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12月10日，就溶出度試驗(yàn)的相關(guān)要求，歐洲藥典委員會(huì)發(fā)布一項(xiàng)通知?；谄?68屆會(huì)議的結(jié)論，對(duì)于速釋固體制劑，將在每個(gè)藥物專(zhuān)論中包括溶出度或崩解檢驗(yàn)。同時(shí)將在通則中提出要求：上市許可申請(qǐng)人必須提出針對(duì)產(chǎn)品的適當(dāng)溶出度試驗(yàn)，以進(jìn)行常規(guī)的質(zhì)量控制，確認(rèn)批次間的一致性。申請(qǐng)人必須證明溶出度試驗(yàn)的適用性，并獲得主管當(dāng)局的認(rèn)可。

 

溶出度試驗(yàn)的現(xiàn)狀

 

Over the last few years, the European Pharmacopoeia (Ph. Eur.) has been elaborating monographs on medicinal products containing chemically defined active substances, applicable to immediate-release solid dosage forms (tablets, capsules).

 

在過(guò)去的幾年中，針對(duì)速釋固體制劑（片劑/膠囊劑）的化學(xué)成分藥物，歐洲藥典一直在撰寫(xiě)相應(yīng)的專(zhuān)論。

 

These monographs include a mandatory test for dissolution or disintegration. However, in justified and authorised cases, manufacturers may propose another procedure and/or, where appropriate, different acceptance criteria as part of their marketing authorisation application. This is indicated in the monographs by the sentence:

 

這些專(zhuān)論包括對(duì)溶出度或崩解的強(qiáng)制性檢驗(yàn)。但是，在論證和批準(zhǔn)的情況下，生產(chǎn)商可以提議另一種程序和/或提出不同的可接受標(biāo)準(zhǔn)（適當(dāng)時(shí)），作為其上市許可申請(qǐng)的一部分。關(guān)于這一點(diǎn)，在專(zhuān)論中有以下句子可以表明：

 

The tablets comply with the test and the acceptance criterion described below, unless otherwise justified and authorised.

 

除非另有論證和批準(zhǔn)，否則片劑應(yīng)符合以下所述的檢驗(yàn)和可接受標(biāo)準(zhǔn)。

 

Since the result of the dissolution test may be affected by the formulation and/or the manufacturing process, the Ph. Eur. Commission launched a substantive examination of users’ expectations with regard to this test in medicinal product monographs.

 

由于溶出度試驗(yàn)的結(jié)果可能會(huì)受到處方和/或生產(chǎn)工藝的影響，因此，就用戶(hù)在藥品專(zhuān)論中對(duì)該檢驗(yàn)的期望，歐洲藥典委員會(huì)進(jìn)行了獨(dú)立的的審查。

 

問(wèn)卷調(diào)查

 

Users in the pharmaceutical industry, the licensing authorities, national pharmacopoeias and OMCLs, for example, were therefore invited to participate in a survey in January 2019.

 

例如，2019年1月，來(lái)自制藥行業(yè)、許可當(dāng)局、國(guó)家藥典和OMCL的用戶(hù)被邀請(qǐng)參加了問(wèn)卷調(diào)查。

 

Three options were proposed:

 

當(dāng)時(shí)，提出了三個(gè)選項(xiàng)：

 

keep a mandatory dissolution test in the monographs;

 

include a dissolution test as an example in the monographs;

 

do not include a dissolution test since the dosage form monographs on Tablets (0478) and Capsules (0016) contain the requirement to carry out such a test, in addition to the prescriptions of guideline ICH Q6A.

 

在專(zhuān)論中，保留強(qiáng)制性的溶出度試驗(yàn)；

 

在專(zhuān)論中，溶出度試驗(yàn)以示例的方式列出

 

不包含溶出度試驗(yàn)，因?yàn)樵谄瑒?478）和膠囊（0016）劑型專(zhuān)論中，除了包含指南ICH Q6A的要求外，還包含了進(jìn)行該檢驗(yàn)的要求。

 

歐洲藥典委員會(huì)結(jié)論

 

Based on the results of the survey and on experience gained by other pharmacopoeias elaborating such monographs, a compromise was found and adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). The latter decided that a dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form.

 

根據(jù)調(diào)查結(jié)果和其它藥典編寫(xiě)此類(lèi)專(zhuān)論的經(jīng)驗(yàn)，在歐洲藥典委員會(huì)第168屆會(huì)議（2020年11月）上找到了折衷方案，并予以采納。后者決定：對(duì)于速釋固體制劑，溶出度或崩解檢驗(yàn)應(yīng)包括在上每個(gè)藥物專(zhuān)論中。

 

The details of the scope of such a test and the conditions for its use in a marketing authorisation application will be included in the General Notices (Chapter 1 of the Ph. Eur.). An excerpt is shown below:

 

有關(guān)此類(lèi)檢驗(yàn)的范圍及其在上市許可申請(qǐng)中使用的條件，其詳細(xì)信息將包含在通則中（歐洲藥典第1章）。摘錄如下所示：

 

“In line with the relevant guidelines applied nationally or regionally (such as the ICH Q6A guideline) and with the relevant Ph. Eur. dosage form monograph, a suitable product-specific dissolution test has to be proposed by the applicant for routine quality control to confirm batch-to-batch consistency. This test must be described in the MAA for submission to the competent authority, unless there is data justifying the replacement of the dissolution test by a disintegration test (see below). The demonstration of the suitability of the dissolution test has to be made by the applicant to the satisfaction of the competent authority.

