Application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of Ambroxol

An oral controlled release (CR) matrix system of Ambroxol hydrochloride was developed using a binary hydrophilic polymer mixture of chitosan (CH) and xanthan gum (XG) (1:1 w/w ratio). Two test tablet formulations were prepared using drug to polymer mixture ratios (D:P) of 1:1 and 1:3 (w/w), designat...

Full description

Bibliographic Details
Main Authors: Mayyas Al Remawi, Faisal Al-Akayleh, Mutaz S. Salem, Munther Al Shami, Adnan Badwan
Format: Article
Language:English
Published: International Pharmaceutical Excipients Council 2016-11-01
Series:Journal of Excipients and Food Chemicals
Online Access:https://jefc.scholasticahq.com/article/1087-application-of-an-excipient-made-from-chitosan-and-xanthan-gum-as-a-single-component-for-the-controlled-release-of-ambroxol
_version_ 1797254415375138816
author Mayyas Al Remawi
Faisal Al-Akayleh
Mutaz S. Salem
Munther Al Shami
Adnan Badwan
author_facet Mayyas Al Remawi
Faisal Al-Akayleh
Mutaz S. Salem
Munther Al Shami
Adnan Badwan
author_sort Mayyas Al Remawi
collection DOAJ
description An oral controlled release (CR) matrix system of Ambroxol hydrochloride was developed using a binary hydrophilic polymer mixture of chitosan (CH) and xanthan gum (XG) (1:1 w/w ratio). Two test tablet formulations were prepared using drug to polymer mixture ratios (D:P) of 1:1 and 1:3 (w/w), designated as T1 and T2, respectively. The in vitro drug release data was best fitted to the Higuchi equation. The 1:1 ratio (T1) demonstrated in vitro dissolution similarity with the commercial product, Mucosolvan LA. A preliminary in vivo study was performed using six volunteers. The study was designed to include open, randomized, singledose, three-treatment, six-sequence, crossover (Williams design) under fasting conditions. The data showed that T1 was bioequivalent to Mucosolvan LA ® after the administration of a single 75mg oral dose. Two in vivo, in vitro correlations (IVIVC) were established between Cmax versus the fraction of drug dissolved (FRD) after 4 hours, and AUC versus the ratio of fraction of drug dissolved (FRD) after 10 hours where a multiple point level C correlation of IVIVC was obtained.
first_indexed 2024-04-24T21:49:35Z
format Article
id doaj.art-fef85a9611734793b527835f7e512887
institution Directory Open Access Journal
issn 2150-2668
language English
last_indexed 2024-04-24T21:49:35Z
publishDate 2016-11-01
publisher International Pharmaceutical Excipients Council
record_format Article
series Journal of Excipients and Food Chemicals
spelling doaj.art-fef85a9611734793b527835f7e5128872024-03-20T18:01:25ZengInternational Pharmaceutical Excipients CouncilJournal of Excipients and Food Chemicals2150-26682016-11-0142Application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of AmbroxolMayyas Al RemawiFaisal Al-AkaylehMutaz S. SalemMunther Al ShamiAdnan BadwanAn oral controlled release (CR) matrix system of Ambroxol hydrochloride was developed using a binary hydrophilic polymer mixture of chitosan (CH) and xanthan gum (XG) (1:1 w/w ratio). Two test tablet formulations were prepared using drug to polymer mixture ratios (D:P) of 1:1 and 1:3 (w/w), designated as T1 and T2, respectively. The in vitro drug release data was best fitted to the Higuchi equation. The 1:1 ratio (T1) demonstrated in vitro dissolution similarity with the commercial product, Mucosolvan LA. A preliminary in vivo study was performed using six volunteers. The study was designed to include open, randomized, singledose, three-treatment, six-sequence, crossover (Williams design) under fasting conditions. The data showed that T1 was bioequivalent to Mucosolvan LA ® after the administration of a single 75mg oral dose. Two in vivo, in vitro correlations (IVIVC) were established between Cmax versus the fraction of drug dissolved (FRD) after 4 hours, and AUC versus the ratio of fraction of drug dissolved (FRD) after 10 hours where a multiple point level C correlation of IVIVC was obtained.https://jefc.scholasticahq.com/article/1087-application-of-an-excipient-made-from-chitosan-and-xanthan-gum-as-a-single-component-for-the-controlled-release-of-ambroxol
spellingShingle Mayyas Al Remawi
Faisal Al-Akayleh
Mutaz S. Salem
Munther Al Shami
Adnan Badwan
Application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of Ambroxol
Journal of Excipients and Food Chemicals
title Application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of Ambroxol
title_full Application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of Ambroxol
title_fullStr Application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of Ambroxol
title_full_unstemmed Application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of Ambroxol
title_short Application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of Ambroxol
title_sort application of an excipient made from chitosan and xanthan gum as a single component for the controlled release of ambroxol
url https://jefc.scholasticahq.com/article/1087-application-of-an-excipient-made-from-chitosan-and-xanthan-gum-as-a-single-component-for-the-controlled-release-of-ambroxol
work_keys_str_mv AT mayyasalremawi applicationofanexcipientmadefromchitosanandxanthangumasasinglecomponentforthecontrolledreleaseofambroxol
AT faisalalakayleh applicationofanexcipientmadefromchitosanandxanthangumasasinglecomponentforthecontrolledreleaseofambroxol
AT mutazssalem applicationofanexcipientmadefromchitosanandxanthangumasasinglecomponentforthecontrolledreleaseofambroxol
AT muntheralshami applicationofanexcipientmadefromchitosanandxanthangumasasinglecomponentforthecontrolledreleaseofambroxol
AT adnanbadwan applicationofanexcipientmadefromchitosanandxanthangumasasinglecomponentforthecontrolledreleaseofambroxol