Dosage forms having prolonged active ingredient release

Details Dosage forms having prolonged active ingredient release Dosage forms having prolonged active ingredient release

2002-09-04

2009-11-03

Hartley, Michael G (Department: 1618)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C514S001000

Reexamination Certificate

active

07611729

ABSTRACT:
The present invention relates to prolonged-release oral dosage forms of 4-phenylbutyric acid salts, such as sodium 4-phenylbutyrate. The prolonged release oral dosage forms are preferably tablets. The prolonged release is achieved by formulating 4-phenylbutyric acid with a delaying matrix material, such as hydroxypropylmethyl cellulose. The prolonged release oral dosage forms of the present invention may be administered once or twice a day to a patient suffering from a disease such as cancer or a urea cycle disorder.

REFERENCES:
patent: 4457942 (1984-07-01), Brusilow
patent: 5569680 (1996-10-01), Wu
patent: 5654333 (1997-08-01), Samid
patent: 5661179 (1997-08-01), Samid
patent: 5710178 (1998-01-01), Samid
patent: 5912269 (1999-06-01), Tung et al.
patent: 5945407 (1999-08-01), Bemis et al.
patent: 5972995 (1999-10-01), Fischer et al.
patent: 6011000 (2000-01-01), Perrine et al.
patent: 6037376 (2000-03-01), Samid
patent: 6207195 (2001-03-01), Walsh et al.
patent: 6362226 (2002-03-01), Phillips, III et al.
patent: 6372938 (2002-04-01), Burzynski et al.
patent: 6403646 (2002-06-01), Perlmutter et al.
patent: 6495719 (2002-12-01), Lan-Hargest et al.
patent: 6635632 (2003-10-01), Wu et al.
patent: 6656912 (2003-12-01), Perlmutter et al.
patent: 2002/0115619 (2002-08-01), Rubenstein et al.
patent: 2002/0143037 (2002-10-01), Lan-Hargest et al.
patent: 2002/0143052 (2002-10-01), Lan-Hargest et al.
patent: 2002/0143196 (2002-10-01), Lan-Hargest et al.
patent: 2003/0083521 (2003-05-01), Lan-Hargest et al.
patent: 2003/0096762 (2003-05-01), Fischer et al.
patent: 2003/0114525 (2003-06-01), Kammer et al.
patent: 2003/0125306 (2003-07-01), Lan-Hargest et al.
patent: 2003/0166554 (2003-09-01), Cohen et al.
patent: 2003/0195256 (2003-10-01), Singh
patent: 2004/0044049 (2004-03-01), Pei et al.
patent: 2004/0077591 (2004-04-01), Dangond
patent: 2004/0142859 (2004-07-01), Steffan et al.
patent: 1 249 246 (2001-04-01), None
patent: 1 206 936 (2002-05-01), None
patent: 1 232 746 (2002-08-01), None
patent: WO 85/04805 (1985-11-01), None
patent: WO 93/07866 (1993-04-01), None
patent: WO 95/10271 (1995-04-01), None
patent: WO 95/10281 (1995-04-01), None
patent: WO 96/27369 (1996-09-01), None
patent: WO 98/40078 (1998-09-01), None
patent: WO 98/56370 (1998-12-01), None
patent: WO 99/37150 (1999-07-01), None
patent: WO 00/18394 (2000-04-01), None
patent: WO 00/56153 (2000-09-01), None
patent: WO 01/52830 (2001-07-01), None
patent: WO 01/97791 (2001-12-01), None
patent: WO 00/18394 (2002-04-01), None
patent: WO 02/056823 (2002-07-01), None
patent: WO 02/066672 (2002-08-01), None
patent: WO 02/076941 (2002-10-01), None
patent: WO 02/083173 (2002-10-01), None
patent: WO 02/090534 (2002-11-01), None
patent: WO 03/022253 (2003-03-01), None
patent: WO 03/066035 (2003-08-01), None
Remington's Pharmaceutical Sciences (18thEd, MACK publishing Co., 1990) Chpt 89 and 90.
UcyclydPharma www.buphenyl.com/about—buphenyl.htm Jun. 21, 2006.
Brettman, L.R., et al., “Pharmacokinetics and safety of single oral doses of VX-366 (isobutyramide) in healthy volunteers,”J. Clin. Pharmacol., 36(7):617-622 (Jul. 1996).
Brusilow, S.W., et al, “Urea cycle disorders: Diagnosis, pathophysiology, and therapy,”Adv. Pediatr., 43:127-170 (1996).
