References
REFERENCES
Andersson et al. (1993). Pharmacokinetics of Omeprazole in Patients with Liver
Cirrhosis, Clin. Pharmacokinetics. 24(1): 71-78.
Andersson et al. (1990). Pharmacokinetics of Various Single Intravenous and Oral
Doses of Omeprazole, Eur J. Clin. Pharmacol. 39:195-197.
Andersson, T., Andren, K., Cederberg, C., Lagerstrom, P.O., Lundborg, P., and
Skanberg, I. (1990). Pharmacokinetics and bioavailability of omeprazole after
single and repeated oral administration in healthy subjects. British Journal of
Clinical Pharmacology, 29: 557—563.
Andersson, T. (1996). Pharmacokinetics, metabolism, and interactions of acid
pump inhibitors: Focus on omeprazole, lansoprazole, and pantoprazole. Clinical
Pharmacokinetics, 31: 9—28.
Araujo, A.A.S., Storpirtis, S., Mercuri, L.P., Carvaiho, RM.S., Santos Filho, M.,
and Matos, J.R. (2003). Thermal analysis of the antiretroviral zidovudine (AZT)
and evaluation of the compatibility with excipients used in solid dosage forms.
International Journal of Pharmaceutics. 260: 303—314.
Arias, M.J., Moyano, J.R., Munoz, P., Gines, J.M., Justo, A., and Giordano, F.
(2000). Study of omeprazole-cyclodextrin complexation in the solid state. Drug
Development and Industrial Pharmacy 26, 3: 253-259.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Avner DL. (2000). Clinical experience with pantoprazole in gastroesophageal
reflux disease. Clin. Ther. 22:1169–1185; discussion 1149–1150.
Balaban, D.H., and Peura, D.A. (1997). In Gastrointestinal Infections, Diagnosis
and Management LaMont, J.T. (Ed). New York: Marcel Dekker. p. 29-69.
Barie et al. (1992), Therapeutic Use of Omeprazole for Refractory Stress induced Gastric Mucosal Hemorrhage, Crit. Care Med., 20:899-901.
Barry E Gidal. (2006). Drug absorption in the elderly: Biopharmaceutical
considerations for the antiepileptic drugs. Epilepsy Research. 68S: S65–S69.
Berntsson, P.B., Carisson, S.A.I., Garberg, L.E., Junggren, U.K., Sjostrand, S.E.
and Von Wittken Sundell, G.W. (1977). Substituted 2- benzimidazoles with
gastric acid secretion inhibiting effects. US Patent No. 4,045,563 AB Hassle.
Besancon, M., Simon, A., Sachs, G., and Shin, J.M. (1997). Sites of reaction of
the gastric H+K+-ATPase with extracytoplasmic thiol reagents. Journal of
Biological Chemistry. 272 (22): 438-446.
Borenstein, M.R. (2001). Handout for Pharmaceutical Analysis, Infrared
Spectroscopy.
Bowtle, W. (2002). Options in materials for liquid-filled capsules. Pharmaceutical
Manufacturing and Packing Sourcer. http://www.samedanltd.com.
Bowtle, W. (2003). Advances in liquid fill capsule technology. Business Briefing:
Pharmatech. 1-4.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Bramhankar D.M., Jaiswal S.B. (1998). Biopharmaceutics and Pharmacokinetics:
A Treatise, 5th edition. Vallabh Prakashan, Delhi.
Bruni, G., Amici, L., Berbenni, V., Marini, A., and Orlandi, A. (2002). Drugexcipient compatibility studies, search of interaction indicators. Journal of
Thermal Analysis and Calorimetry. 68: 56 1-573.
Brunton, (1990). Agents for the Control of Gastric Acidity and Treatment of
Peptic Ulcers, IN, Goodman AG, et al. The Pharmacologic Basis of Therapeutics.
(New York, p. 907).
Brunton, L.L. (1996). Agents for control of gastric acidity and treatment of peptic
ulcers. In: Hardman, J.G., Limbird, L.E. (Eds). Goodman & Gilman’s The
Pharmacological Basis of Therapeutics, New York, McGraw-Hill, pp. 90:1-13.
Calabrese, C., Fabbri, A., DiFebo, G. (2007). Long-term management of GERD
in the elderly with pantoprazole. Clin Interv Aging. 2: 85–92.
Carao, J.J., Salas, M., and Ward, A. (2001). Healing and relapse rates in
gastroesophageal reflux disease treated with the newer proton pump inhibitors
lansoprazole, rabeprazole, and pantoprazole compared with omeprazole,
ranitidine, and placebo: Evidence from randomized clinical trials. Clinical
Therapeutics. 23, 7: 998-1017.