 

“與國(guó)家或地區(qū)適用的相關(guān)指南（例如ICH Q6A指南）以及相關(guān)的歐洲藥典劑型專(zhuān)論相一致，申請(qǐng)人必須提出針對(duì)產(chǎn)品的適當(dāng)溶出度試驗(yàn)，以進(jìn)行常規(guī)的質(zhì)量控制，確認(rèn)批次之間的一致性。除非有數(shù)據(jù)證明用崩解檢驗(yàn)代替溶出度試驗(yàn)是合理的，否則必須在MAA中描述該檢驗(yàn)，以提交主管當(dāng)局。申請(qǐng)人必須證明溶出度試驗(yàn)的適用性，并獲得主管當(dāng)局的認(rèn)可。

 

Where appropriate, a dissolution test is described in an individual monograph on a medicinal product. In such cases, the applicant may either select the monograph dissolution test or develop an in-house dissolution test as the product-specific dissolution test. In any case, the applicant has to demonstrate the suitability of the selected test to the satisfaction of the competent authority.

 

在適當(dāng)?shù)那闆r下，在針對(duì)藥物的單個(gè)專(zhuān)論中將對(duì)溶出度試驗(yàn)進(jìn)行描述。在這種情況下，申請(qǐng)人可以選擇專(zhuān)論溶出度試驗(yàn)，也可以開(kāi)發(fā)內(nèi)部溶出度試驗(yàn)，作為特定產(chǎn)品的溶出度試驗(yàn)。無(wú)論如何，申請(qǐng)人必須證明所選檢驗(yàn)的適用性，使主管當(dāng)局滿(mǎn)意。

 

If an in-house dissolution test is proposed, justification for not selecting the monograph dissolution test and demonstration of compliance with the monograph dissolution test is normally not requested in the MAA.

 

如果提議進(jìn)行內(nèi)部溶出度試驗(yàn)，則在MAA中通常不要求論證不選擇專(zhuān)論溶出度試驗(yàn)的理由，也不要求證明符合專(zhuān)論溶出度試驗(yàn)。

 

However, when tested, the medicinal product has to comply with the monograph dissolution test, unless otherwise justified by the applicant.

 

但是，除非經(jīng)過(guò)申請(qǐng)人另行論證，否則在進(jìn)行檢驗(yàn)時(shí)，藥品必須符合專(zhuān)論溶出度試驗(yàn)。

 

Where a given medicinal product does not comply with the monograph dissolution test and this product is approvable by a competent authority, then the competent authority shall bring this to the attention of the Ph. Eur. Commission so it can review the monograph and revise it where appropriate.”

 

如果給定的藥品不符合專(zhuān)論中的溶出度試驗(yàn)，且該產(chǎn)品經(jīng)主管當(dāng)局批準(zhǔn)，則主管當(dāng)局應(yīng)將此事提請(qǐng)歐洲藥典委員會(huì)注意，以便該委員會(huì)可以審查專(zhuān)論，并在適當(dāng)時(shí)進(jìn)行修改。”

 

后續(xù)修訂

 

Consequently, the following monographs have been revised to delete the sentence in italics mentioned above and to add a footnote referring to the General Notices:

 

因此，對(duì)以下專(zhuān)論進(jìn)行了修訂，以刪除上述用斜體字表示的句子，并添加引用“通則”的腳注：

Deferiprone tablets (2986)

Dronedarone tablets (3038)

Lacosamide tablets (2989)

Raltegravir chewable tablets (2939)

Raltegravir tablets (2938)

Regorafenib tablets (3023)

Riociguat tablets (3079)

Rivaroxaban tablets (3021)

Rosuvastatin tablets (3008)

Sitagliptin tablets (2927)

Sorafenib tablets (3022)

Ticagrelor tablets (3097)

 

去鐵酮片（2986）

決奈達(dá)隆片（3038）

拉考酰胺片（2989）

拉格韋韋咀嚼片（2939）

雷格列韋片劑（2938）

雷戈非尼片（3023）

里奧西瓜片（3079）

利伐沙班片（3021）

瑞舒伐他汀片（3008）

西他列汀片（2927）

索拉非尼片（3022）

替卡格雷片（3097）

These monographs and the revised General Notices will be published in Supplement 10.6.

 

這些專(zhuān)論和經(jīng)修訂的通則將在補(bǔ)編10.6中發(fā)布。

 

Ref:

 

New policy for dissolution and disintegration testing in Ph. Eur. Monographs. 10 DECEMBER 2020. EDQM