United States Patent [19]
`United States Patent
`[19]
`Zaffaroni
`Zaffaroni
`
`3,797,494
`[11]
`[11] 3,797,494
`[45]*Mar. 19, 1974
`[45]*Mar. 19, 1974
`
`[54] BANDAGE FOR THE ADMINISTRATION OF
`[54] BANDAGE FOR THE ADMINISTRATION OF
`DRUG BY CONTROLLED METERING
`DRUG BY CONTROLLED METERING
`THROUGH MICROPOROUS MATERIALS
`THROUGH MICROPOROUS MATERIALS
`Inventor: Alejandro Zaffaroni, Atherton,
`[75]
`[75] Inventor; Alejandro Zaffaroni, Atherton,
`Calif.
`Calif.
`Assignee: Alza Corporation, Palo Alto, Calif.
`[73]
`[73] Assignee: Alza Corporation, Palo Alto, Calif.
`The portion of the term of this
`Notice:
`[*]
`Notice: (cid:9)
`The portion of the term of this
`*
`patent subsequent to Aug. 10, 1988,
`patent subsequent to Aug. 10, 1988,
`has been disclaimed.
`has been disclaimed.
`Aug. 9, 1971
`Filed:
`[22]
`Aug. 9, 1971
`[22] Filed: (cid:9)
`Appl. No.: 169,976
`[21]
`[21] Appl. No.: 169,976
`Related U.S. Application Data
`Related U.S. Application Data
`Continuation-in-part of Ser. Nos. 812,116, April 1,
`[63]
`[63] Continuation-in-part of Ser. Nos. 812,116, April 1,
`1969, Pat. No. 3,598,122, and Ser. No. 8 12,117,
`1969, Pat. No. 3,598,122, and Ser. No. 812,117,
`April 1, 1969, Pat. No. 3,598,123, and Ser. No.
`April 1, 1969, Pat. No. 3,598,123, and Ser. No.
`150,085, June 4, 1971, Pat. No. 3,731,683.
`150,085, June 4, 1971, Pat. No. 3,731,683.
`
`U.S. Cl. ............................................... . 128/268
`[52]
` 128/268
`[52] U.S. CI. (cid:9)
`Int. Cl.............................................. A611 15/06
`[51]
` A611 15/06
`[51] Int. Cl (cid:9)
`Field of Search ........... 128/260,268, 156, 155,
`[58]
`[58] Field of Search (cid:9)
` 128/260, 268, 156, 155,
`128/296; 424/19, 20, 28
`128/296; 424/19, 20, 28
`
`[56]
`[56]
`
`3,598,122
`3,598,122 (cid:9)
`
`References Cited
`References Cited
`UNITED STATES PATENTS
`UNITED STATES PATENTS
`Zaffaroni............................ 128/268
` 128/268
`8/1971
`Zaffaroni (cid:9)
`8/1971 (cid:9)
`
`3,598,123
`3,598,123
`3,426,754
`3,426,754
`3,053,255
`3,053,255
`3,464,413
`3,464,413
`3,512,997
`3,512,997
`
`8/1971
`Zaffaroni............................ 128/268
`128/268
`
`8/ 1 971 Zaffaroni (cid:9)
`2/1969 Bierenbaum.................... 128/268 X
`2/1969 Bierenbaum (cid:9)
`
`128/268 X
`9/1962 Meyer................................. 128/268
`9/1962 Meyer (cid:9)
`
`128/268
`9/1969 Goldfarb et al..................... 128/268
`9/1 969 Goldfarb et al (cid:9)
`
`128/268
`5/1970 Cohly et al..................... 128/296 X
`5/1970 Cohly et al. (cid:9)
`
`128/296 X
`
`Primary Examiner—Dalton L. Truluck
`Primary Examiner—Dalton L. Truluck
`Assistant Examiner—J. C. McGowan
`Assistant Examiner—J. C. McGowan
`
`ABSTRACT
`[57]
`ABSTRACT
`[57] (cid:9)
`A bandage for use in the continuous administration of
`A bandage for use in the continuous administration of
`drugs to the skin or mucosa, comprising a backing
`drugs to the skin or mucosa, comprising a backing
`member defining one exterior surface, a surface of
`member defining one exterior surface, a surface of
`pressure-sensitive adhesive defining a second exterior
`pressure-sensitive adhesive defining a second exterior
