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416301116木蟲(chóng) (正式寫(xiě)手)
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[交流]
體外酒精突實(shí)驗(yàn)設(shè)計(jì)
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The sponsor should conduct in vitro assessments of the drug release from the drug product using media with various alcohol concentrations on the lowest and highest strengths of the MR drug product. The following points should be considered during the evaluation of the in vitro,alcohol-induced, dose dumping of MR drug products: 申請(qǐng)者應(yīng)對(duì)MR藥品（改良藥品包括，緩控釋片和遲釋片）在不同酒精濃度的溶出介質(zhì)中的釋放進(jìn)行體外評(píng)估。即評(píng)估MR藥品的體外酒精誘導(dǎo)的劑量?jī)A瀉實(shí)驗(yàn)，過(guò)程中應(yīng)考慮以下幾點(diǎn)： Dissolution testing should be conducted using the optimal apparatus and agitation speed. Dissolution data should be generated from twelve dosage units (n=12) at multiple time points to obtain a complete dissolution profile. 溶出度測(cè)試應(yīng)在最佳的裝置和攪拌速度進(jìn)行。溶出度測(cè)試應(yīng)采用十二個(gè)劑量單位（n = 12），并設(shè)置多個(gè)時(shí)間點(diǎn)取樣，最終以獲得完整的溶出度曲線。 The following alcohol concentrations are recommended for the in vitro dissolution studies: 0, 5, 10, 20, and 40 percent. 建議在體外溶出度研究中使用以下酒精濃度：0％，5％，10％，20％和40％。 The general considerations for selecting the media are as follows: 溶出介質(zhì)選擇的注意事項(xiàng)如下： -If the optimal dissolution medium is 0.1N HCl: Dissolution profiles in 0.1 N HCl (pH 1.2) containing the above range of alcohol concentrations are sufficient. -如果最佳溶解介質(zhì)為0.1N HCl，則在上述酒精濃度范圍內(nèi)的0.1 N HCl（pH 1.2）中測(cè)試溶解曲線就足夠了。 -If the optimal dissolution medium is not 0.1N HCl: Dissolution profiles using the above range of alcohol concentrations in 0.1N HCl and in the optimal dissolution medium are recommended. -如果最佳溶解介質(zhì)不是0.1N HCl：建議使用上述濃度的酒精在0.1N HCl和最佳溶解介質(zhì)中分別測(cè)試溶解曲線。 -If the optimal dissolution medium has not been identifie d: Dissolution profiles using the above range of alcohol concentrations in three physiologically relevant pH media (i.e. pH 1.2, 4.5, and 6.8) are recommended. -如果尚未確定最佳的溶出介質(zhì)，則建議在三種生理相關(guān)的pH介質(zhì)（即pH 1.2、4.5和6.8）中使用上述酒精濃度測(cè)試溶出曲線。 -If the dissolution is pH-independent: Dissolution data in 0.1N HCl with the above range of alcohol concentrations are sufficient. 如果溶出度與pH無(wú)關(guān)：在上述濃度的酒精濃度范圍內(nèi)的0.1N HCl中測(cè)試溶解度數(shù)據(jù)就足夠了。 -For a delayed-release (enteric-coated) product: Dissolution data in 0.1N HCl with the above range of alcohol concentrations are sufficient. -對(duì)于延遲釋放（腸溶衣）產(chǎn)品：在上述濃度的酒精濃度范圍內(nèi)的0.1N HCl中的溶解數(shù)據(jù)已足夠。 The shape of the dissolution profiles should be compared to determine if the modified release characteristics are maintained, especially in the first 2 hours. 應(yīng)該比較溶出曲線的形狀，以確定是否維持改良的釋放特性，尤其是在最初的2小時(shí)內(nèi)。 The f2 values assessing the similarity (or lack thereof) between the dissolution profiles should be estimated (using 0 percent alcohol as the reference). 應(yīng)評(píng)估f2值，以評(píng)估溶出曲線之間的相似性（或缺乏相似性）（以0％的酒精為參考）。 The report should include complete data (i.e., individual, mean, standard deviation, comparison plots, f2 values, etc.) collected during the evaluation of the in vitro, alcohol- induced, dose-dumping study. 該報(bào)告應(yīng)包括在體外，酒精誘導(dǎo)的劑量?jī)A銷研究評(píng)估期間收集的完整數(shù)據(jù)（即單個(gè)數(shù)據(jù)，平均值，標(biāo)準(zhǔn)差，比較圖，f2值等）。 Based on the results of the in vitro assessments, an in vivo BA study of the drug product when administered with alcohol may be needed. 根據(jù)體外評(píng)估的結(jié)果，可能需要對(duì)藥物與酒精一起進(jìn)行體內(nèi)BA研究。 Sample Text |
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