Pharmaceutical compositions comprising alpelisib
一种药学、片剂的技术，应用在新分散片领域，能够解决不切实际、不理想、无法方便地吞咽等问题
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Embodiment 1
[0160] Embodiment 1: Dispersible tablet preparation (50mg dispersible tablet, disintegration time is less than 3 minutes)
[0161]
[0162]
[0163] The tablets are prepared as follows: Granules with inner and outer phases are formed via (i.) Wet granulation of the inner phase comprising 50.00 mg Compound I, 23.00 mg Microcrystalline Cellulose (Avicel PH101), 23.00 mg Mandew Alcohol, 3.0 mg sodium starch glycolate and 3.00 mg low-substituted hydroxypropyl cellulose, then (ii.) by mixing the resulting mixture with 4.06 mg sodium starch glycolate and 15.86 mg microcrystalline cellulose (Avicel PH102) sieved, The resulting mixture was then mixed with 5.08 mg of sieved sodium stearyl fumarate to form the external phase.
[0164] Tablets are obtained by compressing the mixture obtained in step (ii) above. Above step (ii) gained composition is used Compression on a 102i rotary tablet press, using a compression force of about 5-11 kN (preferably about 8 kN), with a 7mm diam...
Embodiment 2
[0167] Embodiment 2: dispersible tablet preparation (200mg dispersible tablet, disintegration time is less than 3 minutes)
[0168]
[0169] The tablets are prepared by wet granulation of the inner phase via (i.) wet granulation of the inner phase comprising 200.00 mg of compound I, 92.00 mg of microcrystalline cellulose (Avicel PH101 ), 92.00 mg of mannitol, 12.00 mg sodium starch glycolate and 12.00 mg low-substituted hydroxypropyl cellulose, then (ii.) form the external phase by mixing the resulting mixture with sieved 16.24 mg sodium starch glycolate and 63.44 mg microcrystalline cellulose (Avicel pH 102), the resulting mixture was then mixed with 20.32 mg of sieved sodium stearyl fumarate.
[0170] Tablets are obtained by compressing the mixture obtained in step (ii) above. Above step (ii) gained composition is used Compression on a 102i rotary tablet press, using a compression force of about 12-20 kN (preferably about 16 kN), with a 16.0 x 6.3 mm die and standard...
Embodiment 3
[0174] Example 3: Example of disintegration time
[0175] The table below provides examples of disintegration times in minutes for tablets formulated according to Example 1 or Example 2:
[0176]
[0177] In the above test, a particular tablet formulated according to Example 1 or Example 2 was evaluated to determine whether the tablet disintegrated in less than 5 minutes when placed in a liquid medium. Tablet disintegration time was evaluated according to the procedure outlined in European Pharmacopoeia, Eighth Edition, Appendix 8.2, pp. 285-287, Section 2.9.1 (January 2014), which is hereby incorporated by reference in its entirety. Discs were not used in these experiments.
[0178] Complete disintegration was defined as the state of any tablet remaining on the test device screen as a soft mass with no palpable hard core except for insoluble coating fragments.
[0179] Rack assemblies were used for these tests. The basket assembly consisted of 6 open transparent tubes (...
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