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Development and evaluation of a novel extended-release formulation of ivabradine hydrochloride
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| Author:
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C.V.N.SATYAJIT , M.E.BHANOJI RAO
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| Abstract:
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Ivabradine hydrochloride (IBH) is the first of a new class of antianginal drug treatments. It is licensed for the treatment of patients with chronic stable angina who are in sinus rhythm, and for whom beta-blockers are either contraindicated or poorly tolerated. IBH is a second-line antianginal agent and as an alternative to the rate-slowing calcium-channel blockers. Currently, conventional immediate release tablet dosage form is approved. The main objective of the present work was to develop sustained release matrix tablets of water soluble IBH using combination of two polymers viz. Hydroxypropylmethyl cellulose K 100M (HPMC) and Sodium alginate (SA). The sustained release tablets were prepared by wet granulation method. The selected batches (F1 to F6) were prepared using different ratios of SA: HPMC in order to design ideal formulae for once a day dosage regimen for the management of angina pectoris with better patient compliance. The compressed tablets were evaluated and showed compliance with standard limits. Based on the experimental results, the F6 was considered as an ideal formulation and the release mechanism was monitored with application of mathematical models. From all the evaluation studies, the release of IBH from its dosage from (F6) was sustained and thereby expected to provide patient compliance with reduced frequency of administration and side effects by avoiding the sudden burst release. These in vitro results highlight the potential of IBH sustained release formulation in the treatment of angina pectoris after performing in vivo studies.
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| Keyword:
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Ivabradine hydrochloride, sustained release, sodium alginate, HPMC
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP2. 485
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| Download:
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