Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
1999-07-14
2001-01-16
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S451000, C424S455000, C424S456000, C424S457000
Reexamination Certificate
active
06174547
ABSTRACT:
FIELD OF THE INVENTION
The present invention pertains to a dosage form comprising a liquid formulation comprising a drug. More particularly, the invention concerns a dosage form comprising a liquid formulation comprising a drug that can self-emulsify to enhance the solubility, the dissolution, and the bioavailability of the drug. The invention concerns also a method of enhancing the therapeutic effect of a drug by using the dosage form of the invention
BACKGROUND OF THE INVENTION
Many drugs administered by the drug dispensing art possess hydrophobic properties that diminish their bioavailability caused by the slow rate of dissolution and concomitantly diminish their therapeutic effect. This is a serious problem with hydrophobic drugs. For example, the preparation and use of stable aqueous formulations comprising a hydrophobic drug, such as insoluble steroids including cortisone acetate, progesterone, testosterone propionate, estradiol monobenzoate, and the like hydrophobic drugs often leads to unwanted problems. These problems are exemplified by the growth of large crystals that can (1) diminish solubility, dissolution, and bioavailability of a drug; (2) be a source of irritation to a patient; and (3) give rise to mechanical difficulties in attempting to pass large crystals through hypodermic needles and through enteral and parenteral tubes.
It will be appreciated by those versed in the drug dispensing arts that if a dosage form comprising a drug formulation is made available that overcomes the tribulations of the prior art, such a dosage form would have a positive value in the drug dispensing art. Likewise, it will be scientifically self-evident to those versed in the drug delivery art, that if a dosage form is made available that delivers the essentially prescribed dose, such a dosage form would have immediate acceptance in the fields of human and veterinary medicine.
OBJECTS OF THE INVENTION
Accordingly, in view of the above presentation, it is an immediate object of this invention to provide a dosage form for the sustained release and the controlled delivery of a beneficial drug that overcomes the shortcomings associated with the prior art.
Another object of the invention is to provide a dosage form comprising a liquid formulation comprising a drug that can be delivered in a preselected and prescribed does of drug to a patient in need of therapy.
Another object of the invention is to provide a liquid formulation containing an aqueous insoluble drug that can now be dispensed in a known dose for a therapeutic use.
Another object of the invention is to provide a dosage form comprising a liquid formulation that undergoes conversion to an in situ, self-emulsifying formulation to enhance the oral bioavailability of a drug.
Another object of the invention is to provide a stable emulsion comprising an aqueous insoluble drug that remains relatively free of crystal growth, even after extended periods of time.
Another object of the invention is to provide a liquid formulation that can self-emulsify in sit to an oil-in-water microemulsion and thereby essentially prevent drug particles from aggregation/agglomeration during storage and drug delivery over time.
Another object of the invention is to provide an oil-in-water microemulsion wherein a drug has a higher solubility than in water.
Another object of the invention is to provide a self-emulsifying liquid carrier that enhances bioavailability in vivo of poorly absorbed drugs and is compatible with osmotic dosage forms.
Another object of the invention is to provide a dosage form for delivering in vivo a beneficial drug that is difficult to deliver and now can be delivered by this invention in a therapeutically effective dose over twenty-four hours.
Another object of the invention is to provide a dosage form comprising a capsule coated with a semipermeable that comprises a drug in a microemulsion formulation.
Another object of the invention is to provide an injection-molded dosage form comprising a hydrophobic drug in a microemulsion for delivery at a known rate over a sustained release period.
Other objects, features, aspects and advantages of this invention will be more apparent to those versed in the drug delivery art from the following detailed specification taken in conjunction with the drawings and the accompanying claims.
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Dong Liang-Chang
Espinal Steven
Wong Patrick S.-L.
ALZA Corporation
Dhuey John A.
Page Thurman K.
Queeney P. M.
Stone Steven F.
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