The Experts below are selected from a list of 180 Experts worldwide ranked by ideXlab platform
Lucinda F Buhse - One of the best experts on this subject based on the ideXlab platform.
-
Cold flow measurement of transdermal drug delivery systems (TDDS)
International Journal of Adhesion and Adhesives, 2015Co-Authors: Anna M Wokovich, Caroline Strasinger, Jennifer Kessler, Benjamin J. Westenberger, Moo Jhong Rhee, Lucinda F BuhseAbstract:Abstract Cold flow, the movement of adhesive beyond the edge of a transdermal drug delivery system (TDDS) or between the Release Liner slit, can affect the quality of the drug product and result in patient use issues such as difficulty in removal from packaging and unintentional removal of the product during wear due to increased tackiness on the edge and backing of the TDDS. In this study, different techniques for measuring cold flow of United States marketed transdermal drug delivery systems are assessed including a wiping method with various ways of calculating cold flow, a macroscopic rating method and a microscope evaluation. The amount of cold flow measured from the wiping method was dependent upon the calculation method. Assessment of cold flow may be a combination of quantitative and qualitative methods. Appearance criteria can assess potential use issues caused by cold flow if TDDS are difficult to remove from pouches and if Release Liners detach from the adhesive matrix during attempted removal due to cold flow adhering the backing to the pouch. A quantitative cold flow method captures the degree to which cold flow extends beyond the perimeter of the backing and through the Release Liner slit. The method(s) selected by a TDDS manufacturer to measure cold flow should be applicable to the individual product and scientifically justified.
-
evaluating elevated Release Liner adhesion of a transdermal drug delivery system tdds a study of daytrana methylphenidate transdermal system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:Background: Complaints from healthcare providers that the adhesive on the Daytrana™ methylphenidate transdermal drug delivery system (TDDS) adhered to the Release Liner to such an extent that the Release Liner could not be removed prompted this study. Daytrana™ has a packaging system consisting of a moisture-permeable pouch contained within a sealed tray containing a desiccant; the tray is impermeable to ambient moisture. The objective of this project was to determine if the Daytrana™ packaging system influenced the difficulty in removing the Release Liner.Method: Both a sealed tray and an open tray containing sealed pouches were placed into an environmental chamber at 25°C and 60% relative humidity for 30 days; afterwards, Release Liner removal testing using a peel angle of 90° and a peel speed of 300 mm/min was performed.Results: TDDS from open chamber trays required less force to remove the Release Liner than did TDDS from closed chamber trays. For the 10 mg/9 h TDDS and the 15 mg/9 h TDDS (the dosages...
-
Release Liner removal method for transdermal drug delivery systems tdds
Journal of Pharmaceutical Sciences, 2010Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:ABSTRACT A Release Liner removal test is a valuable test for assessing the quality of a transdermal drug delivery system (i.e., TDDS, patch). This test measures the force required to remove the Release Liner from a patch. The objective of the present study was to establish sample preparation and instrument parameters for measuring Release Liner removal adhesion for TDDS. Ten TDDS were evaluated (six drugs for a total of 29 lots). Patches which had a ratecontrolling membrane were run as-is, since they could not be cut to a precise width without sacrificing their structural integrity. Patches that were square or rectangular in shape were run as-is, and the width of these patches was determined using a digital caliper. Patches which were not square or rectangular in shape and did not have a rate-controlling membrane were cut to a precise width using a specimen cutter. Double-sided tape was used to adhere the Liner side of the transdermal system to a clean stainless steel test panel. A Release Liner peel adhesion method for TDDS is proposed using a dwell time of approximately 3 min, a peel angle of 90°, and a peel speed of 300 mm/min.
Anna M Wokovich - One of the best experts on this subject based on the ideXlab platform.
-
Cold flow measurement of transdermal drug delivery systems (TDDS)
International Journal of Adhesion and Adhesives, 2015Co-Authors: Anna M Wokovich, Caroline Strasinger, Jennifer Kessler, Benjamin J. Westenberger, Moo Jhong Rhee, Lucinda F BuhseAbstract:Abstract Cold flow, the movement of adhesive beyond the edge of a transdermal drug delivery system (TDDS) or between the Release Liner slit, can affect the quality of the drug product and result in patient use issues such as difficulty in removal from packaging and unintentional removal of the product during wear due to increased tackiness on the edge and backing of the TDDS. In this study, different techniques for measuring cold flow of United States marketed transdermal drug delivery systems are assessed including a wiping method with various ways of calculating cold flow, a macroscopic rating method and a microscope evaluation. The amount of cold flow measured from the wiping method was dependent upon the calculation method. Assessment of cold flow may be a combination of quantitative and qualitative methods. Appearance criteria can assess potential use issues caused by cold flow if TDDS are difficult to remove from pouches and if Release Liners detach from the adhesive matrix during attempted removal due to cold flow adhering the backing to the pouch. A quantitative cold flow method captures the degree to which cold flow extends beyond the perimeter of the backing and through the Release Liner slit. The method(s) selected by a TDDS manufacturer to measure cold flow should be applicable to the individual product and scientifically justified.