`surface, and disposed therebetween a reservoir con
`surface, and disposed therebetween a reservoir con-
`taining drug formulation confined therein. The reser
`taining drug formulation confined therein. The reser-
`voir can comprise a distinct layer of the bandage or a
`voir can comprise a distinct layer of the bandage or a
`plurality of microcapsules distributed throughout the
`plurality of microcapsules distributed throughout the
`adhesive surface, and in either case the drug can be
`adhesive surface, and in either case the drug can be
`confined within an interior chamber of the reservoir
`confined within an interior chamber of the reservoir
`or distributed throughout a reservoir matrix. The drug
`or distributed throughout a reservoir matrix. The drug
`passes through drug release rate controlling micropo
`passes through drug release rate controlling micropo-
`rous material which continuously meters the flow of
`rous material which continuously meters the flow of
`drug by viscous or diffusive transfer to the skin or mu
`drug by viscous or diffusive transfer to the skin or mu-
`cosa at a controlled and predetermined rate over a pe
`cosa at a controlled and predetermined rate over a pe-
`.
`riod of time.
`riod of time.
`7 Claims, 5 Drawing Figures
`7 Claims, 5 Drawing Figures
`
`
`
`A3
`
`
`
`
`
`Par Pharm., Inc., et al.
`Exhibit 1016
`Page 001
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`PATENTED MAR 1 9 1974
`PAIENIEDMAR 19 1874
`
`3,797,494
`3.3'97:494
`
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`13 (cid:9)
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`21 (cid:9)
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`a Fig. 5
`
`-
`
`INVENTOR.
`INVENTOR.
`BY Alejandro Zaffaroni
`Alejandro Zaffaroni
`BY
`
`<!…] j ?lanº.4% Attorney
`d1,1,-02,61 S 11) Jae Attorney
`
`Par Pharm., Inc., et al.
`Exhibit 1016
`Page 002
`
`(cid:9)
`(cid:9)
`

`

`5
`
`3,797,494
`3,797,494
`1
`2
`2
`1
`the blood and body compartments. Thus, a plot of drug
`BANDAGE FOR THE ADMINISTRATION OF DRUG
`BANDAGE FOR THE ADMINISTRATION OF DRUG
`the blood and body compartments. Thus, a plot of drug
`BY CONTROLLED METERING THROUGH
`in circulation after administration of several tablets a
`BY CONTROLLED METERING THROUGH
`in circulation after administration of several tablets a
`day has the appearance of a series of peaks which may
`MICROPOROUS MATERIALS
`MICROPOROUS MATERIALS
`day has the appearance of a series of peaks which may
`surpass the toxic threshold of the drug, and valleys
`surpass the toxic threshold of the drug, and valleys
`which fall below the critical point needed to achieve
`which fall below the critical point needed to achieve
`RELATED APPLICATIONS
`RELATED APPLICATIONS
`the desired therapeutic effect.
`the desired therapeutic effect.
`This application is a continuation-in-part of Ser. No.
`The administration of drugs by injection can entail
`This application is a continuation-in-part of Ser. No.
`The administration of drugs by injection can entail
`certain disadvantages. For example, very strict asepsis
`812,116, filed Apr. 1, 1969, and now issued on Aug.
`812,116, filed Apr. 1, 1969, and now issued on Aug.
