Nempo 39,(1987),1-44.

Newa M,Bhandari KH.,Preparation,characterization and in vvo evaluation of ibuprofen

binary solid dispersion with poloxamer 188.Int.J Pharm.,34,(2007),228-237.

Nernst W., ‘Theory der reaktionsgeschwindigkeit in heterogen systemen, Z Phys.Chem.,47

(1904),52-55.

Noyes A.A, Whitney W.R., ‘The rate of solution of solid substances in their own solutions’,J

Am.Chem.Soc.,19 (1897),930-934.

Nokhodchi,A., Bolourtchian,N., Dinarvand,R., ‘Crystal modification of phenytoin using

different solvents and crystallization conditions’,Int.J. Pharm., 250,1,(2003),85-97.

Organization of Economic Co-operation & Development (OECD), The OECD guidelines

for testing of chemical: 420 Acute Oral Toxicity. France. 2001.

Overbeek JTG., The First Rideal Lecture. Microemulsions, a field at the border between

lyophobic and lyophilic colloids Faraday Discuss.Chem. Soc., 65(1978), 7-19.

Panchagnula R, Dhanikula A, Singh R., ‘In vivo pharmacokinetic and tissue distribution

studies in mice of alternative formulations for local and systemic delivery of paclitaxel: Gel,

Film, Prodrug, Liposomes and Micelles’, Curr. Drug Del., 2, 2005, 35-44.

Pandit,J.K.,Gupta,S.K.,Gode,K.D.,Mishra,B., ‘Effect of crystal form on oral absorption of

phenylbutazone’, Int.J.Pharm.,21,(1984),129-132.

Pang X, Liu L, Zhang W, Wang S. Formulation design and in vitro evaluation of silymarin

loaded self microemulsifying drug delivery systems. Asian J Pharm Sci 2007;2(4):150-160.

Pathak,P.,Meziani,M.J.,Desai,T.,Sun,Y.P., ‘Formulation and stabilization of ibuprofen

nanoparticles in supercritical fluid processing’,J Supercrit.Fluid.,37(2006),279-286.

Pathak K , Kumar M, Misra A. Formulation and Characterization of Nanoemulsion-Based

Drug Delivery System of Risperidone. Drug Dev. Ind. Pharm.,35,(2009),387–395.

Peters,K., Müller,R.H., ‘Nanosuspensions for the oral application of poorly soluble drugs’

in:Proceeding European Symposium on Formulation of poorly available drugs for oral

administration’,APGI,Paris,1996,330-333.

Peters,K.,Leitzke,S.,Diederichs,J.E.,Borner,K., ‘Preparation of a clofazimine

nanosuspension for intravenous use and evaluation of its therapeutic efficacy in murine

Mycobacterium avium infection, J.Antimicrob.Chemother.45(1) (1999),77-83.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 297

Phillips,E.M.,Valentino,J.S., ‘Rapid expansion from supercritical solutions:application to

pharmaceutical processes’, Int.J.Pharm.,94(1993),1-10.

Pitha,J.,Anaisse,E.J.,Uekama,K., ‘γ-cyclodextrin: Testosterone complex suitable for

sublingual administration ’, J.Pharm.Sci.,76(1987),788-90.

Prentis,R.A.,Lis,Y.,Walker,SR., ‘Pharmaceutical innovation by seven UK-owned

pharmaceutical companies’Bri.J.Clin.Pharmacol.,25 (1988),387-396.

Qiao, P.H.,Wang,J.X.,Chen,G.Z.,Shen,Z.G., ‘Micronization of gemfibrozil by reactive

precipitation process’ Int.J Pharm.,360 (2008),58-64.

Rabinow,B.E., ‘Nanosuspensions in drug delivery’Drug Discov.,3,2004,785-796.

Rasenack,N., Steckel,H., Müller,B.W., ‘Preparation of microcrystals by in situ

micronization’ Powder Technol.,143-144 (2004),291-296.

Rasenack,N.,Hartenhauer,H.,Mϋller,B., ‘Microcrystals for dissolution rate enhancement of

poorly water-soluble drugs’,Int.J.Pharm.,254 (2003),137-145.

