Transdermal

14,000,000 Leading Edge Experts on the ideXlab platform

Scan Science and Technology

Contact Leading Edge Experts & Companies

Scan Science and Technology

Contact Leading Edge Experts & Companies

The Experts below are selected from a list of 67761 Experts worldwide ranked by ideXlab platform

Lucinda F Buhse - One of the best experts on this subject based on the ideXlab platform.

  • Transdermal drug delivery system tdds adhesion as a critical safety efficacy and quality attribute
    European Journal of Pharmaceutics and Biopharmaceutics, 2006
    Co-Authors: Anna M Wokovich, Suneela Prodduturi, William H Doub, Ajaz S Hussain, Lucinda F Buhse
    Abstract:

    Transdermal drug delivery systems (TDDS), also known as "patches," are dosage forms designed to deliver a therapeutically effective amount of drug across a patient's skin. The adhesive of the Transdermal drug delivery system is critical to the safety, efficacy and quality of the product. In the Drug Quality Reporting System (DQRS), the United States Food and Drug Administration (FDA) has received numerous reports of "adhesion lacking" for Transdermal drug delivery systems. This article provides an overview of types of Transdermals, their anatomy, the role of adhesion, the possible adhesion failure modes and how adhesion can be measured. Excerpts from FDA reports on the lack of adhesion of Transdermal system products are presented. Pros and cons of in vitro techniques, such as peel adhesion, tack and shear strength, in vivo techniques used to evaluate adhesive properties are discussed. To see a decrease in "adhesion lacking" reports, adhesion needs to become an important design parameter and suitable methods need to be available to assess quality and in vivo performance. This article provides a framework for further discussion and scientific work to improve Transdermal adhesive performance.

  • Transdermal drug delivery system tdds adhesion as a critical safety efficacy and quality attribute
    European Journal of Pharmaceutics and Biopharmaceutics, 2006
    Co-Authors: Anna M Wokovich, Suneela Prodduturi, William H Doub, Ajaz S Hussain, Lucinda F Buhse
    Abstract:

    Abstract Transdermal drug delivery systems (TDDS), also known as “patches,” are dosage forms designed to deliver a therapeutically effective amount of drug across a patient’s skin. The adhesive of the Transdermal drug delivery system is critical to the safety, efficacy and quality of the product. In the Drug Quality Reporting System (DQRS), the United States Food and Drug Administration (FDA) has received numerous reports of “adhesion lacking” for Transdermal drug delivery systems. This article provides an overview of types of Transdermals, their anatomy, the role of adhesion, the possible adhesion failure modes and how adhesion can be measured. Excerpts from FDA reports on the lack of adhesion of Transdermal system products are presented. Pros and cons of in vitro techniques, such as peel adhesion, tack and shear strength, in vivo techniques used to evaluate adhesive properties are discussed. To see a decrease in “adhesion lacking” reports, adhesion needs to become an important design parameter and suitable methods need to be available to assess quality and in vivo performance. This article provides a framework for further discussion and scientific work to improve Transdermal adhesive performance.

Anna M Wokovich - One of the best experts on this subject based on the ideXlab platform.

  • Transdermal drug delivery system tdds adhesion as a critical safety efficacy and quality attribute
    European Journal of Pharmaceutics and Biopharmaceutics, 2006
    Co-Authors: Anna M Wokovich, Suneela Prodduturi, William H Doub, Ajaz S Hussain, Lucinda F Buhse
    Abstract:

    Transdermal drug delivery systems (TDDS), also known as "patches," are dosage forms designed to deliver a therapeutically effective amount of drug across a patient's skin. The adhesive of the Transdermal drug delivery system is critical to the safety, efficacy and quality of the product. In the Drug Quality Reporting System (DQRS), the United States Food and Drug Administration (FDA) has received numerous reports of "adhesion lacking" for Transdermal drug delivery systems. This article provides an overview of types of Transdermals, their anatomy, the role of adhesion, the possible adhesion failure modes and how adhesion can be measured. Excerpts from FDA reports on the lack of adhesion of Transdermal system products are presented. Pros and cons of in vitro techniques, such as peel adhesion, tack and shear strength, in vivo techniques used to evaluate adhesive properties are discussed. To see a decrease in "adhesion lacking" reports, adhesion needs to become an important design parameter and suitable methods need to be available to assess quality and in vivo performance. This article provides a framework for further discussion and scientific work to improve Transdermal adhesive performance.

