SpineStrip™

A Point-Of-Care Transdermal Corticosteroid Delivery Device for Regulation

of Inflammatory Response Following Spinal Cord Injury.
N. Chakravarty, H. Hiraki, A. Sriram
SCI-Induced Inflammatory Response

 Spinal Cord Injury (SCI) is a two step process1

 Primary: Mechanical Injury
 Secondary: Inflammation and Apoptosis
 Secondary Response leads to demyelination of axons, neurological dysfunction
and possible transient paralysis2
 No established cure for secondary SCI, however treatment within the first
eight hours is shown to be most effective3

1. Hausmann, O. N. (2003). Post-traumatic inflammation following spinal cord injury. Spinal cord, 41(7), 369-378.
2. Zhang, N., Yin, Y., Xu, S. J., Wu, Y. P., & Chen, W. S. (2012). Inflammation & apoptosis in spinal cord injury. Indian journal of medical research, 135(3), 287.
3. Bracken, Michael B., et al. "A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: results of the Second
National Acute Spinal Cord Injury Study." New England Journal of Medicine 322.20 (1990): 1405-1411.
Drug Delivery Device for Emergency
Medicine
 Envision anti-inflammatory drug delivery device
 First Responders
 Transport from site to hospital
 The average response time of land and air
Ambulances: 6.06 and 23.25 minutes respectively

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biker.html
Design Constraints

 Localized administration of anti-inflammatory agents

 Contours to spine to deliver drugs efficiently while minimizing stress on spinal
column
 Cost-efficient materials
 Compact and portable profile
 Able to tolerate a variety of environmental conditions
 Long shelf life
 Requires little to no user training

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directions.html
Introducing SpineStrip™

 A transdermal corticosteroid delivery device

 Mediates spinal inflammation to mitigate
effects of secondary SCI
 Easy-To-Use and portable!

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Drug Specifications

 2 types of Corticosteroids: glucocorticoids and mineralocorticoids

 Glucocorticoids are anti-inflammatory; typically used to treat localized arthritis
 The glucocorticoid methylprednisolone is effective in treating
Secondary SCI - especially if administered within the
first 8 hours of injury

1. Ogbru, P. O. (n.d.). Corticosteroids: Drug Facts, Side Effects and Dosing. Retrieved February 14, 2017.
2. Bracken, Michael B., et al. "A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: results of the Second
National Acute Spinal Cord Injury Study." New England Journal of Medicine 322.20 (1990): 1405-1411.
Drug Dosage Specifications

 Methlyprednisolone dosage is specified according to body surface area of

individual
 Each 60cm of strip corresponds to 30mL
dose of methylprednisolone
 Diluted in water to 62.5 mg/mL
 Can adjust length/number of strips based
on size of patient

1. Bracken, Michael B., et al. "A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: results of the Second
National Acute Spinal Cord Injury Study." New England Journal of Medicine 322.20 (1990): 1405-1411.
Drug Administration Specifications

 Trade-off between penetrating stratum corneum and damaging dermis layers

 Hollow Microneedle Patch
 Painless
 Bypasses stratum corneum
 Hollow vs. Solid
 Length: 200 μm
 Max width of 170 μm
 Thickness of 35 μm

1. Prausnitz, Mark R., and Robert Langer. "Transdermal drug delivery." Nature biotechnology 26.11 (2008): 1261-1268.
2. Cormier, M., Johnson, B., Ameri, M., Nyam, K., Libiran, L., Zhang, D. D., & Daddona, P. (2004). Transdermal delivery of desmopressin using a coated microneedle
array patch system. Journal of controlled release, 97(3), 503-511.
Drug Release Properties Specifications

 Diffusion coefficients for macromolecules1 in solution are on the order of 10-11

m2 s-1
 Macromolecular crowding v dilute system
 Simulate bolus dose
 Methylprednisolone not incorporated into lattice for faster absorption

1. W.A. Wakeham, N.H. Salpadoru, C.G. Caro, Diffusion coefficients for protein molecules in blood serum, Atherosclerosis, Volume 25, Issue 2, 1976, Pages 225-235,
ISSN 0021-9150.
Material & Dimension Specifications

 Roll of tape format

 60 cm strip length – 30mL Methylprednisolone dosage
 60cm x 6cm microneedle array, spaced 0.5 cm apart
 Each microneedle delivering 0.45M Methylprednisolone
 Strip dimensions: 60cm x 8cm
 Hollow Microneedle Material – silicon
 Adhesive Layer - low-density polyethylene backing with an acrylate adhesive
 Drug Reservoir - Hydrogel
 Backing - polyurethane

1. Bracken, Michael B., et al. "A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: results of the Second
National Acute Spinal Cord Injury Study." New England Journal of Medicine 322.20 (1990): 1405-1411.
2. Cormier, M., Johnson, B., Ameri, M., Nyam, K., Libiran, L., Zhang, D. D., & Daddona, P. (2004). Transdermal delivery of desmopressin using a coated microneedle
array patch system. Journal of controlled release, 97(3), 503-511.
SpineStrip™ COMSOL Model Assumptions

 Assumptions: 0.45M initial concentration gradient

 Everything diffuses into dermis
 Uniform diffusion only out of the tips of the needles, radially
 Skin is represented by water
 Assume dilute system, binary diffusion, no macromolecular crowding
SpineStrip™ COMSOL Model

Dermis Layer

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SpineStrip™ COMSOL Model

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SpineStrip™ COMSOL Model

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SpineStrip™ COMSOL Model

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SpineStrip™ COMSOL Model

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SpineStrip™ COMSOL Model

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SpineStrip™ Model Schematic
Side View

Top View
Future Work

 Incorporate Biodegradable Microneedles

 Silicon needles often break
 Possible adaptation for low-resource settings
 Low-Cost
 Incorporate cooling sensation
 Education outreach on Secondary SCI
 Partner with REI, Patagonia
Thank You!
QUESTIONS?