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United States Patent 19 11) Patent Number: 5,302,172 Sage, Jr

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United States Patent 19 11) Patent Number: 5,302,172 Sage, Jr III USOO5302172A United States Patent 19 11) Patent Number: 5,302,172 Sage, Jr. et al. (45) Date of Patent: Apr. 12, 1994 54 METHOD AND COMPOSITION FOR 5,068,226 11/1991 Weinshenker et al. ............... 604/20 ONTOPHORESS 88. M I E. et al. .............. - 32. www. PPS . sessor asses to (75) Inventors: Burton H. Sage, Jr.; Jim E. Riviere, 5,088,977 2/1992 Sibalis ............ ... 604/20 both of Raleigh, N.C. 5,135,480 8/1992 Bannon et al. ........................ 604/20 (73) Assignees: North Carolina State University, OTHER PUBLICATIONS tpickinson and Lattin, Gary A. "Method to Control Delivery of Un pany, N.J. changed Drugs via Iontophoresis' JRE Nov. 1988. 21 Appl. No.: 653,202 D. I. Abramson, et al., Arch Environ Health 19:103 1a. (1969). (22 Filed: Feb. 8, 1991 D. I. Abramson, et al., American Heart Journal 23;817 Related U.S. Application- Data (1942).H. A. Kontos, et al., Circulation Research 21:679 (1967). 63 Continuation-in-part of Ser. No. 494,062, Mar. 15, N. H. Bellantone, et al., International Journal of Pharma 1990, abandoned. ceutics 30:63 (1986). 51) Int. Cl. ............................................... A61N 1/30 Primary Examiner-John D. Yasko (52) U.S. Cl. ......................................... 604/20; 604/49 Assistant Examiner-Michael Rafa 58 Field of Search .................... 62. Attorney, Agent, or Firm-Bell, Seltzer, Park & Gibson www. 57 ABSTRACT 56) References Cited 57 The invention discloses methods and compositions for U.S. PATENT DOCUMENTS enhanced iontophoretic delivery of active agents. The 3,991,755 9/1976 Vernon et al. ........................ 604/20 compositions are pharmaceutically acceptable composi 4,406,658 9/1983 Lattin et al. .......................... 604/20 tions for iontophoretic delivery comprising a delivery 4,702,732 10/987 Powers et al. ........................ 9/20 enhancing amount of a vasodilator and active agent. 4,820,2634,752,285 4/19896/1988 SpevakPetelenz et et al. al. ........................ ...................... 604/20 Methods comprise adding a delivery enhancings amount 4,950,229 8/1990 Sage, Jr 604/20 of a vasodilator to an active agent and delivering by 5,023,085 6/1991 Francoeur et al. ................... 60/20 iontophoresis. 5,047,007 10/1990 McNichols et al. .................. 604/20 5,057,072 10/1991 Phipps ................................... 604/20 11 Claims, 3 Drawing Sheets EFFICIENCYE OF ACTIVE 3O DENT WITH VASODLATOR 25 3 22O 15 O OO3 O1 O3 1 3 %TOLOZOLINE U.S. Patent Apr. 12, 1994 Sheet 1 of 3 5,302,172 FG. U.S. Patent Apr. 12, 1994 Sheet 2 of 3 5,302,172 1 OO O 1 OO 2OO 3OO 4OO 5OO MINUTES FG, 2. NCY OF ACTIVE ENT WITH VASODLATOR 15 O 5 O OO3 O1 O3 1 5 %TOLOZOLINE FG 5. U.S. Patent Apr. 12, 1994 Sheet 3 of 3 5,302,172 d CO oO NOgas No O O 1 Z - - 2 O l n 1. s O O O H o O CO n O O O CN O CO O CO o - N n 24 GNWOOOT n l 5,302,172 1. 2 The rate of delivery would still be limited by the stra METHOD AND COMPOSTON FOR tl COrneum. ONTOPHORESS Vasodilators such as tolazoline, nitrates, papaverine, phentolamine, dipyridamole, cyclandelate, isoxsuprine, CROSS REFERENCE TO RELATED 5 mecholyl (metacholine), histamine and nylidrin are APPLICATION known to dilate blood vessels. Their use with iontopho This application is a continuation in part of patent resis, without other agents, has been studied. Studies application Ser. No. 07/494,062, filed Mar. 15, 1990 include, for example, D.I. Abramson et al., American abandoned. Heart Journal, 23:817 (1942) which describes a signifi O cant increase in blood flow when using vasodilators FIELD OF THE INVENTION alone. Iontophoresis of vasodilators as a means of enhancing The invention relates to iontophoretic transdermal delivery of an active agent delivered with it has not delivery. More specifically, the invention relates to been demonstrated. Despite attempts to optimize ionto methods and compositions for enhancing iontophoretic 15 phoretic delivery by such means as varying compound delivery. concentrations and optimizing ionic moieties in the BACKGROUND system, the efficiency of iontophoretic delivery is still During iontophoresis, charged compounds pass from low. a reservoir attached to the skin of a person or animal 20 SUMMARY OF THE INVENTION into the tissue therebeneath. The process is one wherein The invention discloses methods and compositions the rate of delivery is a function of current, active agent for enhanced iontophoretic delivery of active agents. concentration, and presence of other ions. It is a gener The compositions are pharmaceutically acceptable ally held belief that higher concentration of compound, compositions for iontophoretic delivery which com higher levels of current, and lower concentration of 25 prise a delivery enhancing amount of a vasodilator and other ions will result in greater delivery of the com active agent. pound. Other embodiments of the invention include methods L. Brown