Development and characterization of controlled release bilayered tablets of Citicoline sodium
Objectives: The aim of present investigation was formulation development and evaluation of bi-layer tablets of citicoline sodium. Materials and Methods: An aqueous granulation process was adopted to formulate citicoline sodium (CTS) bilayer tablets. Wet granulation method has been utilized for the formulation of bilayer CTS tablet. Citicoline sodium, microcrystalline cellulose (pH 101 & 102), HPMC K4, K15, K-100, PVP K-30, Magnesium stearate, cross-carmellose sodium, sodium starch glycolate and red oxide were used for preparation. Pre-formulation studies of citicoline sodium and drug excipient compatibility study was carried to optimize the formulation variables. Two layers, immediate release (IR layer) and sustained release (SR) has been developed and evaluated for the various parameters e.g. micromeritic properties, percentage yield, particle size, hardness, thickness, weight variation, percent friability and percent assay, In-vitro dissolution and In-vitro release studies. Result and Discussion: Pre-formulation study of citicoline sodium denotes that evaluated parameters confirm the suitability and compliance of drug with polymers. Drug excipient compatibility study through the DSC confirmed that polymer, excipient and drug were compatible with each other and no incompatibility issue found during the preparation of formulation. FT-IR study is also executed to confirm the drug-excipient incompatibility. In all physical mixtures of drug and polymer, there was neither masking of single characteristic peak nor existence of additional peak in drug spectra; this has proven that drug and polymers are compatible with each other. Hardness 10-11 kg/cm2, thickness 7.3-7.4 mm, percent weight variation 1.2%, friability 0.1-0.3%, assay was 99-101% denotes the successful development of CTS tablets. Conclusion: These all parameters denote that the formulation has optimized, evaluated and were in the standard range. Hence, this optimized bilayer tablet formulation could be a potential formulation to promote sustained release, promote delivery of drugs from a single dosage form to improve patient compliance and give better disease management.
Keywords: Citicoline sodium, bi-layer tablet, DSC, immediate release, sustain release.
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