Castell, D., Bagin, R., Goldlust, B. (2005). Comparison of the effects of
immediate-release omeprazole powder for oral suspension and pantoprazole
delayed-release tablets on nocturnal acid break-through in patients with
symptomatic gastroesophageal reflux. Aliment. Pharmacol. Ther. 21: 1467–1474.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Cederberg, C., Ekenved, G., Lind, T., and Olbe, L. (1985). Acid inhibitory
characteristics of omeprazole in man. Scandinavian Journal of Gastroenterology,
20(supplement 108): 105-112.
Cederberg, C., Andersson, T., and Skanberg, I. (1989). Omeprazole:
Pharmacokinetics and metabolism in man. Scandinavian Journal of
Gastroenterology. 66: 33—40.
Charman,
W.N., Porter,
C.J.H., Mithani, S., Dressman,
J.B. (1997).
Physicochemical and physiological mechanisms for the effects of food on drug
absorption: the role of lipids and pH. J. Pharm. Sci. 86(3): 269-282.
Cheer, S.M., Prakash, A., Faulds, D., Lamb, H.M. (2003). Pantoprazole: an
update of its pharmacological properties and therapeutic use in the management
of acid-related disorders. Drugs. 63: 101–133.
Choi, H.G., and Kim, C.K. (2000). Development of omeprazole buccal adhesive
tablets with stability enhancement in human saliva. Journal of Controlled Release.
68: 397-404.
Chunqin Deng and Julia Graz, Generating Randomization Schedules Using SAS®
Programming, Statistics and Data Analysis.
Clissold, S.P. and Campoli-Richards, D.M. (1986). Omeprazole: A preliminary
review of its pharmacodynamic and pharmacokinetic properties, and therapeutic
potential in peptic ulcer disease and Zollinger-Ellison syndrome. Drugs.32: 15-47.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Committee for Proprietary Medicinal Products (CPMP), “Note for Guidance on
the Investigation of Bioavailability and Bioequivalence”. London, 26 July 2001,
CPMP/EWP/QWP/1401/98.
Dammann, H., Von Kleist. (1997). Efficacy and tolerability of pantoprazole
versus ranitidine and famotidine in patients with gastro-oesopghageal reflux
disease: multicentre, open, randomised, control studies. International Clinical
Practice Series. 15: 23–29.
Dattilo, M., and Figura, N. (1998). Helicobacter pylori infection, chronic gastritis
and proton pump inhibitors. Journal of Clinical Gastroenterology. 27 (Supplement
1): S 163-169.
Dekkers, C.P., Beker, J.A., Thjodleifsson, B., Gabryelewicz, A., Bell, N.E., and
Humphries, T.J. (1999). Comparison of rabeprazole 20 mg versus omeprazole 20
mg in the treatment of active duodenal ulcer: A European multicentre study.
Alimentary Pharmacology and Therapeutics. 13:179—186.
Der, G. (2003). An overview of proton pump inhibitors. Gastroenterology
Nursing, 26, 5:182-90.
Devault KR. (2007). Pantoprazole: a proton pump inhibitor with oral and
intravenous formulations. Expert Rev. Gastroenterol. Hepatol. 1: 197– 205.
Digenis, G.A., Gold, T.B., Shah, V.P. (1994). Cross-linking of gelatin capsules
and its relevance to their in vitro-in vivo performance. Journal of Pharmaceutical
Sciences. 83: 915-921.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Dimenas, E., Glise, H., Hallerback, B., Hernqvist, H., Svedlund, J., Wiklund, I.
(1993). Quality of life in patients with upper gastrointestinal symptoms. An
improved evaluation of treatment regimens. Scand. J. Gastroenterol. 28:681–687.
Ehrlich, A., Luecker, P.W., Wiedemann, A., Sander, P., Huber, R., Mascher, H.
(1999). Comparison of the pharmacodynamics and pharmacokinetics of pantoprazole (40 mg) as compared to omeprazole MUPS (20 mg) after repeated oral
dose administration. Exp. Clin. Pharmacol. 21: 47–51.
El-Serag, H.B., Petersen, N.J., Carter, J., Graham, D.Y., Richardson, P., Genta,
R.M., and Rabeneck, L. (2004). Gastroesophageal Reflux Among Different
Racial Groups in the United States. Gastroenterology. 126: 1692—1699.