`certain disadvantages. For example, very strict asepsis
`10, 1971 as U.S. Pat. No. 3,598,122 entitled “Bandage
`must be maintained to avoid infection of the blood, the
`10, 1971 as U.S. Pat. No. 3,598,122 entitled "Bandage
`must be maintained to avoid infection of the blood, the
`for Administering Drugs”; Ser. No. 812,117, filed Apr.
`vascular system or heart. Drug administration by poor
`for Administering Drugs"; Ser. No. 812,117, filed Apr. 10
`vascular system or heart. Drug administration by poor
`10
`intravenous injection technique may result in perivas
`1, 1969, and now also issued on Aug. 10, 1971 as U.S.
`intravenous injection technique may result in perivas-
`1, 1969, and now also issued on Aug. 10, 1971 as. U.S.
`cular injection when it is not intended; and the typical
`Pat. No. 3,598,123 entitled “Bandage”; and Ser. No.
`Pat. No. 3,598,123 entitled "Bandage"; and Ser. No.
`cular injection when it is not intended; and the typical
`result of injection into the blood is a sudden rise in the
`150,085, filed June 4, 1971, and now issued on May 8,
`150,085, filed June 4, 1971, and now issued on May 8,
`result of injection into the blood is a sudden rise in the
`1973 as U.S. Pat. No. 3,731,683 entitled “Bandage for
`blood concentration followed by an uncontrolled de
`1973 as U.S. Pat. No. 3,731,683 entitled "Bandage for
`blood concentration followed by an uncontrolled de-
`cline. Additionally, administration of drugs by injection
`the Controlled Metering of Topical Drugs to the Skin”;
`the Controlled Metering of Topical Drugs to the Skin"; 15
`cline. Additionally, administration of drugs by injection
`15
`all being applications of Alejandro Zaffaroni.
`is inconvenient and painful. Other dosage forms for sys
`all being applications of Alejandro Zaffaroni.
`is inconvenient and painful. Other dosage forms for sys-
`temic administration of drug, such as rectal supposito
`temic administration of drug, such as rectal supposito-
`BRACKGROUND OF THE INVENTION
`BRACKGROUND OF THE INVENTION
`ries and sublingual lozenges, also produce non-uniform
`ries and sublingual lozenges, also produce non-uniform
`levels of the therapeutic agent in circulation. These
`This invention relates to a device for the administra
`This invention relates to a device for the administra-
`levels of the therapeutic agent in circulation. These
`tion of drug and, more particularly, to a medical ban- 20
`dosage forms require great patient cooperation, have
`tion of drug and, more particularly, to a medical ban
`20
`dosage forms require great patient cooperation, have
`low patient acceptability, and are sparingly used
`dage for the controlled continuous metering of flow of
`dage for the controlled continuous metering of flow of
`low patient acceptability, and are sparingly used
`systemically or topically active drug to the skin or mu
`-
`throughout most of the world.
`systemically or topically active drug to the skin or mu-
`throughout most of the world.
`-
`A large number of locally acting drugs are available
`cosa over a period of time.
`cosa over a period of time.
