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(12) Patent Application Publication (10) Pub. No.: US 2017/0020873 A1 Mitchell (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2017/0020873 A1 Mitchell (43) Pub US 20170020873A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0020873 A1 Mitchell (43) Pub. Date: Jan. 26, 2017 (54) PHARMACEUTICAL COMPOSITIONS Publication Classification (71) Applicant:- - - sy earmaceutical, Inc., Arlington, (51) AInt. 6LX Cl. 3L/505 (2006.01) A63/37 (2006.01) (72) Inventor: Odes W. Mitchell, Arlington, TX (US) A6II 3/167 (2006.01) A6II 3/09 (2006.01) A63/495 (2006.01) (21)21) Appl. No.:No 15/287,0479 A63L/485 (2006.01) 1-1. A63L/35 (2006.01) (22) Filed: Oct. 6, 2016 A6II 3/4402 (2006.01) Related U.S. ApplicationO O Dat ( 52) U.S. Cl. e pplication Uata CPC ........... A61 K3I/505 (2013.01); A61K 3 1/135 (63) Continuation of application No. 14/733.731, filed on (2013.01); A61 K3I/137 (2013.01); A61 K Jun. 8, 2015, now Pat. No. 9,463,191, which is a 3 I/4402 (2013.01); A61 K3I/09 (2013.01); continuation of application No. 13/703.584, filed on A61K 31/495 (2013.01); A61K 31/485 Feb. 2, 2013, now Pat. No. 9,050,289, filed as appli- (2013.01); A61K 31/167 (2013.01) cation No. PCT/US2011/040231 on Jun. 13, 2011. (60) Provisional application No. 61/354,053, filed on Jun. (57) ABSTRACT 11, 2010, provisional application No. 61/354,057, A composition of an antitussive, a decongestant, or an filed on Jun. 11, 2010, provisional application No. antihistamine to treat upper respiratory and oral pharyngeal 61/354,061, filed on Jun. 11, 2010. congestion and related symptoms in a patient. US 2017/0020873 A1 Jan. 26, 2017 PHARMACEUTICAL COMPOSITIONS hydrocodone bitartrate, has generally been administered to relieve pain consistent with the congestion while Suppress CROSS-REFERENCES TO RELATED ing a cough. Also decongestants, such as phenylephrine and APPLICATIONS pseudoephedrine, have been administered to both children and adults in flavored formulations for reducing mucosal 0001. This Application is a continuation of application Swelling and draining the mucus build-up to clear conges Ser. No. 14/733,731, filed Jun. 8, 2015, which is a continu tion in the air passages. Symptoms due to allergies or ation of application Ser. No. 13/703.584, filed Dec. 11, 2012, allergens are often treated with an antihistamine. Antihista which is a US national stage application of PCT/US2011/ mines, often referred to as histamine-class receptor blockers, 040231 under 35 U.S.C. S371 filed Jun. 13, 2011, which are compounds that may antagonistically block the hista claims priority from U.S. Provisional Patent Application No. mine receptor from binding histamine thereby preventing 61/354,053 filed Jun. 11, 2010, U.S. Provisional Patent the symptoms of an allergy. Application No. 61/354,057 filed Jun. 11, 2010, and U.S. 0006. There are many different treatment medications 61/354,061 filed Jun. 11, 2010, all of which are hereby utilizing a combination of agents in therapeutic doses for incorporated by reference as if fully set forth herein. treating multiple symptoms of upper respiratory tract and oral pharyngeal congestion. As one example, a single medi FIELD OF THE INVENTION cation may include an expectorant, in combination with an 0002 The present invention relates to the treatment and antitussive agent, for removing phlegm or mucus that may relief of various symptoms of upper respiratory and oral have accumulated in the lungs and other air passages in pharyngeal congestion, and in particular, to a combination addition to suppressing a cough. The expectorant is helpful medication for treatment and relief thereof. in preventing the progression of a mild case of bronchitis to a more severe case of pneumonia. BACKGROUND OF THE INVENTION 0007 Combination therapy provides many benefits. For 0003. People around the world frequently suffer from example, it allows patients suffering from congestion and upper respiratory tract and oral pharyngeal congestion. This related symptoms to take only a single dosage medication, congestion may be caused by allergies, infections in the as opposed to multiple medications, for relief therefrom. respiratory tract and/or oral and pharyngeal cavities, Further, it enhances compliance in accordance with a regi changes in weather conditions, as well as from the overall men by eliminating the need for the patient to take different health and genetic disposition of the person. This congestion medications. To this end, combination therapy provides is generally diagnosed from partially or fully blocked air convenience, ensures compliance, and saves cost. passages including airways in the lungs, mouth, nose, and 0008 Combined treatment medications may be formu throat. Other symptoms related to the cause typically accom lated as syrups, pills, tablets, and capsules. Formulations pany the congestion. Cough, tickles in the throat, cold may include flavoring agents to mask undesirable flavors or symptoms Such as fever, flu, sinus infections, and throat or tastes from desired medicinal agents and colorants to render gland pain are some of the more