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![Utilization of Eutectic Property of Either Lidocaine or Tetracaine and a Chemical Permeation Enhancer in Topical Patch Development, and the Position of the U.S. Food and Drug Administration on Incorporating Thermal Enhancement in Such Delivery için kapak resmi Utilization of Eutectic Property of Either Lidocaine or Tetracaine and a Chemical Permeation Enhancer in Topical Patch Development, and the Position of the U.S. Food and Drug Administration on Incorporating Thermal Enhancement in Such Delivery için kapak resmi](/client/assets/d79c3e4af2b6d196/ctx/images/no_image.png)
Utilization of Eutectic Property of Either Lidocaine or Tetracaine and a Chemical Permeation Enhancer in Topical Patch Development, and the Position of the U.S. Food and Drug Administration on Incorporating Thermal Enhancement in Such Delivery
Başlık:
Utilization of Eutectic Property of Either Lidocaine or Tetracaine and a Chemical Permeation Enhancer in Topical Patch Development, and the Position of the U.S. Food and Drug Administration on Incorporating Thermal Enhancement in Such Delivery
Yazar:
Varanasi, Ravi, author.
ISBN:
9780438046009
Yazar Ek Girişi:
Fiziksel Tanımlama:
1 electronic resource (273 pages)
Genel Not:
Source: Dissertation Abstracts International, Volume: 79-10(E), Section: B.
Advisors: Monica C. Chuong Committee members: Josephine Babiarz; Harsh Chauhan; Gerard D'Souza; Timothy J. Maher; David A. Williams.
Özet:
A patch product containing two local anesthetics, lidocaine and tetracaine, which form eutectic mixtures have been commercialized to anesthetize the body areas where vascular accesses or minor dermatological procedures are to be done. It also utilizes a heating element to further enhance the permeations of the anesthetics. Although proven safe if used as directed, the presence of a second anesthetic and heat compartment are not desirable due to safety concerns. The project hypothesis was to design a topical patch that contains only one local anesthetic, no heating element, and to achieve a quicker onset of action upon application compared to the aforementioned commercial product. The product will also comply with FDA cGMP (for drug product) and Quality System Requirements (for the patch material as a device). The primary indication is for the drug formulation with the patch serving as the delivery mechanism. To succeed in such goals, the eutectic mixture of lidocaine and tetracaine present in the commercial patch was first characterized using thermal and chemical analytical techniques. Second, the components in the patch were explored layer by layer to understand their roles in drug release performance. Third, a reverse phase HPLC method was developed to simultaneously quantify both lidocaine and tetracaine. Fourth, a new dissolution medium was proposed to test the in vitro drug release. Fifth, a literature-based review was conducted to understand the effect of heat on the pharmacokinetic properties of topical products, and the current thinking and actions of the U.S. Food and Drug Administration on deliberate or unintentional heat exposure to percutaneous products. The supporting evidence of binary mixture formation between a drug (from lidocaine, tetracaine or prilocaine) and a chemical permeation enhancer (from camphor or menthol) was studied using FTIR and DSC. An emulsion-based formulation was compounded using tetracaine and menthol eutectic mixture as oil phase, acacia as surfactant and water (in 3:2:1 ratio), and other additives and subsequently loaded onto the polymer side of a Twill patch which was pre-adhered to a pressure adhesive layer, and then covered with a release liner and secondary packaging. In vitro tetracaine release from the innovative and commercial patches at 10 min was 52.94+/-8.61%, n=9, versus 21.77+/-3.79%, n=3 (p=0.045) respectively after normalizing the initial dose of commercial product to 140 mg to match with the dose of innovative patch. Tetracaine release from the innovative patch continues to release faster up to 30 min compared to the commercial patch. The innovative patch contains fewer layers, thus, is expected to be more cost effective in manufacturing.
Notlar:
School code: 0308
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Yer Numarası | Demirbaş Numarası | Shelf Location | Lokasyon / Statüsü / İade Tarihi |
---|---|---|---|
XX(678521.1) | 678521-1001 | Proquest E-Tez Koleksiyonu | Arıyor... |
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