  • Transdermal drug delivery system tdds adhesion as a critical safety efficacy and quality attribute
    European Journal of Pharmaceutics and Biopharmaceutics, 2006
    Co-Authors: Anna M Wokovich, Suneela Prodduturi, William H Doub, Ajaz S Hussain, Lucinda F Buhse
    Abstract:

    Abstract Transdermal drug delivery systems (TDDS), also known as “patches,” are dosage forms designed to deliver a therapeutically effective amount of drug across a patient’s skin. The adhesive of the Transdermal drug delivery system is critical to the safety, efficacy and quality of the product. In the Drug Quality Reporting System (DQRS), the United States Food and Drug Administration (FDA) has received numerous reports of “adhesion lacking” for Transdermal drug delivery systems. This article provides an overview of types of Transdermals, their anatomy, the role of adhesion, the possible adhesion failure modes and how adhesion can be measured. Excerpts from FDA reports on the lack of adhesion of Transdermal system products are presented. Pros and cons of in vitro techniques, such as peel adhesion, tack and shear strength, in vivo techniques used to evaluate adhesive properties are discussed. To see a decrease in “adhesion lacking” reports, adhesion needs to become an important design parameter and suitable methods need to be available to assess quality and in vivo performance. This article provides a framework for further discussion and scientific work to improve Transdermal adhesive performance.

Michael Strumpf - One of the best experts on this subject based on the ideXlab platform.

  • long term treatment of cancer pain with Transdermal fentanyl
    Journal of Pain and Symptom Management, 1998
    Co-Authors: B Donner, Michael Strumpf, Michael Zenz, Manfred Raber
    Abstract:

    Abstract The long-term therapy of 51 patients using Transdermal fentanyl was evaluated. The Transdermal therapy was performed for 158 days (range, 15–855 days). The need for increasing dosages of Transdermal fentanyl was caused by the progression of the underlying cancer disease (mean initial dose, 69.5 μ g fentanyl/hr; mean final dose, 167.7 μ g fentanyl/hr). The Transdermal system was changed every third day. Application intervals had to be shortened in 23.5% of the patients. Pain reduction was good throughout the study. Severe side effects did not occur. Constipation and the need for laxatives occurred less frequently than with previously administered oral morphine. Skin tolerance of the Transdermal system was good. The treatment of cancer pain with Transdermal fentanyl can be performed as a long-term therapy and result in good pain relief. Considering its specific pharmacokinetic properties, it is an alternative medication on step III of the World Health Organization's guidelines for cancer pain management.

  • direct conversion from oral morphine to Transdermal fentanyl a multicenter study in patients with cancer pain
    Pain, 1996
    Co-Authors: B Donner, M. Tryba, Michael Zenz, Michael Strumpf
    Abstract:

    Abstract Direct conversion from oral morphine to Transdermal fentanyl with a ratio of oral morphine/Transdermal fentanyl (100:1 mg) daily was examined in patients with cancer pain. Patients with a ‘stable and low level of cancer pain’ receiving a constant dosage of sustained release morphine during a pre-study phase of 6 days were included in the study. Initial fentanyl dosage was calculated by a conversion table. The Transdermal system was changed every 72 h and the dosage was adjusted to the needs of the patients according to the VAS scores and the requirement of liquid morphine, which was allowed to achieve sufficient pain relief. Regression analysis at the end of the study revealed a mean morphine/Transdermal fentanyl ratio of 70:1. Pain relief during treatment with Transdermal fentanyl was identical to sustained release morphine. However, significantly more patients took: supplemental medication with liquid morphine during Transdermal fentanyl therapy. The number of patients suffering from pain attacks did not increase with Transdermal fentanyl. Constipation and medication with laxatives decreased significantly during fentanyl therapy. Other side effects and vital signs were identical. Three patients suffered from a morphine withdrawal syndrom beginning within the first 24 h of Transdermal fentanyl therapy. Cutaneous reactions to the patch were rare, mild and transient. Patients and physicians reported satisfaction with the Transdermal therapy. 94.7% of the patients chose to continue the Transdermal fentanyl therapy at the end of the study due to better performance in comparison to oral morphine. Due to these results an initial conversion from oral morphine to Transdermal fentanyl with the ratio of 100:1 is safe and effective.

