Solid oral dosage form containing an enhancer

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants

Reexamination Certificate

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C424S464000, C424S469000

Reexamination Certificate

active

07658938

ABSTRACT:
The invention relates to a solid oral dosage form comprising a pharmaceutically active ingredient in combination with an enhancer which enhances the bioavailability and/or the absorption of the active ingredient. Accordingly, a solid oral dosage form comprises a drug and an enhancer wherein the enhancer is a medium chain fatty acid ester, ether or salt or a derivative of a medium chain fatty acid, which is, preferably, solid at room temperature and which has a carbon chain length of from 6 to 20 carbon atoms. Preferably, the solid oral dosage form is controlled release dosage form such as a delayed release dosage form.

REFERENCES:
patent: 4525339 (1985-06-01), Behl et al.
patent: 4656161 (1987-04-01), Herr
patent: 4789547 (1988-12-01), Song et al.
patent: 5169933 (1992-12-01), Anderson et al.
patent: 5190748 (1993-03-01), Bachynsky et al.
patent: 5221734 (1993-06-01), Burk et al.
patent: 5229130 (1993-07-01), Sharma et al.
patent: 5288497 (1994-02-01), Stanley et al.
patent: 5346701 (1994-09-01), Heiber et al.
patent: 5541155 (1996-07-01), Leone-Bay et al.
patent: 5631347 (1997-05-01), Baker et al.
patent: 5650386 (1997-07-01), Leone-Bay et al.
patent: 5714477 (1998-02-01), Einarsson
patent: 5736161 (1998-04-01), Garces et al.
patent: 5840685 (1998-11-01), Fujii et al.
patent: 5854281 (1998-12-01), Uekama et al.
patent: 5863555 (1999-01-01), Heiber et al.
patent: 5912009 (1999-06-01), Venkateshwaran et al.
patent: 5952000 (1999-09-01), Venkateshwaran et al.
patent: 5977175 (1999-11-01), Lin
patent: 6001390 (1999-12-01), Yum et al.
patent: 6017559 (2000-01-01), Mulqueen et al.
patent: 6124261 (2000-09-01), Stevenson et al.
patent: 6200602 (2001-03-01), Watts et al.
patent: 6270804 (2001-08-01), Getz et al.
patent: 6326360 (2001-12-01), Kanazawa et al.
patent: 6372728 (2002-04-01), Ungell
patent: 6379960 (2002-04-01), Popoff et al.
patent: 6468559 (2002-10-01), Chen et al.
patent: 6638530 (2003-10-01), Ishibashi et al.
patent: 6747014 (2004-06-01), Teng et al.
patent: 7154002 (2006-12-01), Bressi et al.
patent: 2003/0176397 (2003-09-01), Lichtenberger
patent: 2004/0087631 (2004-05-01), Bacopoulos et al.
patent: 2006/0210639 (2006-09-01), Liversidge et al.
patent: 2007/0060509 (2007-03-01), Kanikanti et al.
patent: 2007/0148228 (2007-06-01), Cumming et al.
patent: 2007/0196464 (2007-08-01), Cumming et al.
patent: 2007/0238707 (2007-10-01), Leonard
patent: 2007/0292512 (2007-12-01), Leonard et al.
patent: 2008/0275001 (2008-11-01), Cumming et al.
patent: 0370481 (1989-11-01), None
patent: 0376534 (1990-07-01), None
patent: 0497162 (1992-08-01), None
patent: 0517211 (1992-12-01), None
patent: 0580074 (1994-01-01), None
patent: 953626 (1964-03-01), None
patent: (11) 63119 (1989-11-01), None
patent: (11)63119 (1995-03-01), None
patent: 59 073600 (1984-04-01), None
patent: 03 275633 (1991-12-01), None
patent: 2068689 (1996-11-01), None
patent: WO 8404674 (1984-12-01), None
patent: WO 93/05903 (1993-04-01), None
patent: WO 93/21907 (1993-11-01), None
patent: WO 9522319 (1995-08-01), None
patent: WO 9534294 (1995-12-01), None
patent: WO 97/05903 (1997-02-01), None
patent: WO 99/01579 (1999-01-01), None
patent: WO 99/02120 (1999-01-01), None
patent: WO 99/02485 (1999-01-01), None
patent: WO 99/45934 (1999-09-01), None
patent: WO 00/22909 (2000-04-01), None
patent: WO 00/50012 (2000-08-01), None
patent: WO 02/092070 (2002-11-01), None
patent: WO 03/047493 (2003-06-01), None
patent: WO 2005/055973 (2005-06-01), None
Oda et al., Proc. Int'l Symp. Control. Rel. Bioact. Mater. 24 (1997) pp. 283-284.
Appendix A: Webpage publication provided by Lambent Technologies—www.petroferm.com/prodinfo.asp?bus=2&mkt=4&app=3.
Lambent Technologies: Technical Data Sheet for Lumulse L-4, Lumulse L-12 and Lumulse L-23.
“McGraw-Hill Dictionary of Chemical Terms”; McGraw-Hill Book Company: Ed. S.P. Parker, New York 1985 (pp. 208, 209 and 251).
Andriuoli et al.,. Haemostasis 20(suppl 1):154-158 (1990).
