Abstract:
A pharmaceutical kit for treating migraine headaches and method of preparing the kit that includes a therapeutically effective dosage of pharmaceutical compounds used in the treatment of migraine headache. The pharmaceutical kit is manufactured with a predetermined number of dosage units of migraine treating pharmaceutical compounds. Additionally the kit provides all components necessary for the administering of the drugs in a safe and convenient manner. An aspect of the pharmaceutical kit may include injections and nasal sprays that are fast acting for relief of the migraine sufferer. A preferred pharmaceutical kit with only oral dosage units of drugs may be provided as an attachment to a water bottle.

Description:
RELATED APPLICATION  
       [0001]     This application is a continuation of U.S. patent application Ser. No. 10/125,821, which was filed Apr. 19, 2002. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention broadly relates to a pharmaceutical kit and method of packaging the kit for treating migraine headaches.  
       BACKGROUND  
       [0003]     Migraine is an age old disease which has been described and dealt with in various ways throughout history by many cultures and civilization. For example old English literature described as “Hemicrania”, implying that migraine headache is unilateral in the head. However migraine does not always attack in a unilateral manner. It took several centuries to understand the scientific basis and recognize the wide clinical spectrum of this very common illness.  
         [0004]     As of recent times, in the United States alone, there are 28 million people suffering migraine. Of that population, approximately 21 million are female and 7 million are male. One in four households has at least one migraine Migraine prevalence peaks in the 25 to 55 year age ranges in both genders. In the 1999 HIS (International Headache Society) estimate, 52% of the total population of migraine cases remain undiagnosed. The undiagnosed sufferers are most likely self-medicating with over the counter medications. “Migraine Awareness”, i.e., public knowledge of migraine illness, is much more prevalent in the urban areas than in the interior heartland of the United States, for example.  
         [0005]     Additionally, migraine is the number one cause of lost work days. Migraine sufferers visit emergency rooms and doctor&#39;s offices more frequently than non-migraine patients. The total cost of lost work in the United States alone is approximately in the range of 5.6 to 17.2 billion dollars a year. Attendant health care costs rival these figures.  
         [0006]     Despite tremendous economic pressures to develop a “magic bullet” style treatment useful in treating the full range of the illness, no manufacturer has done so. For example, a most popular migraine remedy, Sumatriptan, has been used to treat around 140 million cases. However this drug addresses just one aspect of the complex migraine illness. Subjects who are being treated with Sumatriptan most likely take other drugs, over the counter or prescription, to treat aspects of the disease that Sumatriptan does not address. There remains a need for a more convenient approach to complete migraine treatment wherein all of the components and medications necessary for migraine treatment are provided.  
         [0007]     The pathogenesis of migraine may be summarized by:  
         [0008]     (1) genetic pre-disposition (Almost 90% of migraine sufferers have a family history of the illness);  
         [0009]     (2) Environmental factors such as food, atmospheric and climatic changes, emotional upheavals, physical stress, sleep deprivation, and social aggravations; and  
         [0010]     (3) The “cascade phenomenon of migraine”, neuro-chemical changes occurring in the brain.  
         [0011]     The most important chemical change in the brain in migraine is the decline in the level of the neurotransmitter serotonin. All modern treatment methods to treat migraine attacks use a generic group of drugs called Triptans. Triptans work by elevating the brain serotonin levels through action at the nerve junctions, synapses. This triggering event results in the release of a variety of other neuro-peptides and around the blood vessels in the meninges, i.e, covering of the brain, and in the brain itself. Some of these important neuro-peptides are bradykinin, prostaglandin. A few of the important mono-amines are dopamine and norepinephrine. Their roles are described in further detail below.  
         [0012]     Migraine is a complex illness in which not only serotonin, but other neuro-are implicated. The acute aseptic, i.e., non-infectious, inflammatory reaction of the meninges which causes the severe headache is mediated through the release of a chemical, prostaglandin. Thus, the common anti-inflammatory drugs like Aspirin, Tylenol, Ibuprofen, etc. are effective in treating the severe headache in migraine attacks because these drugs antagonize prostaglandins.  
         [0013]     During a migraine attack, there is a release of nonrepinephrin which accounts for the sense of anxiety, palpitation and high blood pressure in the migraine sufferer. Anxiety relieving drugs like Valium, Xanax and Paxil are often useful in treating migraine.  
         [0014]     Release of another important chemical substance called dopamine explains the nausea and vomiting and the tremendous mood swings in migraine. Reglan (Chlorpropomide) is a dopamine blocking agent and hence is successfully used in the acute stages of migraine to treat accompanying symptoms other than the headache, such as nausea and mood swings.  
