Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Bile – bile acid – bile salt – amniotic fluid – or ascitic fluid
Reexamination Certificate
2007-12-04
2007-12-04
Shibuya, Mark L. (Department: 1639)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Bile, bile acid, bile salt, amniotic fluid, or ascitic fluid
C424S455000, C424S479000
Reexamination Certificate
active
09778154
ABSTRACT:
Compositions for pharmaceutical and other uses comprising clear aqueous solutions of bile acids which do not form any detectable precipitates over selected ranges of pH values of the aqueous solution and methods of making such solutions. The compositions of the invention comprise water; a bile acid in the form of a bile acid, bile acid salt, or a bile acid conjugated with an amine by an amide linkage; and either or both an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide. The composition remains in solution without forming a precipitate over a range of pH values and, according to one embodiment, remains in solution for all pH values obtainable in an aqueous system. The composition, according to some embodiments, may further contain a pharmaceutical compound in a pharmaceutically effective amount. Non-limiting examples of pharmaceutical compounds include insulin, heparin, bismuth compounds, amantadine and rimantadine.
REFERENCES:
patent: 3845770 (1974-11-01), Theeuwes et al.
patent: 3916899 (1975-11-01), Theeuwes et al.
patent: 4036954 (1977-07-01), Murakami et al.
patent: 4092428 (1978-05-01), Murakami et al.
patent: 4113882 (1978-09-01), Okazaki et al.
patent: 4320146 (1982-03-01), Walser
patent: 4327725 (1982-05-01), Cortese et al.
patent: 4585790 (1986-04-01), Padfield et al.
patent: 4681876 (1987-07-01), Marples et al.
patent: 4879303 (1989-11-01), Davison et al.
patent: 5057321 (1991-10-01), Edgren et al.
patent: 5149537 (1992-09-01), Azria et al.
patent: 5157022 (1992-10-01), Barbul
patent: 5260074 (1993-11-01), Sipos
patent: 5300300 (1994-04-01), Egidio et al.
patent: 5302398 (1994-04-01), Egidio et al.
patent: 5302400 (1994-04-01), Sipos
patent: 5310560 (1994-05-01), Widauer
patent: 5324514 (1994-06-01), Sipos
patent: 5342625 (1994-08-01), Hauer et al.
patent: 5380533 (1995-01-01), Egidio et al.
patent: 5446026 (1995-08-01), Ruff et al.
patent: 5470581 (1995-11-01), Grillo et al.
patent: 5484776 (1996-01-01), Racz et al.
patent: 5516523 (1996-05-01), Heiber et al.
patent: 5534505 (1996-07-01), Widauer
patent: 5578304 (1996-11-01), Sipos
patent: 5599926 (1997-02-01), Still et al.
patent: 5641767 (1997-06-01), Wess et al.
patent: 5653987 (1997-08-01), Modi et al.
patent: 5686588 (1997-11-01), Yoo
patent: 5750104 (1998-05-01), Sipos
patent: 5750707 (1998-05-01), Spargo
patent: 5843929 (1998-12-01), Larson et al.
patent: 5846964 (1998-12-01), Ozeki
patent: 5858998 (1999-01-01), Leuschner
patent: 5863550 (1999-01-01), Maeda et al.
patent: 5945411 (1999-08-01), Larson et al.
patent: 5977070 (1999-11-01), Piazza et al.
patent: 6210699 (2001-04-01), Acharya et al.
patent: 6245753 (2001-06-01), Byun et al.
patent: 0086705 (1983-08-01), None
patent: 0312052 (1989-04-01), None
patent: 55022616 (1980-02-01), None
patent: 62-153220 (1985-12-01), None
patent: 62153220 (1987-07-01), None
patent: 62153220 (1987-07-01), None
patent: 99/61481 (1999-12-01), None
patent: 00/04875 (2000-02-01), None
Nakazawa et al., “Oral aqueous formulation . . . ”, Database CAPLUS, AN 1988:26970, JP 62153220(abstract only), 7-1987
Farraj et al., Modification of the aqueous solubility and . . . Database CAPLUS, AN 1989:445142, International Journal of Pharmaceutics(abstract), 1989, Vo. 52(1), pp. 11-18.
Lee et al., “Complexation of bile acids with beta-cyclodextrin”, Database CAPLUS, Yakhak Hoechi, (abstract) 1994, vol. 38(1), pp. 78-85.
Panini et al., Pharmacological Research, vol. 31, No. 3/4, 1995.
Ventura et al., International Journal of Pharmaceutics, vol. 149, (1997), pp. 1-13.
Vandelli et al, International Journal of Pharmaceutics, vol. 118, (1995), pp. 77-83.
Higginbottom et al., International Journal of Pharmaceutics, vol. 109 (1994), pp. 173-180.
Graham et al., “H. pyloriin the Pathogenesis of Durodenal Ulcer: Interaction Between Duodenal Acid Load, Bile, andH. pylori”, American Journal of Gastroenterology (2000), vol. 95, No. 1, pp. 87-91.
