Perger Ludwig, Rentsch Katharina M, Kullak-Ublick Gerd A, Verotta Davide, Fattinger Karin
Department of General Internal Medicine, Inselspital - University Hospital Bern and University of Bern, CH-3010 Bern, Switzerland.
Eur J Pharm Sci. 2009 Mar 2;36(4-5):421-32. doi: 10.1016/j.ejps.2008.11.008. Epub 2008 Nov 25.
In diacetylmorphine prescription programs for heavily dependent addicts, diacetylmorphine is usually administered intravenously, but this may not be possible due to venosclerosis or when heroin abuse had occurred via non-intravenous routes. Since up to 25% of patients administer diacetylmorphine orally, we characterised morphine absorption after single oral doses of immediate and extended release diacetylmorphine in 8 opioid addicts. Plasma concentrations were determined by liquid chromatography-mass spectrometry. Non-compartmental methods and deconvolution were applied for data analysis. Mean (+/-S.D.) immediate and extended release doses were 719+/-297 and 956+/-404 mg, with high absolute morphine bioavailabilities of 56-61%, respectively. Immediate release diacetylmorphine caused rapid morphine absorption, peaking at 10-15 min. Morphine absorption was considerably slower and more sustained for extended release diacetylmorphine, with only approximately 30% of maximal immediate release absorption being reached after 10 min and maintained for 3-4h, with no relevant food interaction. The relative extended to immediate release bioavailability was calculated to be 86% by non-compartmental analysis and 93% by deconvolution analysis. Thus, immediate and extended release diacetylmorphine produce the intended morphine exposures. Both are suitable for substitution treatments. Similar doses can be applied if used in combination or sequentially.
在针对重度成瘾者的二乙酰吗啡处方项目中,二乙酰吗啡通常通过静脉注射给药,但由于静脉硬化或海洛因曾通过非静脉途径滥用,这种给药方式可能不可行。由于高达25%的患者口服二乙酰吗啡,我们对8名阿片类成瘾者单次口服速释和缓释二乙酰吗啡后的吗啡吸收情况进行了表征。通过液相色谱-质谱法测定血浆浓度。采用非房室方法和反卷积法进行数据分析。速释和缓释剂量的平均值(±标准差)分别为719±297毫克和956±404毫克,吗啡的绝对生物利用度分别高达56%-61%。速释二乙酰吗啡使吗啡快速吸收,在10-15分钟达到峰值。缓释二乙酰吗啡的吗啡吸收相当缓慢且持续时间更长,10分钟后仅达到最大速释吸收量的约30%,并持续3-4小时,且不存在相关的食物相互作用。通过非房室分析计算得出缓释与速释的相对生物利用度为86%,通过反卷积分析为93%。因此,速释和缓释二乙酰吗啡均可产生预期的吗啡暴露量。两者均适用于替代治疗。如果联合使用或先后使用,可应用相似剂量。