桨法（方法2）和篮法（方法1）见图1，是第一批引入药典的溶出度测试方法，广泛应用在USP专论中。 这些USP专论中规定的溶出测试主要是针对药品的质量控制（QC）的，在这些情况下，QC方法也实现了QbD的目标，也可以用于药品的研发中。 QC方法用于药品研发的例子包括含BCS I类或III类药物的速释制剂（IR）和调释制剂（MR）的研发 (Grundy and Foster, 1996; Sandberg et al., 1991)。 图1 USP 篮法（A）和桨法（B） 对于其他剂型，把药典推荐方法转 …

When coning is leading to artificially low dissolution, then one potential solution is the Apex (formerly known as Peak) vessel. To begin, we should discuss coning and differentiate between good and bad cones. Coning is whenever you have a mound of material at the bottom of the dissolution vessel when performing USP Apparatus 2 (paddle) testing.

2020年10月23日 · 对于Peak Vessel这个描述，相信各位小伙伴都已经不陌生了。 没错，这就是指的“带峰底的溶出杯”。 与常规标准溶出杯的区别就是溶出杯底部有一个峰形的突起，避免药物溶出在溶出杯底部形成圆锥形的堆积。

A vessel with a triangular base which occupies the zone of the vessel beneath the paddle is referred to APEX or PEAK (proprietary name) of the vessels. The vessels use exactly same set up as a traditional USP2 dissolution apparatus.

2005年1月1日 · Apex vessels (previously known as PEAK vessels) are an important element of the dissolution scientist's toolbox and are frequently used in pharmaceutical drug product development settings.

Apex vessels, previously referred to as PEAK vessels, are commonly used in dissolution experiments with Apparatus 2. They are mentioned in The Dissolution Procedure: Development and Validation 〈1092〉 for their utility in the possible elimination of coning associated with using standard vessels.

Dissolution peak vessels (Apex vessels) are available to avoid coning in dissolution. Molded vessels are vacuum formed (VF) and offer the tightest precision available to reduce position-to-position variability and improve uniformity.

提供 Peak 溶出杯（Apex 溶出杯），用于避免溶出测试锥形聚积问题。 模塑溶出杯和真空成型 (VF) 溶出杯具有极高精度，可大大减少位置间变异性，同时提高均一性。

Several vessel design modifications have been proposed to overcome the problem. One such proposal is a modified vessel design with a convex bottom such as the one found in wine bottles (7). This vessel became commer-cially available about …

2021年11月17日 · According to the authors of the stimuli article, it is intended to demonstrate the significant benefit of the apex vessels (previously known as PEAK vessels) relative to the standard vessel in overcoming coning for formulations that contain dense insoluble excipients.