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Evaluation of Ionotropic Cross-Linked Chitosan/Gelatin B Microspheres of Tramadol Hydrochloride

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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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ACKNOWLEDGEMENTS

The authors are thankful to Sun Pharmaceutical Industries Ltd., Maharashtra, India for gift sample of TM, Central Institute of Fisheries and Technology, Cochin, India for providing gift sample of chitosan, respectively. The authors greatly acknowledge Indian Institute of Science, Bangalore, India for the technical assistance in analytical studies.

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Authors and Affiliations

  1. Department of Pharmaceutical Technology, Division of Pharmaceutics, Jadavpur University, Kolkata, 700 032, India

    Sanat Kumar Basu

  2. Department of Pharmaceutics, Bharathi College of Pharmacy, Bharathi Nagara, Mandya Dist, Karnataka, 571 422, India

    Kunchu Kavitha

  3. Department of Pharmacology, Bharathi College of Pharmacy, Bharathi Nagara, Mandya Dist, Karnataka, 571 422, India

    Mani Rupeshkumar

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  1. Sanat Kumar Basu
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  2. Kunchu Kavitha
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Correspondence to Kunchu Kavitha.

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Basu, S.K., Kavitha, K. & Rupeshkumar, M. Evaluation of Ionotropic Cross-Linked Chitosan/Gelatin B Microspheres of Tramadol Hydrochloride. AAPS PharmSciTech 12, 28–34 (2011). https://doi.org/10.1208/s12249-010-9537-2

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