Enck, P., Dubois, D., Marquis, P. (1999). Quality of life in patients with upper
gastrointestinal
symptoms:
results
from
the
Domestic/International
Gastroenterology Surveillance Study (DIGEST). Scand. J. Gastroenterol. Suppl.
231: 48–54.
Fassihi, A.R., and Parker, M.S. (1988). Influence of gamma radiation on the gel
rigidity index and binding capability of gelatin. Journal of Pharmaceutical
Sciences. 7, 10: 876-879.
Feliciano, D.V., Ojukwu, J.C., Rozycki, G Ballard, R.B., Ingram, W.L.,
Salomone, J., Namias, N., and Newman, P.G. (1999). The epidemic of cocainerelated pyloric perforations: With a comment on the importance of testing for
Helicobacterpylori. Annals of Surgery. 229: 801—804.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Fitton, A., Wiseman, L. (1996). Pantoprazole: a review of its pharmacologic
properties and therapeutic use in acid related disorders. Drugs. 51:460–82.
Gallo, S., Dibildox, M., Moguel A. (1998). Clinical superiority of pantoprazole
over ranitidine in the treatment of reflux esophagitis grade II and III. A
prospective, double-blind, double-placebo study. Mexican clinical experience.
Mexican Pantoprazole Study Group. Rev. Gastroenterol. Mex. 63: 11–16.
Gan, K.H., Geus, W.P., BakkerW., Lamers, C.B.H.W., and Heijerman, H.G.M.
(1996). In vitro dissolution profiles of enteric-coated microsphere/microtablet
pancreatin preparations at different pH values. Alimentary Pharmacology and
Therapeutics. 10, 5:771.
Garnett, W.R. (2000). Management of peptic ulcer disease.
http://www.aetna.com.
GERD Information Resource Center. http://www.gerd.com/ sponsored by
AstraZeneca LP. Gastroenterology. 95: 634—640.
Glatzel, D., Abdel-Qader, M., Gatz, G., Pfaffenberger, B. (2006). Pantoprazole
40 mg is as effective as esomeprazole 40 mg to relieve symptoms of
gastroesophageal reflux disease after 4 weeks of treatment and superior regarding
the prevention of symptomatic relapse. Digestion.74: 145–154.
Goh, K.L., Benamouzig, R., Sander, P., Schwan, T. (2007). Efficacy of
Pantoprazole 20 mg daily compared with esomeprazole 20 mg daily in the
maintenance of healed gastroesophageal reflux disease: a randomized,
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
doubleblind comparative trial–the emancipate study. Eur. J. Gastroenterol.
Hepatol. 19:205–211.
Gohel, M.C., and Jogani, P.D. (2005). A review of co-processed directly
compressible excipients. Journal of Pharmacy and Pharmaceutical Sciences. 8, 1:
76-93.
Gore, R. M. (2000). In: Modern Imaging of the Alimentary Tube. Margulis, A.R.
(Ed.). Berlin, Springer. pp. 94-101.
Graham, D.Y., and Malaty, H.M.(1999). Alendronate gastric ulcers. Alimentary
Pharmacology and Therapeutics. 13: 513—519.
Graham, D.Y., Lew, G.M., Klein, P.D., Evans, D.G., Evans, D.J., Saeed, Z.A.,
and Malaty, H.M. (1992). Effect of treatment of Helicobacter pylori infection on
the long-term recurrence of gastric or duodenal ulcer: A randomized, controlled
study. Annals of Internal Medicine. 116, 9: 705—708.
Gray, H. (1985). Anatomy of the Human Body Philadelphia, Lea & Febiger.
Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally
Administered Drug Products-General Considerations. U.S Department of Health
and Human Services. Food and Drug Administration. Centre for Drug Evaluation
and Research (CDER) March 2003, BP, Revision1
Hartmann, M., Theiss, U., Huber, R., et al. (1996).Twenty-four-hour intragastric
pH profiles and pharmacokinetics following single and repeated oral
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
administration of the proton pump inhibitor pantoprazole in comparison to
omeprazole. Aliment. Pharmacol. Ther.10:359–366.
Helander, H.F. (1984). Parietal cell structure during inhibition of acid secretion.
Scandinavian Journal of Gastroenterology. 19 (Supplement 101): 21-26.
Hersey, S.J., and Sachs, G. (1995). Gastric acid secretion. Physiological Reviews,
75:155-189.
Hirai, M., Azuma, T., and Ito, S. (1995). A proton pump inhibitor, E3810, has
antibacterial activity through binding to Helicobacter pylori. Journal of
Gastroenterology, 30: 461-464.