`A large number of locally acting drugs are available
`“Topically active” drugs, as that term is used in this
`to treat skin disorders or other conditions which mani
`"Topically active" drugs, as that term is used in this
`to treat skin disorders or other conditions which mani-
`specification and the appended claims, are agents
`fest themselves in a manner such that they are suscepti
`25
`specification and the appended claims, are agents 25
`fest themselves in a manner such that they are suscepti-
`which, when applied to the skin or mucosa, primarily
`ble to treatment via the skin. These drugs are conven
`which, when applied to the skin or mucosa, primarily
`ble to treatment via the skin. These drugs are conven-
`cause a pharmacological or physiological response at
`tionally topically administered to the skin with the ac
`cause a pharmacological or physiological response at
`tionally topically administered to the skin with the ac-
`or near the site of their application. “Systemically ac
`tive agent carried in the form of ointments, creams,
`or near the site of their application. "Systemically ac-
`tive agent carried in the form of ointments, creams,
`tive” drugs, as that term is used in this specification and
`salves, liniments, powders, dressings, and the like. The
`tive" drugs, as that term is used in this specification and
`salves, liniments, powders, dressings, and the like. The
`the appended claims, are agents which, when applied
`popularity of these types of formulations resides in the
`30
`the appended claims, are agents which, when applied 30
`popularity of these types of formulations resides in the
`to the skin or mucosa, are absorbed through the body
`fact that it is quite easy to topically apply the agent to
`to the skin or mucosa, are absorbed through the body
`fact that it is quite easy to topically apply the agent to
`surface to which applied and are transported from their
`the skin in this manner. In most cases, however, it is not
`surface to which applied and are transported from their
`the skin in this manner. In most cases, however, it is not
`site of application by the recipient's circulatory system
`possible to determine how much of the preparation has
`site of application by the recipient's circulatory system
`possible to determine how much off the preparation has
`or lymphatic system, to cause a pharmacologic or phys
`been taken up or effectively administered to the sking
`or lymphatic system, to cause a pharmacologic or phys-
`been taken up or effectively administered to the sking
`iologic response at a remote site in the body. (cid:9)
`iologic response at a remote site in the body.
`since only non-uniform levels of the agent are avail
`35
`35
`since only non-uniform levels of the agent are avail-
`Systemically active drugs are conventionally adminis
`able, nor is there any assurance that sufficient medica
`Systemically active drugs are conventionally adminis-
`able, nor is there any assurance that sufficient medica-
`tered either orally or by injection, with the primary ob
`tion will be available for the duration of periods that it
`tered either orally or by injection, with the primary ob-
`tion will be available for the duration of periods that it
`jective of the mode being to achieve a given desired
`is required. A further undesirable feature is the unsight
`jective of the mode being to achieve a given desired
`is required. A further undesirable feature is the unsight-
`blood level of drug in circulation over a period of time.
`liness of these formulations which often discourages
`blood level of drug in circulation over a period of time.
`liness of these formulations which often discourages
` 40
`patients from using them during their waking hours of
`40
`However, these prior art methods possess certain short
`However, these prior art methods possess certain short-
`patients from using them during their waking hours of
`comings resulting in the failure to obtain these goals.
`the day when they are most likely to be seen by others.
`comings resulting in the failure to obtain these goals.
`the day when they are most likely to be seen by others.
`Further, the preparations are subject to rub off onto
`For example, the oral route is inadequate for several
`For example, the oral route is inadequate for several
`Further, the preparations are subject to rub off onto
`clothing, thus causing much inconvenience and annoy
`reasons even though the drug is administered at peri
`reasons even though the drug is administered at peri-
`clothing, thus causing much inconvenience and annoy-
`odic intervals according to a well defined schedule. The
`-
`odic intervals according to a well defined schedule. The
`ance to the user.
`ance to the user.
`rate of absorption of drug through the gastrointestinal
`45
`45
`suMMARY OF THE INVENTION
`rate of absorption of drug through the gastrointestinal
`SUMMARY OF THE INVENTION
`tract is affected by both the contents of the tract and
`tract is affected by both the contents of the tract and
`Accordingly, an object of this invention is to provide
`the time of passage of drug through the small intestine.
`Accordingly, an object of this invention is to provide
`the time of passage of drug through the small intestine.
`a bandage for the improved continuous administration
`Therefore, such variables as whether the drug is admin
`a bandage for the improved continuous administration
`Therefore, such variables as whether the drug is admin-
`of a predetermined controlled quantity of topically or
`istered before or after eating and the type and quantity
`50 of a predetermined controlled quantity of topically or
`istered before or after eating and the type and quantity
`50
`systemically active drug to or through the skin or body
`of food eaten (for example, high or low fat content), or
`systemically active drug to or through the skin or body
`of food eaten (for example, high or low fat content), or
`mucosa over a period of time, which overcomes the dis
`whether administered before or after a bowel move
`mucosa over a period of time, which overcomes the dis-
`whether administered before or after a bowel move-
`ment, affect the rate of absorption of the drug which
`advantages inherent in the aforesaid prior art modes of
`advantages inherent in the aforesaid prior art modes of
`ment, affect the rate of absorption of the drug which
`takes place in the small intestine. Additionally, the time
`administration.
