Cold flow measurement of transdermal drug delivery systems (TDDS)

International Journal of Adhesion and Adhesives - Tập 59 - Trang 71-76 - 2015
Anna M. Wokovich1, Caroline Strasinger2, Jennifer Kessler2, Bing Cai3, Benjamin Westenberger1, Moo Jhong Rhee2, Andre Raw3, Lucinda F. Buhse1
1Center for Drug Evaluation and Research, Food and Drug Administration, 645 South Newstead, St. Louis, Missouri 63110, USA
2Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire, Silver Spring, Maryland 20993, USA
3Center for Drug Evaluation and Research, Food and Drug Administration, 7500 Standish Place, Rockville, Maryland 20855, USA

Tài liệu tham khảo

Wokovich, 2006, Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy and quality attribute, Eur J Pharm Biopharm, 64, 1, 10.1016/j.ejpb.2006.03.009 Kalia, 1998, Transdermal drug delivery: clinical aspects, Dermatol Clin, 16, 289, 10.1016/S0733-8635(05)70011-5 Bernabei, 2012, Compliance and caregiver satisfaction in Alzheimer׳s disease: results from the AXEPT study, Dement Geriatr Cogn Disord Extra, 2, 418, 10.1159/000338228 Wokovich, 2010, Release liner removal method for transdermal drug delivery systems (TDDS), J Pharm Sci, 99, 3177, 10.1002/jps.22067 Hopp, 2002, Developing custom adhesive systems for transdermal drug delivery products, Pharm Tech, 30 Kandavilli, 2002, Polymers in transdermal drug delivery systems, Pharm Tech, 2002, 62 Purnell, 2011, Advanced adhesive technologies deliver enhanced performance capabilities to transdermal product designs, Drug Dev Deliv, 11, 46 Toddywala, 1990, Evaluation of silicone-based pressure-sensitive adhesives for transdermal drug delivery. I. Effect of penetrant hydrophilicity, J Control Release, 14, 29, 10.1016/0168-3659(90)90058-2 Toddywala, 1991, Evaluation of silicone-based pressure-sensitive adhesives for transdermal drug delivery. II. Effect of penetrant lipophilicity, Drug Dev Ind Pharm, 17, 245, 10.3109/03639049109043823 Cilurzo, 2012, Adhesive properties: a critical issue in transdermal patch development, Expert Opin Drug Deliv, 9, 33, 10.1517/17425247.2012.637107 Fauth, 2002, Adhesive backing foil interactions affecting the elasticity, adhesion strength of laminates, and how to interpret these properties of branded transdermal patches, Drug Dev Ind Pharm, 28, 1251, 10.1081/DDC-120015358 Minghetti, 1999, Evaluation of adhesive properties of patches based on acrylic matrices, Drug Dev Ind Pharm, 25, 1, 10.1081/DDC-100102135 Minghetti, 2004, Measuring adhesive performance in transdermal delivery systems, Am J Drug Deliv, 2, 193, 10.2165/00137696-200402030-00004 1999, 62 Spencer, 1990, Adhesive interactions between polymers and skin in transdermal delivery systems, Polym Mater Sci Eng, 63, 337 Subedia, 2011, Influence of formulation variables in transdermal drug delivery system containing zolmitriptan, Inter J Pharm, 419, 209, 10.1016/j.ijpharm.2011.08.002 Venkatraman, 1998, Skin adhesives and skin adhesion 1. Transdermal drug delivery systems, Biomaterials, 19, 1119, 10.1016/S0142-9612(98)00020-9 ASTM Standard D 3330/D3330M – 04. Standard test method for peel adhesion of pressure-sensitive tape. West Conshohocken, PA: ASTM International; 2010. 〈www.astm.org〉. ASTM Standard D 3654/D 3654M-06. Standard test method for shear adhesion of pressure-sensitive tapes. West Conshohocken, PA: ASTM International; 2011. 〈www.astm.org〉. ASTM Standard D 2979-01. Standard test method for pressure-sensitive tack of adhesives using an inverted probe machine. West Conshohocken, PA: ASTM International; 2009. 〈www.astm.org〉. Kenney, 1992, Medical-grade acrylic adhesives for skin contact, J Appl Polym Sci, 45, 355, 10.1002/app.1992.070450218 Tan, 1999, Pressure-sensitive adhesives for transdermal drug delivery systems, Pharm Sci Technol Today, 2, 60, 10.1016/S1461-5347(99)00119-4 Van Buskirk, 2012, Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles, AAPS PharmSciTech, 13, 218, 10.1208/s12249-011-9740-9 Vollmer U, Cordes G. Physical quality control of transdermal delivery systems. In: Proceedings of the international symposium on controlled release of bioactive materials. 1997. 24, p. 685–6. Barr Clonidine Patient Information. Manufactured by Corium International (Grand Rapids, MI) for Barr Laboratories Inc. (Pomona, NY); May 2010. Catapres-TTS-2 (clonidine) Prescribing Information. Distributed by Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, CT); May 2010. Climara (estradiol) Prescribing Information. Manufactured for Bayer HealthCare Pharmaceuticals Inc. (Wayne, NJ); manufactured by 3M Drug Delivery Systems (Northridge, CA); December 2007. Climara Pro (estradiol/levonorgestrel) Prescribing Information. Manufactured for Bayer HealthCare Pharmaceuticals Inc. (Wayne, NJ); manufactured by 3M Drug Delivery Systems (Northridge, CA); May 2007. CombiPatch (estradiol/norethindrone acetate) Prescribing Information. Manufactured by Noven Pharmaceuticals Inc. (Miami, FL) and distributed by Novartis Pharmaceuticals Corporation (East Hanover, NJ); May 2006. Duragesic fentanyl Full Prescribing Information. Manufactured by ALZA Corporation (Vacaville, CA) for PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals Inc (Raritan, NJ); July 2009. Emsam (selegiline) Prescribing Information. Distributed by Dey L.P. (Napa, CA); manufactured for Somerset Pharmaceuticals Inc. (Morgantown, WV); May 2009. Exelon (rivastigmine) Prescribing Information. Distributed by Novartis Pharmaceuticals Corporation (East Hanover, NJ); August 2010. Hercon Laboratories Nitroglycerin Prescribing Information. Manufactured by Hercon Laboratories Corporation (Emigsville, PA); March 2008. Minitran (nitroglycerin) Prescribing Information. Manufactured for Graceway Pharmaceuticals LLC (Bristol, TN), Manufactured by 3M Drug Delivery Systems (Northridge, CA); April 2007. Mylan Nitroglycerin Prescribing Information. Mylan Pharmaceuticals Inc. (Morgantown, WV); October 2008. Nitro-Dur (nitroglycerin) Product Information. Key Pharmaceuticals, Inc. (Kenilworth, NJ); December 2004. Oxytrol (oxybutynin) Prescribing Information. Watson Pharma/subsidiary of Watson Pharmaceuticals Inc. (Corona, CA); May 2006. Vivelle Dot (estradiol) Prescribing Information. Manufactured by Noven Pharmaceuticals Inc. (Miami, FL); distributed by Novartis Pharmaceuticals Corporation (East Hanover, NJ); August 2004. Muny, 1999, Testing pressure sensitive adhesives, 139 ASTM Standard D 6463/D6463M-06. Standard test Method for time to failure of pressure sensitive articles under sustained shear loading. West Conshohocken, PA: ASTM International; 2012. www.astm.org.