Detection and Analysis of Drug Crystals in Medical Transdermal Patches by Using X-ray Diffraction Measurement

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  • X線回折測定による医療用経皮吸収型製剤中の薬物結晶の検出と解析
  • Xセン カイセツ ソクテイ ニ ヨル イリョウヨウ ケイヒ キュウシュウガタ セイザイ チュウ ノ ヤクブツ ケッショウ ノ ケンシュツ ト カイセキ

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Abstract

<p>The crystallization of active pharmaceutical ingredients (APIs) in matrix-type transdermal patches has implications for the rate of drug absorption through the skin and patch adhesion strength. Therefore, the presence or absence and the degree of API crystallinity must be controlled to guarantee the quality of patches. In this study, the utility of laboratory-level X-ray diffractometers for the detection and analysis of crystalline APIs in transdermal patches was investigated using medical patches of tulobuterol and isosorbide dinitrate. Several matrix-type patches employ a controlled drug delivery system containing intentionally crystallized API. Both benchtop and high-resolution laboratory X-ray diffractometers can detect several characteristic peaks of the APIs in these patches even if the patches are wrapped in an outer bag, although a benchtop model provides peak heights one-seventh to one-fifth that of a high-resolution instrument. An isosorbide dinitrate patch containing an unintentionally crystallized spot was wrapped in an outer bag, followed by measurements using both X-ray diffractometers. For both instruments, several isosorbide dinitrate-derived peaks were detected only at the crystallized spot, although the signal-to-noise ratio was poorer for the benchtop model. These results show that a high-resolution X-ray diffractometer is advantageous for high-detection sensitivity and offers a high degree of freedom of the measurement position on the sample. It was concluded that a laboratory-level high-resolution X-ray diffractometer can be used to examine the crystalline state of APIs in patches inside an unopened outer bag.</p>

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 142 (1), 65-74, 2022-01-01

    The Pharmaceutical Society of Japan

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