`administration.
`takes place in the small intestine. Additionally, the time
`of passage of drug through the small intestine is af
`Another object of this invention is to provide a ban
`Another object of this invention is to provide a ban
`of passage of drug through the small intestine is af-
`55
`55 dage which can be adapted to deliver controlled quan-
`fected by the rate of peristaltic contracting, adding fur
`dage which can be adapted to deliver controlled quan
`fected by the rate of peristaltic contracting, adding fur-
`ther uncertainty. Also important is the rate of circula
`tities of drug having a wide variety of chemical and
`tities of drug having a wide variety of chemical and
`ther uncertainty. Also important is the rate of circula-
`physical properties and over a wide range of drug deliv
`tion of blood to the small intestine and the fact that
`physical properties and over a wide range of drug deliv-
`tion of blood to the small intestine and the fact that
`many drugs administered by this route are rendered in
`many drugs administered by this route are rendered in-
`ery rates.
`ery rates.
`active by gastric acid and digestive enzymes of the gas
`In accomplishing these objects, one feature of the in
`In accomplishing these objects, one feature of the in-
`active by gastric acid and digestive enzymes of the gas-
`60
`60
`vention resides in a bandage for the continuous admin
`trointestinal tract or liver where the drug can be metab
`vention resides in a bandage for the continuous admin-
`trointestinal tract or liver where the drug can be metab-
`olized to an inactive product by that organ. These fac
`istration of controlled quantities of drug to the skin or
`istration of controlled quantities of drug to the skin or
`olized to an inactive product by that organ. These fac-
`mucosa, comprised of a laminate of: (1) a backing
`tors make it difficult to achieve a desired time course
`tors make it difficult to achieve a desired time course
`mucosa, comprised of a laminate of: (1) a backing
`member; bearing (2) a discrete middle reservoir layer
`of concentration of the drug in the blood. The almost
`member; bearing (2) a discrete middle reservoir layer
`of concentration of the drug in the blood. The almost
`containing a drug confined within a body, the body
`inevitable result of oral administration of drugs through
`65 containing a drug confined within a body, the body
`inevitable result of oral administration of drugs through
`65
`the gastrointestinal tract is that the level of drug in cir
`being formed from drug release rate controlling micro
`being formed from drug release rate controlling micro-
`the gastrointestinal tract is, that the level of drug in cir-
`porous material permeable to the passage of the drug,
`culation surges to a peak level at the time the drug is
`culation surges to a peak level at the time the drug is
`porous material permeable to the passage of the drug,
`to continuously meter the flow of a therapeutically ef
`administered, followed by a decline in concentration in
`administered, followed by a decline in concentration in
`to continuously meter the flow of a therapeutically ef-
`
`Par Pharm., Inc., et al.
`Exhibit 1016
`Page 003
`
`(cid:9)
`

`

`3,797,494
`3,797,494
`
`3
`3
`4
`4
`fective amount of the drug to the skin or mucosa from
`dage of the invention is comprised of a backing mem
`fective amount of the drug to the skin or mucosa from
`dage of the invention is comprised of a backing mem-
`the reservoir at a controlled and predetermined rate
`ber having a reservoir on one surface thereof of drug
`the reservoir at a controlled and predetermined rate
`ber having a reservoir on one surface thereof of drug
`over a period of time; and (3) a pressure-sensitive ad
`uniformly distributed throughout a matrix material per
`over a period of time; and (3) a pressure-sensitive ad-
`uniformly distributed throughout a matrix material per-
`hesive surface adapted for contact with the skin or mu
`hesive surface adapted for contact with the skin or mu-
`meable to passage of the drug, and on the surface of the
`meable to passage of the drug, and on the surface of the
`cosa and positioned on one surface of the reservoir re
`cosa and positioned on one surface of the reservoir re-
`reservoir remote from the backing member bearing a
`5
`5 reservoir remote from the backing member bearing a
`mote from the backing member.
