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Method and apparatus for testing transdermal medicaments

A technology of drugs, therapeutic drugs, applied in the direction of measuring devices, testing pharmaceutical preparations, separation methods, etc.

Inactive Publication Date: 2012-03-07
EGIS GYOGYSZERGYAR NYILVANOSAN MUKODO RESZVENYTARSASAG (EGIS PHARMA PLC)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Multiple pools may be used at the same time

Method used

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  • Method and apparatus for testing transdermal medicaments
  • Method and apparatus for testing transdermal medicaments
  • Method and apparatus for testing transdermal medicaments

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Membrane Permeation Detection of Troxerutin 5% Gel

[0078] The test formulation contained 5% troxerutin as active ingredient. In the assay, a 0.9% by weight sodium chloride solution was used as the acceptor phase. The flow rate of the acceptor phase was 1 ml / min. The membrane celophane used in the assay was 10 cm wide by 10 cm long. The temperature of the cell was 34°C. The pool is exposed to natural daylight. In the first (I) test, no artificial air flow was applied. In the second test group (II), the linear air velocity was 2 m / sec. The concentration of the active ingredient was determined online by UV spectroscopy at a wavelength of 349 nm.

[0079] The membrane along with the device was allowed to stabilize for 60 minutes. Thereafter, within 2-3 seconds, an amount of approximately 300 mg of the test formulation as measured by analytical precision was transferred uniformly to the membrane. Thereafter the flow of the acceptor phase is restarted and the concen...

Embodiment 2

[0084] Comparative Membrane Permeation Assay of Piroxicam-Containing Creams Using Cellophane and Human Skin Membranes

[0085] The test formulation contained 1% piroxicam as an active ingredient. In the assay, the acceptor phase contained a 0.9% by weight sodium chloride solution. The flow rate of the acceptor phase was 0.3 ml / min. Cellophane membranes were used during the first test series (I) and human skin membranes during the second test series (II). The temperature of the cell was maintained at 34°C. During the two test series, the pools were exposed to natural daylight. No air flow was applied.

[0086] The membrane was allowed to stabilize for 60 minutes.

[0087] After a stabilization period, 300-400 mg of the test formulation as measured by analytical precision was uniformly applied to the membrane within 2-3 seconds. Flow of the acceptor phase was restarted and effluent fractions were collected for each 30 minute period. The piroxicam and methylparaben concent...

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PUM

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Abstract

The invention relates to an apparatus and method for testing transdermal medicaments, wherein the sample tested in a membrane penetration cell resides in the open sample compartment of said cell and is exposed to environmental factors such as temperature, air flow, light and air humidity during testing the absorption and penetration.

Description

technical field [0001] The present invention relates to an in vitro detection method and device for modeling the release of an active ingredient from a transdermal drug. Background technique [0002] In vitro methods suitable for modeling biological events including in vivo drug release and absorption-permeation phenomena enjoy significant interest in cosmetic and pharmaceutical research. [0003] In vitro models are of great importance during the development of dermal or transdermal formulations used in dermatology because the absorption and fate of active ingredients can be determined only in the skin with great difficulty. Quantitative characterization of treatment effects is likewise a complex task. General recognition of legal and ethical norms related to the care and protection of animals has resulted in a marked reduction in the use of animal models. However, in those cases of formulations intended to release a constant amount on the skin daily, the detection of the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/50
CPCB01D29/48G01N33/15G01N33/5008
Inventor E·米库拉希克P·法泽卡斯P·萨卡利
Owner EGIS GYOGYSZERGYAR NYILVANOSAN MUKODO RESZVENYTARSASAG (EGIS PHARMA PLC)
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