Lindmark et al., J. Pharm. Ex. Therapeutics275(2):958-964 (1995).
Aungst, B.J. et al., Enhancement of the Intestinal Absorption of Peptides and Non-peptides,J. of Controlled Release(1996), 41:19-31.
Lindmark, T. et al., Mechanism of Absorption Enhancement in Humans After Rectal Administration of Ampicillin in Suppositories Containing Sodium Caprate,Pharmaceutical Research(1997), 14: 930-935.
Anderberg, E.K. et al., Sodium Caprate Elicits Dilatations in Human Intestinal Tight Junctions and Enhances Drug Absorption by the Paracellular Route,Pharmaceutical Research(1993), 10: 857-864.
Yeh, P. et al., Effect of Medium-chain Glycerides on Physiological Properties of Rabbit Intestinal Epithelium in Vitro,Pharmaceutical Resarch-(1994), 11:1148-1154.
Artursson, P., Epithelial Transport of Drugs in Cell Culture. I: A Model for Studying the Passive Diffusion of Drugs over Intestinal Absorbative (Caco-2) Cells,J. Pharmaceutical Studies(1990), 79: 476-482.
Doluisio, J.T. et al., Drug Absorption I: An In Situ Rat Gut Technique Yielding Realistic Absorption Rates,J. Pharmaceutical Studies(1969), 59: 1196-1200.
Brayden, D. et al., Heparin Absorption Across the Intestine: Effects of Sodium N-[8-(2-Hydroxybenzoyl)Amino]Caprylate In Rat In Situ Intestinal Instillations and in Caco-2 Monolayers,Pharmaceutical Research(1997), 14:1772-1779.
Cumming, K.I. and A.J. Winfield, In Vitro Evaluation of a Series of Sodium Carboxylates as Dermal Penetration Enhancers,Int. J. Pharm.(1994), 108: 141-148.
Tomita, M. et al., Enhancement of Colonic Drug Absorption by the Paracellular Permeation Route,Pharmaceutical Research(1988), 5: 341-346.
Aungst, Bruce K. et al., Enhancement of the Intestinal Absorption of Peptides and Non-Peptides, Journal of Controlled Release 41 (1996) pp. 19-31.
Palin, K. J. et al., The Oral Absorption of Cefoxitin from Oil and Emulsion Vehicles in Rats, International Journal of Pharmaceutics, 33 (1986) pp. 99-104.
Tomita, M. et al., Enhancement of Colonic Drug Absorption by the Paracellular Permeation Route, Pharmaceutical Research vol. 5, No. 6, (1988), pp. 341-346.
Murakami, M. et al., Effect of Oleic Acid Vesicles on Intestinal Absorption of Carboxyfluorescein in Rats, Pharmaceutical Research, vol. 3, No. 1, 1986, pp. 35-40.
Muranushi, N. et al., The Effects Of Fatty Acids and Their Derivatives on The Intestinal Absorption of Insulin In Rats, Drug Development and Industrial Pharmacy, 19(8), pp. 929-941 (1993).
Tomita, M. et al., Differences in the Enhancing Effects of Sodium Caprate on Colonic and Jejunal Drug Absorption, Pharmaceutical Research, vol. 9, No. 5, 1992, pp. 648-653.
Tomita, M. et al., Enhancement of Colonic Drug Absorption by the Transcellular Permeation Route, Pharmaceutical Research vol. 5., No. 12 (1988), pp. 786-789.
Anderberg, E. K. et al., Sodium Caprate Elicits Dilatations in Human Intestinal Tight Junctions and Enhances Drug Absorption by the Paracellular Route, Pharmaceutical Research vol. 10, No. 6, 1993, pp. 857-864.
Tomita, Mikio, et al., Absorption-Enhancing Mechanism of Sodium Caprate and Decanoylcarnitine in Caco-2 Cells , The Journal of Pharmacology and Experimental Therapeutics, vol. 272, No. 2, 1995, pp. 739-743.
Sawada, T., et al., Role of Paracellular Pathway in Nonelectrolyte Permeation Across Rat Colon Epithelium Enhanced by Sodium Caprate and Sodium Caprylate, Pharmaceutical Research, vol. 8, No. 11, 1991, pp. 1365-1371.
Aungst, “Structure/effect studies of fatty acid isomers as skin penetration enhancers and skin irritants,” Pharm. Res. 6:244-247 (1989).
Chan et al., “Depsipeptide (FR901228, NSC-630176) pharmacokinetics in the rat by LC/MS/MS,” Invest. New Drugs 15:195-206 (1997).
Mishima et al., “Studies on the Promoting Effects of Medium Chain Fatty Acid Salts on the Nasal Absorption of Insulin in Rats,” J. Pharmacobio-Dyn., 10:624-631 (1987).
Morishita et al., “Site-Dependent Effect of Aprotinin, Sodium Caprate, Na2EDTA and Sodium Glycocholate on Intestinal Absorption of Insulin,” Biol. Pharm. Bull. 16:68-72 (1993).
Schneider et al., “Evaluation of drug penetration into human skin ex viv

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