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BACKGROUND. Transdermal Drug Delivery: The passive diffusion of drug molecules through the skin layers into the circulatory system due to a concentration gradient Prevalence: Birth Control, Angina, Pain, Motion Sickness, and Smoking Cessation Aid. BACKGROUND. Advantages: Avoid metabolism by ga
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1. HADD Patch Senior Design Conference
Louisiana Tech University
Dept. of Biomedical Engineering
May 9, 2003
2. BACKGROUND Transdermal Drug Delivery:
The passive diffusion of drug molecules through the skin layers into the circulatory system due to a concentration gradient
Prevalence:
Birth Control, Angina, Pain, Motion Sickness, and Smoking Cessation Aid
3. BACKGROUND Advantages:
Avoid metabolism by gastrointestinal tract
Improves patient compliance
Multi-day therapy in a single application
Limitations:
Stratum corneum limits rate of diffusion
Molecular weight
Lipophilicity
4. PROJECT GOAL Problem:
Drug delivery system must be augmented in such a way as to increase delivery rate of drug
HADD Patch
Project Goals:
Determine optimal temperature for significant increase in drug delivery rate
Create portable and disposable heat source
5. DESIGN CRITERIA Diffusion must increase by approx. 100%
Penetrant must not irritate or damage skin tissue
Zero-order kinetics must be retained
Applicable to current systems
6. METHODS: THEORETICAL CONCEPTS
7. METHODS: THEORETICAL CONCEPTS
8. METHODS: THEORETICAL CONCEPTS
9. METHODS: THEORETICAL CONCEPTS
10. METHODS: THEORETICAL CONCEPTS
11. METHODS: THEORETICAL CONCEPTS
12. TESTS, RESULTS AND ERRORS Dissolution
Franz cell diffusion test
Heat optimization test
Skin conductance
13. METHODS: DRUG DISSOLUTUION TEST Mention UV spectrometer and how we calibrated the curve THINK ABOUT STANDARD CURVEMention UV spectrometer and how we calibrated the curve THINK ABOUT STANDARD CURVE
14. RESULTS:DISSOLUTION TEST
15. RESULTS:DISSOLUTION TEST
16. METHODS: FRANZ CELL DIFFUSION TESTER
17. RESULTS:FRANZ CELL TEST
18. RESULTS:FRANZ CELL TEST
19. RESULTS:FRANZ CELL TEST NULL HYPOTHESIS:
The average concentration of the control (T=32?) is higher than that of the average test concentration (T=39 ?)
P-value = 8.428 * 10^-3
Reject null hypothesis if |t|> T
t= -2.958 and T = 2.101
The null hypothesis was rejected therefore the expected value of concentration at 39 ?C is higher than that of concentration at 32 ? C
20. ERROR IN DIFFUSION & DISSOLUTION TESTS Oil in couvette
Significant loss of product with each sample
Heat was not ideally distributed
21. METHODS: HEAT OPTIMIZATION
22. RESULTS:HEAT OPTIMIZATION
23. RESULTS:HEAT OPTIMIZATION NULL HYPOTHESIS:
5 small pin-holes effect a greater temperature than 1 large pin-hole
P-value = 0.207
Reject null hypothesis if |t|> T
t= 1.315 and T = 2.12
The results are inconclusive because the p-value is greater than 0.05
24. METHODS: SKIN CONDUCTANCE
25. RESULTS:SKIN CONDUCTANCE
26. RESULTS:SKIN CONDUCTANCE
27. ERROR IN SKIN CONDUCTANCE TEST Instrument drift
Recalibration
Emotional influence
Artifacts in baseline signal
Uneven distribution of heat
28. CONSTRUCTION
29. CONSTRUCTION WARNING: For transdermal use only. Other uses may result in damage to the eyes, throat, or soft tissues.
WARNING: Do not cover patch with clothing as this will slow drug delivery.
30. DISCUSSION:Heat Profile
31. DISCUSSION:Ideal vs. Prototype Imperfect Insulation
Temperature @ Aluminum/gel interface was predicted to be 39? C
Lack of adhesive
32. CONCLUSIONS Criteria Satisfaction
The heat was shown to increase the rate of dissolution.
The gel maintained zero-order kinetics.
It was shown that skin conductance increased with an increase in temperature.
The temperature of the heat source did not exceed 42? C and therefore does not irritate or damage tissue.
33. FUTURE WORK Finite difference method for mass and heat transport as functions of time
Adhesive Testing
Animal Testing
Expanding Drug Selection
Miniaturization
34. ACKNOWLEGEMENTS Dr. Mel de Villiers
Marcia Pool
Victoria Mickail
Lester Smith
Mary Caldorera
Dr. Steven Amos Jones
Dr. Schubert
Dr. Mills
Anna Hannibal
35. QUESTIONS
36. COST ANALYSIS