INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
Preformulation studies indicated that the drug had passable flow property and good compressibility. From the drug-excipient interaction study it was observed that there was no significant physical change in the drug when mixed with excipients and kept under stressed conditions for one month. Absence of interaction between the drug and the excipients was confirmed by FTIR graph of pure drug and with various excipients.
Based on the innovator’s product the target in vitro release profile was set to 10-20% at 1 hr, 20-30% at 2 hr, 40-55% at 6 hr, 60-80% at 12 hr, 80-90% at 18 hr, and NLT 85% at 20 hr.
The matrix tablets were formulated by wet granulation technique using hydrophilic, hydrophobic and waxy polymers in various combinations. Initial trials indicated that the combination of EC & HPMC K100M based granules were not helpful in successfully retarding the release. Further addition of HCO both intra granularly and extra granularly helped in retarding the drug release. However, a combination of all these polymers was required to obtain the target release profile.
The granules were evaluated for bulk density, tapped density, carr’s index, hausner’s ratio and angle of repose. The prepared tablets were evaluated for thickness, hardness, percentage friability and drug content. All the results obtained were found to be satisfactory.
The final formulation having 5.8% HCO, 2.1% EC and 34.2% HPMC K100M was found to be successful in prolonging the drug release over a period of 20 hrs. The drug release was found to be by anomalous diffusion.
The prepared tablets were found to be stable at accelerated stability conditions. The prepared matrix tablets of Alfuzosin HCl would be thus helpful in reducing the dosing frequency. The method is also adoptable for large scale production.
Keywords:
extended release, matrix drug delivery, excipients, preformulation studies, alfuzosin HCl.
Cite Article:
"FORMULATION AND EVALUATION OF EXTENDED RELEASE ALFUZOSIN HYDROCHLORIDE TABLETS", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.7, Issue 10, page no.378-391, October-2022, Available :http://www.ijnrd.org/papers/IJNRD2210045.pdf
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ISSN:
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
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