Pharmaceutical formulation
A technology of pharmaceutical activity and medicine, applied in the field of preparation of solid dispersion, can solve the problems of lowering glass transition temperature of amorphous material, crystallization and physical instability, etc.
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Embodiment 1
[0077] Solid dispersions prepared from melt extrudates containing 30% TKA731 and PVPK-30 (ISP Technologies, Wayne, NJ) showed a single glass transition by differential scanning calorimetry, indicating that solid solutions formed by this method were compatible with Dispersions prepared by the solvent method were similar. The extrudate had a glass transition temperature of 137.20°C and an onset temperature of 130.0°C, which was very similar to the dispersion prepared by the solvent method, which had a glass transition temperature of 139.9°C , the initial temperature is 131.9°C.
[0078] The glass transition temperature of PVPK-30 was determined to be 175°C by DSC. Attempts were made to first liquefy PVPK-30 by heating to about 175°C and above, and observation of samples by optical microscopy demonstrated that it did not liquefy even when heated up to 240°C. Additionally, the polymer changed from white to orange / brown, indicating degradation.
[0079] The glass transition temp...
Embodiment 2
[0090] Solid dispersions were prepared from melt extrudates containing 30% TKA731 and PVPK-30 (ISP Technologies, Wayne, NJ), which additionally contained sorbitol at a concentration of 5% or 10% by weight (EM Industries, Darmstadt, Germany ) or without additional sorbitol (control). A single glass transition was shown by differential scanning calorimetry, suggesting that solid solutions formed by this method were similar to dispersions prepared by the solvent method.
[0091] The plasticizing effect of sorbitol (EM Industries, Darmstadt, Germany) on the drug / polymer mixture was shown by no degradation at a processing temperature of 170 °C (see Table 3)
[0092] table 3:
[0093] Amorphous drug
polymer content
Plasticizer Concentration
Processing temperature (℃) 2
X-ray analysis
Drug loading
(PVPK-30)
Tg=175℃
(sorbitol)
20%
70%
10% 1
170
amorphous
no degradati...
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