Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
1999-11-01
2001-09-25
Page, Thurman K. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S451000, C424S464000, C424S489000, C424S045000, C424S046000, C424S405000
Reexamination Certificate
active
06294178
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 sinusitis.
2. Description of the Prior Art
Packaging has been developed for aiding the users of drugs to comply with administration. Dispensing apparatus associated with multiple day administrative drugs are typically directed to the administration of oral 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. 5,830,490 discloses a method and device for organizing, storing, instructing, and coordinating the combined use of aerosol and oral medications for the treatment of disorders including respiratory tract disorders such as rhinitis and asthma in order to reduce medication error and increase therapeutic compliance.
While the market place abounds with pill boxes and organizers for oral medications and while an organizational tool is presently available for a lay person to organize topical medications with oral medications, none of the prior art specifically claims a system for treating sinusitis.
Therefore, what is needed is a device that combines topical and oral modalities of treatment for sinusitis. What is further needed is a method for enhancing compliance of combined therapeutic regimens for treatment of sinusitis.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a system that combines topical and oral modalities of treatment for sinusitis. It is another object of the present invention to provide a method for enhancing compliance of combined therapeutic regimens for treatment of sinusitis. It is a further object of the present invention to provide patients and caregivers with expertly formulated and expertly instructed prepackaged sinusitis treatment regimens and to minimize both caregiver and user uncertainty with regard to appropriate sinusitis treatment. It is still a further object of the present invention to minimize the caregiver's task of instructing sinusitis treatments, particularly the time that is now required to instruct coordinated treatments with single agents which are individually prescribed and individually instructed. It is yet a further object of the present invention to simplify, organize and encourage compliance with the full course of combined oral/topical sinusitis regimens.
The present invention achieves these and other objectives by providing a system which combines topical and oral modes of treatment for sinusitis and for enhancing compliance with combined therapeutic regimens for sinusitis. The device consists of a unifying container which is prepackaged for a user and which incorporates at least one oral antibiotic, at least one topical agent, and indicia and instructions which instruct their coordinated use as a therapeutic regimen.
Sinusitis refers to infection of the paranasal sinuses which develops in approximately 31 million Americans each year. Acute sinusitis typically follows a viral upper respiratory infection or allergic reaction. Swelling of the nasal mucous membranes and obstruction of drainage from the sinus outflow tracts is thought to cause mucous to collect in the paranasal sinuses and become infected. Treatment is typically comprised of killing the overgrown bacteria with antibiotics, and reversing obstruction of drainage from the sinuses to restore the orderly flow of mucous secretions.
Antibiotic treatments for sinusitis are generally administered in an oral form for systemic distribution to accomplish penetration into the tissues. Antibiotics which are presently useful for treating organisms which infect the sinuses include: penicillins (ex: amoxicillin, amoxicillin-clavulanate), sulfas (ex: sulfamethoxazoletrimethoprim, erythromycin-sulfisoxazole), erythromycin analogues (ex: azithromycin, clarithromycin), cephalosporins (ex: cefaclor, cefuroxime axetil, cefpodoxime proxetil, cefprozil, cefixime, ceftibuten), carbacefems (ex: loracarbef), quinolones (ex: ciprofloxacin, levofloxacin), clindamycin, and metronidazole. The inclusion of other oral agents useful in the treatment of sinusitis, including decongestants (example are pseudoephedrine and phenylpropanolamine), antihistamines (examples are chlorpheniramine and diphenhydramine), moisturizing agents (for example, guiafenesin), and anticholinergic agents (for example, methscopolamine), is within the scope of the invention.
Topical treatments are useful in sinusitis because of the accessibility of the nasal membranes to direct applications. An advantage of topical treatments is that systemic side effects can be minimized. Useful topical agents for treating sinusitis include alpha-adrenergic decongestants which act to shrink mucous membranes and increase the patency of the sinus ostia (examples are phenylepherine and oxymetazoline), topical glucocorticoids which inhibit local inflammation (examples are beclomethasone, budesonide, and flunisolide nasal aerosols), and liquefying and moisturizing nasal instillations which facilitate mucous flow (examples are saline, hypertonic saline, propylene glycol, and polyethylene glycol). Topical treatments may be applied by aerosol sprays, drops, or lavages. Antihistamines and anticholinergic agents may be selectively useful either orally or topically in particular situations, for example, when sinusitis occurs as a complication of allergy, and are within the scope of the present invention.
Health care experts estimate that half of the 1.8 billion prescription medications dispensed yearly are not taken as prescribed. Adherence to medication is considered to be adversely affected by inconvenience and complexity of use. Conversely, compliance and the risk of medication error are improved with measures to increase convenience, establish simplicity, and reduce confusion. Poor compliance and error are particularly acknowledged to occur with topical aerosol treatments utilized for respiratory disorders.
Compliance with treatment is important in sinusitis. Individuals with sinusitis are typically required to follow through with treatments over at least a ten-day period. Premature discontinuation of treatment is known to result in an increased likelihood of relapse and complication. Failure of treatment can lead to chronic sinus infection and infection in areas adjacent to the sinuses, including the meninges and brain. Measures which facilitate treatment and encourage completion and success are therefore clearly worthwhile.
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 a 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 carefully considered in the current medical climate. Improvements in organization and teaching including devices and methods, which would 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 can lead to complic
Weinstein Allan M.
Weinstein Robert E.
Deleault, Esq.. Robert R.
Fubara Blessing
Mesner & Deleault PLLC
Page Thurman K.
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