Sustained release of guaifenesin

Details Sustained release of guaifenesin Sustained release of guaifenesin

2003-04-04

2010-11-23

Vu, Jake M. (Department: 1618)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S452000, C424S457000, C424S474000

Reexamination Certificate

active

07838032

ABSTRACT:
The invention relates to a novel pharmaceutical sustained release formulation of guaifenesin. The formulation may comprise a hydrophilic polymer, preferably a hydroxypropyl methylcellulose, and a water-insoluble polymer, preferably an acrylic resin, in a ratio range of about one-to-one (1:1) to about nine-to-one (9:1), more preferably a range of about three-to-two (3:2) to about six-to-one (6:1), and most preferably in a range of about two-to-one (2:1) to about four-to-one (4:1) by weight. This formulation capable of providing therapeutically effective bioavailability of guaifenesin for at least twelve hours after dosing in a human subject. The invention also relates to a modified release product which has two portions: a first portion having an immediate release formulation of guaifenesin and a second portion having a sustained release formulation of guaifenesin. The modified release product has a maximum guaifenesin serum concentration equivalent to that of an immediate release guaifenesin tablet, and is capable of providing therapeutically effective bioavailability of guaifenesin for at least twelve hours after dosing in a human subject.

REFERENCES:
patent: 2738303 (1956-03-01), Blythe
patent: 3065143 (1962-11-01), Christenson et al.
patent: 3362880 (1968-01-01), Sampson
patent: 3362881 (1968-01-01), Klaus et al.
patent: 3458622 (1969-07-01), Hill
patent: 3555151 (1971-01-01), Kaplan et al.
patent: 3634584 (1972-01-01), Poole
patent: 3870790 (1975-03-01), Lowey et al.
patent: 3981984 (1976-09-01), Signorino
patent: 4122157 (1978-10-01), Huber
patent: 4140755 (1979-02-01), Sheth et al.
patent: 4167558 (1979-09-01), Sheth et al.
patent: 4226849 (1980-10-01), Schor
patent: 4248857 (1981-02-01), DeNeale et al.
patent: 4248858 (1981-02-01), Guley et al.
patent: 4259314 (1981-03-01), Lowey
patent: 4308251 (1981-12-01), Dunn et al.
patent: 4309404 (1982-01-01), DeNeale et al.
patent: 4309405 (1982-01-01), Guley et al.
patent: 4357469 (1982-11-01), Schor
patent: 4369172 (1983-01-01), Schor et al.
patent: 4389393 (1983-06-01), Schor et al.
patent: 4424235 (1984-01-01), Sheth et al.
patent: 4540566 (1985-09-01), Davis et al.
patent: 4543370 (1985-09-01), Porter et al.
patent: 4552899 (1985-11-01), Sunshine et al.
patent: 4680323 (1987-07-01), Lowey
patent: 4695464 (1987-09-01), Alderman
patent: 4699779 (1987-10-01), Palinczar
patent: 4704285 (1987-11-01), Alderman
patent: 4756911 (1988-07-01), Drost et al.
patent: 4795643 (1989-01-01), Seth
patent: 4798725 (1989-01-01), Patel
patent: 4814179 (1989-03-01), Bolton et al.
patent: 4826688 (1989-05-01), Panoz et al.
patent: 4834965 (1989-05-01), Martani et al.
patent: 4834984 (1989-05-01), Goldie et al.
patent: 4851392 (1989-07-01), Shaw et al.
patent: 4871548 (1989-10-01), Edgren et al.
patent: 4900557 (1990-02-01), Dell et al.
patent: 4968508 (1990-11-01), Oren et al.
patent: 4971805 (1990-11-01), Kitanishi et al.
patent: 4980170 (1990-12-01), Schneider et al.
patent: 4983398 (1991-01-01), Gaylord et al.
patent: 4990341 (1991-02-01), Goldie et al.
patent: 4994276 (1991-02-01), Baichwal et al.
patent: 5004613 (1991-04-01), Radebaugh et al.
patent: 5032406 (1991-07-01), Dansereau et al.
patent: 5047248 (1991-09-01), Calanchi et al.
patent: 5085865 (1992-02-01), Nayak
patent: 5098715 (1992-03-01), McCabe et al.
patent: 5133974 (1992-07-01), Paradissis et al.
patent: 5164398 (1992-11-01), Sims et al.
patent: 5186943 (1993-02-01), Okada et al.
patent: 5186963 (1993-02-01), Howman
patent: 5200193 (1993-04-01), Radebaugh et al.
patent: 5260073 (1993-11-01), Phipps
patent: 5286493 (1994-02-01), Oshlack et al.
patent: 5292534 (1994-03-01), Valentine et al.
patent: 5326571 (1994-07-01), Wright et al.
patent: 5368861 (1994-11-01), Ushimaru et al.
patent: 5376384 (1994-12-01), Eichel et al.
patent: 5395626 (1995-03-01), Kotwal et al.
patent: 5403593 (1995-04-01), Royce
patent: 5427799 (1995-06-01), Valentine et al.
