Delayed release dosage form

Details Delayed release dosage form Delayed release dosage form

2011-06-21

2011-06-21

Wax, Robert A (Department: 1619)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S474000, C424S482000

Reexamination Certificate

active

07964215

ABSTRACT:
The present invention is directed to a delayed release pharmaceutical composition in solid dosage form comprising a core comprised of a therapeutically effective amount of drug, e.g., mesalamine, and a pH sensitive coating comprising a mixture of two different pH sensitive polymers, the first pH sensitive polymer dissolves in an aqueous solution at a pH of about 7 or greater and the second pH sensitive polymer dissolves in an aqueous solution at a pH of about 6 or greater, wherein the weight ratio of the first pH sensitive polymer to the second pH sensitive polymer ranges from about 2:1 to about 4:1 and the percent weight gain resulting from the addition of the pH sensitive coating ranges from about 8% up to and including 15% by weight of the core, including any subcoating.

REFERENCES:
patent: 4910021 (1990-03-01), Davis et al.
patent: 5013727 (1991-05-01), Halskov
patent: 5171580 (1992-12-01), Iamartino et al.
patent: 5541170 (1996-07-01), Rhodes et al.
patent: 5541171 (1996-07-01), Rhodes et al.
patent: 5914132 (1999-06-01), Kelm et al.
patent: 6039975 (2000-03-01), Shah et al.
patent: 6165513 (2000-12-01), Dansereau et al.
patent: 6228396 (2001-05-01), Watts
patent: 6413494 (2002-07-01), Lee et al.
patent: 6893662 (2005-05-01), Dittmar et al.
patent: 2002/0015735 (2002-02-01), Hedden et al.
Khan et al “A pH Dependent Colon-Targeted Oral Drug Delivery System Using Methacrylic Acid Copolymers. II. Manipulation of Drug Release Using Eudragit® L100 and Eudragit S100 Combinations,” Drug Development and Industrial Pharmacy, 26(5): 549-554 (2000).
Khan et al (“A pH Dependent Colon-Targeted Oral Drug Delivery System Using Methacrylic Acid Copolymers. II. Manipulation of Drug Release Using Eudragit® L100 and Eudragit $100 Combinations,” Drug Development and Industrial Pharmacy, 26(5): 549-554 (2000)).
Khan, et al., “A pH-dependent colon targeted oral drug delivery system using methacrylic acid copolymers, I. Manipulation of drug release using Eudragit®L100-55 and Eudragit® S100 combinations ”, Journal of Controlled Release, 58 (1999) pp. 215-222.
Khan, et al., “A pH-Dependent Colon-Targeted Oral Drug Delivery System Using Methacrylic Acid Copolymers. II. Manipulation of Drug Release Using Eudragit® L100 and Eudragit® S100 Combinations”, Drug Development and Industrial Pharmacy, 26(5), pp. 549-554 (2000).
S.K. Jain, “Pharmaceutical Approaches to Colon Targeted Drug Delivery System”, Research Projects Laboratory, Department of Pharmaceutical Sciences, Gour University, Sagar (M.P.), India (pp. 33-66 (2003).
Saffran, et al., “A New Approach to the Oral Administration of Insulin and other Peptide Drugs”, Science, vol. 233, pp. 1081-1084 ((1986).
Roseman, et al., “Controlled Release of Bioactive Materials”, Proceedings of the 20th International Symposium, Controlled Release Society, Inc., pp. 288-289 (1993).
Rubinstein, et al., In Vitro Evaluation of Calcium Pectinate: A Potential Colon-Specific Drug Delivery Carrier, Pharmaceutical Research, vol. 10, pp. 258-263 (1993).
Rubenstein, et al., “Colonic Drug Delivery, Enhanced Release of Infomethacin from Cross-Linked Chondroitin Matrix in Rat Cecal Content”, Pharmaceutical Research, vol. 9, pp. 276-278 (1992 ).
Rubenstein, et al., “Synthesis and swelling-dependent enzymatic degradation of borax-modified guar gum for colonic delivery purposes”, S.T.P. Pharma Sciences 5(1), 41-46 (1995).
Ashford, et al., “An in vitro investigation into the suitability of pH-dependent polymers for colonic targeting”, International Journal of Pharmaceutics 91, pp. 241-245 (1993).
Schroeder, et al., “Coated Oral 5-AminosalicylicAcid Therapy for Mildly to moderately Active Ulcerative Colitis”, The New England Journal of Medicine, pp. 1625-1629 (1987).
Ashford, et al., “Targeting Drugs to the Colon: Delivery System for Oral Administration”, Journal of Drug Targeting, vol. 2, pp. 241-257 (1994).
Mackay, et al., “Colonic Delivery of Therapeutic Peptides and Proteins”, Colonic Absorption and Metabolism, Human Pharmacology Institute, pp. 159-177 (1993).
Gurny, et al., Pulsatile Drug Delivery, Band 33, pp. 11-25 (1993).

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