FORMULATION STUDIES OF TABLETS CONTAINING ADANSONIA DIGITATA L. MUCILAGE AS MATRIX FORMER
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ABSTRACT
The aim of this study was to investigate the ability of Adansonia digitata mucilage (ADM), a hydrophilic plant polymeric material to prolong the release of Metoprolol tartarate (MPT) from matrix tablet formulations compared with semi -synthetic polymer-HPMC60SH4000 matrices. Phytochemical screening and physicochemical characterization of the extracted ADM was performed using standard and official procedures. Physicochemical tests such as simple (quantitative yield, aqueous solubility and pH tests) and analytical techniques ( viscosity tests by rotational viscometer, elemental analysis by Carbon, Hydrogen, Nitrogen (CHN) method, thermo analysis using Differential Scanning Calorimeter (DSC), functional groups determination via Attenuated Total Reflectance Fourier Infra Red (ATR-FTIR) and structure elucidation by Carbon -13 Nuclear Magnetic Resonance (NMR). Particle characterization via Qicpic and Scanning Electron Microscopy (SEM), moisture content and sorption determination by Karl Fischer and Dynamic vapour sorption (DVS) techniques. Phytochemical screening as well as thermo analysis revealed a level of purity in the extraction process. The mildly acidic mucilage had a low yield (3.5%) and high viscosity that increased with increasing mucilage concentration. Additionally, it was characterized by glass transition and melting temperatures of 74 °C and 173 °C respectively. Finger prints of functional groups revealed azo aromatic groups and other chemical constituents of sugars including glucose, galactose, rhamnose and sugar acids identified by NMR. To assess its ability to cohere powdered drug particles, ADM was used as a binder in concentrations of 0.33 % with addition of surfactant, 0.5 % and 1.0 % w/w in the formulation of immediate release MPT tablets by wet granulation method of tablet manufacture. The granule micrometrics and tablet properties evaluated revealed that 0.5% w/w batch had a better binder ix spread on powdered mix bed that translated into granules with good flow and particle size distribution (PSD) which corroborated well with SEM imaging as well as granule shapes and the corresponding tablets delivered MPT tablets with acceptable strength while DT did not differ significantly when surfactant was added. Furthermore, the matrix forming potential of ADM for prolonged release action was investigated in MPT tablets compressed by direct compression in the ratios of 50/50 and 20/80 of drug polymer concentrations. The in vitro drug release in acid (pH 1.0) and phosphate (pH 6.8) buffers, swelling and liquid uptake studies, drug release kinetics and mechanism were studied while in vivo studies was carried out on 20/80 ADM matrices in dogs and the pharmacokinetic parameters relative to a marketed formulation of same strength; Slow-Lopressor® Divitab 200 mg was obtained. The matrix tablets produced had acceptable tablet quality and the release profiles of the 20/80 matrices displayed a linear and pH independent release while burst effect was only observed in the tablets with low HPMC concentration. The matrix integrity was maintained throughout in vitro dissolution for ADM matrices as a result of better gel strength. The drug release kinetics followed Higuchi model while the mechanism was anomalous Fickian diffusion and super case II transport as a result of the swelling effects of the polymer. Similarity factor (f2) showed that the in vitro release profiles of the 50/50 and 20/80 formulations were similar in both dissolution media used. Besides, statistically, in vitro MPT release from ADM and HPMC60SH4000 (20/80 drug: polymer) and in vivo profiles after oral administration of the test formulations to dogs did not differ significantly from the reference marketed sustained release product (P > 0.05). In conclusion, Adansonia digitata mucilage was found to be an excellent matrix former in prolonged release tablets of MPT that was comparable to semi- synthetic polymer of high viscosity, HPMC60SH4000.
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