Hogan, D., Pratha, V., Riff, D., et al. (2007). Oral pantoprazole in the form of
granules or tablets are pharmacodynamically equivalent in suppressing acid
output in patients with gastro-esophageal reflux disease and a history of erosive
oesophagitis. Aliment. Pharmacol. Ther. 26:249–256.
Holt, S., and Howden, C.W. (1991). Omeprazole: Overview and opinion.
Digestive Diseases and Sciences, 36: 385—393.
Holtmann, G. (2009). International validation of a health-related quality of life
questionnaire in patients with erosive gastro-oesophageal reflux disease. Aliment
Pharmacol. Ther. 29:615–625.
Honkanen, 0. (2004). Biopharmaceutical Evaluation of Orally and Rectally
Administered Hard Hydroxypropyl Methylcellulose Capsules. Academic Ph.D.
Dissertation, University of Helsinki, Helsinki, Finland.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Horn, J. (2000). The proton-pump inhibitors: similarities and differences. Clinical
Therapeutics, 22, 3: 266-80.
Howden, C.W., Forrest, J.A., Meredith, P.A., Reid, J.L. (1985). Antisecretory
effect and oral pharmacokinetics following low dose omeprazole in man. Br. J.
Clin. Pharmacol. 20: 137–139.
Howden, C.W., Meredith, P.A., Forrest, J.A., Reid, J.L. (1984).Oral
pharmacokinetics of omeprazole. Eur. J. Clin. Pharmacol. 26: 641–3.
Howden, C.W. (2005). Immediate-release proton-pump inhibitor therapy-potential advantages, Aliment. Pharmacol. Ther. 25-30.
Howden, C.W. (1997). In Gastrointestinal Pharmacology and Therapeutics.
Friedman, G., Jacobson, E.D., and McCallum, R.W. (Eds.). Philadelphia,
Lippincott-Raven Publishers. pp. 45-54.
Hoyumpa, A.M., Trevino-Alanis, H., Grimes, I., and Humphries, T.J. (1999).
Rabeprazole: Pharmacokinetics in patients with stable, compensated cirrhosis.
Clinical Therapeutics, 21: 691—701. http://www.emedicine.com
Humphries, T.J., and Merritt, G.J. (1999). Drug interactions with agents used to
treat acid-related diseases. Alimentary Pharmacology and Therapeutics.
13(Supplement 3): 18—26.
ICH Harmonized Tripartite Guideline. (2003). Stability testing of new drug
substances and products Q1A(R2), ICH Steering Committee.
Jeffrey owen Philips, Ashland MO. (2002). US patent 6,489,346 B1.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Jennings, D. (1940). Perforated peptic ulcer: changes in age-incidence and sexdistribution in the last 150 years. Lancet. 1: 395- 447.
Midha, K., Blume, H. (1992). “Bio-International, Bioavailability, Bioequivalence
and Pharmacokinetics”, International conference of F.I.P., “Bio-International ‘92”
held in Bad Homburg, Germany, May 20-22, Scientific Publishers Stuttgart.
Kahrilas, P.J., Shaheen, N.J., Vaezi, M.F. (2008). American Gastroenterological
Association Medical Position Statement on the management of gastroesophageal
reflux disease. Gastroenterology. 135: 1383–1391.
Kaspari, S., Kupcinskas, L., Heinze, H., et al. (2005). Pantoprazole 20 mg on
demand is effective in the long-term management of patients with mild gastrooesophageal reflux disease. Eur. J. Gastroenterol. Hepatol. 17:935–41.
Katz, P.O., Anderson, C., Khoury, R., Castell, D.O. (1998). Gastro-esophageal
reflux associated with nocturnal gastric acid breakthrough on proton pump
inhibitors. Aliment. Pharmacol. Ther. 12: 1231–1234.
Kawano, S., Murata, H., and Tsuji, S. (2002). Randomized comparative study of
omeprazole and famotidine in reflux esophagitis. Journal of Gastroenterology and
Hepatology. 17, 9: 955-959.
Kethu, S.R., and Moss, S.F. (2004). Gastritis and peptic ulcer disease. In: Conn’s
Current Therapy Rakel, R.E., and Bope, E.T. (Eds.), W.B. Saunders, Philadelphia,
PA, 542-544.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Koerner, T. (2002). Comparable efficacy of pantoprazole 40 mg vs omeprazole
MUPS 40 mg in patients with GERD II/III. Gut.; 51:A166.
Kovacs, T.O., Wilcox, C.M., DeVault, K., Miska, D., Bochenek, W. (2002).
