Oral formulations and uses thereof
A tablet and diluent technology, applied in their production, can solve the problems of changing the physical and chemical properties of the preparation, production problems, product instability, etc.
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[0155] preformulation research
[0156] Characterization of Active Pharmaceutical Ingredient (API)
[0157] Compound (Ia) HCl(API) is an acidic compound with a pH of about 2.5. Compounds of formula (I), especially compound (Ia) shown below, especially the dihydrochloride salt of compound (Ia) (compound (Ia) 2HCl), were used in all examples.
[0158]
[0159] granularity
[0160] The particle size distribution of compound (Ia)2HCl(API) was determined using a Malvern Mastersizer. The results obtained are summarized in Table 1. D(0.1) means that 10% of the sample is present as particles smaller than this size. D(0.5) means that 50% of the sample is present in the form of particles smaller than this size. D(0.9) means that 90% of the sample is present in the form of particles smaller than this size.
[0161] Table 1: Particle size distribution of compound (Ia)
[0162]
[0163] bulk density and tap density
[0164] Measurements of bulk density and tap density ...
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