Omega-3 fatty acid ester compositions
A technology of fatty acid ester and composition, applied in the field of omega-3 fatty acid ester composition, can solve the problems of uncertainty of final success and high cost of new drugs
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example 1
[0187] The amounts and percentages of these ingredients making up the composition are shown in Table 1:
[0188] Table 1
[0189]
[0190]
[0191] The manufacturing process of a dosage form comprising the composition of an embodiment can be divided into three stages: a) the process of manufacturing the composition (fill mass), b) the process of manufacturing the gel mass used to encapsulate the fill mass, and c) Encapsulation process. Stages (a) and (b) can be carried out in either order.
[0192] The process of making the composition was started by weighing the appropriate amount of Polysorbate 80 and Pluronic F87 according to the desired batch size and mixing them well in a stainless steel tank at 60°C. The substantially pure omega-3 fatty acid ethyl ester mixture was allowed to cool to room temperature before quantitative vacuum transfer to the same stainless steel tank containing polysorbate 80 and Pluronic F87. This mixture was again mixed well at room temperatu...
example 2
[0196]Experiments were carried out to determine the micellar information in the two compositions A and B, as shown in Table 2. Two compositions comprising omega-3 fatty acid ethyl esters were prepared as described in Example 1, wherein the omega-3 fatty acid ethyl esters had increased absorption and the food effect was substantially eliminated.
[0197] Table 2
[0198]
[0199]
[0200] These compositions which form well dispersed micelles generally have a combined surfactant HLB value of from about 15 to about 17.
[0201] Other compositions having polysorbate 80 levels between 27% and 29% combined with Pluronic F87 between about 7% and about 22% generally formed large oil globules. These compositions have combined surfactant HLB values from about 17 to about 19. Based on these experiments, the complete product has an HLB of from about 13 to about 14.4, and the combined surfactant HLB is between 12 and about 17.
example 3
[0203] Compositions A and B (1,000 mg) as shown in Table 2 were added to Separate container containing 500-900 mL of water in 0.1 N HCl and observe. Neither composition was subjected to any agitation or shearing. When viewed under a microscope, very small, well-dispersed micelles are visible. The micelles were stable over twelve months at room temperature, and the omega-3 fatty acid esters did not visibly separate from the other ingredients of the composition. Thus, compositions comprising polysorbate 80 levels between 20% and 31% in combination with 0.7% to 5% Pluronic F87 formed stable micelles.
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