Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1998-12-04
2001-04-03
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S472000, C424S480000, C424S482000
Reexamination Certificate
active
06210712
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to a novel and to an useful dosage form that provides a long duration and linear drug release with time administered to provide a therapeutic benefit. The invention relates, more particularly, to a dosage form comprising a first coat that provides both protection to a formulation comprising a drug and increases the fluid-transmission rate into the dosage form to maintain the linear drug release over time, and to a second and different coat that provides protection to the dosage form in a biological environment of use. The invention concerns further the manufacture of the dosage form comprising the first coat and the second coat using a single solvent system in both coat manufacture.
BACKGROUND OF THE INVENTION
Pharmacy and medicine have discovered the use of dosage forms are increasingly important in the administration of drugs for better health. The dosage forms often provide improved patient compliance accompanied by better control of drug blood levels, reliable and reproducible drug-release profiles, and frequently a reduced coat of therapy.
In the past however, serious short comings were associated with the administration of drugs. For example, the dosage form did not mask an unpleasant taste, or the dosage form did not improve the stability of a drug formulation, or the dosage form did not prevent oxidation of a drug. Then too, materials used to manufacture a coat that enveloped a drug in a dosage form can abstract from the dosage form. For example, coatings made from carbohydrates are water-soluble, they readily disintegrate and give rise to noncontrolled dose dumping of a drug, or a coating made from an enteric phthalate pass intact through the stomach but undergo disintegration in the intestinal tract, or alkylcellulosic polymers such as ethylcellulose exposed to the gastrointestinal tract are lipophilic and absorb endogenous fats and consequently evidence a lack of structural integrity as seen in flaws or cracks in the coat; also, they can become impermeable to aqueous fluids including water and biological fluids to the extent they become nonfunctional for membrane-controlled delivery mechanisms.
It is clear from the above presentation that a long-felt need exists for a dosage form comprising a coat thereon for orally administering a drug at a controlled and sustained-release drug delivery profile with time. The need exists for a dosage form for administering a drug in a linear profile for cardiovascular, arthritic, respiratory, cancer, analgesic and other therapies. A dosage form is needed for replacing immediate-release dose-dumping form administered three or four times daily. There are reasons for seeking a dosage form that replaces immediate-release forms including a means for reducing peak blood levels followed by a sharp drop in blood levels, a means for lessening side effects, a means for maintaining the structural integrity of the dosage form, and a means for reducing the number of solvents to manufacture the dosage form.
OBJECTS OF THE INVENTION
Accordingly, in view of the above presentation, it is an immediate object of this invention to provide a novel and useful dosage form that overcomes the disadvantages associated with the prior art.
Another object of the present invention is to provide a dosage form comprising a first coat and a second coat that provides protection for the first coat from the environment of the gastrointestinal tract.
Another object of the invention is to provide a dosage form comprising a bilayer coat that maintains its integrity in the environment of use.
Another object of the present invention is to provide a dosage form manufactured as an osmotic drug delivery device that can be manufactured by standard manufacturing techniques into sizes, shapes, and forms that comprise an improvement in the drug dispensing art.
Another object of the invention is to make available to the drug dispensing art a dosage form comprising a bioprotective coat for protecting the dosage form in a biological environment of use.
Another object of the invention is to provide a dosage form comprising a coat comprising a blend of an ethylcellulose and a hydroxyalkylcellulose useful for manufacturing a dosage form.
Another object of the invention is to provide a dosage form comprising a first or interior coat consisting of ethylcellulose and hydroxypropylcellulose shielded by a second or exterior coat consisting of poly(cellulose acylate) from the environment of the gastrointestinal tract.
Another object of the invention is to provide a polymer composition comprising a hydrophobic polymer insoluble in the digestive system and a hydrophilic polymer soluble in the digestive system that dissolves from the composition thereby increasing the porosity and increasing the permeability of the composition.
Another object of the invention is to provide a dosage form comprising a seamless coat that surrounds a formulation of drug and a seamless-bioprotective coat that surrounds former coat, which dual coats avoid a break-up in the gastrointestinal tract while correspondingly keeping the structural integrity of the dosage form.
Another object of the invention is to provide a dosage form comprising a dual coat for the controlled delivery of drug at a predetermined rate per hour over an extended time.
Other objects, features, aspects, and advantages of the invention will be more apparent to those versed in the dispensing art from the following detailed specification taken in conjunction with the drawing figures and the accompanying claims.
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Edgren David E.
Skluzacek Robert R.
ALZA Corporation
Fubara Blessing
Page Thurman K.
Sabatine Paul L.
Simboli Paul B.
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