Rasheed Arun , Ashok Kumar C. K., Sravanthi V. V. N. S. S. ‘Cyclodextrins As Drug

Carrier Molecule: A Review’ Sci Pharm. 2008; 76: 567–598.

Rawlinson,C.F.,Williams A.C.,Timmins P., ‘Polymer mediated disruption of drug

crystallinity’Int.J Pharm.,336(2007),42-48.

Raymond A. Mackay in ‘Solubilization’Ed.Schik M.J.,Non-ionic surfactants,Marcel

Dekker Inc, New York., 1987,298-356.

Rege,B.,Kao,J.,Polli,J., ‘Effect of nonionic surfactants on membrane transporters in Caco-2

cell monolayers’, J.Pharm.Sci.,16,(2002),237-246.

Reiss,H., ‘Entropy induced dispersion of bulk liquid’, J Colloid Interface Sci53.,(1975 ),61-

70.

Remenar,J.F.,Morisette,S.L.,Peterson,M.L., ‘Crystal engineering of novel co-crystals of a

triazle drug with 1,4-dicarboxylic acids’,J.Am.Chem.Soc., 125,(2003),8456-8457.

Rogers,T.L.,Nelsen,A.C.,Hu,J.H.,Brown,J.N., ‘A novel particle engineering technology to

enhance dissolution of poorly water soluble drugs:spray-freezing into

liquid’Eur.J.Pharm.Biopharm.,54 (2002),271-280.

Rong,D.,D’Souza,V.T., ‘A convenient method for functionalization of the 2-position of

cyclodextrins’, Tetrahedron Lett.,31,(1990),4275-4278.

Rosen, M. J., 2004. Surfactants and Interfacial phenomena, In: Rosen, M. J. (Ed), 3rd

Edition.

John Wiley & Sons Inc, New Jersey,290-296.

Ruckenstein E., J. C. Chi, Stability of microemulsions, J. Chem. Soc.,Faraday Trans.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 298

II, 71,(1975),1690-1707.

Saha GB, Fundamentals of Nuclear Pharmacy,Springer,New York,6th Ed.,(2010),101-107.

Salole, E.G., Al-Sarraj, F.A., ‘Spironolactone crystal forms’, Drug

Dev.Ind.Pharm.,11,4,(1985),855-864.

Schulman H., W. Stoeckenius,L. M. Prince, ‘Mechanism of formation and structure of micro

emulsions by electron microscopy,’ J. Phys. Chem., 1959, 63(10), 1677-1680.

Sekiguchi,K.,Obi,N., ‘Studies on absorption of eutectic mixtures.I.A comparison of the

behavior of eutectic mixtures of sulphathiazole and that of ordinary sulphathiazole in

man’,Chem.Pharm.Bull.,9,(1961),866-872.

Shan,.N.,Toda,F.,Jones,W., ‘Mechanochemistry and co-crystal formation:effect of

solvent on reaction kinetics’,Chem.Commun., 20,(2002),2372-2373.

Shankar Swaminathan, Linda Pastero, Loredana Serpe, Francesco Trotta, Pradeep Vavia,

Dino Aquilano, Michele Trotta, Gianpaolo Zara, Roberta Cavalli ‘Cyclodextrin-based

nanosponges encapsulating camptothecin: physicochemical characterization, stability and

cytotoxicity’, Eur.J Pharm.Biopharm.74,(2),(2010),193-201.

Shah,N.H.,Carvajal,M.T.,et.al., ‘Self-emulsifying drug delivery systems(SEDDS) with

polyglycolized glycerides for improving in vitro dissolution and oral absorption of lipophilic

drugs’, Int.J Pharm., 106 (1994),15-23.

Sharma,M.K., Shiao,S.Y., Bansal.V.K., Shah,D.O., in : D.O.Shah (ed),Macro- and

Microemulsions,Am.Chem.Soc., Washington DC,(1985),87-103.

Shin,S.C.,Kim,J., ‘Physicochemical characterization of solid dispersion of furosemide with

TPGS’, Int.J Pharm., 251,(2003),79-84.

