Development, Evaluation And Application Of Co-Processed Adjuvant Containing Inulin, Mannitol And Polyvinylpyrrolidone

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Date
2019-02
Authors
Emily Wong, Yii Ling
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Publisher
Universiti Sains Malaysia
Abstract
Inulin has wide application in food, beverage and pharmaceutical industries. In view of the advantages of inulin as prebiotic, having low calory with no effect on blood sugar level, it was explored as parent excipient in preparation of co-processed adjuvant. Inulin was co-processed with either lactose monohydrate or mannitol. Good flowability was obtained with mannitol, which was attributed to enhanced granule growth. Increase in the amount of inulin increased the hygroscopicity of co-processed adjuvant. The low dilution potential and moderate lubricant sensitivity of the co-processed inulin-mannitol led to the incorporation of a ternary component, PVP K-30. The effect of PVP K-30 at different concentration in three granulating fluids, water, ethanol and isopropranol, towards the physical properties of co-processed granules were investigated. The dilution potential and lubricant sensitivity were significantly improved after the incorporation of PVP K-30 dissolving in ethanol. The inulin-mannitol-PVP co-processed adjuvant Mannulin PV was applied in the development of two solid oral dosage forms, chewable tablet and conventional immediate release tablet. Montelukast chewable tablet was prepared through direct compression method. A stability-indicating HPLC-UV method was developed and validated for the quantification of montelukast in chewable tablet. There was no incompatibility between Mannulin PV and other components in the chewable tablet formulation. The optimized formulation F7 was stable up to 6 months when kept under accelerated (40 °C/75 %RH) and real time (30 °C/75 %RH) conditions.
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Keywords
Adjuvant , Polyvinylpyrrolidone
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