References
- Noven. (2006). Noven announces FDA approval of Daytrana™ methylphenidate transdermal system, April 6. http://www.noven.com.
- Shire. (2006). Press release: Shire’s Daytrana™ transdermal patch approved by FDA for treatment of ADHD. April 6. http://www.daytrana.com.
- Shire News. (2006). Shire’s Daytrana™ transdermal patch approved. April 7. http://www.shire.com.
- Noven. (2006). Noven confirms availability of Daytrana™ methylphenidate transdermal system. June 29. http://www.noven.com.
- Shire. (2006). Press release: Shire’s Daytrana™ first transdermal medication for treatment of attention deficit hyperactivity disorder (ADHD) in children, now available in pharmacies. June 29. http://www.daytrana.com.
- Daytrana™ (methylphenidate transdermal system) prescribing information. Wayne, PA: Shire, 03/07.
- Daytrana™ (methylphenidate transdermal system) medication guide. Wayne, PA: Shire, 03/07.
- ISMP. (2006–2007). Daytrana adhesive. Pediatrics/Neonatal Messages: Daytrana Adhesive. Available at: http://www.ismp.org/Forum/default.asp. Accessed 14 June 2007.
- ISMP. (2007). Requirement #1 stick to patient. Institute for Safe Medical Practices Medication Safety Alert Community/Ambulatory Edition, June. http://www.ismp.org/newsletters/ambulatory/archives/200706_1.asp
- ISMP. (2007). Requirement #1 patch should stick to the patient. Institute for Safe Medical Practices Medication Safety Alert Acute Care Edition. July. http://www.ismp.org/newsletters/acutecare/articles/20070712.asp
- my3cents.com. (2007). Shire Pharmaceuticals complaint Daytrana patch defective. http://www.my3cents.com/showReview.cgi?id=19838. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/1-6. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/7-16. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/17–26. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/27–36. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/37–46. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/47–56. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/57–66. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/67–76. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/77–86. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/87–96. Accessed 14 June 2007.
- Plumley K. (2006). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/97–106. Accessed 14 June 2007.
- Plumley K. (2007a). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/107–116. Accessed 14 June 2007.
- Plumley K. (2007). Special needs education Daytrana patch chat. http://specialneedseducation.suite101.com/discussion.cfm/1964/117–126. Accessed 14 June 2007.
- Department of Health and Human Services. (2008). Warning letter FLA-08-05. January 4, www.fda.gov.
- Megget K. (2007). ADHD transdermal patches withdrawn. September 05. http://www.in-pharmatechnologist.com/Materials-Formulation/ADHD-transdermal-patches-withdrawn. Accessed 18 January 2008.
- Noven. (2007). Noven provides update on Daytrana™ Methylphenidate transdermal system: product licensee Shire undertakes voluntary market withdrawal of a limited portion of Daytrana™ product. September 4. http://www.noven.com.
- Shire. (2007). Press release: Shire voluntarily withdraws a limited portion of Daytrana™ (methylphenidate transdermal system) patches. September 4. http://www.daytrana.com. Accessed 13 May 2008.
- Shire News. (2007). Shire voluntarily withdraws a limited portion of Daytrana™ (methylphenidate transdermal system) patches. September 4. http://www.shire.com. Accessed 18 May 2009.
- Macdonald G. (2008). Second Daytrana recall as liner problems continue. http://www.in-pharmatechnologist.com/Packaging/Second-Daytrana-recall-as-liner-problems-continue. Accessed 18 May 2009.
- Noven. (2008). Noven provides update on Daytrana™ methylphenidate transdermal system: product licensee Shire undertakes voluntary recall of a limited portion of Daytrana™ product. June 9. http://www.noven.com.
- Shire. (2008). Press release: Non-safety-related voluntary recall of a limited portion of Daytrana™ (methylphenidate transdermal system) patches announced. June 9. http://www.daytrana.com.
- Shire News. (2008). Non-safety-related voluntary recall of a limited portion of Daytrana™ (methylphenidate transdermal system) patches announced. June 9. http://www.shire.com. Accessed 9 June 2008.
- Noven (2008). Noven provides update on Daytrana® methylphenidate transdermal system: Shire undertakes voluntary recall of two lots of Daytrana® product. August 25. http://www.noven.com/PR082508.htm.
