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Sci. Pharm. 2010; 78: 79–92

Evaluation of Ketorolac Tromethamine Microspheres by Chitosan/Gelatin B Complex Coacervation

Sanat Kumar BASU 1, Kunchu KAVITHA * 2, Mani RUPESHKUMAR 3

1 Division of Pharmaceutics, Department of Pharmaceutical Technology, 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.

* Corresponding author. E-Mail: kaviyaju@yahoo.co.in (K. Kavitha)

Abstract

Microspheres (MS) of Ketorolac Tromethamine (KT) for oral delivery were prepared by complex coacervation (method-1) and simple coacervation (method-2) methods without the use of chemical cross–linking agent (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 (Na-TPP) as cross linking agent. Chitosan and gelatin B were used as polymer and copolymer respectively. All the prepared microspheres were subjected to various physico-chemical studies, such as drug-polymer compatibility by Thin Layer Chromatography (TLC) and Fourier Transform Infra Red Spectroscopy (FTIR), surface morphology by Scanning Electron Microscopy (SEM), frequency distribution, encapsulation 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 powder Diffractometry (XRD). TLC and FTIR studies indicated no drug-polymer incompatibility. All the MS showed release of drug by a fickian diffusion mechanism. DSC and XRD analysis indicated that the KT trapped in the microspheres existed in an amorphous or disordered-crystalline status in the polymer matrix. It is possible to design a controlled drug delivery system for the prolonged release of KT, improving therapy by possible reduction of time intervals between administrations.

Keywords

Ketorolac tromethamine • Chitosan • Gelatin B • Complex coacervation • Microspheres

Received March 28th, 2009 | Accepted December 17th, 2009 | Published Online December 19th, 2009

doi:10.3797/scipharm.0903-16