-
evaluating elevated Release Liner adhesion of a transdermal drug delivery system tdds a study of daytrana methylphenidate transdermal system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:Background: Complaints from healthcare providers that the adhesive on the Daytrana™ methylphenidate transdermal drug delivery system (TDDS) adhered to the Release Liner to such an extent that the Release Liner could not be removed prompted this study. Daytrana™ has a packaging system consisting of a moisture-permeable pouch contained within a sealed tray containing a desiccant; the tray is impermeable to ambient moisture. The objective of this project was to determine if the Daytrana™ packaging system influenced the difficulty in removing the Release Liner.Method: Both a sealed tray and an open tray containing sealed pouches were placed into an environmental chamber at 25°C and 60% relative humidity for 30 days; afterwards, Release Liner removal testing using a peel angle of 90° and a peel speed of 300 mm/min was performed.Results: TDDS from open chamber trays required less force to remove the Release Liner than did TDDS from closed chamber trays. For the 10 mg/9 h TDDS and the 15 mg/9 h TDDS (the dosages...
-
Release Liner removal method for transdermal drug delivery systems tdds
Journal of Pharmaceutical Sciences, 2010Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:ABSTRACT A Release Liner removal test is a valuable test for assessing the quality of a transdermal drug delivery system (i.e., TDDS, patch). This test measures the force required to remove the Release Liner from a patch. The objective of the present study was to establish sample preparation and instrument parameters for measuring Release Liner removal adhesion for TDDS. Ten TDDS were evaluated (six drugs for a total of 29 lots). Patches which had a ratecontrolling membrane were run as-is, since they could not be cut to a precise width without sacrificing their structural integrity. Patches that were square or rectangular in shape were run as-is, and the width of these patches was determined using a digital caliper. Patches which were not square or rectangular in shape and did not have a rate-controlling membrane were cut to a precise width using a specimen cutter. Double-sided tape was used to adhere the Liner side of the transdermal system to a clean stainless steel test panel. A Release Liner peel adhesion method for TDDS is proposed using a dwell time of approximately 3 min, a peel angle of 90°, and a peel speed of 300 mm/min.
William H Doub - One of the best experts on this subject based on the ideXlab platform.
-
evaluating elevated Release Liner adhesion of a transdermal drug delivery system tdds a study of daytrana methylphenidate transdermal system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:Background: Complaints from healthcare providers that the adhesive on the Daytrana™ methylphenidate transdermal drug delivery system (TDDS) adhered to the Release Liner to such an extent that the Release Liner could not be removed prompted this study. Daytrana™ has a packaging system consisting of a moisture-permeable pouch contained within a sealed tray containing a desiccant; the tray is impermeable to ambient moisture. The objective of this project was to determine if the Daytrana™ packaging system influenced the difficulty in removing the Release Liner.Method: Both a sealed tray and an open tray containing sealed pouches were placed into an environmental chamber at 25°C and 60% relative humidity for 30 days; afterwards, Release Liner removal testing using a peel angle of 90° and a peel speed of 300 mm/min was performed.Results: TDDS from open chamber trays required less force to remove the Release Liner than did TDDS from closed chamber trays. For the 10 mg/9 h TDDS and the 15 mg/9 h TDDS (the dosages...
-
Release Liner removal method for transdermal drug delivery systems tdds
Journal of Pharmaceutical Sciences, 2010Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:ABSTRACT A Release Liner removal test is a valuable test for assessing the quality of a transdermal drug delivery system (i.e., TDDS, patch). This test measures the force required to remove the Release Liner from a patch. The objective of the present study was to establish sample preparation and instrument parameters for measuring Release Liner removal adhesion for TDDS. Ten TDDS were evaluated (six drugs for a total of 29 lots). Patches which had a ratecontrolling membrane were run as-is, since they could not be cut to a precise width without sacrificing their structural integrity. Patches that were square or rectangular in shape were run as-is, and the width of these patches was determined using a digital caliper. Patches which were not square or rectangular in shape and did not have a rate-controlling membrane were cut to a precise width using a specimen cutter. Double-sided tape was used to adhere the Liner side of the transdermal system to a clean stainless steel test panel. A Release Liner peel adhesion method for TDDS is proposed using a dwell time of approximately 3 min, a peel angle of 90°, and a peel speed of 300 mm/min.
