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A packaged pharmaceutical preparation, comprising a plurality of the unit dosage forms of claim 21 each in a discrete sealed housing, and instructions for administering the dosage forms orally to effect weight loss. Cellulose ethers containing no ester groups, e. A packaged pharmaceutical preparation comprising a plurality of the unit dosage forms of claim 21 in a sealed container and instructions for administering the dosage forms orally to effect weight loss. The dosage form of claim 1, wherein the controlled release topiramate formulation comprises controlled release beads of the topiramate, a binder, and a polymeric filler in a matrix core, wherein the matrix core is provided with a delayed release coating comprising ethyl cellulose and polyvinyl pyrrolidone.
Generally, the packaged preparation contains a plurality of orally administrable unit dosage forms, with, preferably, each individual dosage form in a separate sealed housing, e. 5 mg and the unit dosage of topiramate is 46 mg. This is a condition in which the blood pressure in the pulmonary arteries is abnormally high in the absence of other diseases of the heart or lungs. In these methods, the daily doses of topiramate and phentermine may also be administered to treat one or more conditions associated with excess weight or obesity.
The dosage form of claim 1, wherein the unit dosage of topiramate is in the range of 15 mg to 25 mg. Symptoms include an increasing sense of tension or arousal before committing an act, and then experiences pleasure, gratification, or release at the time of committing the act. This invention is further illustrated by the following examples which should not be construed as limiting.
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D-fructopyranose sulfamate as well as individual enantiomers, individual diastereomers, or mixtures thereof. EXAMPLES The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to make and use the present invention, and are not intended to limit the scope of what the inventors regard as their invention nor are they intended to represent that the experiments below are all or the only experiments performed. Although any methods and materials similar or equivalent to those described herein may be useful in the practice or testing of the present invention, preferred methods and materials are described below.
Most or all of these problems are relieved or improved by permanent significant weight loss. Generally, although not necessarily, the combination of the active agents is administered orally. According to the American Diabetes Association, there are over one million juvenile diabetics in the United States. The method of administration can involve simultaneous administration of the two active agents, in a single composition or in two discrete compositions each containing one of the active agents. Suitable acid addition salts may be prepared from organic acids, e. Some or all of the included components may be packaged in suitable packaging to maintain sterility.
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Example 2 Controlled release topiramate beads and immediate release phentermine beads are prepared as in Example 1. At dosages previously believed to be required for therapeutic efficacy, administration of topiramate has been associated with significant adverse effects, as noted above, including, without limitation, dizziness, psychomotor slowing, difficulty with memory, fatigue, and somnolence. A causal linkage among obesity, impaired glucose tolerance, and Type II diabetes has been proposed, but a physiological basis has not yet been established. Unless defined otherwise, all technical and scientific terms used herein have the meaning commonly understood by one of ordinary skill in the art to which the invention pertains.
Sleep apnea is diagnosed utilizing a sleep test, called polysomnography but treatment methodologies differ depending on the severity of the disorder. 7,351,695, supra, and Physicians’ Desk Reference, supra. An example of a suitable daily dose of topiramate that would prevent the loss of effectiveness of phentermine alone is 15 mg to 50 mg, e. In addition to the formulations described previously, the active agent may be formulated as a depot preparation for controlled release of the active agent, preferably sustained release over an extended time period. Additionally, peripheral tissues are generally resistant to the effects of insulin. The Bi-level machine is different in that it blows air at two different pressures.
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The cause of primary pulmonary hypertension is unknown. Example 1 Controlled release topiramate beads are made using an extrusion spheronization process to produce a matrix core comprised of topiramate, 40. There are two major types of migraines. While society has seen tremendous advances in the field of pharmaceuticals, there are, of course, drawbacks to the administration of any given pharmaceutical agent. The laminated structure may contain a single reservoir, or it may contain multiple reservoirs.
SUMMARY OF THE INVENTION Accordingly, in a first embodiment, the present invention is directed to a method for effecting weight loss in a subject by administering continually over a significant period of time a daily dose of phentermine in the range of 2 mg to 8 mg and in combination therewith a daily amount of topiramate selected to prevent the loss of effectiveness of phentermine alone. 75 mg phentermine is in the form of 4. Pulmonary hypertension develops in response to increased resistance to blood flow. The topiramate cores were then coated with ethyl cellulose, 5.
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For example, administration may be transmucosal, e. The method of administration may also involve administration of the two active agents at different times of day, with the phentermine generally administered earlier in the day and the topiramate generally administered later in the day. The dosage form of claim 1, wherein the unit dosage of phentermine is in the range of 2 mg to 5 mg. The dosage form of claim 10, wherein the unit dosage of topiramate is in the range of 15 mg to 25 mg.
