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Pub. No.: US 2007/0231396 A1 Ray (43) Pub US 20070231396A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0231396 A1 Ray (43) Pub. Date: Oct. 4, 2007 (54) MEDICATION SPRAY FORMULATION Publication Classification (51) Int. Cl. A 6LX 36/899 (2006.01) A6IR 36/47 (2006.01) (76) Inventor: Charles D. Ray, Santa Barbara, CA A6II 3/56 (2006.01) (US) A6II 3/545 (2006.01) A 6LX 9/50 (2006.01) (52) U.S. Cl. ......................... 424/490; 424/731; 424/750; 514/200: 514/179 Correspondence Address: DICKE, BILLIG & CZAJA FIFTH STREET TOWERS (57) ABSTRACT 100 SOUTH FIFTH STREET, SUITE 2250 MINNEAPOLIS, MN 55402 (US) Formulations for delivery of a pharmaceutical agent include a thixotropic agent. The pharmaceutical agent may be slowly released from a hydrogel or microcapsule in the spray formulation. Various formulations of reasonable thixotropic (21) Appl. No.: 11/392.403 and hydrogel media are useful. Droplet size and thixotropy determine the distribution of the material along body sur faces and tissues such as the respiratory passages, and limit the displacement, running or dripping of the sprayed (22) Filed: Mar. 29, 2006 medium from its intended sites. US 2007/0231396 A1 Oct. 4, 2007 MEDCATION SPRAY FORMULATION would be welcomed by both manufacturers of health care products and consumers of Such products. FIELD OF THE INVENTION SUMMARY OF THE INVENTION 0001. The invention relates to thixotropic formulations for spray media delivery to body Surfaces and tissues such 0006 The present invention provides a thixotropic fluid as nasopharyngeal passages. The thixotropic effect allows media composition that is capable of being sprayed onto a for good fluidity during spraying but prevents running or patient's tissue (e.g., skin, wound, nasal cavity/mucous drippage loss of the medication from the body Surface so membrane), and generally consists of a primary carrier sprayed. Additionally, a suitable hydrogel or microencapsu component (or 'suspended medium') and a thixotropic lation is provided into which a medication is carried and agent. slowly released into absorptive tissues receiving the spray. 0007 Specifically, the invention provides an aqueous fluid Suspension for delivery of a pharmaceutical agent, said 0002. 2. Description of the Relevant Art Suspension having a sheared viscosity and an unsheared 0003 Atomization or jet spray of fluid media to deliver Viscosity, wherein said sheared viscosity is less than about various compounds, such as emollients, thin creams, oils, 200 centipoise, the Suspension being sprayable when aqueous or powdered Substances or medication to tissues, sheared, and wherein said unsheared viscosity is at least particularly within the nasopharyngeal mucosa or other body about 5 times greater than said sheared viscosity, and the Surfaces, have been known and practiced for centuries. Suspension returns to its unsheared viscosity within about 20 Various means to deliver a burst or steady flow of media by seconds after shearing, the Suspension comprising said phar a repelling agent, usually air, as by blowing through a maceutical agent and a carrier therefore, said carrier com hollow reed or using a compressible bulb or by a pressurized prising a thixotropic agent. compound or gas, are well described in existing art. The 0008. In one embodiment, the invention provides an expelled material may be atomized, fluidized or ejected in a aqueous fluid Suspension for delivery of a pharmaceutical stream. In order to obtain an optimized dispensing of the agent, said Suspension having a sheared viscosity and an medium to be sprayed, several interdependent functions unsheared Viscosity, wherein said sheared viscosity is less must be considered. These are related to the expulsion force, than about 200 centipoise, the Suspension being sprayable the nozzle or spray jet and the medium to be sprayed. For the when sheared, and wherein said unsheared Viscosity is spraying to continue with satisfaction, the following must be greater than about 400 centipoise said suspension compris optimized: applied ejection pressure, Velocity, fluidity (vis ing said pharmaceutical agent and a carrier therefore which cosity), turbulence and Surface tension of the Suspending includes a thixotropic agent, medium, as well as characteristics of the dissolved or Suspended particulates in the expellant medium. Also impor 0009. In another embodiment, the thixotropic agent com tant is the structure of the spray nozzle, or ventura. In the prises a hydrogel. case of plain or medicated Substances sprayed along the 0010. It will be recognized that the suspension in accor nasopharyngeal passages, additional parameters of conse dance with the present invention may have a variety of quence are the Substance particle or droplet size, the atom different carrier