Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2000-02-25
2001-04-03
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C604S085000, C604S058000, C424S489000
Reexamination Certificate
active
06210713
ABSTRACT:
FIELD OF THE INVENTION
The present invention is related to the oral delivery of an active agent More particularly, it is method and device for oral delivery of an active agent formulation in the form of discrete units mixed with a fluid, by inserting the discrete units into a hollow active agent formulation chamber. A retainer in a first end of the chamber prevents the release of the discrete units from the first end of the chamber while allowing for fluid flow when suction is applied at the second end of the chamber. The discrete units can easily be swallowed in admixture with the fluid drawn through the chamber.
BACKGROUND OF THE INVENTION
Tablets, capsules, caplets and many other types of devices have been used for oral delivery of active agents. These forms are relatively easy to manufacture and convenient for use in the hospital or other institutional settings or at home. Many different types of active agents have been incorporated into such dosage forms—ranging from analgesics to antibiotics to hormones.
There are patients that, because of age or infirmity, have difficulty swallowing solid oral dosage forms. According to Kikendall et al.,
Digestive Diseases and Sciences
28:2(1983), there were 221 cases documented between 1970-1982 of tablet and capsule induced cesophageal injury. The most commonly implicated drugs were tetracycline (108 cases), emepromium bromide (36 cases), potassium chloride (16 cases) and ferrous salts (12 cases).
In view of the above, there exists a need for oral dosage forms where swallowing of a large solid system is avoided that are easy to use and manufacture.
U.S. Pat. No. 2,436,505 to DuRall describes a pill douser for administering medicines in liquid form or in pills or tablets. The device has a bowl at the top for containing the medicine and a tube that can be submerged in a liquid held in a drinking glass. The liquid is drawn upward for administering the liquid and any pill or tablet present in the bowl.
U.S. Pat. No. 2,867,536 to Mead et al. describes an improved drinking straw where a soluble flavoring material is contained within an annular space contained within an inner and an outer tube. The inner tube has a bore through which liquid can be drawn. During use, the upper and lower caps are removed, the flavoring material emptied into the liquid and the flavored liquid drawn up through the inner tube and into the mouth.
U.S. Pat. No. 3,610,483 to Visconti describes a dispensing device for liquid medication that is formed in the shape of a straw. A predetermined dose of liquid medication is loaded into the straw which is then capped at both ends until the medication is dispensed when a patient removes the caps and sucks air into the device.
A variety of other oral delivery systems have been described. These include a medicated pacifier (U.S. Pat. No. 5,123,915 to Miller et al.) and a lollipop type device for a solid medicament (U.S. Pat. No. 5,223,259 to Lackney). None of these devices or the devices described previously provide for the delivery of a solid medicament into the oral cavity as a bolus dose, while avoiding the difficulties inherent in swallowing a solid system such as a tablet or a capsule or the shelf-life problems encountered when a medicine is dissolved or dispersed in a fluid, preferably an aqueous liquid.
SUMMARY OF THE INVENTION
Accordingly, in one aspect, the present invention is directed to an oral delivery system for delivering discrete units of an active agent formulation in admixture with a fluid. The system comprises a hollow active agent formulation chamber. The chamber has a first end and a second end and contains an active agent formulation in the form of discrete units. The active agent formulation comprises an active agent. The system further compries a fluid passing active agent formulation retainer in the first end of the chamber. The retainer prevents release of the discrete units from the first end while permitting fluid entry into the chamber.
In one embodiment, the discrete units contained within the chamber are in particulate form.
In a second embodiment, the discrete units contained within the chamber are in the form of multiple active agent dosage forms.
In a second aspect, the present invention is directed to a method for orally delivering discrete units of an active agent formulation in admixture with a fluid. The method involves inserting discrete units of an active agent formulation into a hollow drug delivery chamber of a drug delivery device. The chamber has a first end and a second end. The first end of the chamber has a fluid passing active agent formulation retainer. The drug delivery device has a first and second end. The first end of the drug delivering device is inserted into a fluid and the second end is inserted into the mouth of a patient. The patient then applies suction to the second end of the device to cause delivery of the fluid and discrete units of active agent formulation into the patient's mouth.
REFERENCES:
patent: 1661400 (1928-03-01), Yehle
patent: 2436505 (1948-02-01), DuRall
patent: 2867536 (1959-01-01), Mead et al.
patent: 3409224 (1968-11-01), Harp et al.
patent: 3610483 (1971-10-01), Visconti et al.
patent: 3845770 (1974-11-01), Theeuwes et al.
patent: 3995631 (1976-12-01), Higuchi et al.
patent: 4034756 (1977-07-01), Higuchi et al.
patent: 4111202 (1978-09-01), Theeuwes et al.
patent: 4320759 (1982-03-01), Theeuwes et al.
patent: 4327725 (1982-05-01), Cortese et al.
patent: 4449983 (1984-05-01), Cortese et al.
patent: 4581013 (1986-04-01), Allen
patent: 4765989 (1988-08-01), Wong et al.
patent: 4792333 (1988-12-01), Kidder
patent: 4981468 (1991-01-01), Benefiel et al.
patent: 5094861 (1992-03-01), D'Auguste et al.
patent: 5110597 (1992-05-01), Wong
patent: 5123915 (1992-06-01), Miller et al.
patent: 5222940 (1993-06-01), Wilk
patent: 5223259 (1993-06-01), Lackney
patent: 5391381 (1995-02-01), Wong
patent: 5509605 (1996-04-01), Cripe
patent: 5718681 (1998-02-01), Manning
patent: 5780058 (1998-07-01), Wong et al.
patent: 1906964 (1969-02-01), None
Gardner Phyllis I.
Rosen Howard B.
Roth Nathan
Wong Patrick S.-L.
ALZA Corporation
Covington & Burling
Reister Andrea G.
Spear James M.
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