patent: 5445829 (1995-08-01), Paradissis et al.
patent: 5451409 (1995-09-01), Rencher et al.
patent: 5472704 (1995-12-01), Santus et al.
patent: 5486364 (1996-01-01), King et al.
patent: 5494681 (1996-02-01), Cuca et al.
patent: 5529791 (1996-06-01), Deboeck et al.
patent: 5576022 (1996-11-01), Yang et al.
patent: 5593694 (1997-01-01), Hayashida et al.
patent: 5650169 (1997-07-01), Conte et al.
patent: 5656296 (1997-08-01), Khan et al.
patent: 5662933 (1997-09-01), Baichwal et al.
patent: 5738874 (1998-04-01), Conte et al.
patent: 5773031 (1998-06-01), Shah et al.
patent: 5780057 (1998-07-01), Conte et al.
patent: 5807580 (1998-09-01), Luber
patent: 5840329 (1998-11-01), Bai
patent: 5945123 (1999-08-01), Hermelin
patent: 5968554 (1999-10-01), Beiman et al.
patent: 5993858 (1999-11-01), Crison et al.
patent: 6120802 (2000-09-01), Breitenbach et al.
patent: 6210710 (2001-04-01), Skinner
patent: 6217903 (2001-04-01), Skinner
patent: 6294199 (2001-09-01), Conley et al.
patent: 6312724 (2001-11-01), Odidi et al.
patent: 6372252 (2002-04-01), Blume et al.
patent: 6475521 (2002-11-01), Timmins et al.
patent: 6623756 (2003-09-01), Wilber et al.
patent: 6838094 (2005-01-01), Grimmett et al.
patent: 6955821 (2005-10-01), Davis et al.
patent: 2002/0022058 (2002-02-01), Lovercheck
patent: 2002/0142044 (2002-10-01), Vendola
patent: 2003/0012820 (2003-01-01), Upadhyay
patent: 2003/0039691 (2003-02-01), Waterman
patent: 2003/0091624 (2003-05-01), Szymczak et al.
patent: 2003/0147952 (2003-08-01), Lim et al.
patent: 2003/0215508 (2003-11-01), Davis et al.
patent: 2004/0022851 (2004-02-01), Davis et al.
patent: 2004/0033258 (2004-02-01), Koike
patent: 2004/0156902 (2004-08-01), Lee et al.
patent: 2004/0180085 (2004-09-01), Ohkouchi et al.
patent: 2005/0095288 (2005-05-01), Honea
patent: 2005/0152967 (2005-07-01), Tengler et al.
patent: 2005/0276852 (2005-12-01), Davis et al.
patent: 0409781 (1994-06-01), None
patent: 0 875 245 (1999-09-01), None
patent: 2255344 (1992-11-01), None
patent: 7277962 (1995-10-01), None
patent: WO 87/00044 (1987-01-01), None
patent: 94/06416 (1994-03-01), None
patent: 94/27557 (1994-12-01), None
patent: 95/20946 (1995-08-01), None
patent: 95/28148 (1995-10-01), None
patent: 96/04908 (1996-02-01), None
patent: 97/09042 (1997-03-01), None
patent: 98/05305 (1998-02-01), None
patent: 98/22091 (1998-05-01), None
patent: WO 98/22097 (1998-05-01), None
patent: WO 00/33818 (2000-06-01), None
patent: WO 01/19901 (2001-03-01), None
The Physicians' Desk Reference: For Nonprescription Drugs and Dietary Supplements, 20th edition, 1999, Medical Economics Company, Inc, Montvale, NJ USA.
Lacy et al (Drug Information Handbook. p. 481 (1999).
Bodmeier, R. et al., “Prolonged Release Multiple-Unit Dosage Forms Based On Water-Soluble Cellulosic Polymers or Aqueous Latexes,”Proceed. Intern. Sump. Control. Rel. Bioact. Mater., 18 (1991), Controlled Release Society, Inc.
Bauer et al., “Coated Pharmaceutical Dosage Forms,” p. 83 (MedPharm Scientific Publishers 1998).
Request for Reexamination, filed Apr. 20, 2005, USPN 6,372,252, Issued Apr. 16, 2002.
Welling, P.G., “Oral Controlled Drug Administration: Pharmacokinetic Considerations”, Drug Dev. Ind. Pharm., 9, 1185-1225 (1983).
Kim, C., “Pharmacokinetic Considerations in the Design of Controlled Release Dosage Forms,” Controlled Release Dosage Form Design, ch. 11 (Technomic Publishing Co., Inc. 2000)
International Search Report dated Aug. 19, 2003 for International Application No. PCT/US03/11500, filed Apr. 15, 2003.
Physicians' Desk Reference: For Nonprescription Drugs and Dietary Supplements 807 (Medical Economics Company, Inc., 20th ed. 1999).
Ansel HC and Popovich NG. Pharmaceutical Dosage Forms and Drug Delivery Systems, Fifth Edition, Lea & Febiger. 1990. p. 64.
Bankser GS and Rhodes CT. Modern Pharmaceutics, Fourth Edition, Marcel Dekker, Inc. 2002, p. 83.
Curriculum Vitae of Peter Anthony Crooks, MSc, PhD, FRPharmS, CSci, CChem, FRSC (Jul. 2006).
United Research Laboratories and Mutual Pharmaceutical Company, Press Release: United Research Laboratories/Mutual Pharmaceutical Company Announce ANDA Filing for Guaifenesin Extended-Rele

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