Stella G Machado - One of the best experts on this subject based on the ideXlab platform.
-
evaluating elevated Release Liner adhesion of a transdermal drug delivery system tdds a study of daytrana methylphenidate transdermal system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:Background: Complaints from healthcare providers that the adhesive on the Daytrana™ methylphenidate transdermal drug delivery system (TDDS) adhered to the Release Liner to such an extent that the Release Liner could not be removed prompted this study. Daytrana™ has a packaging system consisting of a moisture-permeable pouch contained within a sealed tray containing a desiccant; the tray is impermeable to ambient moisture. The objective of this project was to determine if the Daytrana™ packaging system influenced the difficulty in removing the Release Liner.Method: Both a sealed tray and an open tray containing sealed pouches were placed into an environmental chamber at 25°C and 60% relative humidity for 30 days; afterwards, Release Liner removal testing using a peel angle of 90° and a peel speed of 300 mm/min was performed.Results: TDDS from open chamber trays required less force to remove the Release Liner than did TDDS from closed chamber trays. For the 10 mg/9 h TDDS and the 15 mg/9 h TDDS (the dosages...
-
Release Liner removal method for transdermal drug delivery systems tdds
Journal of Pharmaceutical Sciences, 2010Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:ABSTRACT A Release Liner removal test is a valuable test for assessing the quality of a transdermal drug delivery system (i.e., TDDS, patch). This test measures the force required to remove the Release Liner from a patch. The objective of the present study was to establish sample preparation and instrument parameters for measuring Release Liner removal adhesion for TDDS. Ten TDDS were evaluated (six drugs for a total of 29 lots). Patches which had a ratecontrolling membrane were run as-is, since they could not be cut to a precise width without sacrificing their structural integrity. Patches that were square or rectangular in shape were run as-is, and the width of these patches was determined using a digital caliper. Patches which were not square or rectangular in shape and did not have a rate-controlling membrane were cut to a precise width using a specimen cutter. Double-sided tape was used to adhere the Liner side of the transdermal system to a clean stainless steel test panel. A Release Liner peel adhesion method for TDDS is proposed using a dwell time of approximately 3 min, a peel angle of 90°, and a peel speed of 300 mm/min.
Meiyu Shen - One of the best experts on this subject based on the ideXlab platform.
-
evaluating elevated Release Liner adhesion of a transdermal drug delivery system tdds a study of daytrana methylphenidate transdermal system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:Background: Complaints from healthcare providers that the adhesive on the Daytrana™ methylphenidate transdermal drug delivery system (TDDS) adhered to the Release Liner to such an extent that the Release Liner could not be removed prompted this study. Daytrana™ has a packaging system consisting of a moisture-permeable pouch contained within a sealed tray containing a desiccant; the tray is impermeable to ambient moisture. The objective of this project was to determine if the Daytrana™ packaging system influenced the difficulty in removing the Release Liner.Method: Both a sealed tray and an open tray containing sealed pouches were placed into an environmental chamber at 25°C and 60% relative humidity for 30 days; afterwards, Release Liner removal testing using a peel angle of 90° and a peel speed of 300 mm/min was performed.Results: TDDS from open chamber trays required less force to remove the Release Liner than did TDDS from closed chamber trays. For the 10 mg/9 h TDDS and the 15 mg/9 h TDDS (the dosages...
-
Release Liner removal method for transdermal drug delivery systems tdds
Journal of Pharmaceutical Sciences, 2010Co-Authors: Anna M Wokovich, Meiyu Shen, William H Doub, Stella G Machado, Lucinda F BuhseAbstract:ABSTRACT A Release Liner removal test is a valuable test for assessing the quality of a transdermal drug delivery system (i.e., TDDS, patch). This test measures the force required to remove the Release Liner from a patch. The objective of the present study was to establish sample preparation and instrument parameters for measuring Release Liner removal adhesion for TDDS. Ten TDDS were evaluated (six drugs for a total of 29 lots). Patches which had a ratecontrolling membrane were run as-is, since they could not be cut to a precise width without sacrificing their structural integrity. Patches that were square or rectangular in shape were run as-is, and the width of these patches was determined using a digital caliper. Patches which were not square or rectangular in shape and did not have a rate-controlling membrane were cut to a precise width using a specimen cutter. Double-sided tape was used to adhere the Liner side of the transdermal system to a clean stainless steel test panel. A Release Liner peel adhesion method for TDDS is proposed using a dwell time of approximately 3 min, a peel angle of 90°, and a peel speed of 300 mm/min.