`mote from the backing member.
`pressure-sensitive adhesive coating. A microporous
`pressure-sensitive adhesive coating. A microporous
`Another aspect of this invention resides in a bandage
`Another aspect of this invention resides in a bandage
`membrane is interposed between the reservoir layer
`membrane is interposed between the reservoir layer
`comprised of a laminate of: (1) a backing member;
`comprised of a laminate of: (1) a backing member;
`and the pressure-sensitive adhesive coating;
`and the pressure-sensitive adhesive coating;
`bearing (2) a discrete middle reservoir containing a
`bearing (2) a discrete middle reservoir containing a
`FIG. 3 is a cross-sectional view of another embodi-
`FIG. 3 is a cross-sectional view of another embodi
`drug confined therein, the reservoir being formed of
`drug confined therein, the reservoir being formed of
`10
`ment of the bandage of the invention, wherein the res
`10 ment of the bandage of the invention, wherein the res-
`material permeable to passage of the drug; and (3) a
`material permeable to passage of the drug; and (3) a
`ervoir laminated to the backing member is a hollow
`ervoir laminated to the backing member is a hollow
`pressure-sensitive adhesive surface adapted for contact
`pressure-sensitive adhesive surface adapted for contact
`container permeable to passage of drug by flow
`container permeable to passage of drug by flow
`with the skin or mucosa and positioned on one surface
`with the skin or mucosa and positioned on one surface
`through the pores of one surface thereof, and having
`through the pores of one surface thereof, and having
`of the reservoir remote from the backing member and
`of the reservoir remote from the backing member and
`the drug confined within the interior chamber thereof.
`15 the drug confined within the interior chamber thereof.
`wherein one or more drug release rate controlling mi
`wherein one or more drug release rate controlling mi-
`15
`The reservoir bears a coating of pressure-sensitive ad
`The reservoir bears a coating of pressure-sensitive ad-
`croporous membranes are interposed between the sur
`croporous membranes are interposed between the sur-
`hesive thereon;
`hesive thereon;
`face of the reservoir and pressure-sensitive adhesive so
`face of the reservoir and pressure-sensitive adhesive so
`FIG. 4 is a perspective view of the medical adhesive
`FIG. 4 is a perspective view of the medical adhesive
`as to continuously meter the flow of a therapeutically
`as to continuously meter the flow of a therapeutically
`bandage of the invention, wherein the drug is microen
`bandage of the invention, wherein the drug is microen-
`effective amount of the drug from the reservoir at a
`effective amount of the drug from the reservoir at a
`capsulated with a porous material permeable to the
`20 capsulated with a porous material permeable to the
`controlled and predetermined rate over a period of
`controlled and predetermined rate over a period of
`20
`passage of the drug, and the microcapsules are uni
`passage of the drug, and the microcapsules are uni-
`time. The reservoir can be a container having the agent
`time. The reservoir can be a container having the agent
`formly distributed throughout the pressure-sensitive
`formly distributed throughout the pressure-sensitive
`confined therein or a solid or microporous matrix hav
`confined therein or a solid or microporous matrix hav-
`coating;
`ing agent dispersed therein.
`coating;
`ing agent dispersed therein.
`FIG. 5 is a cross-sectional view of the bandage of the
`FIG. 5 is a cross-sectional view of the bandage of the
`Still another embodiment of this invention resides in
`Still another embodiment of this invention resides in
`invention shown in FIG. 4.