         [0015]     The drug manufacturers typically put out one single product in the market and promote it studiously. There are four different Triptan preparations already being marketed and several more are expected soon. However, as mentioned above, a “single drug” approach using Triptan, for example, cannot treat migraine adequately.  
         [0016]     A well experienced migraine doctor skillfully prescribes a combination of drugs to treat acute migraine. Under current state of the art, depending upon the presenting manifestation of a migraine attack, the migraie doctor may prescribe a Triptan, e.g., Imitrex, an anti-prostaglandin drug, e.g., Ibuprofen and an anti-dopamine drug, Reglan, Patients, very often, use this “cocktail” approach on their own. Surprisingly: it is not at all uncommon to find doctors prescribing only single drug treatment for migraine, which leaves the patient only with partial relief of headache, leaving them unhappy and seeking other opinions. As described above, to successfully treat a migraine attack, there exists the need to use a combination of several drugs. Yet, no manufacturer has assembled a kit with such a combination.  
       SUMMARY OF THE INVENTION  
       [0017]     This invention comprises a pharmaceutical kit for treating migraine headaches, and a method for preparing the pharmaceutical kit. The preparation is a manufacturing process which includes packaging in a plurality of specific compounds used in the of migraine that are serotonin level elevating, prostaglandin inhibiting and dopamine blocking, preferably a therapeutically effective amount of each compound sufficient to treat at least 2 separate migraine headache attacks, and, providing use instructions for the effective administering of the compounds for migraine headache treatment. The invention further comprises useful features that provide advantages to the patient as well as the provider, i.e., doctor and pharmacy. For example, preferably separate packages for each compound are packed in separated compartments within the container.  
         [0018]     Specifically, there is provided a method for preparing a migraine headache treatment which comprises: packaging in a container a therapeutically effective dosage of a serotonin level elevating pharmaceutical compound used in the treatment of migraine; packaging in the container a therapeutically effective dosage of a prostaglandin antagonizing, i.e., inhibiting, pharmaceutical compound used in the treatment of migraine; packaging in the container a therapeutically effective dosage of a blocking pharmaceutical compound used in the treatment of migraine; including and packaged with said container a vessel of water for use in administering the pharmaceutical compounds which are to be orally administered; and packaging in the container instructions for usage of all of the packaged compounds which are contained in the container. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0019]     The present invention will now be described in more detail referring to the drawings that accompany the present application. It is noted that in the accompanying drawings like reference numerals are used for describing like and correspondence elements thereof.  
         [0020]      FIG. 1  shows a preferred pharmaceutical kit including injection devices and pharmaceutical compounds of the present invention;  
         [0021]      FIG. 2  shows a preferred-container including a nasal spray device and alternative pharmaceutical compounds within the container;  
         [0022]      FIG. 3  shows a pharmaceutical kit including pharmaceutical compounds solely for oral administration;  
         [0023]      FIG. 4   a  shows a implementation comprising a bottle having coupling threads for attaching the pharmaceutical kit container;  
         [0024]      FIG. 4   b  shows a side cutaway view of a preferred container having the complete regimen of orally administered, individually packaged pharmaceutical compounds;  
         [0025]      FIG. 4   c  shows a top down plane view of the preferred container of  FIG. 4   b;    
         [0026]      FIG. 5  shows the water bottle coupled to the pharmaceutical kit container; and  
         [0027]      FIG. 6  shows the bottom of the water bottle and pharmaceutical kit container with access means. 
     
    
     DETAILED DESCRIPTION  
       [0028]     An aspect of this invention applies to the preparation of a kit for the treatment of migraine headaches. In a preferred embodiment of this invention quantities representing a therapeutically effective dosage of several compounds for treatment of a migraine headache are packaged along with additional components such as a vessel of water, alcohol swabs and instructions for use, in a container by a manufacturing process which, preferably, seals the container and its contents into a self-contained, unitary, migraine headache treatment kit. Known pharmaceutical compounds may be provided, it should be understood that yet to be developed compounds may also be used as they become available.  