Migraine headaches begin with mild pain, which increases in intensity over a short period of time. 9, 2008, the disclosure of which is incorporated by reference. BACKGROUND OF THE INVENTION The prevalence of obesity in both children and adults is on the rise in first world countries, especially in the United States, as well as in many developing countries such as China and India. These data indicate a lower maximum and extent of phentermine exposure between tests versus reference treatments after multiple-dose administration. Sleep apnea is classified as either obstructive sleep apnea, the more common form that occurs when throat muscles relax, or central sleep apnea, which occurs when the brain doesn’t send proper signals to the muscles that control breathing.
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5 mg phentermine in the form of 9. 2 mg to 5 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. The dosage form of claim 15, wherein the 3. Suitable capsules may be either hard or soft, and are generally made of gelatin, starch, or a cellulosic material, with gelatin capsules preferred. Depending on the intended mode of administration, the pharmaceutical formulation may be a solid, semi-solid or liquid, such as, for example, a tablet, a capsule, a caplet, a liquid, a suspension, an emulsion, a suppository, granules, pellets, beads, a powder, or the like, preferably in unit dosage form suitable for single administration of a precise dosage.
Both sets of beads are then encapsulated into each of a plurality of capsules, with each capsule containing 7. It has now been surprisingly discovered that a combination of a low daily dose of topiramate and a low daily dose of phentermine is effective in achieving weight loss, treating obesity, treating conditions related to overweight and obesity, and addressing other indications as will be discussed herein. The present method for effecting weight loss in a subject involves administering a daily dose of phentermine in the range of 2 mg to 8 mg, e. Juvenile diabetics must, therefore, receive exogenous insulin during their lifetime.
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The dosage forms may also be provided with a delayed release coating, e. As such, phentermine may be in the form of either the free base or an acid addition salt prepared with an acid that yields a pharmaceutically acceptable anion. The subject can be any vertebrate, but will typically be a mammal.
These disorders include impulse control disorders, panic syndrome, general anxiety disorder, phobic syndromes of all types, mania, manic depressive illness, hypomania, unipolar depression, stress disorders, PTSD, somatoform disorders, personality disorders, psychosis, and schizophrenia. Secondary pulmonary hypertension is a serious disorder that arises as a complication of other conditions such as, for example, scleroderma. In a further embodiment, a packaged pharmaceutical preparation is provided that contains a composition of the invention in a sealed container, with instructions for administration, typically self-administration, of the composition. D-fructopyranose sulfamate and the molecular formula C12H21NO8S. The risks of undiagnosed obstructive sleep apnea include heart attacks, strokes, high blood pressure, heart disease, irregular heartbeat, and impotence.
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Without treatment, excessive acidosis, dehydration, kidney damage, and death may result. 75 mg phentermine and, in combination therewith, a daily dose of 23 mg topiramate. In a specific embodiment, controlled release topiramate beads for oral administration, e. The fundamental relationship between these disease states, and a method of treatment, has not been established. Preparations according to this invention for parenteral administration include sterile aqueous and nonaqueous solutions, suspensions, and emulsions.
Also provided are packaged pharmaceutical preparations for practicing the subject methods. In another embodiment, the invention is directed to a method for effecting weight loss in a subject by administering continually over a significant period of time a daily dose of 7. As such, the controlled release formulation of topiramate reduced drug interaction with phentermine which in turn will reduce further side effects associated with phentermine. In addition to the active agent, tablets will generally contain inactive, pharmaceutically acceptable carrier materials such as binders, lubricants, disintegrants, fillers, stabilizers, surfactants, coloring agents, and the like. Generally, the dosage forms provide for sustained release, i. It is more common as people grow older and is both more common and more serious in African Americans.
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The dosage regimen involves continual, i. Autoantibodies produced by the patients completely or partially destroy the insulin producing cells of the pancreas. The dosage form of claim 1, wherein the unit dosage of phentermine is 3.
The dosage form of claim 1, wherein the unit dosage of phentermine is 7. Two weeks after the start of her weight loss program she reports that her exercise tolerance is markedly improved and previous chest pressure and shortness of breath on exertion are gone. The essential feature of an impulse control disorder is the failure to resist an impulse, drive, or temptation to perform an act that is harmful to the person or to others.
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Type I Diabetes is a form of autoimmune disease. Other indications for which the present invention is readily adapted include epilepsy and certain psychiatric indications such as impulse control disorders. It has now been discovered that a significantly lower dose combination product is effective in achieving weight loss, treating obesity, and treating conditions associated with obesity and excessive weight. In still another embodiment, the method, composition, and packaged preparation of the invention are adapted to administer phentermine and topiramate to treat adolescent and juvenile obesity.
5 mg phentermine is in the form of 9. Additionally, some people have mixed sleep apnea, which is a combination of both obstructive and central sleep apneas. The mean and statistical comparisons for plasma phentermine PK parameters at steady state in multiple dose administrations are summarized in Table 1. The composition prepared in Example 2 is administered to the patient on a daily basis, and the patient additionally proceeds with a low fat, low carbohydrate diet and daily exercise.