Development and Evaluation of a Novel Modified-Release Pellet-Based Tablet System for the Delivery of Loratadine and Pseudoephedrine Hydrochloride as Model Drugs |
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Authors: | Farrukh Zeeshan Nadeem Irfan Bukhari |
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Institution: | (1) Department of Pharmaceutical Technology, School of Pharmacy and Allied Health Sciences, International Medical University, Bukit Jalil, 57000 Kuala Lumpur, Malaysia |
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Abstract: | Modified-release multiple-unit tablets of loratadine and pseudoephedrine hydrochloride with different release profiles were
prepared from the immediate-release pellets comprising the above two drugs and prolonged-release pellets containing only pseudoephedrine
hydrochloride. The immediate-release pellets containing pseudoephedrine hydrochloride alone or in combination with loratadine
were prepared using extrusion–spheronization method. The pellets of pseudoephedrine hydrochloride were coated to prolong the
drug release up to 12 h. Both immediate- and prolonged-release pellets were filled into hard gelatin capsule and also compressed
into tablets using inert tabletting granules of microcrystalline cellulose Ceolus KG-801. The in vitro drug dissolution study conducted using high-performance liquid chromatography method showed that both multiple-unit capsules
and multiple-unit tablets released loratadine completely within a time period of 2 h, whereas the immediate-release portion
of pseudoephedrine hydrochloride was liberated completely within the first 10 min of dissolution study. On the other hand,
the release of pseudoephedrine hydrochloride from the prolonged release coated pellets was prolonged up to 12 hr and followed
zero-order release kinetic. The drug dissolution profiles of multiple-unit tablets and multiple-unit capsules were found to
be closely similar, indicating that the integrity of pellets remained unaffected during the compression process. Moreover,
the friability, hardness, and disintegration time of multiple-unit tablets were found to be within BP specifications. In conclusion,
modified-release pellet-based tablet system for the delivery of loratadine and pseudoephedrine hydrochloride was successfully
developed and evaluated. |
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Keywords: | |
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