- Noven (2009). Noven provides update on Daytrana® methylphenidate transdermal system: Shire undertakes non-safety-related voluntary market withdrawal/recall of a limited portion of Daytrana® product: financial reserve established by Noven in 2008 expected to cover Noven’s costs related to voluntary withdrawal/recall. March 20. http://www.noven.com.
- Shire (2009). Press release: Non-safety-related voluntary market withdrawal of a limited portion of Daytrana® (methylphenidate transdermal system) patches announced. March 20. http://www.daytrana.com.
- Shire News (2009). Non-safety-related voluntary market withdrawal of a limited portion of Daytrana® (methylphenidate transdermal system) patches announced. March 20. http://www.shire.com.
- Shire (2009). Press release: Non-safety-related voluntary recall of a limited portion of Daytrana® (methylphenidate transdermal system) patches announced. December 3. http://www.shire.com.
- Kanios DP, Mantelle JA, Johnson PA, Houze DW. (2006). The effect of primary and secondary packaging materials on the stability of drug-in-adhesive (DIA) transdermal drug delivery systems (TDDSs). http://www.noven.com/research.htm. Accessed 5 October 2007.
- United States Patent Application Publication US 2005/0214354 A1. Publication date September 29, 2005. Inventors Kanios, DP, Mantelle, JA, Johnson, P, Li, C. Assignee: Noven Pharmaceuticals, Inc. (Miami, FL, US). Packaging system for transdermal drug delivery systems.
- United States Patent 6905016. Publication date 14 June 2005. Packaging system for transdermal drug delivery systems. Inventors Kanios, DP, Mantelle, JA, Johnson, P, Li, C. Assignee: Noven Pharmaceuticals, Inc. (Miami, FL, US).
- Wokovich AM, Brown SA, McMaster FJ, Doub WH, Cai B, Sadrieh N et al. (2008). Evaluation of substrates for 90 degrees peel adhesion–a collaborative study. I. Medical tapes. J Biomed Mater Res Part B Appl Biomater, 87:105–113.
- Wokovich AM, Brown SA, Shen M, Doub WH, Cai B, Sadrieh N et al. (2009). Evaluation of substrates for 90 degrees peel adhesion–a collaborative study. II. Transdermal drug delivery systems. J Biomed Mater Res Part B Appl Biomater, 88:61–65.
- Wokovich AM, Shen M, Doub WH, Machado SG, Buhse LF. (2010). Release liner removal method for transdermal drug delivery systems (TDDS). J Pharm Sci, 99:3177–3187.
- American Society of Testing Materials. Standard test method for peel adhesion of pressure-sensitive tape. ASTM D 3330/D 3330M-02 2003.
- Pressure Sensitive Tape Council. (2004). PSTC 101 test method: peel adhesion of pressure sensitive tape. Test Methods for Pressure Sensitive Tapes, 14th Edition. Northbrook, IL: Pressure Sensitive Tape Council, 101.1–101.10.
- Li C, Cashman JS, Johnson PA, Kanios DP, Mantelle JA. (2002). Kinetic study of threo-methylphenidate degradation reaction to erythro isomer in MethyPatch transdermal system, November. http://www.noven.com/research.htm. Accessed 5 October 2007.
- Arnold LE, Lindsay RL, López FA, Jacob SE, Biederman J, Findling RL et al. (2007). Treating attention-deficit/hyperactivity disorder with a stimulant transdermal patch: the clinical art. Pediatrics, 120:1100–1106.
- Chen Y, Li Y. (2003). A new model for predicting moisture uptake by packaged solid pharmaceuticals. Int J Pharm, 255:217–225.
- Chen Y, Li Y. (2008). Determination of water vapor transmission rate (WVTR) of HDPE bottles for pharmaceutical products. Int J Pharm, 358:137–143.
- Farag Badawy SI, Gawronski AJ, Alvarez FJ. (2001). Application of sorption–desorption moisture transfer modeling to the study of chemical stability of a moisture sensitive drug product in different packaging configurations. Int J Pharm, 223, 1–13.
- Food and Drug Administration. Q8 Pharmaceutical Development, May 2006. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128029.pdf
- Food and Drug Administration. Q9 Quality Risk Management Guidance for Industry, June 2006. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128053.pdf
- ISMP (Institute for Safe Medication Practices). (2001). Failure Mode and Effects Analysis can help guide error prevention effort. ISMP Medication Safety Alert! 17 October 2001 issue. http://www.ismp.org/Newsletters/acutecare/articles/20011017.asp. Accessed 1 February 2010.