and R. Langer, Ann. Rev. Med 39:221 for enhancing iontophoretic delivery of active agents (1988) describe the generally held belief that the rate which comprise adding a delivery enhancing amount of limiting barrier for transdermal drug delivery is the 30 a vasodilator to an active agent and delivering by ionto stratum corneum. There continues to be a large re phoresis. search effort to find methods to reduce or eliminate the rate limiting property of the stratum corneum. BRIEF DESCRIPTION OF THE DRAWINGS N.H. Bellantone et al., International Journal of Phar FIG. 1 is a schematic presentation of the skin (10), maceutics 30:63 (1986) describes how iontophoresis can 35 which shows the upper capillary loops (12) of the vas be used in place of other means to enhance drug trans culature of the skin and the deeper blood vessels that port through the epidermal barrier such that the need feed the upper capillary loops and the shunt blood ves for chemical penetration enhancers could be obviated. sels (14) which connect the deeper blood vessels. Alternatively, the article suggests use of penetration FIG. 2 is a plot of data showing that addition of the enhancers could lower drug concentrations or lower vasodilator tolazoline to a concentration of lidocaine energy required for delivery. enhances the iontophoretic rate of delivery of lidocaine. Another technique believed to enhance the delivery FIG. 3 is a plot of data showing the concentration of of certain types of active agents by iontophoresis is a vasodilator wherein delivery of the active agent is disclosed in European patent application 0278 473 Al. enhanced. The application describes the addition of compounds to 45 FIG. 4 is a contour plot showing delivery of an active proteins and other macromolecules to decrease the agent when iontophoresed with a vasodilator. degree of aggregation of the molecules in the active reservoir. The added compounds have the ability to aid DETALED DESCRIPTION OF THE solubility and disassociation of the macromolecules. NVENTION It is also well-known in the iontophoresis art (for 50 While this invention is satisfied by embodiments in example, see "ontophoretic Delivery of Nonpeptide many different forms, there is shown in the drawings Drugs Formulation Optimum for Maximum Skin Per and will herein be described in detail, preferred embodi meability” by J. E. Sanderson et al., J. Pharm Sci 78:361 ments of the invention, with the understanding that the (1989) that the presence of ions other than the desired present disclosure is to be considered as exemplary of compound in the donor reservoir formulation reduces 55 the principles of the invention and is not intended to iontophoretic efficiency. limit the invention to the embodiments illustrated. The In the situation of transdermal delivery where the scope of the invention will be measured by the ap rate limiting barrier is the stratum corneum, the dermal pended claims and their equivalents. vasculature, which acts as the means of compound re The presen invention discloses methods and composi moval from the dermal tissue, has no effect on the deliv tions for enhanced iontophoretic delivery of active ery rate. Regardless of its state of dilation, it is capable agents. of removing all the compound that reaches it. Other Embodiments of the invention include pharmaceuti wise, the vasculature would become the rate limiting cally acceptable compositions for iontophoretic deliv barrier. ery comprising a delivery enhancing amount of vasodi If the stratum corneun is the rate limiting barrier, 65 lator and active agent. placing a vasodilator near the dermal vasculature for In addition, embodiments of the invention provide the purpose of enhancing the blood flow through the methods for enhancing iontophoretic delivery of active dermal vasculature by any means, would have no effect. agents comprising: 5,302,172 3 4. (a) adding a delivery enhancing amount of a vasodi It is understood that most active agents have more lator to an active agent; and than one effect in the body. For example, lidocaine is a (b) delivering of a pharmaceutically acceptable com local anesthetic which also exhibits vasoactive proper position of (a) by iontophoresis. ties (i.e. a vasolidator). Therefore, consideration of The methods and compositions of the present inven these factors for any active agent must be taken into tion are particularly advantageous compared to prior account when determining optimum ranges of each for methods and compositions. Prior methods and composi iontophoretic delivery together. tions typically relied on skin damaging or skin altering The response surface method (RSM) is a known compositions such as permeation enhancers. Unlike skin method that can be used to study the effects of active permeation enhancers that alter the stratum corneum, 10 agent properties and vasodilator properties. Other the compositions and methods of the present invention methods for measuring the effects of the active agent are not directed toward altering the stratum corneum and vasodilator are known.
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