Development of Sustained Release Pellets of Galantamine HBr by Extrusion Spheronization Technique Incorporating Risk based QbD Approach

[...]its pharmacological activities administered by oral method or injection would be likely to cause some severe adverse effects in the gastrointestinal tract, and some organs or systems outside the central nervous system. [...]a more efficient 2administration route and pharmaceutical preparation t...

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Veröffentlicht in:Research journal of pharmacy and technology 2018-11, Vol.11 (11), p.4899-4910
Hauptverfasser: Rana, Hardik B., Gohel, Mukesh C., Dholakia, Mansi S., Gandhi, Tejal R., Omri, Abdelwahab, Thakkar, Vaishali T.
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Sprache:eng
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Zusammenfassung:[...]its pharmacological activities administered by oral method or injection would be likely to cause some severe adverse effects in the gastrointestinal tract, and some organs or systems outside the central nervous system. [...]a more efficient 2administration route and pharmaceutical preparation to enhance delivery ability are urgently needed6,7. [...]order polynomial model: y= b0 + bÄ + b2X2 + b3X1 X2+ b4X1X3 + bsX2X3 + be X12 + b7 X22 + b8 X32 Where, y is the measured response, b0 is an intercept and bi-bs are the regression coefficients, Xi, X2 represents the main effect, Xi2, X22 the quadratic effect, and X1X2, X2X3 and X1X3 are the interaction effect. [...]the pellets were passed through a 16-22 mesh and then stored in sealed glass bottles. [...]it was not further investigated and marked as low risk in risk control strategy.
ISSN:0974-3618
0974-360X
0974-306X
DOI:10.5958/0974-360X.2018.00892.2