Evaluation of Ionotropic Cross-Linked Chitosan/Gelatin B Microspheres of Tramadol Hydrochloride |
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Authors: | Sanat Kumar Basu Kunchu Kavitha Mani Rupeshkumar |
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Institution: | (1) Department of Pharmaceutical Technology, Division of Pharmaceutics, Jadavpur University, Kolkata, 700 032, India;(2) Department of Pharmaceutics, Bharathi College of Pharmacy, Bharathi Nagara, Mandya Dist, Karnataka, 571 422, India;(3) Department of Pharmacology, Bharathi College of Pharmacy, Bharathi Nagara, Mandya Dist, Karnataka, 571 422, India; |
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Abstract: | Microspheres of tramadol hydrochloride (TM) for oral delivery were prepared by complex coacervation method without the use
of chemical cross-linking agents such as glutaraldehyde to avoid the toxic reactions and other undesirable effects of the
chemical cross-linking agents. Alternatively, ionotropic gelation was employed by using sodium-tripolyphosphate as cross-linking
agent. Chitosan and gelatin B were used as polymer and copolymer, respectively. All the prepared microspheres were subjected
to various physicochemical studies, such as drug–polymer compatibility by thin layer chromatography (TLC) and Fourier transform
infrared (FTIR) spectroscopy, surface morphology by scanning electron microscopy, frequency distribution, drug entrapment
efficiency, in vitro drug release characteristics and release kinetics. The physical state of drug in the microspheres was determined by differential
scanning calorimetry (DSC) and X-ray diffractometry (XRD). TLC and FTIR studies indicated no drug–polymer incompatibility.
All the microspheres showed initial burst release followed by a fickian diffusion mechanism. DSC and XRD analysis indicated
that the TM trapped in the microspheres existed in an amorphous or disordered-crystalline status in the polymer matrix. From
the preliminary trials, it was observed that it may be possible to formulate TM microspheres by using biodegradable natural
polymers such as chitosan and gelatin B to overcome the drawbacks of TM and to increase the patient compliance. |
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Keywords: | |
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