Shinoda K., S. Friberg, ‘Microemulsions: Colloidal aspects’, Adv. Colloid Interface Sci.,

(1975), 4(4), 281-300.

Shinoda,K., Friberg,S., (1986),’Emulsions and solubilization’, John Wiley and Sons,

Chichester ,pp.xiii.

Simonelli,A.P.,Mehta,S.C.,Higuchi,W.I., ‘Dissolution rates of high energy sulphathiazole-

povidone coprecipitates II:characterization of form of drug controlling its dissolution rate via

solubility studies’,J.Pharm.Sci.,65,(1976),355-361.

Singhal,D.,Curatolo,W., ‘Drug polymorphism and dosage form design:a practical

perspective’,Adv.Drug Deliv.Rev.,56(2004),335-347.

Sinko P., in ‘Martin’s Physical Pharmacy and Pharmaceutical Sciences’ Lippincott Williams

& Williams, Philadelphia, USA, 5th ed.,(2006),466.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 299

Sohma,Y.,Hayashi,Y.,Ito,T.,Matsumoto,H., ‘Development of water-soluble prodrugs of

the HIV-1 protease inhibitor KNI-727’,J.Med.Chem.,46 (19),(2003),4124-4135.

Spernath A, Aserin A., ‘Microemulsions as carriers for drugs and

nutraceuticals’,Adv.Colloid Interface Sci.,128-130,(2006),47–64.

Stella,V.J., ‘A case for prodrugs:fosphenytoin’, Adv.Drug Del.Rev.,19,(2),(1996),311-330.

Strickley,R.G., ‘Solubilizing excipients in oral and injectable formulations’,

Pharm.Res.,21(2),(2004),201-230.

Swaminathan S, Pastero L, Vavia P, et al. Cyclodextrin-based nanosponges encapsulating

camptothecin: Physicochemical characterization, stability and cytotoxicity. Eur. J Pharm.

Biopharm.,74(2),(2010),193-201.

Swaminathan S, Vavia PR, Trotta F, Torne S., ‘Formulation of betacyclodextrin based

Nanosponges of itraconazole’, J Incl. Phenom. Macro;57,(2007),89–94.

Szejtli,J., ‘Introduction and general overview of cyclodextrin chemistry’,

Chem.Rev.,98,(1998),1743-1753.

Tachibana,T.,Nakamura,A., ‘A method for preparing aqueous colloidal dispersion of organic

materials by using water-soluble polymers:dispersion of beta-carotene by

polyvinylpyrrolidone, Kolloid-Z.Polym., 203,(1965),130-133.

Taylor,L.S.,Zografi,G., ‘Spectroscopic characterization of interactions between PVP and

indomethacin in amorphous molecular dispersions,Pharm.Res.,14,(1997),1691-1698.

Tayel S.A.,Soliman,II,Louis,D., ‘Improvement of dissolution properties of carbamazepine

through application of liquisolid technique’, Eur.J.Pharm.Biopharm.Sci.,69,(2008),342-347.

Tharwat F.Tadros,‘Surfactants as Dispersants and Stabilisation of Suspensions’ in Applied

Surfactants: Principles and Applications., 2005, WILEY-VCH Verlag GmbH & Co. KGaA,

Weinheim,188-189.

Tharwat F. Tadros in Applied Surfactants, Principles and Applications, Wiley-VCH Verlag,

Gmbh & Co.,KGaA,(2005),115-183.

Thies,J., Müller,W., ‘Size controlled production of biodegradable microparticles with

supercritical gases,’ Eur.J Pharm.Biopharm.,45,(1998),67-74.

Ting-Ting Hu , Hong Zhao, Li-Chuan Jiang, Yuan Le, Jian-Feng Chen , Jimmy Yun,

‘Engineering Pharmaceutical Fine Particles of Budesonide for Dry Powder Inhalation

(DPI)’, Ind. Eng. Chem. Res.,47,23,(2008),9623–9627.