  • direct conversion from oral morphine to Transdermal fentanyl a multicenter study in patients with cancer pain
    Pain, 1996
    Co-Authors: B Donner, M. Tryba, Michael Zenz, Michael Strumpf
    Abstract:

    Direct conversion from oral morphine to Transdermal fentanyl with a ratio of oral morphine/Transdermal fentanyl (100:1 mg) daily was examined in patients with cancer pain. Patients with a 'stable and low level of cancer pain' receiving a constant dosage of sustained release morphine during a pre-study phase of 6 days were included in the study. Initial fentanyl dosage was calculated by a conversion table. The Transdermal system was changed every 72 h and the dosage was adjusted to the needs of the patients according to the VAS scores and the requirement of liquid morphine, which was allowed to achieve sufficient pain relief. Regression analysis at the end of the study revealed a mean morphine/Transdermal fentanyl ratio of 70:1. Pain relief during treatment with Transdermal fentanyl was identical to sustained release morphine. However, significantly more patients took supplemental medication with liquid morphine during Transdermal fentanyl therapy. The number of patients suffering from pain attacks did not increase with Transdermal fentanyl. Constipation and medication with laxatives decreased significantly during fentanyl therapy. Other side effects and vital signs were identical. Three patients suffered from a morphine withdrawal syndrome beginning within the first 24 h of Transdermal fentanyl therapy. Cutaneous reactions to the patch were rare, mild and transient. Patients and physicians reported satisfaction with the Transdermal therapy. 94.7% of the patients chose to continue the Transdermal fentanyl therapy at the end of the study due to better performance in comparison to oral morphine. Due to these results an initial conversion from oral morphine to Transdermal fentanyl with the ratio of 100:1 is safe and effective.

B Donner - One of the best experts on this subject based on the ideXlab platform.

  • long term treatment of cancer pain with Transdermal fentanyl
    Journal of Pain and Symptom Management, 1998
    Co-Authors: B Donner, Michael Strumpf, Michael Zenz, Manfred Raber
    Abstract:

    Abstract The long-term therapy of 51 patients using Transdermal fentanyl was evaluated. The Transdermal therapy was performed for 158 days (range, 15–855 days). The need for increasing dosages of Transdermal fentanyl was caused by the progression of the underlying cancer disease (mean initial dose, 69.5 μ g fentanyl/hr; mean final dose, 167.7 μ g fentanyl/hr). The Transdermal system was changed every third day. Application intervals had to be shortened in 23.5% of the patients. Pain reduction was good throughout the study. Severe side effects did not occur. Constipation and the need for laxatives occurred less frequently than with previously administered oral morphine. Skin tolerance of the Transdermal system was good. The treatment of cancer pain with Transdermal fentanyl can be performed as a long-term therapy and result in good pain relief. Considering its specific pharmacokinetic properties, it is an alternative medication on step III of the World Health Organization's guidelines for cancer pain management.

  • direct conversion from oral morphine to Transdermal fentanyl a multicenter study in patients with cancer pain
    Pain, 1996
    Co-Authors: B Donner, M. Tryba, Michael Zenz, Michael Strumpf
    Abstract:

    Abstract Direct conversion from oral morphine to Transdermal fentanyl with a ratio of oral morphine/Transdermal fentanyl (100:1 mg) daily was examined in patients with cancer pain. Patients with a ‘stable and low level of cancer pain’ receiving a constant dosage of sustained release morphine during a pre-study phase of 6 days were included in the study. Initial fentanyl dosage was calculated by a conversion table. The Transdermal system was changed every 72 h and the dosage was adjusted to the needs of the patients according to the VAS scores and the requirement of liquid morphine, which was allowed to achieve sufficient pain relief. Regression analysis at the end of the study revealed a mean morphine/Transdermal fentanyl ratio of 70:1. Pain relief during treatment with Transdermal fentanyl was identical to sustained release morphine. However, significantly more patients took: supplemental medication with liquid morphine during Transdermal fentanyl therapy. The number of patients suffering from pain attacks did not increase with Transdermal fentanyl. Constipation and medication with laxatives decreased significantly during fentanyl therapy. Other side effects and vital signs were identical. Three patients suffered from a morphine withdrawal syndrom beginning within the first 24 h of Transdermal fentanyl therapy. Cutaneous reactions to the patch were rare, mild and transient. Patients and physicians reported satisfaction with the Transdermal therapy. 94.7% of the patients chose to continue the Transdermal fentanyl therapy at the end of the study due to better performance in comparison to oral morphine. Due to these results an initial conversion from oral morphine to Transdermal fentanyl with the ratio of 100:1 is safe and effective.