Comparison of the efficacy of pantoprazole vs nizatidine in the treatment of
erosive esophagtitis: a randomized active-controlled, double blind study. Aliment.
Pharmacol. Ther. 16: 2043–2052.
Kromer, W., Kruger, U., Huber, R., et al. (1998). Differences in pH-dependent
activation rates of substituted benzimidazoles and biological in vitro correlates.
Pharmacology. 56:57–70.
Kurata, J.H., and Nogawa, A.N. (1997). Meta-analysis of risk factors for peptic
ulcers: Nonsteroidal anti-inflammatory drugs, Helicobacter pylori and smoking.
Journal of Clinical Gastroenterology. 24: 2—17.
Landahl et al., (1992). Pharmacokinetics Study of Omeprazole in Elderly Healthy
Volunteers, Clin. Pharmacokinetics. 23 (6): 469-476.
Larsson, H., Mattson, H. and Sundell, G. (1985). Structure activity relationship of
substituted benzimidazoles. Scandinavian Journal of Gastroenterology. 20
(Supplement 8): 23-35.
Laurtisen. (2000). Comparable efficacy of pantoprazole and omeprazole to
prevent relapse in patients with GERD. Gut. 47 Suppl III: 39(A60).
Lentner C, Basle. 1999. CIBA GEIGY, Units of measurement, Body fluids,
Composition of the body, Nutrition, Geigy Scientific Tables (1981) 1:123-133;
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
yamada, Tadataka (ed.), “Text book of Gastroenterology”, Volume 1, Lippincott
Williams & Wilkens, pp 284-285.
Levine, M.S. (2000). In Textbook of Gastrointestinal Radiology Gore, R.M., and
Levine, M.S. (Eds). Philadelphia: W.B. Saunders Company. pp 5 14-516.
Lew, E.A. (1999). Pharmacokinetic concerns in the selection of anti-ulcer
therapy. Alimentary Pharmacology and Therapeutics. 13 (Supplement 5): 11—16.
Li, C.L., Martini, L.G., Ford, J.L., and Roberts, M. (2005). The use of
hypromellose in oral drug delivery. Journal of Pharmacy and Pharmacology 57, 5:
533-546.
Lindberg, P., Nordberg, P., Alminger, T., Brandstrom, A., and Walimark, B.
(1986). The mechanism of action of the gastric acid secretion inhibitor
omeprazole. Journal of Medicinal Chemistry. 29, 8: 1327-1329.
Lovgren, K. I., Pilbrant, A.G., Yasumura, M., Morigaki, S., Oda. M., and Ohishi,
N. (1988). Pharmaceutical preparation for oral use. US Patent No. 4,786,505 AB
Hassle.
Lowe, C.E., Depew, W.T., Vanner, S.J., Paterson, W.G., and Meddings, J.B.
(2000). Upper gastrointestinal toxicity of alendronate. American Journal of
Gastroenterology. 95: 634—640.
Marshall, B.J., and Warren, J.R. (1984). Unidentified curved bacilli in the
stomach of patients with gastritis and peptic ulceration. Lancet. 1, 8390: 1311-13
15.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Marshall, B.J. (1994). Helicobacterpylori. American Journal of Gastroenterology.
89 (Supplement): S116—S 128.
Martin de Argila C. (2005). Safety of potent gastric acid inhibition. Drugs.
65(Suppl 1):97-104.
McQuaid K., Laine L. (2005). Early heartburn relief with proton pump inhibitors:
a systematic review and meta-analysis of clinical trials. Clin. Gastroenterol.
Hepatol. 3:553-63.
Mendes, C.A.M., and De Sousa, G.J.P. (2000). Inclusion amino acid salts
compounds of benzimidazole derivatives with cyclodextrins, their preparation
and pharmaceutical formulations containing them. EP Patent No. 1018340.
Metz, D.C., Pratha, V, Martin, P., et al. (2000). Oral and intravenous dosage
forms of pantoprazole are equivalent in their ability to suppress gastric acid
secretion in patients with gastroesophageal reflux disease. Am. J. Gastroenterol.
95:626–633.
Morçol, T., Nagappan, P., Nerenbaum, L., Mitchell, A., and Bell, S.J.D. (2004).
Calcium phosphate-PEG-insulin-casein (CAPIC) particles as oral delivery
systems for insulin, International Journal of Pharmaceutics. 277, 9:1—97.
