Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form.

Gliclazide (1-(3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrol-2-yl)-3-(4-methylphenyl)sulfonylurea) is a second-generation sulfonylurea which is orally administered in the treatment of non-insulin-dependent diabetes mellitus in adults. Sustain release drugs help to improve drugs bioavailability by c...

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Main Authors: Mohd Nawi, Mohamed Sufian, Abul Bashar Mohammed, Helaluddin, Kasmuri, Abdul Razak, Tan, Soo Choon
Format: Monograph
Language:English
Published: 2018
Subjects:
Online Access:http://irep.iium.edu.my/63437/
http://irep.iium.edu.my/63437/1/Research%20Completion%20Report%20RIGS%2015-090-0090_SUFIAN.pdf
id iium-63437
recordtype eprints
spelling iium-634372018-05-05T16:31:14Z http://irep.iium.edu.my/63437/ Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form. Mohd Nawi, Mohamed Sufian Abul Bashar Mohammed, Helaluddin Kasmuri, Abdul Razak Tan, Soo Choon RS192 Materia Medica-Pharmaceutical Technology RS403 Materia Medica-Pharmaceutical Chemistry Gliclazide (1-(3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrol-2-yl)-3-(4-methylphenyl)sulfonylurea) is a second-generation sulfonylurea which is orally administered in the treatment of non-insulin-dependent diabetes mellitus in adults. Sustain release drugs help to improve drugs bioavailability by controlling the time of drug release or prolonging it. We are reporting the formulations of 60 mg sustain release gliclazide tablets with careful choice of all the ingredients and processes related to syariah compliance manufacturing of pharmaceutical products. In this work, different ratios of xanthan gum, a natural gum and hydroxypropyl methylcellulose (HPMC) had been used as the release retardants to achieve the sustain release criteria. The tablets were produced by wet granulation and semi-automatic tableting process. All the formulations were evaluated for the thickness, hardness, friability, weight variation, content of active ingredient, and in vitro dissolution profile following the British Pharmacopoeia (BP) criteria. Tablet assay of active pharmaceutical ingredient (High Performance Liquid Chromatography [HPLC] method) was adopted from British Pharmacopoeia (BP) with some modification. The HPLC method validation covered the specificity, linearity, range, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ). We expect that the outcome of our study could be useful for the formulation of such product that will be helpful for the Muslim patient especially during the fasting month. 2018 Monograph NonPeerReviewed application/pdf en http://irep.iium.edu.my/63437/1/Research%20Completion%20Report%20RIGS%2015-090-0090_SUFIAN.pdf Mohd Nawi, Mohamed Sufian and Abul Bashar Mohammed, Helaluddin and Kasmuri, Abdul Razak and Tan, Soo Choon (2018) Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form. Project Report. UNSPECIFIED. (Unpublished)
repository_type Digital Repository
institution_category Local University
institution International Islamic University Malaysia
building IIUM Repository
collection Online Access
language English
topic RS192 Materia Medica-Pharmaceutical Technology
RS403 Materia Medica-Pharmaceutical Chemistry
spellingShingle RS192 Materia Medica-Pharmaceutical Technology
RS403 Materia Medica-Pharmaceutical Chemistry
Mohd Nawi, Mohamed Sufian
Abul Bashar Mohammed, Helaluddin
Kasmuri, Abdul Razak
Tan, Soo Choon
Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form.
description Gliclazide (1-(3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrol-2-yl)-3-(4-methylphenyl)sulfonylurea) is a second-generation sulfonylurea which is orally administered in the treatment of non-insulin-dependent diabetes mellitus in adults. Sustain release drugs help to improve drugs bioavailability by controlling the time of drug release or prolonging it. We are reporting the formulations of 60 mg sustain release gliclazide tablets with careful choice of all the ingredients and processes related to syariah compliance manufacturing of pharmaceutical products. In this work, different ratios of xanthan gum, a natural gum and hydroxypropyl methylcellulose (HPMC) had been used as the release retardants to achieve the sustain release criteria. The tablets were produced by wet granulation and semi-automatic tableting process. All the formulations were evaluated for the thickness, hardness, friability, weight variation, content of active ingredient, and in vitro dissolution profile following the British Pharmacopoeia (BP) criteria. Tablet assay of active pharmaceutical ingredient (High Performance Liquid Chromatography [HPLC] method) was adopted from British Pharmacopoeia (BP) with some modification. The HPLC method validation covered the specificity, linearity, range, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ). We expect that the outcome of our study could be useful for the formulation of such product that will be helpful for the Muslim patient especially during the fasting month.
format Monograph
author Mohd Nawi, Mohamed Sufian
Abul Bashar Mohammed, Helaluddin
Kasmuri, Abdul Razak
Tan, Soo Choon
author_facet Mohd Nawi, Mohamed Sufian
Abul Bashar Mohammed, Helaluddin
Kasmuri, Abdul Razak
Tan, Soo Choon
author_sort Mohd Nawi, Mohamed Sufian
title Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form.
title_short Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form.
title_full Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form.
title_fullStr Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form.
title_full_unstemmed Addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form.
title_sort addressing formulation issues of syariah compliant generic sustained release antidiabetic solid dosage form.
publishDate 2018
url http://irep.iium.edu.my/63437/
http://irep.iium.edu.my/63437/1/Research%20Completion%20Report%20RIGS%2015-090-0090_SUFIAN.pdf
first_indexed 2023-09-18T21:29:58Z
last_indexed 2023-09-18T21:29:58Z
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