FIELD: pharmaceuticals.
SUBSTANCE: method for preparing a pharmaceutical product includes the steps of: (a) providing an undiluted active pharmaceutical ingredient (API) that meets at least five of the following parameters (i)-(viii) determined using an FT4 powder rheometer: (i) basic specific energy flow (sBFE) no more than 60 mJ/g; (ii) a stability index (SI) from 0.75 to 1.25; (iii) specific energy (SE) not more than 10 mJ/g; (iv) maximum principal stress at 15 kPa (MPS-15) not more than 40; (v) current functions at 15 kPa (FF-15) not less than 1.3; (vi) compacted bulk density at 15 kPa (CBD-15) not less than 0.26 g/ml; (vii) compressibility not more than 47% and (viii) angle of friction at the wall (WFA) not more than 40°; (b) dispensing the undiluted API from step (a) into the bottom of a pharmaceutical carrier using a dosing and filling vacuum device and (c) encapsulating the bottom of said pharmaceutical carrier with a corresponding closure portion of said pharmaceutical carrier, thereby obtaining a pharmaceutical product.
EFFECT: obtaining a method of preparing pharmaceutical product.
13 cl, 2 ex, 6 dwg
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Authors
Dates
2023-05-16—Published
2018-09-28—Filed