Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2001-04-18
2002-09-10
Dees, Jose ′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S046000, C424S464000, C424S400000
Reexamination Certificate
active
06447751
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method and device for organizing and coordinating combined aerosol and oral medications for treating diabetes mellitus.
2. Description of the Prior Art
Diabetes mellitus is a chronic illness caused by an effective lack of insulin and manifested by elevation of blood sugar. It is the fourth leading cause of death by disease in the United States and the leading cause of irreversible blindness and chronic renal failure. Treatment for diabetes is directed to lowering blood sugar and to preventing long term complications which include neuropathy, accelerated atherosclerosis, myocardial infarction, gangrene of the lower extremities, retinopathy and nephropathy. Diabetic individuals are typically required to comply with treatments over very long periods to avoid these complications. Measures to enhance convenience and compliance are therefore especially desirable.
The two pharmacological modalities presently used to lower blood sugar are oral hypoglycemic (antidiabetic) agents and insulin. Insulin replacement is presently accomplished by injection and is based upon the lack of insulin or limitation of its action in diabetes mellitus. Oral antidiabetic agents are not chemically akin to insulin and their sugar-lowering mechanism differs from the action of direct insulin replacement. Oral hypoglycemic agents and insulin are, at present, therapeutically utilized alone or in concert with each other, according to the needs of the diabetic individual. Some individuals are best treated with more than one oral agent, with, or without insulin.
Oral hypoglycemic agents presently include sulfonylureas, biguanides, alphaglucosidase inhibitors and thiazolidinediones. Each of these classes operates by a different mechanism, and these agents are known to be used both alone and in various combinations to lower blood sugar. Sulfonureas lower blood sugar by stimulating insulin release from pancreatic islet cells. Examples include tolbutamide, acetohexamide, tolazamide, and chlorpropamide, so-called first-generation agents, and glyburide, glipizide, and glimeperide, second-generation agents. First and second generation sulfonyureas differ in their potency, adverse effects and duration of action. Metformin has an “insulin sparing” action, and is an example of a biguanide. Acarabose has an action of reducing the rate of carbohydrate absorption, and is an example of an alpha-glucosidase inhibitor. Troglitizone acts to potentiate the action of insulin (but has been found to cause idiosyncratic liver injury) and is an example of the thiazolidinedione class.
More recently, an additional agent, the carbamoylmethyl benzoic acid derivative, repaglinide, has become available for treatment in the United States, representing an additional class of oral hypoglycemic agent, the meglitinides. These agents, like the sulfonylureas, stimulate insulin secretion from pancreatic insulin-producing cells, although they are chemically distinct and bind to a different receptor. They can be used alone as well as in concert with other oral agents. Characteristics of the meglitinide analogues, repaglinide and nateglinide, are their rapid absorption, stimulation of insulin release within a few minutes, and rapid biliary excretion, such short action making them particularly useful for the immediate regulation of blood sugar after eating.
Recent clinical studies in diabetic individuals have disclosed that insulin can be administered topically to the nasal and lung mucosa and be absorbed and function to reduce blood sugar. As with injected insulin, oral hypoglycemic medication may be utilized together with insulin administered by respiratory aerosol to lower blood sugar. Because of the more limited action of topical insulin compared to injected insulin, it is likely that topical insulin usage will frequently require complementary use of oral antidiabetic agents for diabetic control.
Compliance with medication therapy is important in successful long-term diabetic care. Health care experts estimate that half of the 1.8 billion prescription medications dispensed yearly are not taken as prescribed. Adherence to medication is known to be adversely affected by inconvenience and complexity of use.
Topical aerosol medications are frequently used to treat respiratory disorders. Poor compliance and frequent errors with aerosol medications are known to occur in treating respiratory disease and results in a relapse of cough, shortness of breath, wheezing, nasal congestion, and chest congestion. The result of non-compliance with diabetes treatment may not result in such apparent consequences, but would rather dispose the individual to long-term, insidious and irreversible damage.
Multiple therapeutic components may be a source of confusion and frustration to users. Individual components lack indicia signifying use of the components together and components may be lost, misplaced, or ignored. Instructions issued separate from medication, as by the physician, may be lost. Furthermore, in spite of careful oral and written instructions from the health care provider, many patients are known to use what they have conveniently available. Haphazard applications of medication can result in treatment failure and in the requirement for additional medical attention and cost.
Cost factors and outcomes are being carefully considered in the current medical climate. Improvements in organization and teaching, including devices and methods to facilitate treatments, are considered desirable in view of limitations in time and costs for medical personnel. Successful therapy is less costly than unsuccessful treatment, which eventuates in complications, multiple clinic visits, or hospitalizations.
Packaging has been developed for aiding the users of medications to comply with proper administration. Dispensing apparatus associated with multiple day administrative drugs are typically directed to the administration of pills or capsules, or similar solid medication.
U.S. Pat. No. 4,039,080, for example, discloses a tray having individual compartments for pills which may contain a week's medication with indicia indicating the day of the week and the time of the day the medication is to be taken.
U.S. Pat. No. 4,553,670 discloses another device comprising a support on which are located two different ingestible medical substances in a single dose form with an adjacent portion for instructional information.
U.S. Pat. No. 4,593,819 discloses a covered pill tray of rectangular configuration having an array of open-topped compartments to hold a supply of medication arranged by the day and time of taking the medication.
U.S. Pat. No. 4,736,849 discloses a method and another type of dispenser for the storage and dispensing of calendar-oriented pills. U.S. Pat. No. 5,181,189 discloses a device for storage and time-regulated dispensing of drugs which includes a drug container to which is secured a signal generator.
U.S. Pat. No. 5,377,841 discloses a sleep therapy package which includes an audio recording for inducing sleep.
U.S. Pat. No. 5,830,490 discloses an organizational tool for a lay person to organize oral medications together with topical medications, and a method for reducing medication error and enhancing therapeutic compliance of combined topical and systemic modality therapeutic regimens. This patent however, does not disclose the application of such devices and methods to the treatment of diabetes.
U.S. Pat. No. 6,187,291 teaches a dispensing container which incorporates an aerosolizable topical insulin preparation, at least one oral hypoglycemic agent, and indicia and instructions for their coordinated use as a single therapeutic regimen for treating diabetes mellitus in a human, in order to make such regimens more convenient, encourage compliance and minimize error. What is not specified is the incorporation of oral agents from the meglitinide class.
Therefore, what is needed is a system that facilitates treatments that utilize topical aerosolized and oral medication together
Weinstein Allan M.
Weinstein Robert E.
Dees Jose ′ G.
Deleault, Esq. Robert R.
Haghighatian M.
Mesmer & Deleault, PLLC
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