METHODS AND APPARATUS FOR DRUG DELIVERY INVOLVING PHASE CHANGING FORMULATIONS
First Claim
1. A formulation for dermal drug delivery to a body surface comprising:
- a drug, a conversion agent, and a vehicle medium, said formulation being in a less-than-solid form.
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Accused Products
Abstract
This invention relates to an apparatus and method of drug delivery on a human body surface. The formulation comprises a drug, a conversion agent capable of converting the formulation from a less solid phase to a coherent, soft, solid phase, and a vehicle medium or carrier for the drug and conversion agent. The drug formulation is applied to this human body surface in its less than solid phase and is subsequently converted to a soft solid phase while the drug is being delivered through the human body surface. After delivery of the drug is complete, the soft solid formulation can be removed or peeled from the body surface as a coherent solid formulation. The drug formulation provides control over drug delivery rates and allows the formulation to be removed without leaving a messy, residual formulation on the body surface.
183 Citations
241 Claims
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1. A formulation for dermal drug delivery to a body surface comprising:
- a drug, a conversion agent, and a vehicle medium, said formulation being in a less-than-solid form.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 155)
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24. A method of dermal drug delivery onto a human body surface and tissues under said surface comprising the steps of:
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applying a drug formulation to a human body surface, said formulation comprising a drug, a conversion agent, and a vehicle medium;
converting said formulation from a less-than-solid phase to a coherent, soft solid phase;
delivering the drug to said human body surface upon which said formulation is applied and tissues under said surface; and
removing said formulation. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 230)
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61. A formulation for anesthetizing a human body surface and tissues under said surface, comprising:
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at least one local anesthetic agent;
a gelling agent; and
an evaporable liquid, the formulation being in a less-than-solid form and said gelling agent capable of facilitating a conversion of said formulation into a coherent, soft solid after a portion of said evaporable liquid is evaporated. - View Dependent Claims (65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92)
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62. The formulation of claim 62, further comprising a plasticizing substance;
- said plasticizing substance being capable of maintaining said formulation in the form of soft solid after said evaporable liquid is substantially all evaporated.
- View Dependent Claims (63, 64)
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93. A formulation for anesthetizing a human body surface and tissues under said surface, comprising:
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at least one local anesthetic agent selected from the group of lidocaine, tetracaine, prilocaine, benzocaine, bupivacaine, mepivacaine, dibucaine, etidocaine, butacaine, cyclomethycaine, hexylcaine, proparacaine, and lopivacaine, and a thermal gel, said formulation being capable of becoming more solid at a temperature between 20°
C. to 37°
C.
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94. A method for noninvasive dermal drug delivery to a human body surface and tissues under said surface, comprising the steps of:
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applying a layer of formulation comprising a drug and a liquid onto human body surface;
said formulation being in the form which is less solid than a coherent, soft solid before being applied onto a human body surface;
converting said layer of formulation into a layer of coherent solid; and
removing said coherent solid layer of formulation from said human body surface. - View Dependent Claims (95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138)
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118. The method as recited in claim l l7, wherein said step of controlling the time it takes to convert said formulation comprises applying a layer of said formulation with predetermined thickness onto said human body surface.
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139. A method for delivering a drug into a human body, comprising the steps of:
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providing a formulation comprising a pharmaceutically active substance and a crosslinkable but substantially uncrosslinked polymer;
providing a patch with a shallow cavity with a predetermined area;
the bottom of said shallow cavity comprising a crosslinking agent capable of converting said formulation into a more solid form,placing said formulation into said cavity, and applying said patch with said formulation onto a human body surface. - View Dependent Claims (140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154)
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156. An apparatus for anesthetizing human body surface and tissues under said surface comprising:
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a formulation, said formulation comprising a local anesthetic agent;
a solidifying sheet; and
a crosslinkable but substantially uncrosslinked polymer;
said solidifying sheet comprising a sheet of material impregnated with a crosslinking agent capable of crosslinking said polymer in said formulation. - View Dependent Claims (158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177)
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157. The apparatus of 156, wherein said local anesthetic agent is tetracaine.
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178. An applicator for applying a layer of dermally delivered drug formulation to have uniform and predetermined thickness onto a human body surface, comprising:
a formulation container, and a nozzle, said nozzle comprising one input end and one output end;
said input end comprising means to attach said applicator to said container capable of containing said drug formulation and dispensing said formulation;
said output end of said nozzle comprising an opening with predetermined width and length.- View Dependent Claims (179, 180, 181, 182)
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183. A method for noninvasively anesthetizing human skin, comprising the steps of:
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applying a layer of a less-than-a-solid formulation containing water onto human skin; and
peeling said layer of formulation off said human skin after enough of said water is evaporated from the formulation so that more than 50% of said formulation becomes a coherent, soft solid. - View Dependent Claims (184, 185, 186, 187, 188, 189, 190, 191, 192)
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- 193. An apparatus for anesthetizing human skin, comprising a formulation and a solidifying sheet impregnated with a crosslinking agent chosen from the group of sodium borate, salts of boric acid or boric acid.
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197. A method of simultaneously hydrating and anesthetizing a human body surface with a scab before debridement, comprising:
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applying a layer of a formulation comprising at least one local anesthetic agent, one conversion agent, and water onto a human body surface with scab that needs to be debrided;
applying a sheet of material impregnated with a substance capable of activating said conversion agent and converting said formulation into a coherent, soft, solid gel;
said sheet of material further comprises a layer of material that is barrier to water;
waiting sufficient time so that said layer of formulation is substantially converted into a coherent, soft, solid gel; and
removing said layer of coherent, soft, solid gel from said human body surface after said human body surface is anesthetized and said scab is significantly softened. - View Dependent Claims (198, 199)
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200. A formulation for controlled anesthetic delivery to a human body surface that is not covered by stratum corneum and to tissues under said surface, comprising:
- a local anesthetic agent disposed within said formulation, more than 60% of said local anesthetic agent existing in a nondissolved state in said formulation.
- View Dependent Claims (201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216)
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217. A method for improving the function of topically applied pharmaceutical formulations comprising:
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applying a layer of formulation comprising a pharmaceutically active compound and a liquid onto a human body surface;
said formulation being in less-than-solid form before being applied onto a human body surface;
converting said layer of formulation into a layer of coherent solid, and peeling said layer of formulation from said human body surface after more than 50% of said formulation becomes a coherent soft solid. - View Dependent Claims (218, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240)
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241. A combination of a method and a solidifying sheet for protecting the application time of said formulation on human body surface and for facilitating easy removal of said formulation after its application, said formulation comprising:
a pharmaceutically active agent selected from the following group of drugs;
antibiotics, agents for promoting hair growth, drugs for treating skin diseases, medications for treating wound; and
a crosslinkable but substantially uncrosslinked polymer,said solidifying sheet comprising a sheet of material impregnated with a crosslinking agent capable of crosslinking said polymer in said formulation.
Specification