Breaking through the "bottleneck" of dissolution, fish oil absorption efficiency is upgraded.

1. Fish oil softgel capsules and their routine dissolution difficulties in brief

Fish oil softgels, as a common dietary supplement, are typically lipophilic formulations whose contents are mainly fatty acid-rich fish oil. Such softgels often encounter the following challenges in routine dissolution experiments:

1) After the capsule shell rupture, fish oil, like a naughty "elf", always likes to float on the top of the dissolution cup, and collects into droplets that are difficult to be dispersed. This not only requires strong mechanical stirring, but also directly leads to unstable dissolution data, which affects the accurate assessment of product quality.

2)Excessive stirring force, while forcing the dispersion of oil droplets, may deviate from the gentle physiological environment of the human digestive tract. What we are looking for is a more realistic test result that is more in line with the absorption process of the human body, rather than a simple violent dissolution.

3)Over time, the capsule skin of a softgel may "cross-link" and become difficult to break, as if it were wearing a layer of "armor". This can make the dissolution process unusually slow or incomplete, leading to large variations in data between batches and making quality control difficult.

4)The time to rupture may also vary from capsule to capsule, like a race without a uniform starting gun, resulting in a lack of consistency in dissolution results.

2. Intelligent dissolution program to unlock the potential of fish oil absorption

In the face of these difficult challenges, we know that choosing the right test method is critical! As an industry leader, we strictly follow international guidelines (e.g. FIP/AAPS, USP, BP) and thoroughly study the characteristics of various dissolution devices.

Among the basket, paddle, reciprocating cylinder and other options, we found that the flow cell method is ideal for in vitro dissolution testing of lipophilic fish oil softgel capsules due to its unique advantages. It can simulate a physiological environment closer to the human body and more realistically reflect the release and absorption process of fish oil, providing the most solid scientific guarantee for the quality of your products!

3. In vitro capsule release case sharing

Experimental results:

1.Examination of method reproducibility: in this experiment, we tested 3 groups of fish oil soft gelatin capsules of the same batch in parallel, and the test results are shown below. The results showed that the reference formulation started to dissolve significantly after 15 min, in which the relative standard deviation ranged from 0.63% to 13.58% during 15 min-120 min. The self-developed formulation started to dissolve significantly after 10 min, in which the relative standard deviations ranged from 0.79% to 13.96% during the period of 10 min-120 min.

reference

self-research

2. Examination of method differentiation power:

Under the current experimental conditions, there is a significant difference in the in vitro release behavior of the sample to be tested and the reference preparation: the shell of the softgel capsule of the sample to be tested ruptures significantly faster than that of the reference preparation, resulting in faster release of its contents. Under the condition that there is no more than one time point when the release degree exceeds 85%, the average release degree of the two samples was taken from 5min to 50min, and the similarity factor (f2) was calculated to be 26.81. It means that the in vitro release behavior of the two samples is not similar.

Summarize:

Raytor RT7 for your fish oil softgels casting excellent quality

In a competitive market, the superior quality of a product is the only way to win the trust of consumers. Fish oil softgels as a highly effective nutritional supplements, its unique oil solution form determines its absorption rate in the body is usually better than ordinary tablets. However, in order to truly unleash its full potential, a scientific and rigorous dissolution test method is crucial!