Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2002-02-25
2004-09-21
Levy, Neil S. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S438000, C424S442000, C424S464000, C424S679000
Reexamination Certificate
active
06793935
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is directed to a novel flavored extended release composition which forms a non-effervescent suspension when dropped into a liquid, and the methods of using said supplement, thereby improving swallowing through dispersing a large mass in a liquid and minimizing and eliminating gastric discomfort. This flavored extended release composition provides the additional benefits of palatable taste and pleasant appearance when dispersed into a liquid.
2. Description of the Related Art
Patients often encounter difficulty in complying with their drug regimen for various reasons. For example, dosage forms are often too large to comfortably swallow. In addition, many dosage forms taste unpalatable and even cause gastric discomfort. Further, patients have to take many doses throughout the day in order to maintain an effective blood level without taking toxic amounts.
An extended release dosage form remedies this problem because it can deliver the same amount of biologically active substance in one dose that an immediate release dosage form delivers in many doses. An extended release composition is one that achieves slow release of a biologically active substance over an extended period of time and extends the duration of action over that achieved by conventional delivery. An extended release drug delivery system provides several advantages over an immediate release drug delivery system of the same ingredient. These benefits include reduction of the frequency of administration and the maintenance of effective concentrations of the biologically active substance in the blood. The maintenance of an effective concentration in the blood reduces the chance of side effects and toxicity of the biologically active substance. This benefit is especially important when a toxic amount of a biologically active substance can cause illness and death.
Numerous approaches for administering extended and controlled release formulations have also been described in various references. For example, Busetti et al., U.S. Pat. No. 5,891,474, disclose a method of achieving a time specific delivery of a pharmaceutically active agent to a patient. The pharmaceutical agent is encased in a swellable polymeric coating, which delays the release of the pharmaceutical agent for a predetermined period of time depending on the thickness of the polymeric coating.
Baichwal et al., U.S. Pat. No. 5,662,933, disclose a extended release pharmaceutical formulation. The extended release formulation includes a gelling agent, an inert pharmaceutical diluent, a hydrophobic material and/or coating and a medicament for extended oral administration.
Goldie et al., U.S. Pat. No. 4,990,341, disclose a solid, controlled release oral dosage form. The dosage form comprises a therapeutic amount of hydromorphone or salt in a matrix for use with moderate to severe pain. The dosage is formulated such that the peak plasma level of hydromorphone is attained at 2-4 hours following administration of the dosage form.
Acharya, U.S. Pat. No. 5,686,094, discloses a controlled release formulation for the treatment of xerostomia. The delivery system comprises a polycarbophil coating surrounding an active agent. The coating system may also be used with cosmetics and household items where a controlled release effect is beneficial.
Yang et al., U.S. Pat. No. 5,576,022, disclose a controlled release tacrine drug delivery system comprising a sustained release composition and a controlled release composition wherein the controlled release composition is present at specific ratios to the immediate release composition.
Barry et al., U.S. Pat. No. 5,051,263, disclose a controlled release formulation comprising granules containing a carbomer and enough of an active substance to form a dose of the active substance. The granules are coated with an acrylic polymer. The solubility of the acrylic polymer controls the rate of dosage.
Sparks et al., U.S. Pat. No. 4,952,402, disclose a controlled release powder containing microparticles. The microparticles, which can contain an active pharmaceutical, have a predetermined dissolution rate which controls the rate of dosage. The powder is useful in foods and pharmaceuticals.
Staniforth et al., U.S. Pat. No. 5,858,412, disclose a sustained release formulation comprising augmented microcrystalline cellulose, and active ingredient and a sustained release carrier. The sustained release dosage form may be a tablet or a capsule containing excipients appropriate for sustained release technology.
Akiyama et al., U.S. Pat. No. 5,399,357, disclose a matrix prepared by dispersing a pharmaceutical active into a matrix comprised of either a fatty acid ester or a polyglycerol. The preparation has stable release controlling abilities, which contribute to the reduction of administration time of the active as well as a reduction of side effects.
Smith et al., U.S. Pat. No. 5,888,930, disclose a controlled release spray comprising a polymeric microporous bead containing an active ingredient. The bead has an anisotropic pore structure of large pores in the interior and small pores at the surface, with the graduation of pore size being continuous. The controlled diffusion of the active ingredient results in a controlled release product that reduces side effects and has a high stability.
Gergely et al., U.S. Pat. No. 5,587,179, disclose a pharmaceutical formulation in the form of an effervescent and/or disintegrating tablet. The biologically active substance, having an irritating taste, is coated by a matrix. This mixture may additionally contain a composition to compensate for electrolyte and salt loss in the body. Barry et al., U.S. Pat. No. 5,051,263, disclose a controlled release formulation comprising granules containing a carbomer and enough of an active substance to form a dose of the active substance. The granules are coated with an acrylic polymer. The solubility of the acrylic polymer controls the rate of dosage.
Sparks et al., U.S. Pat. No. 4,952,402, disclose a controlled release powder containing microparticles. The microparticles, which can contain an active pharmaceutical, have a predetermined dissolution rate which controls the rate of dosage. The powder is useful in foods and pharmaceuticals.
Staniforth et al., U.S. Pat. No. 5,858,412, disclose a sustained release formulation comprising augmented microcrystalline cellulose, an active ingredient and a sustained release carrier. The sustained release dosage form may be a tablet or a capsule containing excipients appropriate for sustained release technology.
Akiyama et al., U.S. Pat. No. 5,399,357, disclose a matrix prepared by dispersing a pharmaceutical active into a matrix comprised of either a fatty acid ester or a polyglycerol. The preparation has stable release controlling abilities, which contribute to the reduction of administration time of the active as well as a reduction of side effects.
Smith et al., U.S. Pat. No. 5,888,930, disclose a controlled release spray comprising a polymeric microporous bead containing an active ingredient. The bead has an anisotropic pore structure of large pores in the interior and small pores at the surface, with the graduation of pore size being continuous. The controlled diffusion of the active ingredient results in a controlled release product that reduces side effects and has a high stability.
Gergely et al., U.S. Pat. No. 5,587,179, disclose a pharmaceutical formulation in the form of an effervescent and/or disintegrating tablet. The active ingredient, having an irritating taste, is coated by a matrix. This mixture may additionally contain a composition to compensate for electrolyte and salt loss in the body.
Pöllinger et al, U.S. Pat. No. 5,695,784, disclose a flavor-masked pharmaceutical preparation. The preparation allows the administration of pharmaceutically active substances having a very unpleasant organoleptic taste, even in liquid form.
Cherukuri et al., U.S. Pat. No. 5,004,595, disclose a free-flowing particulate delivery system for providing enhanced flavor
Garegnani James A.
Hermelin Marc S.
Paradissis George
K-V Pharmaceutical Company
Levy Neil S.
Nath Gary M.
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