         [0029]     Preferably, each drug, i.e., pharmaceutical compound, in the kit is packed separately, yet the separately drugs are contained in a single, easy to use container, such as the container  100  shown in  FIG. 1 . In a preferred aspect of this pharmaceutical kit for treating migraine headaches, precise instructions  140  for use of all the constituents are also provided. Additionally, it is preferable that a kit contain enough medications, pharmaceutical compounds, to treat at least two migraine attacks. As shown in  FIG. 1 , in a preferred implementation, the container is manufactured such that its compartments  130 ,  160 ,  165  fit neatly around the individually packaged predetermined number of pharmaceutical compounds  132 , injection administration devices  110  for drug injection below the skin of a user, and a vessel of water, e.g., water bottle  120 . Sufficient space is also provided for additional components such as alcohol swab packet  170  and instructions  140 . Additionally, the separately packed drugs, the individually packaged pharmaceutical compounds  132  preferably include labels on the separate packaging identifying the particular pharmaceutical compound contained in the package. Preferably, a container surface such as  105  includes a latching device  155  for keeping the contents secure within the container. Additionally, a preferred implementation of this invention includes a hand strap  150  for carrying the kit  100 . Although a container with basically rectilinear surfaces  105 ,  145  is shown, the container may be provided in any shape and size which provides sufficient space for all of the kit components and pharmaceutical compounds, e.g., water bottle  120 , injection administration devices  110 , alcohol swab packet  170 , instructions  140 , pharmaceutical package  132 , and the like. The container may be made of a relatively soft material such as vinyl and foam, or may provide a relatively hard covering such as high impact plastic.  
         [0030]     The container contents include a therapeutically effective dosage of pharmaceutical used in the treatment of migraine, as well as other components to assist administration, such as alcohol swab packet  170 . Water bottle  120  is preferably a component that is provided in all implementations of this invention in order to facilitate administering oral dosage units of the pharmaceutical compounds, such as pills, capsules, tablets, and the like. The pharmaceutical compounds are chosen to address various aspects of the migraine condition, such as, e.g., headache, nausea and mood swings. In a preferred implementation of the current invention where all pharmaceutical compounds are oral dosage units, the container may be manufactured to contain more than one water bottle, as shown in  FIG. 3  at  120  and  165 .  
         [0031]     In another preferred implementation of this invention, the provided container is manufactured as a permanent attachment to a water bottle, such as container  410  attached to water bottle  415  so that container  410  and water bottle  415  form one integral manufactured drug kit  500  as shown in  FIG. 5 . The container  410  and water bottle  415  may be manufactured as an integrated, unitary member, with opening means, such as a sliding door, hinged door, or, as shown in  FIG. 6 ,a revolving cover with hinge pin  610  and a cut out window  605 , over a bottom of container  410 , for providing access to the contents  132  of the pharmaceutical kit.  
         [0032]     In another preferred implementation of this invention, it is understood that container  410  is, preferably, cylindrical, having an inner sidewall  409 , an outer sidewall  408 , and having a depth and size to permit the pharmaceutical compounds  132  and usage  5  instructions  140  to fit inside the  410 , and to permit the container  410  to securely attach, i.e., mate to e.g. the lower portion  417  of preferably cylindrical water bottle  415  by coupling lower portion  417  of water bottle  415  and container  410  together such that lower portion  417  and container  410  are securely held together by friction contact between them. Additionally, the coupling, in a preferred implementation, as shown in  FIG. 4   b  at  413 , may be provided by threads, preferably on inner sidewall  409  for threading the container  410  on to water bottle  415 . Water bottle  415  comprises complementary threads  419  on its lower portion  417  to accommodate threading the container  410  on to the lower portion  417  of water bottle  415 . Container  410  may also be divided into compartments  412  for a complete regimen of orally  15  administered, individually packaged pharmaceutical compounds ( FIG. 4   c    132 ) such as those discussed below in Migraine Kit-Type III. Preferably, a disk shaped lid  414 , with strap  416  for removal is included to cover the contents of compartments  412 , yet permitting the secure attachment of container  410  with lid  414  to water bottle  415 . However, with or without the lid  414 , the water bottle  415  mated to container  410  provides a convenient, self contained migraine headache treatment kit.  
         [0033]     Because, as discussed above, the most important chemical change in the brain in migraine is the decline in the level of the neurotransmitter serotonin, it is important to provide in the treatment kit  100  a means for elevating serotonin levels. To that end, preferably, a therapeutically effective dosage of a serotonin level elevating pharmaceutical compound used in the treatment of migraine is provided. Additionally, alternative methods of administering the serotonin elevating compound, such as injection devices  110  or nasal spray device  210  (shown in  FIG. 2 ), are provided for fastest relief of symptoms associated with lower serotonin levels during a migraine attack. It should be understood that when the nasal spray device  210  is supplied, the container is manufactured such that compartment  260  fits neatly around it. When one or more injection devices  110  are used, alcohol swab packet  170  is provided for skin preparation of the migraine sufferer. All modern treatment methods to treat this aspect of a migraine attack use a genericgroup of drugs called Triptans. One of the most popular Triptan drugs is Imitrex, manufactured by Glaxo Wellcome, now GlaxoSmithKline (GSK). Imitrex, i.e., Sumatriptan, is currently marketed in a tablet form (50 mg and 100 mg), a nasal spray from (20 mg) and a 6 mg injectable form, i.e., a statdose pen. In a preferred embodiment of this invention, Sumatriptan may be provided in tablet, as well as liquid forms.  
