Stable pharmaceutical composition and methods of using same
A composition and drug technology, applied in the direction of drug combination, botanical equipment and methods, pharmaceutical formulations, etc., can solve problems such as not being approved
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Embodiment 1
[0150] A test composition (TC) comprising the following was prepared: ultrapure ethyl-EPA (>96% E-EPA, ~3% related fatty acid material (without DHA), and ~0.2% α-tocopherol), the capsule shell is composed of gelatin (~44%), glycerin (~7%), sorbitol solution (~17%), maltitol solution, gelatin and purified water Gel preparation. A comparative composition (CC) was prepared comprising the same filler as the test compound, but filled into type IIa capsules prepared from a gel comprising glycerol (-20%), gelatin (43.4%) and water (-36.6%) .
[0151] The test and comparative compositions were then placed in plastic bags, which were sealed and stored at 25°C / 60%RH or 30°C / 65%RH for periods of 1, 3, or 6 months. At the end of storage, the capsules were opened and the filling material analyzed for peroxide value. The results are shown in Table 1 (average of three different batches of capsules).
[0152] Table 1. Peroxide value after storage (Meq / kg)
[0153]
[0154] As can be s...
Embodiment 2
[0156] The test and comparative compositions of Example 1 were prepared and packaged in blister packs (50 μPCTFE laminated to 190 μ clear PVC with water-based adhesive and heat sealed to aluminum foil). The test and comparison compositions were packaged and then stored at 25°C / 60%RH or 40°C / 70%RH for a period of 1, 3, 6, 12 or 36 months. At the end of storage, the peroxide values of the opened capsules and filler contents were analyzed as in Table 2 (average value of three batches).
[0157] Table 2. Peroxide value after storage (Meq / kg)
[0158]
[0159] As seen in Table 2, compared with the comparative composition, after 3, 6, 9 and 12 months of storage at 25°C / 60%RH and after 1, 3 and 6 months of storage at 40°C / 75%RH, the tested The composition exhibits a very low peroxide value.
[0160] At 40°C, the test composition showed an average reduction in E-EPA efficacy of 0.30% per month, while the comparative composition showed an average reduction in E-EPA efficacy of 0...
Embodiment 3
[0165] Dissolution tests were performed on capsules of Example 1 containing 500 mg E-EPA using as described in Yamazaki et al., Dissolution tests by RDC method for soft capsules containing ethyl icosapentate, Pharmaceutical Technology Japan, 15:595-603 (1999) The rotating dialysis cell method. The conditions are as stated below:
[0166]
[0167]
[0168] Samples were analyzed against a 0.5 mg / ml reference standard prepared in ethanol and the amount of product dissolved at each time point was calculated. For about 60 minutes of Q 85 , resulting in a good dissolution profile, very similar to that produced by Yamazaki (JP data; succinylated capsules). The dissolution of the capsule composition of the present invention was also assessed by the stirring method in a medium containing buffer, SDS and IPA (100 rpm stirring speed, 1000 ml, 37° C.). Samples were removed at intervals and analyzed by HPLC against a standard solution (9.5 ml / ml in methanol). All data in figure ...
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