Tipnis HP & Bajaj Amrita in ‘Principles and Applications of Biopharmaceutics and

Pharmacokinetics’,Career Publications,Mumbai,(2008),78.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 300

Tremblay D, Dupront A, Ho C, et.al., ‘Pharmacokinetics of cefpodoxime in young and

elderly volunteers after single doses’, J Antimicrob. Chemother., 26(suppl E),(1990),21-28.

Todd Wesley Mark, ‘Cefpodoxime proxetil: a comprehensive review’, Int.J Antimicrobial

Agents,4,(1994),37-62.

Tong,P.,Zografi,G., ‘A study of amorphous molecular dispersions of indomethacin and its

sodium salt’, J.Pharm.Sci.,90,(2001),1991-2004.

Tommy Julianto, Kah Hay Yuen, Azmin Mohammad Noor, ‘Improved bioavailability of

vitamin E with a selfemulsifying formulation’, Int.J Pharm.,200,(2000),53–57.

Tomoki O, Yoshiki C., ‘Synthesis of Organic Inorganic Polymer Hybrids by Means of Host

Guest Interaction Utilizing Cyclodextrin’, Macromolecules,36,(2003),654-660.

Torchillin, V.P., ‘Micellar nanocarriers: Pharmaceutical perspectives’

Pharm.Res.,24,1,(2007),1-16

Track,A.V.,Motherwell,W.D.S.,Jones,W., ‘Solvent-drop grinding:green polymorph control

of co-crystallisation’,Chem.Commun.,(2004),890-891.

Tran PH,Lee BJ, ‘Modulation of microenvironmental pH and crystallinity of ionizable

telmisartan using alkalizers in solid dispersions’, J Contro. Rel.,129 (2008),59-65.

Trotta F, Tumiatti W, Roggero C, et al. Inventors: Ultrasound assisted synthesis of

cyclodextrin based Nanosponges, Description of EP1632503(A1),2006

(esp@centerdatabase).

Trotta F, Tumiatti W., ‘Cyclodextrin-based nanosponges as a vehicle for antitumoral drugs’

World patent number (WO/2009/003656).

United States Pharmacopoeia 30,National Formulary 25.The official compendia of

standards,29th edition (Asian edition), 2007.

Veiga,M.D.,Escoar,C.,Bernard,M.J., ‘Dissolution behavior of drugs from binary and ternary

systems’,Int.J.Pharm., 93(1993),215-220.

Vierling,P.,Greiner,J., ‘Prodrugs of HIV protease inhibitors’, Curr.Pharm.Des.,9(22)

(2003),1755-1770.

Violante,M.R.,Fischer,H.W., ‘Method for making uniformly-sized particles from insoluble

compounds’, United States Patent 4,997,454,The University of Rochester,USA,1991.

Volmer M., A. Weber, Z. Phys. Chem.,119, (1925),277.

Vonderscher,J.,Meinzer,A., ‘Rationale for the development of Sandimmune Neoral’,

Transplant Proc.,26,(1994),2925-2927.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 301

Wacker,S., Soliva,M., Speiser,P., ‘Injection molding as a suitable process for manufacturing

solid dispersions or solutions’, Pharmazeutische Industrie,53,(1991),853-856.

Wakerly,M.G.,Pouton,C.W.,et.al., ‘Self-emulsification of vegetable oil-nonionic surfactant

mixtures’, ACS Symp.Ser.,311 (1986),242-255.

Wandel,C.,Kim,R.B.,Stein,M., ‘Inactive excipients such as Cremophor can affect in vivo

drug disposition’, Clin.Pharmacol.Ther., 73(5),(2003),394-396.

Wang, L., Dong, J.,Chen, et.al., ‘Design and optimization of a new self-nanoemulsifying

drug delivery system’ J Colloid and Interface Sci., 330 (2009),443-448.

Wei,L., Yonggang,Y., Yongshou,T., et.al., ‘Preparation and in vitro/in vivo evaluation of

revaprazan hydrochloride’, Int. J Pharm., 408 (2011),157-162.

Wolfgang Wienen,Michael Entzeroth,Jacobus C. A. et.al., ‘A Review on Telmisartan: A

Novel, Long-Acting Angiotensin II-Receptor Antagonist’, Cardiovascular Drug Reviews,

Vol. 18, No. 2,(2000),127–154.

