Extended release promethazine HCl using acrylic polymers by freeze-drying and spray-drying techniques: formulation considerations
DOI:
https://doi.org/10.1590/S1984-82502009000400029Keywords:
Promethazine hydrochloride^i1^sextended rele, Drugs^i1^sextended rele, Eudragit RL100, Eudragit S100, Acrylic polymers, Spray drying^i1^spharmacotechn, Freeze drying^i1^spharmacotechn, Extended realease^i1^spharmacotechn, Pharmaceutical formulations^i1^sevaluatAbstract
The present study investigated a novel extended release system of promethazine hydrochloride (PHC) with acrylic polymers Eudragit RL100 and Eudragit S100 in different weight ratios (1:1 and 1: 5), and in combination (0.5+1.5), using freeze-drying and spray-drying techniques. Solid dispersions were characterized by Fourier-transformed infrared spectroscopy (FT-IR), differential scanning calorimetry (DSC), Powder X-ray diffractometry (PXRD), Nuclear magnetic resonance (NMR), Scanning electron microscopy (SEM), as well as solubility and in vitro dissolution studies in 0.1 N HCl (pH 1.2), double-distilled water and phosphate buffer (pH 7.4). Adsorption tests from drug solution to solid polymers were also performed. A selected solid dispersion system was developed into capsule dosage form and evaluated for in vitro dissolution studies. The progressive disappearance of drug peaks in thermotropic profiles of spray-dried dispersions were related to increasing amount of polymers, while SEM studies suggested homogenous dispersion of drug in polymer. Eudragit RL100 had a greater adsorptive capacity than Eudragit S100, and thus its combination in (0.5+1.5) for S100 and RL 100 exhibited a higher dissolution rate with 97.14% drug release for twelve hours. Among different formulations, capsules prepared by combination of acrylic polymers using spray-drying (1:0.5 + 1.5) displayed extended release of drug for twelve hours with 96.87% release followed by zero order kinetics (r²= 0.9986).Downloads
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Published
2009-12-01
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Original Papers
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How to Cite
Extended release promethazine HCl using acrylic polymers by freeze-drying and spray-drying techniques: formulation considerations . (2009). Brazilian Journal of Pharmaceutical Sciences, 45(4), 829-840. https://doi.org/10.1590/S1984-82502009000400029