Mulder, C.J., Westerveld, B.D., Smit, J.M., et al. (2002). A double-blind,
randomized comparison of omeprazole Multiple Unit Pellet System (MUPS) 20
mg, lansoprazole 30 mg and pantoprazole 40 mg in symptomatic reflux
esophagitis followed by 3 months of omeprazole MUPS maintenance treatment: a
Dutch multicentre trial. Eur. J. Gastroenterol. Hepatol. 14: 649–656.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Munson, K., Lambrecht, N., Shin J.M., and Sachs, G. (2000). Analysis of the
membrane domain of the gastric H+ /K+ ATPase, Journal of Experimental
Biology. 203: 161 - 170.
Nagata, S. (2002). Advantages to HPMC Capsules: A New Generation. Drug
Delivery and Technology. 2, 2: 34-39.
Nagata, S., and Tochio, S. (2002). The influence of the composition of the test
fluids on dissolution from HPMC capsules, Poster Presentation. AAPS annual
meeting and exposition.
Nahao, M., and Malfertheiner, P. (1998). Growth inhibitory and bactericidal
activities of lansoprazole compared with those of omeprazole and pantoprazole
against Helicobacter pylori. Helicobacter. 3: 21-27.
Nakagawa, et al. (1991), Lansoprazole: Phase I Study of lansoprazole (AG -1749)
Anti - ulcer Agent, J. Clin. Therapeutics & Med.
OECD Series on Principles of Good Laboratory Practice and Compliance
Monitoring, Number 1. “The OECD Principles of Good Laboratory Practice”,
Environment Monograph No. 45, Paris 1992.
Ogura, T., Furuya, Y., and Matsuura, S. (1998). HPMC capsules — an alternative
to gelatin. Pharmaceutical Technology. 11: 32-42.
Orr, W.C. (2005). Night-time gastro-esophageal reflux disease: prevalence,
hazards, and management. Eur. J. Gastroenterol. Hepatol. 17: 113–120.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Ours, T.M., Fackler, W.K., Richter, J.E., Vaezi, M.F. (2003). Nocturnal acid
breakthrough: Clinical significance and correlation with esophageal acid
exposure. Am. J. Gastroenterol. 98(3): 545–550.
Paul W. (2000). Pantoprazole: A New Proton Pump Inhibitor. Clinical
Therapeutics. 22: 1268-1293.
PDR (Physician’s Reference Desk), (2004). Montvale, NJ, Thomson PDR.
Peghini, P.L., Katz, P.O., Bracy, N.A., Castell, D.O. (1998). Nocturnal recovery
of gastric acid secretion with twice daily dosing of proton pump inhibitors. Am. J.
Gastroenterol. 93: 763–767.
Petersen, K.U. (1995). Omeprazole and the cytochrome P450 system. Alimentary
Pharmacology and Therapeutics. 9: 1—9.
Pichard, L., Curi-Pedrosa, R., Bonfils, C., Jacqz-Aigrain, E., Domergue, J.,
Joyeux, H., Cosme, J., Guengerich, F.P., and Maurel, P. (1995). Oxidative
metabolism of lansoprazole by human liver cytochromes P450. Molecular
Pharmacology. 47: 410—418.
Pilbrant, A., and Cederberg, C. (1985). Development of an oral formulation of
omeprazole. Scandinavian Journal of Gastroenterology. 20 (Supplement 108):
113-120.
Pillay, V., and Fassihi, R. (2001) Probing the dynamics of matrix hydration in the
presence of electrolytes. Drug Delivery. 8, 2: 87-92.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Podczeck, F., and Jones, B.E. (2004) Pharmaceutical Capsules; Pharmaceutical
Press:London.
Poole P. (2001). Pantoprazole. Am. J. Health Syst. Pharm. 58: 999– 1008.
Quali-V® HPMC capsules, Technical Manual (2004). Shionogi Qualicaps, Inc.
http://www.gualicaps.com.
Ralph E Small. (2005). Advances in Proton Pump Inhibitor Therapy: An
Immediate-Release Formulation of Omeprazole, P&T. 30(12): 698-713.
Rang, H.P., Dale, M.M., Ritter, J.M., and Gardner, P. (1995). Pharmacology, New
York, Churchill Livingstone, Inc., 385-388.
Regardh et al. (1990). The Pharmacokinetics of Omeprazole in Humans—A
Study of Single Intravenous and Oral Doses, Ther. Drug Mon. 12:163-72.
Richter, J.E., Fraga, P., Mack, M., Sabesin, S.M., Bochenek, W. (2004).
Prevention of erosive esophagitis relapse with pantoprazole. Aliment. Pharmacol.