formulations, each specifically selected to izer nozzle and Suspension medium. They must all be generate a desired end effect in the patient. Thus, the present optimized relative to the delivery means, usually a hand invention is in no way limited to a particular carrier formu operated rubber bulb. Optimizing the media, medication lation (or desired end use), although in Some embodiments Suspension and dispensing device must be performed by a described below, a hydrogel material is included with the trial and error method. carrier component. Rather, the present invention is premised 0004 Further, for many applications the fluidity (viscos upon the provision of the thixotropic agent in combination ity) of the medium must be relatively low to permit easy with the primary carrier component to achieve the overall spray atomizing or dispersal as micro particles. After the reduced viscosity upon spraying to the targeted tissue, medium is in place, a preferred medium should not run down thereby minimizing undesired 'dripping of the sprayed from or drip out or off of the sprayed surface(s). These two compound from the targeted tissue. characteristics (spray fluidity and non-drip) are found in 0011. As used herein, these terms have the defined mean non-Newtonian thixotropic fluids. A Newtonian fluid shows ings. a viscosity that is directly related to the velocity of motion 0012 1. The term “thixotropic agent’ means an agent of the fluid. Water, air and most aqueous solutions typify which causes a Suspension to exhibit a consistency that such fluids. Thixotropic fluids show a viscosity that falls is viscous at rest, but fluid when agitated. Such a with increased velocity, becoming thicker when the fluid material has high Static shear strength and low dynamic medium is quiet or still. Unfortunately, much of the usual shear strength simultaneously. sprayed, watery material will coalesce and drain by gravity, especially when further diluted into the mucous, serous fluid 0013 2. The term “pharmaceutical agent’ means an or sweat present on body surfaces. The thixotropic effect agent which has a therapeutic or palliative effect. Such agent is not restricted to those agents requiring a reduces Such coalescence and drainage. prescription for availability. 0005. It would be very desirable to provide a means to dispense a pharmaceutical agent under low pressure using a DETAILED DESCRIPTION OF THE medium that has a low sheared viscosity, and which, after INVENTION spraying and deposition on the body Surface, returns to the 0014. The aqueous suspensions of the invention com unsheared viscosity and does not drip or run. Such a product prises a pharmaceutical agent in particle form, a carrier for US 2007/0231396 A1 Oct. 4, 2007 the pharmaceutical agent which includes a thixotropic agent 0020 Examples of useful vaccines include but are not and may also include bioacceptable additional ingredients limited to those for HIV, flue, avian flu, polio, rubella and and adjuvants. Such as preservatives, emollients and the like. rubeola. 0.015 Individual spray components may vary widely and 0021 Examples of useful diuretics include furosemide, particular pharmaceutical formulations are not the Subject of bumetanide, torsemide, ethacrynic acid, thiazides such as this invention. Any particulate pharmaceutical agent which clorothiazide, hydrochlorothiazide, hydrofluormethazide, is capable of being Suspended in an aqueous Suspension may bendroflumethazide, nethyclothiazide, metolazone, polythi be used in the Suspension. The pharmaceutical agents are azide, QuinethaZone and tichlormethiazide, potassium spar present in amounts effective to provide the desired treatment ing diuretics such as spironolactone, triamterene, and to the body Surfaces and/or tissues. Typical Suspensions will amiloride, and others, contain pharmaceutical agents in amounts of from about 0022. Examples of useful antihistamines include but are 0.001 weight percent up to about 20 weight percent, more not limited to ethylenediamines such as pyrilamine and typically from about 0.001 weight percent to about 10 antazoline, ethanolamines Such as diphenhydramine and weight percent or less. doxylamine, alkylamines such as pheniramine, chlorphe 0016 Numerous classes of useful pharmaceutical agents niramine, dexclorpheniramine, and brompehmiramine, pip exist. Useful agents include but are not limited to, analgesic erazines such as hydroxy Zine, meclizine, and cyclizine, agents for pain relief Such as opiods and non-steroidal tricyclics such as cyproheptidine, azatadine, and promethaZ anti-inflammatory agents, local anesthetics, antibiotics, hor ine, H1-receptor antagonists such as loratidine, fexofena mones, steroids such as soluble cortisones, antihistamines, dine, and other antihistamines known
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