Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-07-12
2003-12-02
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S451000, C424S453000, C424S400000, C424S465000
Reexamination Certificate
active
06656501
ABSTRACT:
BACKGROUND OF THE INVENTION
COPYRIGHT NOTICE
© Copyright 2000, John T. Cooker. All rights reserved.
A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the USPTO patent file or records, but otherwise reserves all copyright rights whatsoever.
1. Field of the Invention
The present invention generally relates to an oral delivery system.
2. Problem to be Solved
Over the years, the pharmaceutical industry has developed a variety of medications, medicaments, vitamins, nutritional supplements, etc. (collectively referred to herein as “oral dosages”) that can be taken orally and which are in the form of capsules, tablets, gel caps and their like (collectively referred to herein as “oral dosage forms”). However, many consumers have experienced difficulty in swallowing such oral dosage forms. Specifically, many types of available oral dosage forms become buoyant on the liquid with which they are taken. This is especially the case with capsules which are hardened reservoirs of gelatin filled with powdered ingredients and air. As a result of such a configuration, the powdered ingredients and air become bubbles sealed in gelatin.
The buoyancy of the oral dosage forms on the liquid causes discomfort and creates difficulty in swallowing. Specifically, the buoyancy property creates the following problems:
1) the buoyancy of the oral dosage form works against the downward motion of swallowing and also reduces control of the oral dosage form by the tongue and pharynx muscles;
2) the dry gelatin outer surface of a capsule or gel cap, when wetted, quickly becomes sticky and easily adheres to surfaces it contacts. As a result, the oral dosage form may be left behind as it follows the liquid down the pharynx and esophagus thereby requiring successive swallows of additional liquid to flush down the oral dosage form; and
3) a capsule, while floating on the liquid, may move out of its intended aligned position in which the narrow end of its cylindrical shape points toward the pharynx and esophagus and as a result, is swallowed at an uncomfortable angle, possibly becoming lodged in the process.
Oral dosage forms that have a cylindrical, oval or rectangular shape (but not round), and are not heavy enough to sink on the liquid with which they are taken may move out of their aligned position while being propelled by the tongue toward the pharynx and esophagus thereby being swallowed at an uncomfortable angle.
The pharmaceutical industry has attempted to solve these problems by developing various oral dosage forms that supposedly have improved swallowabilty. In their attempt to solve the aforementioned problem relating to swallowability, the pharmaceutical industry has focused on the size, shape and surface composition of the capsules, tablets, gel caps, etc. In another attempt to address the problem of swallowability, the industry developed and produced cylindrical-shaped tablets which were to replace round shaped tablets, (i.e. a capsule shaped tablet),. One result of the pharmaceutical industry's attention to this problem was the development of the gelatin-coated caplet which not only addressed the problems relating to swallowability but also consumers' wariness of capsule tampering. Such a caplet is disclosed in U.S. Pat. No. 5,314,537. Although the gelatin-coated caplet has provided improvement in the swallowability of such caplets, the pharmaceutical industry's attempts to solve this problem are basically limited to the application of coatings to the exterior of the caplet, tablet, etc.
Despite the improvements discussed above, consumers still continue to express desire for oral dosage forms that exhibit improved swallowability characteristics.
It is therefore an object of the present invention to provide new and improved oral dosage forms that solve the problems discussed above.
Still other objects and advantages of the present invention will in part be obvious and will in part be apparent from the specification.
SUMMARY OF THE INVENTION
The present invention is directed to improved oral dosage forms that are significantly easier to swallow. In accordance with the present invention, the oral dosage forms are configured to have relatively greater weight and/or density to effect partial or total submergence in the liquid with which the oral dosage form is taken.
In one embodiment, the present invention is directed to an oral dosage form for ingestion with liquid, comprising, an active ingredient with or without excipient ingredients, and a substance having a predetermined weight that effects at least partial sinking of the oral dosage form in the liquid.
In one embodiment, the substance is a filler that is added to the active ingredient and, if used, the excipient, of the oral dosage form.
In another embodiment, a filler is added to the medium of the oral dosage form.
In a further embodiment, a filler is added to the exterior of the oral dosage form.
In another embodiment, a relatively heavier, denser or larger amount of active and excipient ingredients are used to formulate the oral dosage form.
In yet a further embodiment, the substance is a binder that is used to increase the weight and/or density of the oral dosage form.
In yet another embodiment, a combination comprising a binder and a relatively heavier, denser or larger amount of ingredient is used to formulate the oral dosage form.
In accordance with the present invention, oral dosages are configured to have a predetermined weight and/or density while conforming its size to what can be comfortably swallowed.
Oral dosage forms have a variety of physical characteristics, such as the medium used for transport. Thus, the present invention teaches a variety of configurations of oral dosage forms and methods for making these oral dosage forms, that solve the aforementioned problems and deficiencies associated with conventional oral dosage forms.
The configurations and methods of the present invention are applicable to the three major types of oral dosage forms: (1) capsules, (2) tablets and caplets, and (3) soft-gels.
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“ABCs of the Human Body”, 1987, Editor, Alma E. Guinnes, p. 240.
“The Human Body”, Vol.: Digestion, 1984, Editor, Beryl Leith, pp. 60-61.
Joynes Robert M.
Nuzzo Raymond
Page Thurman K.
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