Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-09-29
2002-01-08
Dudash, Diana (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S464000, C424S466000, C424S451000
Reexamination Certificate
active
06337083
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to oral delivery compositions and methods to facilitate the swallowing of solid objects such as pills, tablets, caplets, capsules and solid food.
Solid oral medications and dietary supplements, and other solid materials taken orally in the form of pills, capsules and tablets are typically placed in the mouth and swallowed with a mouthful of water or other beverage. It has been estimated that more than one quarter of the population perceives that they have difficulty swallowing these solid materials such as oral medications and dietary supplements that are in the form of capsules and tablets. Just as a boat in shallow water can ground itself, so can a tablet or capsule ground itself on the tongue and make swallowing difficult. Further, even after a tablet or capsule is swallowed, it can cause discomfort as it travels down the esophagus.
One reason that swallowing a tablet or capsule can be difficult is that when a tablet or capsule is exposed to ordinary fluids such as water or juice, it becomes sticky. This problem may be illustrated by a simple experiment of placing a tablet or capsule in an elongated beaker, adding a small amount of water, and inverting the beaker. In many cases, the tablet or capsule will stick to the side of the beaker instead of flowing out with the fluid.
Attempts to make tablets easier to swallow by, for example, coating them with a gelatinous coating do not completely solve the problem, and may even make the problem worse. Most of the coatings that are commonly used, by virtue of their “gelatinous” nature, begin to soften or dissolve in the mouth. This can cause a coated tablet to stick to the tongue if it is not immediately swallowed, and any hesitation can make swallowing thereafter even more difficult than if the tablet were not coated.
More recently, attempts to provide medications that are more easily swallowed have been directed toward “quick dissolve tablets”, that is, medications that are stored in tablet form but that disintegrate in the mouth. A drawback of this approach is that a dissolved medication becomes more exposed to mouth and throat surfaces, exposing the user to the bitter taste of the medication, which may be difficult to mask. Further, many medications have a harmful effect on the teeth, gingiva and throat and mouth surfaces. Therefore, prolonged exposure of these surfaces to a dissolved medication, which can occur if the dissolved medication is not completely swallowed or washed out of the mouth each time, is undesirable. Also, providing medications in the form of quick dissolve tablets tends to add significantly to the cost of the medication.
Many solid materials that are taken orally, such as medications and food supplements, come in the form of elongated capsules, pill, caplets or tablets. This dosage form presents a further problem in swallowing because in the mouth of the user, the elongated capsule, pill or tablet can become oriented transversely in relation to the passage down the throat (a situation analogous to that of a canoe sitting sideways in a narrow, swift-flowing river), still further increasing the tendency of the solid material, such as a medication or food supplement, to become grounded or lodged in the throat or esophagus. Water and juice are typically unable to provide sufficient force, coupled with wetting, lubrication and viscosity to straighten out the elongated capsule, pill or tablet and to prevent the lodging or grounding.
Moreover, there are certain people who, because of age or medical conditions, have difficulty in swallowing solid food, even when the food is taken with water or juice.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide an oral delivery composition that facilitates the swallowing of a solid object such as a pill, capsule or tablet or solid food.
It is further object of the present invention to provide a method for swallowing a solid object such as a pill, capsule, tablet, caplet or solid food.
It is a further object of the present invention to provide an oral delivery composition that, when ingested with a solid object such as a pill, capsule, caplet or tablet or solid food, encapsulates and buoys the pill, capsule, caplet or tablet or solid food so that the pill, capsule, caplet or tablet or solid food is swallowed without becoming lodged or grounded on surfaces in the mouth or esophagus of the user.
It is a further object of the present invention to provide an oral delivery composition that facilitates the swallowing of elongated pills, capsules, caplets or tablets.
These and other objects are accomplished by providing an oral delivery composition made up of a base liquid and one or more additives, wherein the one or more additives are selected and are present in the oral delivery composition in a sufficient concentration such that the oral delivery composition has improved physical properties, in comparison with the base liquid by itself, such that when the oral delivery composition and the solid object are administered together to a user and swallowed, the solid object is less likely to become lodged or stuck on tongue, throat, palate or esophageal surfaces of the user, in comparison to when the base liquid and the solid object are administered together and swallowed. In particular, the additive or additives are selected to give the oral delivery composition at least one of the following properties:
(1) a density that is greater than the density of the base liquid,
(2) a surface tension that is less than the surface tension of the base liquid,
(3) a viscosity that is greater than the viscosity of the base liquid,
(4) a wettability that is greater that the wettability of the base liquid,
(5) a lubricity that is greater than the lubricity of the base liquid, and
(6) interfacial tension that is less than that of the base liquid.
The present invention is further directed to an additive composition that can be added to a base liquid to provide improved properties, such as those listed above, to facilitate the swallowing of a solid object.
The present invention is further directed to methods of swallowing of a solid object such as a pill, capsule, caplet or tablet or solid food by administering the solid object together with the oral delivery composition.
REFERENCES:
patent: 5670168 (1997-09-01), Baichwal et al.
patent: 6143276 (2000-11-01), Unger
Am J of Gastroenterology, vol. 94, No. 7, Virender K. Sharma, M.D. et al, Oct. 1998.*
Database CAPLUS on STN, AN 1996:565491. JONES, R. et al. “Kapanol capsules: Peller formulation provides alternative methods of administration of sustained-release morphine sulfate”. Clinical Drug Investigation. 1996, vol. 12, No. 2, pp. 88-93, whole Abstract.
Antonelli Terry Stout & Kraus LLP
Dudash Diana
Haghighatian Mina
International Fluidics
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