Azithromycin for treatment of skin disorders
A technology for azithromycin and skin diseases, which is applied in the field of systemic drug therapy for the treatment of dermatological diseases, can solve problems such as not being very effective, and achieve the effect of improving safety
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Embodiment 1
[0077] Example 1 - Azithromycin Levels in Plasma
[0078] Plasma levels of azithromycin were determined as follows. Thirty-nine patients were randomized into one of three treatment groups. Each patient received oral azithromycin 40 mg (n=13), 80 mg (n=11) or 120 mg (n=15) daily. After the initial dose on day 0, a second dose was administered until 72 hours later to enable measurement of plasma levels on a single dose basis, as well as determination of pharmacokinetic parameters. Blood samples were collected from each patient at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after the initial oral dose. After 72 hours, each patient received azithromycin daily for the remainder of the six weeks (42 days). Blood samples were also taken at 0 (pre-dose) and 3 hours post-dose on day 21 and at 0, 1 , 2, 3, 4, 6, 8 and 24 hours after the last dose on day 42. After collection, plasma samples from blood samples were stored at -20°C or below until processed and analyzed.
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Embodiment 2
[0087] Example 2 - Azithromycin Levels in Sebum
[0088] use (CuDerm Corporation, Dallas TX) collected sebum from the subjects of Example 1. On days 0, 21, 42, and 70 of the study, three patches were placed on each subject's facial skin on the forehead, left and right cheeks Apply the sheet and let it stay for 30-40 minutes. The patch was then removed, folded in half with the adhesive side inward, placed in an airtight glass bottle and frozen at -20°C to -70°C.
[0089] A 250:150:100:0.5:0.1 mixture of ethyl acetate, methanol, acetonitrile, formic acid, and morpholine was used as the mobile phase to extract each Paste the sebum collected in the patch. Extracts were fortified with internal standard azaerythromycin. Aliquots of 5 microliters are injected into a suitable high pressure liquid chromatography (HPLC) equipped with suitable mass spectrometry-mass detection, such as a Sciex API 3000 LC-MS-MS. The HPLC column used was PVA-Sil, 5 micron, 4.0 x 50 mm column. The...
Embodiment 3
[0098] Example 3 - Azithromycin Levels in Skin
[0099] On study days 0, 21, 42, and 70, normalized hair follicle biopsy samples representing dermal pilosebaceous units were obtained from the upper back of each subject in Example 1 . These samples were analyzed to determine the tissue levels of azithromycin in each biopsy. The results are shown in Table 3.
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[0101] table 3
[0102] As shown in Table 3, the median amount of azithromycin in skin hair follicle biopsy samples increased with increasing doses of azithromycin. The difference in the amount of azithromycin obtained between the doses of 80 mg / day and 120 mg / day was much smaller than the difference in the amount of azithromycin obtained between the doses of 40 mg / day and 80 mg / day. The data suggest that the skin, particularly the pilosebaceous unit revealed by follicle biopsy, is saturated with azithromycin at doses of 80-120 mg / day. From this data, it was inferred that the skin was saturated with azithro...
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