  • direct conversion from oral morphine to Transdermal fentanyl a multicenter study in patients with cancer pain
    Pain, 1996
    Co-Authors: B Donner, M. Tryba, Michael Zenz, Michael Strumpf
    Abstract:

    Direct conversion from oral morphine to Transdermal fentanyl with a ratio of oral morphine/Transdermal fentanyl (100:1 mg) daily was examined in patients with cancer pain. Patients with a 'stable and low level of cancer pain' receiving a constant dosage of sustained release morphine during a pre-study phase of 6 days were included in the study. Initial fentanyl dosage was calculated by a conversion table. The Transdermal system was changed every 72 h and the dosage was adjusted to the needs of the patients according to the VAS scores and the requirement of liquid morphine, which was allowed to achieve sufficient pain relief. Regression analysis at the end of the study revealed a mean morphine/Transdermal fentanyl ratio of 70:1. Pain relief during treatment with Transdermal fentanyl was identical to sustained release morphine. However, significantly more patients took supplemental medication with liquid morphine during Transdermal fentanyl therapy. The number of patients suffering from pain attacks did not increase with Transdermal fentanyl. Constipation and medication with laxatives decreased significantly during fentanyl therapy. Other side effects and vital signs were identical. Three patients suffered from a morphine withdrawal syndrome beginning within the first 24 h of Transdermal fentanyl therapy. Cutaneous reactions to the patch were rare, mild and transient. Patients and physicians reported satisfaction with the Transdermal therapy. 94.7% of the patients chose to continue the Transdermal fentanyl therapy at the end of the study due to better performance in comparison to oral morphine. Due to these results an initial conversion from oral morphine to Transdermal fentanyl with the ratio of 100:1 is safe and effective.

Chad M Vandenberg - One of the best experts on this subject based on the ideXlab platform.

  • Pharmacokinetics and absolute bioavailability of selegiline following treatment of healthy subjects with the selegiline Transdermal system (6 mg/24 h): a comparison with oral selegiline capsules.
    Journal of clinical pharmacology, 2007
    Co-Authors: Albert J Azzaro, John Ziemniak, Eva M Kemper, Bryan J Campbell, Chad M Vandenberg
    Abstract:

    The selegiline Transdermal system is a monoamine oxidase inhibitor that was recently approved by the US Food and Drug Administration for the treatment of major depressive disorder. The current study was conducted during the selegiline Transdermal system development program to characterize the single-dose pharmacokinetics and absolute bioavailability of selegiline administered by the 6-mg/24-h selegiline Transdermal system in healthy volunteers. Selegiline Transdermal system results were compared with those obtained after a single 10-mg oral dose of selegiline HCl. The selegiline pharmacokinetics differed greatly between the 2 routes of administration. Transdermal selegiline administration reduced metabolism and produced a high, sustained plasma selegiline concentration over the dosing period, with an absolute bioavailability of 73%. By contrast, oral dosing produced a sharp plasma selegiline peak that occurred within 1 hour and declined rapidly, with an absolute bioavailability of 4%. The data provide the basis for therapeutic advantages of the selegiline Transdermal system in administering antidepressant doses of selegiline.

  • evaluation of the potential for pharmacodynamic and pharmacokinetic drug interactions between selegiline Transdermal system and two sympathomimetic agents pseudoephedrine and phenylpropanolamine in healthy volunteers
    The Journal of Clinical Pharmacology, 2007
    Co-Authors: Albert J Azzaro, Chad M Vandenberg, John Ziemniak, Eva M Kemper, Lawrence F Blob, Bryan J Campbell
    Abstract:

    Selegiline Transdermal system is a recently approved monoamine oxidase inhibitor antidepressant. Medications that inhibit monoamine oxidase type A can augment the pressor effects of sympathomimetic amines, increasing the potential for hypertensive crisis. This study examined the potential for drug-drug interactions during treatment with selegiline Transdermal system and pseudoephedrine or phenylpropanolamine. Two studies were conducted with 25 healthy volunteers to assess changes in blood pressure and heart rate during administration of pseudoephedrine or phenylpropanolamine alone or together with selegiline Transdermal system. No significant differences in mean maximum changes in vital signs occurred with pseudoephedrine. No significant differences were found in mean maximum changes in systolic heart rate with phenylpropanolamine; however, 4 of 12 subjects each experienced 1 isolated protocol-defined minimal pressor response without concurrent adverse effects (1 with phenylpropanolamine alone; 3 with phenylpropanolamine + selegiline Transdermal system). Pharmacokinetic parameters obtained following selegiline Transdermal system and pseudoephedrine or phenylpropanolamine were unremarkable. The results suggest that selegiline Transdermal system 6 mg/24 h does not significantly alter the pharmacodynamics or pharmacokinetics of either pseudoephedrine or phenylpropanolamine when administered to healthy volunteers; however, it is prudent to avoid coadministration of selegiline Transdermal system and sympathomimetics.