Hammad et al., “Solubility and Stability of Lorazepam in Bile Salt/Soya Phosphatidylcholine-Mixed Micelles”, Drug Development and Industrial Pharmacy, (1999) vol. 25, No. 4, pp. 409-417.
Itoh et al. “The interaction of bile acids andHelicobacter pylori”, J. GASTROENTEROL (1999), 34:653-654.
Invernizzi et al., “Differences in the Metabolism and Disposition of Ursodeoxycholic Acid and of its Taurine-Conjugated Species in Patients with Primary Biliary Cirrhosis”, HEPATOLOGY, (1999) vol. 29, No. 2 pp. 320-327.
Itoh et al., “Antibacterial action of bile acids againstHelicobacter pyloriand changes in its ultrastructural morphology: effect of unconjugated dihydroxy bile acide”, J. GASTROENTEROL, (1999) 34:571-576.
Knopp et al., “Long-Term Blood Cholesterol-Lowering Effects of a Dietary Fiber Supplement”, Am J. Pre. Med (1999) 17(1):18-23.
F. Lanzarotto et al., “Effect of Long-Term Simvastatin Administration as an Adjunct to Ursodeoxycholic Acid: Evidence for a Synergistic Effect on Biliary Bile Acid Composition by Not on Serum Lipids in Humans”, GUT, (1999) vol. 4 pp. 552-556.
Leuschner et al., “Oral Budesonide and Ursodeoxycholic Acid for Treatment of Primary Biliary Cirrhosis: Results of a Prospective Double-Blind Trial”, GASTROENTEROLOGY, (1999) vol. 117 pp. 918-925.
Na et al., “Cloud Point of Nonionic Surfactants: Modulation with Pharmaceutical Excipients”, Pharmaceutical Research, (1999) vol. 16, No. 4 pp. 562-568.
Osato et al., “Osmotic Effect of Honey on Growth and Viability ofHelicobacter pylori”, Digestive Diseases and Sciences, (1999) vol. 44, No. 3 pp. 462-464.
Sinisalo et al., “Ursodeoxycholic Acid and Endothelial-Dependent, Nitric Oxide-Independent Vasodilatation of Forearm Resistance Arteries in Patients with Coronary Heart Disease”, Br. J. Clin. Pharamcol., (1999) vol. 47 pp. 661-665.
Verrips et al., “Effect of Simvastatin in Addition to Chenodeoxycholic Acid in Patients with Cerebrotendinous Xanthomatosis”, METABOLISM, (1999) vol. 48, No. 2 pp. 233-238.
Wacker Biochem. Corp., advertisement,C&EN, 31 (Apr. 12, 1999).
M. A. Hammad, B. W. Müller, Increasing Drug Solubility by Means of Bile Salt-Phosphatidylcholine-Based Mixed Micelles, European J. of Pharmaceutics and Biopharmaceutics. (1998) vol. 46 pp. 361-367.
M. A. Hammad et al., “Solubility and Stability of Tetrazepam in Mixed Micelles”, European J. of Pharmaceutical Sciences, (1998) vol. 7 pp. 49-55.
Oliva et al., “Ursodeoxycholate Alleviates Alcoholic Fatty Liver Damage in Rats”, Alcohol Clin Exp Res., (1998), vol. 22, No. 7,pp. 1538-1543.
Rodrigues et a;l, “Ursodeoxycholic Acid May Inhibit Deoxyxholic Acid-Induced Apoptosis by Modulating Mitochondrial Transmembrane Potential and Reactive Oxygen Production”, Molecular Medicine (1998) 4: 165-178.
Invernizzi et al., “Ursodeoxycholate inhibits induction of NOS in human intestinal epithelial cells and in vivo”, Am J Physiol (1997) 273:G131-138.
Shinya Nagamatsu, “Phase I Clinical Study of Ursodesoxycholic Acid”, Jpn. Pharmacol. Ther., (1997) vol. 25, No. 6 pp. 145-159.
Keith D. Lindor, M.D., “Ursodiol For Primary Sclerosing Cholangitis”, The New England Journal of Medicine, (1997) vol. 336, No. 10., pp. 691-695.
Binek et al., “Bedeutung von Ursodeoxycholsäure bei der Eradikation vonHelicobacter pylori”, Schweitz Med Wochenschr (1996) 126 (Suppl. 79): 44S-46S.
Crosignani, et al., “Clinical Pharamcokinetics of Therapeutic Bile Acids”, Clin. Pharmacokinet, (1996) vol. 30, No. 5 pp. 333-358.
Han et al., “The Interaction of pH, Bile andHelicobacter pyloriMay Explain Duofenial Ulcer”, American Journal of Gastroenterology (1996) vol. 91, No. 6, pp. 1135-1137.
Mohler et al., “Effect of Ursodeoxycholic Acid on HCV Replication in Subtyped Chronic Hepatitis C”, Digestive Disease and Sciences, (1996) vol. 41, No. 6 p. 1276.
Newman et al., “Starch”, Analytical Pro
LandOfFree
Preparation of aqueous clear solution dosage forms with bile... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Preparation of aqueous clear solution dosage forms with bile..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Preparation of aqueous clear solution dosage forms with bile... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3889627