         [0034]     While no skin patch preparation is yet available, it is within the scope of this invention to include a skin patch when a skin patch becomes available. Other available serotonin level elevating compounds which are successfully used and may. preferably, be provided by this invention include Rizatriptan, Zolmitriptan, and Almotriptan. A predetermined number of serotonin level elevating compound dosage units is provided in the manufactured drug kit  100 .  
         [0035]     To combat the nausea and moodswings experienced by a large number of sufferers, a blocking pharmaceutical compound may be prescribed. A preferred implementation of this invention provides a therapeutically effective dosage of dopamine blocking pharmaceutical compound such as Reglan, i.e., Metoclopramide, or Compazine, i.e., Prochlorperazine. A predetermined number of dopamine blocking pharmaceutical compound dosage units is provided in the manufactured drug kit  100 . Elevated prostaglandin, associated with the severe headache caused by inflamed meninges of migraine sufferers may be combated by lowering, i.e., antagonizing the prostaglandin levels. Thus, preferably a therapeutically effective dosage of a prostaglandin inhibiting pharmaceutical compound, such as, for example, 30 inflammatory drugs like Aspirin, i.e., Acetyl Salicylic Acid (325 mg to 500 mg), Tylenol (250 mg to 750 mg), i.e., Acetaminophen, Ibuprofen, and Naproxyn is provided to antagonize, i.e., lower the prostaglandin levels by inhibiting prostaglandin production of the migraine sufferer, wherein relief from the headache is obtained. A predetermined number of prostaglandin inhibiting pharmaceutical compound dosage units is provided in the manufactured drug kit  100 . It should be understood that all of the migraine treatment pharmaceutical compounds discussed above and provided in manufactured drug kit  100  may also be provided in manufactured drug kit  500 .  
         [0036]     Listed below are preferable migraine kit compositions with sufficient dosage units, preferably, to provide treatment of at least two separate migraine attacks. It should be understood that the lists are representative examples and do not limit the scope of the migraine kit compositions.  
         [0037]     Migraine I:  
         [0038]     Imitrex (Sumatriptan) Injection ( Stat Dose Pen) quantity 2;  
         [0039]     Imitrex (Sumatriptan) Tablet 50 mg, quantity 2;  
         [0040]     Reglan (Metoclopromide HCL) 10 mg, quantity 2; and  
         [0041]     Select either Ibuprofen 800 mg, quantity 2 (or) Naproxyn quantity 2.  
         [0042]     Migraine Kit-Type II  
         [0043]     Imitrex (Sumatriptan) Nasal Spray 5 mg to 20 mg, quantity 2\ 
         [0044]     Imitrex (Sumatriptan) Tablets 50 mg, quantity 2  
         [0045]     2 Select from either Reglan (Metoclopromide HCL) 5 mg to 10 mg,  
         [0046]     quantity 2 (or) Prochlorperazine 5 mg to 10 mg, quantity 2  
         [0047]     Select from either Ibuprofen 400 mg to 800 mg, quantity 2 (or) Naproxyn 500 mg to 750 mg, quantity 2.  
         [0048]     Migraine Kit-Type  
         [0049]     Imitrex (Sumatriptan) Tablet quantity 2  
         [0050]     Imitrex (Sumatriptan) Tablet quantity 2  
         [0051]     Reglan (Metoclopromide HCL) 10 mg, quantity 2  
         [0052]     Ibuprofen 800 mg. quantity 2 (or) Naproxyn 500 mg, quantity 2  
         [0053]     In one aspect of this invention, instead of providing the Imitrex tablet in Migraine Kit type III, one of the following compounds may be provided:  
         [0054]     Maxalt Tablet or MLT, 5 mg to  
         [0055]     Zomig Tablet or ZMT, to 5 mg Tablet to 12.5 mg  
         [0056]     Axert Tablet 6.25 mg to 12.5 mg (Almotriptan).  
         [0057]     Now that the invention has been described by way of a preferred embodiment, various modifications and improvements will occur to those of skill in the art. For example, a treatment kit of multiple pharmaceutical compounds could be prepared for the treatment of hypertension, congestive heart failure, or asthma. Thus, it should be understood that the preferred embodiment is provided as an example and not as a limitation. The scope of the invention is defined by the appended claims.