Example 2

Dosage forms B and C were prepared as follows. 20 wt % acetaminophen drug particles were first mixed with the excipient, 80 wt % HPMC of molecular weight 120 kg/mol. The mixture was then combined with a solvent, either DMSO (for preparing dosage form B) or water (for dosage form C). The volume of solvent per mass of excipient was 5.5 ml/g and 3.33 ml/g, respectively, for preparing dosage forms B and C. The drug-excipient-solvent mixture was then extruded through a laboratory extruder to form a uniform viscous paste. The viscous paste was put in a syringe equipped with a hypodermic needle of inner radius, Rn=130 μm (for preparing dosage form B) or Rn 500 μm (for preparing dosage form C). The paste was then extruded through the needle and patterned as a fibrous dosage form with cross-ply arrangement of fibers. The nominal inter-fiber distance in a ply was uniform and equal to 730 μm (for preparing dosage form B) or 2800 μm (for preparing dosage form C). During and after patterning, warm air at a temperature of 60° C. and a velocity of about 2.3 m/s was blown over the fibrous dosage forms for a time, tdry˜40 minutes, to evaporate the solvent and freeze the structure. The process parameters to prepare the dosage forms are summarized in Table 1. After drying, the structure was trimmed to a square disk shaped dosage form of side length, L0˜8 mm. The thickness, H0, of the dosage forms B and C was about 3 mm.

Single fibers B and C were prepared as dosage forms B and C, but without structuring the fibrous extrudate to a dosage form.

TABLE1
Process parameters to prepare the single fibers and fibrous dosage forms.
v'sRnλntdry
solvent(ml/g)(μm)(μm)Rnn(min)
ADMSO0.90130 7300.1835
BDMSO5.50130 7300.1840
Cwater3.3350028000.1840
v's : volume of solvent/ mass of excipient,
Rn: inner radius of needle,
λn: nominal inter-fiber spacing,
td: drying time.
The microstructural parameters of dry dosage forms differ from the nominal parameters because the dosage form shrinks during drying (Table 2, later). In all formulations the drug weight fraction in the drug-excipient mixture was 0.2.

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