Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2000-05-24
2001-05-01
Dees, Jose' G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S438000, C424S451000, C424S464000
Reexamination Certificate
active
06224908
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the oral delivery of a liquid dispersion of an active agent. More particularly, improved flow controller configurations are disclosed which prevent active agent formulation particles tom slipping in between the controller and the inner wall of the tubular delivery device. The controllers of the present invention allow a liquid to pass through or around the controller to form a suspension or slurry of the active agent formulation while preventing the controller from becoming stuck within the delivery device during administration of the active agent. The controllers of the present invention also provide an indication of the amount of the dose administered. Improved controller retention structures are also disclosed.
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 hormones.
There are patients that because of age or infirmity, have difficulty allowing 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 oesophageal 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 doser 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.
U.S. Pat. No. 4,581,013 to Allen is directed to a doser for orally administering a medication. A tube with a removable closure and a radially extending plate supports a solid medication and permits passage of a stream of liquid. The tube is fitted on top of a straw that is placed into a liquid.
U.S. Pat. No. 4,792,333 to Kidder describes a tamper proof package for containing and orally administering a solid substance. A tube has two portions that are separated by a supporting and confining means that supports and confines the solid substance but permits fluid flow. The ends of the tube are hermetically sealed.
U.S. Pat. No. 4,981,468 to Benefiel et al. is directed to a unit dosage form for delivering a therapeutic agent in free-flowing form. A slanted grid supports the dose between two ends of a tube.
Published PCT Application WO 97103634 to Wong et al. describes an oral active agent delivery system comprising a hollow chamber that contains discrete units of active agent. A fluid passing retainer prevents release of the discrete units but permits fluid entry into the chamber. The retainer is transportable with the fluid entering the system.
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).
SUMMARY OF THE INVENTION
In one aspect, the present invention provides improved flow controllers for oral active agent delivery devices. The active agent is in the form of discrete units and is contained within the lumen of a hollow tubular active agent delivery device. The controllers prevent release of the discrete units from the first end of the delivery device and permit fluid to enter into the lumen to form a suspension or slurry while lifting the formulation up the lumen towards the second end of the tubular member to the point of drug delivery.
In another aspect, improved flow controller retention structures are provided which prevent the controller from exiting through either end of the delivery device and facilitate use of the device.
In still another aspect, an improved controller for an oral active agent delivery system for delivering discrete units of active agent formulation in admixture with a fluid is provided. The system comprises a hollow tubular member having a first end and a second end and containing an active agent formulation in the form of discrete units between the ends, the controller being located within the hollow tubular member and capable of permitting fluid entry into the tubular member while preventing release of the discrete units from the first end of the tubular member and being transportable toward said second end by the fluid entering the system, and the controller comprises a core of bonded fibers.
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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.
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patent: 4320759 (1982-03-01), Theeuwes
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: 5985324 (1999-11-01), Wong et al.
patent: 6103265 (2000-08-01), Wong et al.
patent: 1906964 (1969-02-01), None
patent: WO97/03634 (1997-02-01), None
Etter Jeffrey W.
Ferrari Vincent J.
Horvath James
Martin Miriam A.
Ohms Christopher M. G.
ALZA Corporation
Covington & Burling
Dees Jose' G.
Reister Andrea G.
Shelborne Kathryne E.
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