Chang, S.M., et al, “Phase II study of phenylacetate in patients with recurrent malignant glioma: A North American Brain Tumor Consortium Report,”J. Clin. Oncol., 17(3):984-990 (Mar. 1999).
Collins, A.F., et al., “Oral sodium phenylbutyrate therapy in homozygous beta thalassemia: a clinical trial,”Blood, 85(1):43-49 (Jan. 1, 1995).
Desmet, G., et al., “Pharmacokinetics of butyric acid derivative with xylitol,”Eur. J. Drug Metabol. Phar-macokinet, 3:348-351 (1991).
Fibach, E., et al, “Enhanced fetal hemoglobin production by phenylacetate and 4-phenylbutyrate in erythroid precursors derived from normal donors and patients with sickle cell anemia and beta-thalassemia,”Blood. 82(7):2203-2209 (Oct. 1, 1993).
Gilbert, J., et al., A phase I dose escalation and bioavailability study of oral sodium phenylbutyrate in patients with refractory solid tumor malignancies,Clin. Cancer Res., 7(8):2292-2300 (Aug. 2001).
Gore, S.D., et al., Impact of the putative differentiating agent sodium phenylbutyrate on myelodysplastic syndromes and acute myeloid leukemia,Clin. Cancer Res., 7(8):2330-2339 (Aug. 2001).
Johnstone, R.W., “Histone-deacetylase inhibitors: Novel drugs for the treatment of cancer,”Nat. Rev. Drug Discovery, 1(4):287-299 (Apr. 2002).
Lu, Q., et al., “Zn2+-chelating motif-tethered short-chain fatty acids as a novel class of histone deacetylase inhibitors,”J. Med. Chem., 47(2):467-474 (Jan. 15, 2004).
MacMillan, M.L., et al., “Treatment of Two Infants with Cooley's Anemia with Sodium Phenylbutyrate,”Ann. N. Y. Acad. Sci., 850:452-454 (Jun. 30, 1998).
Pellizzaro, C., “Cholesteryl butyrate in solid lipid nanospheres as an alternative approach for butyric acid delivery,”Anticancer Res., 19(5B):3921-3925 (Sep.-Oct. 1999).
Perlmutter, D.H., “Chemical Chaperones: A Pharmacological Strategy for Disorders of Protein Folding and Trafficking,”Pediatric Research, 52(6):832-836 (Dec. 2002).
Planchon, P., et al., “Differential elimination of synthetic butyric triglycerides in vivo: a pharmacokinetic study,”J. Pharm. Sci., 82(10):1046-1048 (Oct. 1993).
Pouillart, P., et al. “Butyric monosaccharide ester-induced cell differentiation and anti-tumor activity in mice. Importance of their prolonged biological effect for clinical applications in cancer therapy,”Int. J. Cancer, 49(1):89-95 (Aug. 19, 1991).
Pouillart, P., et al, “Pharmacokinetic studies of N-butyric acid mono- and polyesters derived from monosaccharides,”J. Pharm. Sci., 81(3):241-244 (1992).
Resar, L.M., et al., “Induction of fetal hemoglobin synthesis in children with sickle cell anemia on low-dose oral sodium phenylbutyrate therapy,”J. Pediatr. Hematol. Oncol., 24(9):737-741 (Dec. 2002).
Rubenstein, R.C., et al., “Sodium 4-phenylbutyrate downregulates Hsc70 Implications for intracellular trafficking of ΔF508-CFTR,”Am. Physiol. Soc., 278(2):C259-C267 (Feb. 2000).
Sung, M.W., and Waxman, S., “Chemodifferentiation Therapy with Fluorouracil (FU) and Phenyl-butyrate (PB) in Advanced Colorectal Cancer: a Phase I Trial,”Proc. Am. Assoc. Cancer Res., 40:339 Abstract No. 2245 (Mar. 1999).
Virgushin, D.M., et al, “Targeted histone deacetylase inhibition for cancer therapy,”Curr. Cancer Drug Targets, 4(2):205-218 (Mar. 2004).

Affiliated with

Also associated with

Rating

Dosage forms having prolonged active ingredient release does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Dosage forms having prolonged active ingredient release, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Dosage forms having prolonged active ingredient release will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-4071707