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Abstract

CONTROLLED RELEASE MICROSPHERES OF AMBROXOL HYDROCHLORIDE: EFFECTS OF FORMULATION PARAMETERS

Nayana S. Baste, Dilip V. Derle, Charulata T. Nemade, Vandana R. Daga

ABSTRACT

The present work was undertaken to examine the potential for the controlled release of ambroxol hydrochloride by forming microspheres. The effect of formulation variables such as polymer concentration and variation of dispersing agent on microsphere properties such as average particle size, encapsulation efficiency and drug release from the microspheres were studied. Microspheres were prepared by solvent evaporation technique using ethyl cellulose as a matrix-forming agent. Morphological and physicochemical properties of microspheres were investigated by scanning electron microscopy, X-ray diffractometry, differential scanning calorimetry, and Fourier transform infrared spectroscopy. SEM revealed that microspheres were spherical, discrete having smooth and non-porous structure. Encapsulation efficiency of microspheres was found to be 81-94% and drug release was extended up to 12 h. The infrared spectra and differential scanning calorimetry thermographs showed stable character of ambroxol hydrochloride in the drug-loaded microspheres and revealed the absence of any drug-polymer interactions. X-ray diffraction patterns showed that there was decrease in crystallinity of the drug. The best-fit release kinetics was achieved with zero order kinetics and drug release was found to be diffusion controlled. Encapsulation efficiency and drug release was affected by both, concentration of polymer and presence of aluminium tristearate. Particle size was affected by polymer concentration not aluminium tristearate.

Keywords: Ambroxol hydrochloride, Ethyl cellulose, Solvent evaporation method.


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