Xinyuan Z, Liang C, Deyue Y,et al. ‘Supramolecular Self-Assembly of Inclusion

Complexes of an Multiarm Hyperbranched Polyether with Cyclodextrins’,

Langmuir,20,(2004),484-490.

Xiang-Shan Li., Wang,J., Shen,Z.,et.al., ‘Preparation of uniform prednisolone microcrystals

by a controlled microprecipitation method’,Int.J.Pharm.,342,(2007),26-32.

Yeni P., ‘Tipranavir: A protease inhibitor from a new class with distinct antiviral activity’,

JAIDS, 34,(2003),S91-94.

York,P.,Saleh,A., ‘Modification of diffusion rates of benzocaine from topical vehicles using

sodium salicylate as complexing agent’, J.Pharm.Sci.,65(1976),493-497.

Yu,L., Zhi,F., Heng-Yi,Z., Chun-Hua D., ‘Binding ability and self-assembly behavior of

linear polymeric supramolecules formed by modified β

cyclodextrin’,Org.Lett.,2(3),(2000),315-318.

Zaworotko,M.J., ‘Polymorphism in co-crystals and pharmaceutical co-crystals’,XX

Congress of the International Union of Crystallography’,Florence,2005.

Zhang,J.Y, Shen,Z.G., Zhong.J., Chen,J.F., ‘Preparation of amorphous cefuroxime axetil

nanoparticles by nanoprecipitation method without surfactants’ Int.J.Pharm.,323(2006),153-

160.

Zhang H, Yao M, Morrison RA, Chong S Commonly used surfactant, Tween 80, improves

absorption of P-glycoprotein substrate, digoxin, in rats Arch Pharm Res. 2003

Sep;26(9):768-72.53.114.

Bibliography

Solubility enhancement of BCS Class II/IV drugs 302

Zhong,J., Shen,Z.G., Yang,Y., Chen,J.F., ‘Preparation and characterization of uniform

nanosized cephradine by combination of reactive precipitation and liquid anti-solvent

precipitation under high gravity environment’Int.J.Pharm.,301(2005),286-293.

Zoglio,M.A., ‘Complexes of ergot alkaloids and derivatives I: The interaction of caffeine

with ergotamine tartrate in aqueous solution’,J.Pharm.Sci.,58(1969),222-225.

WEB REFERENCES:

1. http://en.wikipedia.org/wiki/Kelvin_equation (Accessed on 15.12.2011)

2. http://www.drugbank.ca/drugs/DB00966 Telmisartan (Accessed on 25 .09.2011)

3. http://en.wikipedia.org/wiki/Sessile_drop_technique (Accessed on 15.02.2011)

4. http://www.greatvistachemicals.com/industrial&specialtychemicals/polyvinylpyrrolidone.html

(Accessed on 26.05.2011)

5. http://en.wikipedia.org/wiki/Gibbs_free_energy (Accessed on 27.05.2011)

6. http://www.sigmaaldrich.com/etc/medialib/docs/Sigma-

Aldrich/Product_Information_Sheet/p8074pis.Par.0001.File.tmp/p8074pis.pdf). (Accessed on

23.06.2011)

7. http://www.antareshealthproducts.com/about_tpgs/properties.html). (Accessed on 14.05.2011)

8. http://en.wikipedia.org/wiki/Torque (Accessed on 16.11.2011)

9. http://www.sju.edu/~phabdas/physics/rheo.html (Accessed on 16.11.2011)

10. http://www.lifehugger.com/doc/120/ecg-100-steps. Retrieved 2010-02-11. ((Accessed on

16.11.2011)

11. https://data.epo.org/publication-server/pdf-

document?PN=EP1786841%20EP%201786841&iDocId=7234685&iepatch=.pdf (Accessed on

16.11.2011)

12. http://www.investopedia.com/terms/r/residual-sum-of-squares.asp#ixzz1eskVH7OU (Accessed

on 20.11.2011)

13. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-

_Scientific_Discussion/human/000209/WC500027637.pdf). (Accessed on 28.11.2011)