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Novel Microneedle Patches for Active Insulin Delivery are Efficient in Maintaining Glycaemic Control: An Initial Comparison with Subcutaneous Administration
KTH, School of Electrical Engineering (EES), Microsystem Technology.
KTH, School of Electrical Engineering (EES), Microsystem Technology.ORCID iD: 0000-0001-9552-4234
2007 (English)In: Pharmaceutical research, ISSN 0724-8741, E-ISSN 1573-904X, Vol. 24, no 7, 1381-1388 p.Article in journal (Refereed) Published
Abstract [en]

Purpose. Good glycaemic control is essential to minimize the risk for diabetes-induced complications. Also, compliance is likely to be higher if the procedure is simple and painless. This study was designed to validate painless intradermal delivery via a patch-like microneedle array.

Materials and Methods. Diabetes was induced by an intravenous injection of streptozotocin (50 mg/kg bw) in adult male Sprague Dawley rats. Plasma insulin and blood glucose were measured before, during and after subcutaneous or intradermal (microneedles) infusion of insulin (0.2 IU/h) under Inactin-anaesthesia.

Results. Before insulin administration, all animals displayed a pronounced hyperglycaemia (19 +/- 1 mM; 359 mg/dl). Administration of insulin resulted in a reduced plasma glucose independently of administration route (subcutaneous 7.5 +/- 4.2, n=9, and intradermal 11 +/- 1.8, n=9 after 240 min), but with less errors of the mean in the intradermal group. In the intradermal group, plasma insulin was increased in all latter measurements (72 +/- 22, 81 +/- 34, and 87 +/- 20 mu IU/ml), as compared to the first measurement (26 +/- 13). In the subcutaneous group, plasma insulin was elevated during the last measurement (to 154 +/- 3.5 mu IU/ml from 21 +/- 18).

Conclusion. This study presents a novel possibility of insulin delivery that is controllable and requires minimal training. This treatment strategy could improve compliance, and thus be beneficial for patients' glycaemic control.

Place, publisher, year, edition, pages
2007. Vol. 24, no 7, 1381-1388 p.
Keyword [en]
diabetes; insulin lispro; intradermal; microneedles; rats; transdermal; DIABETES-MELLITUS; TRANSDERMAL DELIVERY; HOLLOW MICRONEEDLES; IN-VITRO; INHALED INSULIN; RAT DERMIS; INJECTION; TYPE-1; SKIN; STREPTOZOTOCIN
National Category
Chemical Sciences
Identifiers
URN: urn:nbn:se:kth:diva-7462DOI: 10.1007/s11095-007-9256-xISI: 000247429700015Scopus ID: 2-s2.0-34249872741OAI: oai:DiVA.org:kth-7462DiVA: diva2:12493
Note
QC 20100628Available from: 2007-09-10 Created: 2007-09-10 Last updated: 2017-12-14Bibliographically approved
In thesis
1. A Fully Integrated Microneedle-based Transdermal Drug Delivery System
Open this publication in new window or tab >>A Fully Integrated Microneedle-based Transdermal Drug Delivery System
2007 (English)Doctoral thesis, comprehensive summary (Other scientific)
Abstract [en]

Patch-based transdermal drug delivery offers a convenient way to administer drugs without the drawbacks of standard hypodermic injections relating to issues such as patient acceptability and injection safety. However, conventional transdermal drug delivery is limited to therapeutics where the drug can diffuse across the skin barrier. By using miniaturized needles, a pathway into the human body can be established which allow transport of macromolecular drugs such as insulins or vaccines. These microneedles only penetrate the outermost skin layers, superficial enough not to reach the nerve receptors of the lower skin. Thus, microneedle insertions are perceived as painless.

The thesis presents research in the field of microneedle-based drug delivery with the specific aim of investigating a microneedle-based transdermal patch concept. To enable controllable drug infusion and still maintain an unobtrusive and easy-to-use, patch-like design, the system includes a small active dispenser mechanism. The dispenser is based on a novel thermal actuator consisting of highly expandable microspheres. When actuated, the microspheres expand into a liquid reservoir and, subsequently, dispense stored liquid through outlet holes.

The microneedles are fabricated in monocrystalline silicon by Deep Reactive Ion Etching. The needles are organized in arrays situated on a chip. To allow active delivery, the microneedles are hollow with the needle bore-opening located on the side of the needle. This way, the needle can have a sharp and well-defined needle tip. A sharp needle is a further requirement to achieve microneedle insertion into skin by hand.

The thesis presents fabrication and evaluation of both the microneedle structure and the transdermal patch as such. Issues such as penetration reliability, liquid delivery into the skin and microneedle packaging are discussed. The microneedle patch was also tested and studied in vivo for insulin delivery. Results show that intradermal administration with microneedles give rise to similar insulin concentration as standard subcutaneous delivery with the same dose rate.

Place, publisher, year, edition, pages
Stockholm: KTH, 2007. x, 82 p.
Series
Trita-EE, ISSN 1653-5146 ; 2007:046
Keyword
Microneedle, Transdermal, Intradermal, Drug delivery, DRIE, MEMS, Microsystem
National Category
Biomedical Laboratory Science/Technology
Identifiers
urn:nbn:se:kth:diva-4484 (URN)978-91-7178-751-4 (ISBN)
Public defence
2007-09-28, F3, Lindstedsvägen 26, Stockholm, 10:00
Opponent
Supervisors
Note
QC 20100623Available from: 2007-09-10 Created: 2007-09-10 Last updated: 2010-06-28Bibliographically approved

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