Ther. 20: 567–575.
Robertson, M. I. (1999). Regulatory Issues with Excipients. International Journal
of Pharmaceutics. 187: 273-276.
Roll, J., Weng, A., and Newman, J. (1997). Diagnosis and treatment of
Helicobacter pylori infection among California Medicare Patients. Archives of
Internal Medicine. 157: 994—998.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Rowe, R.C., Sheskey, P.J., Quinn, M.E. (eds), Pharmaceutical Excipients 5. [CDROM] London: Pharmaceutical Press, 2009.
Rowe, R.C., Sheskey, P.S., and Weller, P.J. (2003). Handbook of Pharmaceutical
Excipients; Pharmaceutical Press: London.
Ryan-Harshman, M., and Aldoori, W. (2004). How diet and lifestyle affect
duodenal ulcers. Review of the evidence. Canadian Family. 50: 727-32.
Sachs, G., Munson, K., Hall, K., and Hersey, S.J. (1990). Gastric H+ K+ ATPase
as a therapeutic target in peptic ulcer disease. Digestive Diseases and Sciences.
35: 1537—1544.
Sachs, G., Shin, J.M., Besancon, M., et al. (1993). The continuing development of
gastric acid pump inhibitors. Aliment. Pharmacol. Ther. 7: 4–12.
Sachs,
G.
(1997).
Proton
pump
inhibitors
and
acid-related
diseases.
Pharmacotheraphy. 17: 22–37.
Sachs, G., (2003). Physiology of the parietal cell and therapeutic implications,
Pharmacotherapy. 23, 10-2: 68S-73S.
Sarisuta, N., and Kumpugdee, M. (2000). Crystallinity of omeprazole in various
film polymers. Pharmacy and Pharmacology Communications. 6: 7-11.
Scholten T. (2000). Pantoprazole 40 mg relieves primary reflux symptoms more
rapidly than omeprazole MUPS 20 mg in patients with severe GERD
symptomatology. Gastroenterology. 118: A1303.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Scholten, T., Dekkers, C.P.M., Schutze, K., et al. (2005). On-demand therapy
with pantoprazole 20 mg as effective long term management of reflux disease in
patients with mild GERD: the Orion trial. Digestion. 72:76–85.
Scholten, T., Teutsch, I., Bohuschke, M., Gatz, G. (2007). Pantoprazole ondemand effectively treats symptoms in patients with gastro-esophageal reflux
disease. Clin. Drug Investig. 27:287–296.
Schreiber, S., Nguyen, T.H., Stüben, M., and Scheid, P. (2000). Demonstration of
a pH gradient in the gastric gland of the acid-secreting guinea pig mucosa.
American Journal of Physiology. Gastrointestinal and liver physiology. 279, 3:
G597-G604.
Scott, M., and Gelhot, A.R. (1999). Gastroesophageal Reflux Disease: Diagnosis
and Management. American Family Physician. 3: 1161-1176.
Seth, P. (2001). Pharmaceutical composition containing an acid-labile omeprazole
and process for its preparation. US Patent No. 6,248,355 Schwarz Pharma AG.
Shayne, P. (2004). Gastritis and peptic ulcer disease. eMedicine.com, Inc.
Sheppard, S.E., Houck, R.C., and Dittmar, C. (1942). The Sorption of Soluble
Dyes by Gelatin. Journal of Physical Chemistry. 46, 158-176.
Sherman, A., and Bini, E.J. (1999). Pill-induced gastric injury. American Journal
of Gastroenterology. 94, 2: 511-513.
Shi, S., Klotz, U. (2008). Proton pump inhibitors: an update of their clinical use
and pharmacokinetics. Eur. J. Clin. Pharmacol. 64: 935–951.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Shike, M., Gillin, J.S., Kemeny, N., Daly, J.M., and Kurtz, R.C. (1986). Severe
gastroduodenal ulcerations complicating hepatic artery infusion chemotherapy for
metastatic colon cancer. American Journal of Gastroenterology. 81: 176—179.
Simmons, T.C., Hogan, D.L., Selling, J.A., Maxwell, V., Isenberg, J.I. (1986).
The effect of sodium bicarbonate versus aluminum-magnesium hydroxide on
postprandial gastric acid in duodenal ulcer patients. J. Clin. Gastroenterol. 86(2):
146-149.
Simon, B., Muller, P., Pascu, O., Gatz, G., Sander, P., Huber, R., Mascher, H.
(2003). Intra-esophageal pH profiles and pharmacokinetics of Pantoprazole and
esomeprazole: a crossover study in patients with gastroesophageal reflux disease.
