Surgery – Controlled release therapeutic device or system – Osmotic or diffusion pumped device or system
Reexamination Certificate
1999-06-25
2001-02-06
Page, Thurman K. (Department: 1615)
Surgery
Controlled release therapeutic device or system
Osmotic or diffusion pumped device or system
C424S451000, C424S452000, C424S453000
Reexamination Certificate
active
06183466
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to a controlled-release dosage form. More particularly, the invention relates to a dosage form comprising a wall encapsulating a space for holding and storing a capsule. The invention concerns also (1) a process for providing a controlled-release dosage form comprising a wall that defines a space for housing an internal capsule, and (2) a process for converting a non-controlled drug releasing capsule into a controlled-release dosage form.
BACKGROUND OF THE INVENTION
Capsules are dosage form in which a composition comprising a drug is enclosed within a wall. Capsules are a popular method for administering a drug in both prescription practice and in over-the-counter practice. Capsules are used widely in hospitals, nursing homes, retirement centers, homes, and in other environments, such as the military and naval environments. Capsules enjoy this popularity because they are tasteless, essentially innocuous, easily administered, easily filled extemporaneously, and they can be manufactured in large numbers. Additionally, some capsule users find it easier to swallow capsules than other dosage forms, such as a solid tablet.
While the above advantages and patient preference contribute to the continuing acceptance of capsules, there are certain shortcomings associated with capsules. For example, after oral administration, capsules give up all their useful drug immediately. That is, capsules are dose-dumping dosage forms. The therapeutic consequence of this dose-dumping is non-controlled therapy consisting of an initially high dose of drug, followed by a total absence of drug between later administered capsules. For many drugs, this form of administration can have undesirable therapeutic effects, especially if the drug has a low therapeutic index and is not suited to time-varying rates of administration. Another shortcoming associated with capsules is they are poorly suited for administering drugs with short biological half-lives, and this results in exclusion of large drugs including mammalian biochemicals, natural hormones, humoral factors, and the like.
Yet another shortcoming associated with capsules is their instant delivery and its accompanying detrimental effects. Because of this inherency, capsules require a high frequency of use, and this can lead to a failure of patient compliance for a prescribed dosage schedule. Such failures are reflected in a lack of therapeutic effectiveness, and in possible toxic effects. The latter effects can occur when patients double or triple their dosage to compensate for their prior omissions. Faulty non-compliance associated with the use of capsules is a common and largely ignored problem.
It will be appreciated by those versed in the drug delivery art in the light of this presentation that if a dosage form is provided comprising a capsule that is essentially free of the tribulations known to the prior art, such a dosage form comprising a capsule would have a positive therapeutic value and it would also represent an unexpected advancement in the drug delivery art. The present invention advances the state of the drug delivery art by providing a dosage form manufactured to house a capsule for optimizing the therapeutic effects of a drug. The dosage form comprising the capsule administers a drug at a controlled rate for a prescribed period of time. The dosage form provides continuous control over the administration of the drug, and it maintains this control over an extended period of time.
OBJECTS OF THE INVENTION
Accordingly, it is an immediate object of this invention to provide a dosage form comprising a capsule for delivering a drug at a controlled rate over a sustained period of time, which dosage form represents both an unexpected improvement and an unexpected advancement in the drug delivery art.
Yet another object of the invention is to provide a dosage form comprising a capsule which capsule comprises a solution, oil, emulsion, sol or suspension, that can be delivered by the dosage form at a programmed, controlled rate over a prolonged period of time.
Yet another object of this invention is to provide a dosage form comprising a capsule, which capsule comprises a composition in solid form selected from the group consisting of solid, powdered, pulverized, micronized and particle form, which forms in the presence of fluid imbibed into the dosage form forms a solution or a suspension that is delivered by the dosage form in a sustained-release period up to twenty-four hours.
Yet another object of this invention is to provide a dosage form comprising a capsule, which dosage form is simple in construction and exhibits all the practical benefits of controlled and continuous administration of a drug formulation during the dosage form's residency in a biological environment of use over a prolonged period of time up to twenty-four hours.
Yet another object of this invention is to provide a dosage form for administering a drug in the gastrointestinal tract by making available a dosage form that maintains its integrity in the gastrointestinal tract during its complete transit therethrough.
Yet another object of this invention is to provide a dosage form comprising a wall that envelopes a space for receiving a capsule, which capsule comprises a drug formulation that includes a pharmaceutically acceptable carrier, and which drug can be delivered by the dosage form at meaningful and therapeutic rates over a prolonged period of time.
Yet another object of the invention is to provide a dosage form comprising a composition comprising an expandable hydrogel.
Yet another object of the invention is to provide a dosage form comprising a wall that comprises a semipermeable composition, which wall encapsulates an internal placed capsule comprising a drug formulation.
Yet another object of the invention is to provide a dosage form comprising both a capsule and a composition comprising an expandable hydragel for displacing the contents of the capsule from the dosage form.
Yet another object of the invention is to provide a process for converting a non-controlled capsule into a controlled-release dosage form.
Yet another object of the invention is to provide a process for providing a dosage form comprising an exterior wall that defines an internal space for storing and holding a capsule.
Yet another object of the invention is to provide a process for manufacturing a dosage form, wherein the process comprises shaping a wall to define an internal compartment that functions as a space for receiving a capsule, which dosage form comprises a closed-end and an opened-end, placing a capsule comprising a drug formulation in the compartment, and closing the opened-mouth end while simultaneously providing an orifice in the dosage for delivering the drug formulation from the dosage form to a patient in need of therapy.
Other objects, features, aspects and advantages of the 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.
REFERENCES:
patent: 3916899 (1975-11-01), Theeuwes et al.
patent: 4627850 (1986-12-01), Deters et al.
patent: 5324280 (1994-06-01), Wong et al.
patent: 5614578 (1997-03-01), Dong et al.
Dong Liang C.
Ferrari Vincent J.
Theeuwes Felix
Wong Patrick S.-L.
ALZA Corporation
Dhuey John A.
Page Thurman K.
Pulliam Amy E.
Stone Steven F.
LandOfFree
Dosage form comprising a capsule 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 form comprising a capsule, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Dosage form comprising a capsule will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2601812