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Oral controlled release formulation for sedatives and hypnotic agentsOral controlled release formulation for sedatives and hypnotic agents description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20090123535, Oral controlled release formulation for sedatives and hypnotic agents. Brief Patent Description - Full Patent Description - Patent Application Claims
This application claims the benefit of provisional application Ser. No. 60/778,346 filed on Mar. 2, 2006. 1. Field of the Invention The present invention relates to modified release dosage forms containing sedative and hypnotic agents, preferably short acting sedatives and hypnotic agents. The dosage form of the present invention should provide therapeutically effective amounts of the sedative or hypnotic agent relatively quickly and maintain therapeutic levels for about four to eight hours after administration. 2. Description of the Related Art In todays fast pace, instant information society, there is an increase in stress and sleep disorders. A number of sedatives and hypnotics have been developed to manage and control stress and sleep disorders. Some of the more common sedatives and hypnotic agents commercially available are VALIUM, XANAX, AMBIEN, SONATA and LUNESTA. These commercially available pharmaceutical products provide immediate release of the active pharmaceutical ingredient after administration allowing an immediate effect on the patient, however, they often do not maintain the effect long enough for a patient to obtain the recommended eight hours of sleep. Although controlled release pharmaceutical dosage forms which release therapeutic amounts of the active ingredient over 8 to 24 hours are well known in the pharmaceutical industry, there are very few that control the release of sedative or hypnotic agents in a manner that allows a patient to obtain therapeutic amounts of a sedative or hypnotic agent rapidly after administration and maintain the therapeutic levels for about eight hours after administration so that a patient can obtain a full eight hours of restful sleep. One controlled release product that attempts to obtain therapeutic amounts of a sedative or hypnotic agent rapidly after administration and maintain the therapeutic levels for about eight hours after administration so a patient can obtain a full eight hours of restful sleep is AMBIEN CR. AMBIEN CR is a biphasic tablet wherein one layer provides an immediate release amount of zolpidem tartrate and the other layer provides a slow or controlled release of zolpidem tartrate. See AMBIEN CR labeling. It is believed that the AMBIEN CR product is described in U.S. Pat. No. 6,514,531. According to the teachings of U.S. Pat. No. 6,514,531, the bilayer tablet should release at least 40% of the zolpidem tartrate within 30 minutes when tested in a type II dissolution apparatus according to the U.S. Pharmacopoeia in 0.01M HCl buffer at 37° C. Bilayer tablets such as AMBIEN CR can be difficult to manufacture because they require the precise measurement of the drug into two distinct regions of a tablet press and the compressing of these distinct regions into a unitary tablet. According to the product labeling for AMBIEN CR, a further drawback of the AMBIEN CR product is that bioavailability, as measured by area under the curve (AUC) and maximum plasma concentration (Cmax), was decreased by at least 20% and the median time to maximum plasma concentration (Tmax) was increased from 2 to 4 hours when the AMBIEN CR bilayered tablet was administered within 30 minutes after a meal. This decrease in bioavailability resulted in a slower or delayed onset of sleep. United States Published Patent Application No. 2004/0258750 discloses another attempt to prepare a suitable controlled release dosage form for sedative and hypnotic agents. United States Published Patent Application No. 2004/0258750 discloses a multi-particulate dosage form that comprises a combination of immediate release pellets and delayed release pellets. The delayed release pellets are prepared by coating a drug core with a coating that is impermeable to the drug on contact with aqueous fluids but that breaks down or becomes permeable to the drug after a suitable period of time. As with the bilayered AMBIEN CR tablet, the multi-particulate dosage forms described in United States Published Patent Application No. 2004/0258750 can be difficult to manufacture. The present invention is a novel controlled release dosage form that releases therapeutic amounts of a sedative or hypnotic agent rapidly after administration and maintains therapeutic levels for about four to eight hours after administration. The present invention also relates to a method for manufacturing the aforementioned controlled release dosage form. The dosage form prepared according to the present invention should release less than 40%, preferably not more than 35% and most preferably not more than 30% of the sedative or hypnotic agent within 30 minutes when tested according to the United States Pharmacopiea 29 using Apparatus II (paddles), 900 ml of 0.01 N HCl at 50 rpms and 37° C. The dosage form of the present invention can be a tablet or capsule. The tablet can be mono or multi phasic, i.e two or more layers. The dosage form of the present invention can also be prepared from a plurality of beads, pellets or mini tablets that are formulated to release the sedative or hypnotic agent in the aforementioned manner. The beads, pellets or mini tablets can be a homogeneous population, i.e the beads, pellets or mini tablets have the same ingredients and composition or a heterogeneous population, i.e more than one type of bead, pellet or mini tablet. The beads, pellets or mini tablets can be placed into a gelatin capsule or mixed with conventional tableting excipients and compressed into a tablet. It is also an object of one embodiment of the present invention to provide a controlled release dosage form that is monophasic with respect to the sedative or hypnotic agent. As used herein, monophasic means that the sedative or hypnotic agent is present in a homogeneous or unitary form. For example the present invention, prior to administration, does not employ multiple layers or multiple components where the sedative or hypnotic agent is present in different concentrations, or with different excipients. The fact that the present invention is monophasic results in a much simpler manufacturing process than the process described in the prior art. It is a further object of the present invention to provide a controlled release dosage form that does not exhibit substantial differences in bioavailability when the dosage form is administered under fed (non-fasting) and fasting conditions. More specifically, it is an object of one embodiment of the present invention to provide a dosage form that does not exhibit a substantial decrease in AUC, Cmax and/or and increase in Tmax when the dosage form is administered within 30 minutes of a meal. The foregoing objectives and others are obtained by an embodiment of the present invention that comprises a unitary core and optionally a functional coating surrounding the unitary core. In one embodiment of the present invention, the unitary core comprises a pharmaceutically acceptable sedative or hypnotic agent and a matrix forming material. The matrix forming material maybe a hydrogel polymer or a hydrophobic material combined with water soluble materials to aid in the hydration of the hydrogel or formation of pores in the hydrophobic material. If a functional coating surrounding the unitary core is employed it should, but not necessarily, comprises a pH dependent material and/or a pore forming material. The pH dependent material and the pore forming material can be the same component depending upon the composition of the coating selected. In one embodiment of the present invention the pH dependent material of the coating comprises about 10% or less of the total weight of the final dosage form, preferably about 7.5% or less of the total weight of the final dosage form and most preferably about 5% or less of the total weight of the final dosage form. The term functional coating as used in this application means a coating that affects the release of the drug from the core of the dosage form, i.e the tablet core or the bead or pellet core. The functional coating does not include coatings applied solely for aesthetic reasons such as a wax polishing coat. Other objects, features and advantages of the invention are not taught in the prior art but will be more apparent to those versed in the art from the following specifications, taken in conjunction with the accompanying claims. Continue reading about Oral controlled release formulation for sedatives and hypnotic agents... 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