Eur. J. Gastroenterol. Hepatol.15: 791–799.
Sjostrand, S.E. and Junggren, U.K. (1979). Substituted pyridylsulfinyl
benzimidazoles having gastric acid secretion properties, pharmaceutical
preparations containing same, and intermediates for their preparation. EP Patent
No. 0005129 AB Hassle.
Smout, A.J.P.M., Van der Schee, E.J., and Grashuis, J.L. (1980). What is
measured in electrogastrography? Dig Diseases and Sciences. 25: 179-88.
Snape, W.J. (2000). Disorders of Gastrointestinal Motility. In: Goldman, L., and
Bennett, J.C. Cecil Textbook of Medicine Philadelphia, PA, W. B. Saunders
Company.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Soll, A.H. (1993). Gastric duodenal and stress ulcer. In: Gastrointestinal Disease:
Pathophysiology Diagnosis Management Sleisenger, M.H., and Fordtran, J.S.
(Eds.). WB Saunders, Philadelphia, PA, 580—679.
Solvell, L. (1990). The clinical safety of omeprazole. Digestion. 47 (Supplement
1): 59-63.
Spechler, S.J. (2002). Peptic ulcer disease and its complications. In: Sleisenger &
Fordtran’s Gastrointestinal and Liver Disease Feldman, M., Friedman, L.S., and
Sleisenger, M.H. (Eds.), W.B. Saunders, Philadelphia, pp. 747-796.
Tabata, T., Makino, T., Kashihara, T., Hirai, S., Kitamori, N., and Toguchi, H.
(1992). Stabilization of new antiulcer drug (lansoprazole) in the solid dosage
forms. Drug Development and Industrial Pharmacy. 18, 13: 1437-1447.
Takumurá, T., and Machida, Y. (2001). UV absorption should not he applied for
determining amoxicillin in acidic dissolution test medium. International Journal of
Pharmaceutics. 228:1-4.
Talukder, R. (2004). Design and development of a rupturable drug delivery
system for delivering drug to the distal gastrointestinal tract-colon. Ph.D.
Dissertation. Temple University School of Pharmacy, Philadelphia, PA.
Tanaka,
M.,
Ohkubo,
T.,
Otani,
K.,
et
al.
(2001).
Stereoselective
pharmacokinetics of pantoprazole, a proton pump inhibitor, in extensive and poor
metabolizers of S-mephenytoin. Clin. Pharmacol. Ther. 69: 108–113.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
University of Michigan, Medicinal Chemistry Group. (2004). Introduction to
Penicillins http://www.sitemaker.umich.edu/medchemgroup4/files/j
USP 28/ NF 23. (2005). United States Pharmacopoeial Convention, Inc.
Rockville.
Van Rensburg, C.J., Honiball, P.J., Van Zyl, J.H., et al. (1999). Safety and
efficacy of pantoprazole 40 mg daily as relapse prophylaxis in patients with
healed reflux esophagitis – a 2-year follow-up. Aliment. Pharmacol. Ther.
13:1023–1028.
Verma, R.K., and Garg, S. (2005). Selection of excipients for extended release
formulations of glipizide through drug-excipient compatibility testing. Journal of
Pharmaceutical and Biomedical analysis. 38: 633-644.
Volberding, P.A., and Mitsuyasu, R. (1985). Recombinant interferon alpha in the
treatment of acquired immune deficiency syndrome-related Kaposi’s sarcoma,
Seminars in Oncology. (Supplement 5): 2-6.
Walsh, J.H., and Peterson, W.L. (1995). The treatment of Helicobacter pylon
infection in the management of peptic ulcer disease. New England Journal of
Medicine. 333: 984—991.
Weidolf, L., and Castagnoli, N. (2001). Study of the electrospray ionization mass
spectrometry of the proton pump inhibiting drug Omeprazole. Rapid
Communications in Mass Spectrometry. 15: 283-290.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole
References
Wei-Youh Kuua, Rao Chilamkurtia, Chi Chenb. (1998).
Effect of relative
humidity and temperature on moisture sorption and stability of sodium
bicarbonate powder. Int. J. Pharm. 167-175.
Yasuda, S., Ohnishi, A., and Ogawa, T., (1994). Pharmacokinetic properties of
E3810, a new proton pump inhibitor, in healthy male volunteers. International
Journal of Clinical Pharmacology and Therapeutics. 32: 466-473.
Design And Development Of A Novel Concept For Immediate Release Of Pantoprazole