Soft candy is a kind of dosage form with high moisture content, softness, elasticity and toughness. Nutritional soft candy or therapeutic soft candy can be made by adding nutritional components or therapeutic drugs to soft candy.
The main characteristic of soft candy is that they contain different kinds of colloids, so that they have gel properties. Traditional dissolution methods may not be able to normally investigate the release behavior of soft candy in vitro, because soft candy will be insoluble as a whole.
This article will share the case of using the reciprocating cylinder dissolution system to determine the in vitro release of soft candy preparations, hoping to bring you help and inspiration.
Experimental Method
Reciprocating cylinder method（USP Apparatus 3)
Dissolution system: Raytor RT3-AT reciprocating cylinder automatic sampling dissolution system
Volume of dissolution medium: 250 mL
Temperature: 37.0 ± 0.5 ℃
Reciprocating stroke: 10 cm
Experimental Result
This case summarizes the in vitro release results of two soft candy preparations, and draws the cumulative dissolution rate time curve respectively:
Soft candy preparation A
Soft candy preparation B
Both types of soft candy can be completely dissolved under the corresponding test conditions of reciprocating cylinder method. The relative standard deviation of the final dissolution result of soft cand preparation A in 120 min was 1.0%; The relative standard deviation of the final dissolution result of soft cand preparation B in 60 min was 1.1%. The repeatability of the test results is good.
Result Discussion
In soft candy, there is a network structure synthesized by linear colloidal knot, which forms the skeleton of soft candy. These reticular or dendritic skeleton structures are filled with various substances such as water, various excipients and main drug components.
If need to effectively release various material components in the skeleton, the skeleton structure in the soft candy need to be opened. However, the fluid shear force generated by the traditional dissolution method is not enough to effectively open these skeleton structures, and the soft candy may only show a swelling state.
The reciprocating cylinder method can provide greater fluid shear force. The framework structure of fudge is gradually opened with the reciprocating fluid shear force up and down, and the contents are gradually dissolved until they are completely released. In addition, some studies have pointed out that glass beads can be added to the reciprocating cylinder to simulate the chewing state of drugs in the mouth and further increase the external shear force borne by drugs.