common symptoms found the medication more attractive and appealing to the eye. For with upper respiratory and oral pharyngeal congestion. example, many formulations have a raspberry, cherry, 0004 Congestion of the upper respiratory tract and oral orange, or grape flavor well liked by both children and pharyngeal cavity and related symptoms generally have adults. Moreover, these flavors are easily identified by their undesirable effects for the afflicted person. For example, the color. In combination formulations, the individual ingredi congestion may affect performance in the workplace, School, ents are included in amounts proven to be effective to treat and at home up to and including loss of work and loss of targeted symptoms. Effective amounts have varied depend School attendance. Further, congestion may reduce the abil ing on the particular formulation, type and degree of the ity to perform routine activities, such as housework, driving, symptoms, and desired user or consumer. For example, a running errands, and may even totally incapacitate the child's dose of an elixir or syrup for the relief of cough and person. Severe and intolerable congestion often requires pain related to congestion may have the antitussive and visits to the hospital and treatment. In addition, viral or analgesic in reduced quantities based on size, weight, and bacterial infections of the sinus passage or other airway may age of the child targeted, comparable to a composition or be passed to healthy persons through symptoms of the formulation for an adult which may have double the dosage congestion. For example, a cough or Sneeze may convey a of the antitussive and analgesic. bacterium or virus to another person. Thus, upper respira 0009. Accordingly, it is desirable to have an adminis tory tract and oral pharyngeal congestion and its symptoms trable composition to reduce symptoms of upper respiratory need to be treated. tract and oral pharyngeal congestion. It is further desirable 0005 Generally, there are two typical approaches to that the composition be effective in reducing cough, con treating symptoms of the congestion. One approach involves gestion, histamine-stimulated allergy symptoms and related initially treating the underlying cause of the symptom. For pain. Still further, it is desirable for the composition to example, a bacterial infection is generally treated by admin contain dosages Suitable for administration to a child as well istering an antibiotic to kill the bacteria causing the infec as an adult. In addition, it is desirable to have the compo tion. The second approach involves treating the symptoms sition in a convenient and pharmaceutically acceptable dos themselves, typically in addition to treating the underlying age form. cause, by independently administering one or more medi cations for relief of specific symptoms. For example, an SUMMARY OF THE INVENTION antitussive agent, commonly referred to as a cough Suppres 0010. The present invention provides compositions and sant, has been typically administered for the treatment or methods for treating upper respiratory and oral pharyngeal relief of cough. An opioid medication, such as codeine and congestion and related symptoms in a person Suffering US 2017/0020873 A1 Jan. 26, 2017 therefrom. To this end, and in accordance with the principles infections, and common cold and flu, the symptoms of the present invention, there is provided a composition of described herein may also be due to poor health or a a decongestant, and an antihistamine. Optionally, a compo predisposition for the symptom through genetic make-up. sition may include an antitussive, an expectorant and an The terms “treating and “alleviating, as used herein with analgesic. The combination of an antitussive, a deconges respect to upper respiratory and oral pharyngeal congestion tant, and an antihistamine in a single composition provides and related symptoms, include any reduction in severity or relief of cough, congestion in the air passageways, and duration, of any degree, of the congestion and/or one or common allergy-type symptoms resulting from exposure to more of the related symptoms. The terms also include any various allergens, in a convenient and effective dosage delays in onset of and any general relief from the congestion formulation. and/or one or more of the related symptoms. Thus, the 0011. The composition is formulated in pharmaceutically present invention encompasses palliative compositions and acceptable forms such as liquids, pills, capsules, tablets, and methods. the like. Suitable capsule forms include, without limitation, 0014) To this end, and in accordance with the principles liquid gelatin capsules and enteric-coated capsules. The of the present invention, the compositions include an anti tablet form may be chewable, may melt or disintegrate in the tussive, a decongestant, and an antihistamine. Inclusion of mouth, or may be enteric-coated to provide delayed-release an antihistamine, in combination with an antitussive and a and Sustained-release characteristics for the composition.
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