`an adhesive bandage comprising a laminate of: (1) a
`25 invention shown in FIG. 4.
`25
`an adhesive bandage comprising a laminate of: ( 1) a
`backing member; bearing (2) a pressure-sensitive ad
`backing member; bearing (2) a pressure-sensitive ad-
`DETAILED DESCRIPTION OF THE INVENTION
`DETAILED DESCRIPTION OF THE INVENTION
`hesive on one surface thereof adapted for contact with
`hesive on one surface thereof adapted for contact with
`In accordance with this invention there is provided a
`the skin or mucosa, said pressure-sensitive adhesive
`In accordance with this invention there is provided a
`the skin or mucosa, said pressure-sensitive adhesive
`bandage suitable, by virtue of the microporous materi
`having distributed therethrough, (3) a plurality of dis
`bandage suitable, by virtue of the microporous materi-
`having distributed therethrough, (3) a plurality of dis-
`crete microcapsules, each of which microcapsules
`als employed therein, for the predetermined controlled
`30
`30 als employed therein, for the predetermined controlled
`crete microcapsules, each of which microcapsules
`comprises a drug confined within a body of drug re
`administration of drug to the skin or mucosa of the
`administration of drug to the skin or mucosa of the
`comprises a drug confined within a body of drug re-
`lease rate controlling porous material to continuously
`body over a period of time. To use the bandage of the
`lease rate controlling porous material to continuously
`body over a period of time. To use the bandage of the
`meter the flow of a therapeutically effective amount of
`invention it is applied to the patient's skin or mucosa
`meter the flow of a therapeutically effective amount of
`invention it is applied to the patient's skin or mucosa
`the drug to the skin or mucosa of the patient from the
`the drug to the skin or mucosa of the patient from the
`and should be in firm contact therewith so as to form
`and should be in firm contact therewith so as to form
`microcapsules at a controlled and predetermined rate
`35
`microcapsules at a controlled and predetermined rate
`a tight seal. Flow of drug from the reservoir is metered
`35 a tight seal. Flow of drug from the reservoir is metered
`over a period of time.
`through the pores of the rate release controlling mate
`over a period of time.
`through the pores of the rate release controlling mate-
`Other objects, features and advantages of the inven
`Other objects, features and advantages of the inven-
`rial in accordance with the laws of hydrodynamics or
`rial in accordance with the laws of hydrodynamics or
`tion will become more apparent from the following de
`tion will become more apparent from the following de-
`diffusion, as hereinafter discussed, at a predetermined
`diffusion, as hereinafter discussed, at a predetermined
`scription when taken in conjunction with the accompa
`scription when taken in conjunction with the accompa-
`rate. In operation, drug molecules are continuously re
`40 rate. In operation, drug molecules are continuously re-
`40
`nying drawings.
`nying drawings.
`-
`moved from the reservoir and migrate to the skin or
`moved from the reservoir and migrate to the skin or
`The term “reservoir”, as used herein to define the
`The term "reservoir", as used herein to define the
`mucosa of the patient. In the case of systemic drugs, the
`mucosa of the patient. In the case of systemic drugs, the
`drug containing portion of the subject bandage, is in
`drug containing portion of the subject bandage, is in-
`drugs are absorbed by the skin or mucosa and enter cir
`drugs are absorbed by the skin or mucosa and enter cir-
`tended to connote a broad class of structures capable
`tended to connote a broad class of structures capable
`culation through the capillary network.
`-
`culation through the capillary network.
