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Intradermal delivery of substances

a technology of intradermal delivery and substance, which is applied in the direction of drug composition, peptide/protein ingredient, metabolic disorder, etc., can solve the problems of insufficient reproducibility of the transdermal delivery system, variable clinical results, and maintaining the placement of the needle in the intradermal space, so as to improve the clinical utility of id delivery, prevent the leakage of substances out of the skin, and improve the absorption within the intradermal space

Inactive Publication Date: 2005-05-05
PETTIS RONALD J +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention improves the way drugs and other substances are delivered to humans or animals through small needles. By placing the needle outlet in a specific area, the substance can be delivered more effectively without leaking out of the skin. The method of delivery called infusion is preferred because it requires lower pressures and reduces the amount of substance lost to the skin surface. The pharmacokinetics of the drugs delivered according to this method are similar to traditional delivery methods, but with the advantage of reduced pain for the patient. Delivery devices that control the volume and rate of fluid delivery provide accurate delivery without leakage. Overall, this invention makes the delivery of substances through small needles more effective and comfortable for patients."

Problems solved by technology

However, such transdermal delivery systems are not sufficiently reproducible and give variable clinical results.
However, intradermal (ID) injection is rarely used due to the difficulty of correct needle placement in the intradermal space, the difficulty of maintaining placement of the needle in the intradermal space, and a lack of information and knowledge of the pharmacokinetic profiles for many drugs delivered ID.
In addition, little is known about fluid absorption limits in dermal tissue and the effect of depot time on drug stability.
However, the present inventors have found that, in the case of microneedles, breaching the stratum corneum alone is not sufficient for clinically efficacious intradermal delivery of substances.
These authors do not disclose the depth of penetration of the microneedles nor do they report any results suggesting a clinically useful glucose response using this method of administration.
Further, there is no evidence of accurate or reproducible volume of delivery using such a device.
However, it fails to appreciate that clinical efficacy is dependent upon both accurate, quantitative, and reproducible delivery of a volume or mass of drug substance and the pharmacokinetic uptake and distribution of that substance from the dermal tissue.

Method used

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Examples

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example 1

[0017] ID infusion of insulin was demonstrated using a stainless steel 30 gauge needle bent at the tip at a 90° angle such that the available length for skin penetration was 1-2 mm. The needle outlet (the tip of the needle) was at a depth of 1.7-2.0 mm in the skin when the needle was inserted and the total exposed height of the needle outlet was 1.0-1.2 mm. The needle was constructed in a delivery device similar to that described in U.S. Pat. No. 5,957,895, with infusion pressure on the insulin reservoir provided by a plastic Belleville spring and gravimetrically measured flow rates of 9 U / hr (90 mL / hr). The corresponding flow rates for SC control infusions were set using MiniMed 507 insulin infusion pumps and Disetronic SC catheter sets. Basal insulin secretion in swine was suppressed by infusion of octreotide acetate (Sandostatin®, Sandoz Pharmaceuticals, East Hanover, N.J.), and hyperglycemia was induced by concomitant infusion of 10% glucose. After a two hour induction and basel...

example 2

[0019] ID insulin delivery was demonstrated in swine using a hollow silicon microneedle connected to a standard catheter. The catheter was attached to a MiniMed 507 insulin pump for control of fluid delivery.

[0020] A hollow, single-lumen microneedle (2 mm total length and 200×100 μm OD, corresponding to about 33 gauge) with an outlet 1.0 μm from the tip (100 μm exposed height) was fabricated using processes known in the art (U.S. Pat. No. 5,928,207) and mated to a microbore catheter commonly used for insulin infusion (Disetronic). The distal end of the microneedle was placed into the plastic catheter and cemented in place with epoxy resin to form a depth-limiting hub. The needle outlet was positioned approximately 1 mm beyond the epoxy hub, thus limiting penetration of the needle outlet into the skin to approximately 1 mm, which corresponds to the depth of the intradermal space in swine. The patency of the fluid flow path was confirmed by visual observation, and no obstructions wer...

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Abstract

The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage.

Description

FIELD OF THE INVENTION [0001] The present invention relates to methods and devices for administration of substances into the skin. BACKGROUND OF THE INVENTION [0002] Conventional needles have long been used to deliver drugs and other substances to humans and animals through the skin, and considerable effort has been made to achieve reproducible and efficacious delivery through the skin while reducing or eliminating the pain associated with conventional needles. Certain transdermal delivery systems eliminate needles entirely, and rely on chemical mediators or external driving forces such as iontophoretic currents or sonophoresis to breach the stratum corneum painlessly and deliver substances through the skin. However, such transdermal delivery systems are not sufficiently reproducible and give variable clinical results. [0003] Mechanical breach of the stratum corneum is still believed to be the most reproducible method of administration of substances through the skin, and it provides...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61D7/00A61K38/28A61K38/22A61M5/158A61M5/30A61M5/32A61M5/46A61M37/00A61P3/10
CPCA61M5/158A61M5/32A61M5/3286A61M2037/0061A61M5/46A61M37/0015A61M2037/0038A61M5/3291A61P3/10A61M37/00A61K38/28A61K38/29A61M5/3295
Inventor PETTIS, RONALD J.DOWN, JAMES A.HARVEY, NOEL G.
Owner PETTIS RONALD J
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