Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1997-07-24
2001-03-06
Clardy, S. Mark (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S449000, C424S443000, C424S447000, C602S003000, C602S041000, C604S890100
Reexamination Certificate
active
06197331
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention is directed to a sustained- or controlled-release solid composition for the oral cavity or “pharmaceutical oral patch” that adheres to hard dental surfaces, such as teeth and dentures, and releases a pharmaceutical agent. Release of the agent is for a predetermined period of time and at a predetermined concentration. The site of action of the agent is topical, local or systemic. The invention is also directed to suitable polymers for the pharmaceutical oral patch, in particular the polymers known as Eudragit™. The patch can comprise a single adherent release layer or a non-adherent layer adhered in the oral cavity by a separate adherent layer.
2. Related Art
The advantages of controlled-release products are well-known in the pharmaceutical field and include the ability to maintain a desired level of medicament over a desired period of time while increasing patient compliance by reducing the number of administrations necessary to achieve the same level.
Oral controlled-release delivery systems should ideally be adaptable so that release rates and profiles can be matched to physiological and chronotherapeutic requirements. The art describes free forms, such as sublingual tablets, troches, and buccals. In addition to non-attached oral sustained- or controlled-release forms, other forms are designed to adhere to the oral mucosa and deliver an active pharmaceutical agent either directly into the oral mucosa, or into the saliva. Ointments and other sticky adhering compositions also have been used. The active ingredient in all these forms can act locally or systemically.
U.S. Pat. No. 4,829,056 describes a buccal tablet consisting of etorphine, at least one monosaccharide, disaccharide or mixture thereof, and a mixture of xanthan gum and locust bean gum in a weight ratio of 3:1 to 1:1, wherein the total weight of the mono- and/or disaccharides relative to the combined weight of xanthan and locust bean gums is in the ratio of 20:1 to 3:1. The buccal tablet is intended to be placed between the gingival surface of the jaw and the buccal mucosa where it gels to produce a soft hydrated tablet which may be retained in position so as to provide release of etorphine for up to two hours. The buccal tablet is said to provide improved bioavailability.
U.S. Pat. No. 4,948,580 describes a bioadhesive composition which may be employed as an oral drug delivery system and includes a freeze-dried polymer mixture formed of the copolymer poly(methyl vinyl ether/maleic anhydride) and gelatin dispersed in an ointment base. This composition is said to be useful to deliver active ingredients such as steroids, antifungal agents, and antibacterial agents, to the oral mucosa.
U.S. Pat. No. 4,597,959 describes a cosmetic breath freshener composition in wafer form which is said to have slow release properties. The composition includes a multiplicity of microencapsulated liquid droplets of flavoring material contained in an adhesive base.
U.S. Pat. No. 5,077,051 describes bioadhesive microcapsules which comprise xanthan gum, locust bean gum, a bulking agent and an active agent. The microcapsules are said to be useful for delivering buffering agents to the oral cavity for anticarious purposes. The microcapsules are prepared by preparing a hot aqueous solution or suspension of the active agent; adding xanthan gum, locust bean gum and a bulking agent to form a viscous solution; and then (a) cooling and then drying the viscous solution to obtain a solid material which is then formed into microcapsules, or (b) spray-drying the viscous solution to form the microcapsules.
U.S. Pat. No. 4,915,948 describes a tablet which is said to have improved adhesion to mucous membranes. The tablet includes a water soluble biopolymer selected from xanthan gum, a pectin and mixtures thereof, and a solid polyol having a solubility at room temperature in water greater than about 20 g/100 g solution.
U.S. Pat. Nos. 4,994,276, 5,128,143, and 5,135,757, describe a controlled release excipient comprised of synergistic heterodisperse polysaccharides (e.g., a heteropolysaccharide, such as xanthan gum in combination with a polysaccharide gum capable of cross-linking with the heteropolysaccharide, such as locust bean gum) that is capable of processing into oral solid dosage forms using either direct compression, following addition of drug and lubricant powder, conventional wet granulation, or a combination of the two. Release of the medicament from the formulations is reported to proceed according to zero-order or first-order mechanisms.
U.S. Pat. No. 4,059,686 describes a pharmaceutical preparation for oral cavity administration characterized by being a mixture of a pharmacologically active agent, a pharmaceutical carrier, and sodium polyacrylate in conventional dosage form. It adheres strongly to a local site and dissolves gradually over a prolonged period of time, releasing appropriate amounts of the active agent. The preparation is designed to adhere to mucosal membranes.
U.S. Pat. No. 4,876,092 describes a sheet-shaped adhesive preparation comprising an adhesive layer containing, as essential components, a carboxyvinyl polymer, a water-insoluble methacrylic copolymer, a polyhydric alcohol, and a pharmaceutically active agent, and a water-impermeable and water-insoluble carrier layer containing, as essential components, a pharmaceutically active, water-insoluble, film-forming high molecular weight compound and a plasticizer, which can adhere within the oral cavity over a period of time and release an active agent. The preparation is designed to be adhered to the mucous membrane.
U.S. Pat. No. 3,972,995 describes a dosage form for buccal administration of a drug, and which is directly applicable to the interior surfaces of the mouth. The dosage form is comprised of a support member which is water-insoluble, waterproof and flexible, a moisture-activated adhesive precursor applied to one surface of the support member, and an active ingredient applied to the central portion of the support member, either directly or dispersed in a matrix. The dosage form is applied directly to the interior surface of the mouth. Contact with saliva activates the adhesive and causes the support member to adhere to the interior surface of the mouth, thereby exposing the active ingredient to a limited area of the oral mucosa while isolating the active ingredient from the remainder of the oral environment.
U.S. Pat. No. 5,330,761 describes a controlled release bioadhesive tablet which includes a locally active agent, a heterodisperse gum matrix, and a pharmaceutically acceptable diluent. The final product adheres to mucous membranes and releases the locally active agent over a desired period of time.
Nagai, T. et al. (J. Cont. Rel. 6:353 (1987)) describes a sustained-release tablet capable of sticking tightly to human gingiva and not the cheek mucosa. Further described is a self-administered plaster with a water-impermeable backing layer (film).
U.S. Pat. No. 4,772,470 discloses an oral bandage comprising a soft adhesive film comprising a mixture of polycarboxylic acid and/or a polycarboxylic acid anhydride and a vinyl acetate polymer in a compatible state, and an oral preparation comprising such an oral bandage having incorporated therein a topical drug. The oral bandage or preparation is reported to exhibit strong adhesion of long duration when applied to the oral mucosa or teeth. This patent purports to teach a composition for topical administration of pharmaceutically active agents. It is drawn primarily to the use of anesthetic compositions, but may comprise other agents as well. The composition comprises the active agent in a pharmaceutically acceptable solvent, and in an admixture also includes a bioadhesive. This patent, however, does not teach the use of a sustained-release composition wherein the composition can be attached to a tooth or other dental surface by separate adhesive.
U.S. Pat. No. 4,900,554 describes an adhesive device for application to body tissue having an adhesive layer a
Flashner Moshe
Lerner E. Itzhak
Rosenberger Vered
Clardy S. Mark
Graeser D'Vorah
Perio Products Ltd.
Williamson Michael A.
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