`of fulfilling the intended function, and includes both
`of fulfilling the intended function, and includes both
`The reservoir containing the drug is formed of mate
`45 (cid:9)
`The reservoir containing the drug is formed of mate-
`45
`discrete porous microcapsules, as well as distinct reser
`discrete porous microcapsules, as well as distinct reser-
`rial permeable to the drug to permit passage of the
`rial permeable to the drug to permit passage of the
`voir compartments or layers. Likewise, as will be here
`voir compartments or layers. Likewise, as will be here-
`drug. Depending upon the particular embodiment as
`drug. Depending upon the particular embodiment as
`inafter more completely developed, the foregoing term
`inafter more completely developed, the foregoing term
`described above, the drug reservoir can be of micropo
`described above, the drug reservoir can be of micropo-
`encompasses containers having one or more interior
`encompasses containers having one or more interior
`rous material or otherwise. However, as is apparent in
`rous material or otherwise. However, as is apparent in
`drug containing chambers, as well as solid matrices and
`drug containing chambers, as well as solid matrices and
`the latter case, the drug must first pass through a micro
`50 the latter case, the drug must first pass through a micro-
`50
`microporous matrices having a systemically or topically
`microporous matrices having a systemically or topically
`porous membrane material prior to reaching the skin or
`porous membrane material prior to reaching the skin or
`active drug distributed therethrough.
`active drug distributed therethrough.
`mucosa. It is therefore critical to the practice of this in
`mucosa. It is therefore critical to the practice of this in-
`The term “drug or agent”, when not further quali
`The term "drug or agent", when not further quali-
`vention for all embodiments that, at some point after or
`vention for all embodiments that, at some point after or
`fied, includes both topically active and systemically ac
`fied, includes both topically active and systemically ac-
`concurrent with the release of drug from the reservoir
`concurrent with the release of drug from the reservoir
`tive drugs, as hereinbefore defined.
`tive drugs, as hereinbefore defined.
`and prior to reaching the skin or mucosa, the drug pass
`55
`55 and prior to reaching the skin or mucosa, the drug pass
`through the drug release rate controlling microporous
`BRIEF DESCRIPTION OF THE DRAWINGS
`BRIEF DESCRIPTION OF THE DRAWINGS
`through the drug release rate controlling microporous
`membrane or matrix material to meter the flow thereof.
`membrane or matrix material to meter the flow thereof.
`In the drawings:
`In the drawings:
`The rate of passage or permeation of drug through the
`The rate of passage or permeation of drug through the
`FIG. 1 is a cross-sectional view of an embodiment of
`FIG. 1 is a cross-sectional view of an embodiment of
`microporous material is determined by the transfer
`microporous material is determined by the transfer
`the medical bandage of the invention, wherein the drug
`the medical bandage of the invention, wherein the drug
`60
`60
`mechanism which can be either by:
`is uniformly distributed throughout a matrix of micro
`mechanism which can be either by:
`is uniformly distributed throughout a matrix of micro-
`1. diffusive flux of drug molecules as is the case, as
`porous material permeable to the passage of the drug
`1. diffusive flux of drug molecules as is the case, as
`porous material permeable to the passage of the drug
`hereinafter described, where the micropores of the
`by flow through the pores of the material and the mate
`hereinafter described, where the micropores of the
`by flow through the pores of the material and the mate-
`rate controlling microporous membrane or matrix
`rial is laminated to a backing member. The matrix ma
`rate controlling microporous membrane or matrix
`rial is laminated to a backing member. The matrix ma-
`material are impregnated with a diffusive medium
`terial which acts as a reservoir for the drug bears a
`material are impregnated with a diffusive medium
`terial which acts as a reservoir for the drug bears a
`65 (cid:9)
`65
`coating of the pressure-sensitive adhesive thereon;
`for the drug in which the drug molecules can dis
`coating of the pressure-sensitive adhesive thereon;
`for the drug in which the drug molecules can dis-
`solve in and flow through to a direction of lower
`FIG. 2 is a cross-sectional view of still another em
`FIG. 2 is a cross-sectional view of still another em-
`solve in and flow through to a direction of lower
`chemical potential; or
`bodiment of the invention, wherein the adhesive ban
`bodiment of the invention, wherein the adhesive