Literature DB >> 25685037

Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients.

Abubaker Abdellah1, Mohamed Ibrahim Noordin1, Wan Azman Wan Ismail1.   

Abstract

Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products' quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines' supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients' safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized.

Entities:  

Keywords:  Excipient’s Safety; Excipient’s evaluation; Globalization; Good manufacturing practice; Importance of pharmaceutical excipients

Year:  2013        PMID： 25685037      PMCID： PMC4310996          DOI： 10.1016/j.jsps.2013.06.003

Source DB:  PubMed          Journal:  Saudi Pharm J        ISSN： 1319-0164            Impact factor:   4.330


  20 in total

1.  Drug-excipient interactions and their affect on absorption.

Authors: 
Journal:  Pharm Sci Technolo Today       Date:  2000-10-01

Review 2.  Excipient-drug interactions in parenteral formulations.

Authors:  Michael J Akers
Journal:  J Pharm Sci       Date:  2002-11       Impact factor: 3.534

Review 3.  Solubilizing excipients in oral and injectable formulations.

Authors:  Robert G Strickley
Journal:  Pharm Res       Date:  2004-02       Impact factor: 4.200

Review 4.  The effect of globalization of drug manufacturing, production, and sourcing and challenges for American drug safety.

Authors:  J Woo; S Wolfgang; H Batista
Journal:  Clin Pharmacol Ther       Date:  2008-02-06       Impact factor: 6.875

5.  A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia.

Authors:  Gin Nie Chua; Mohamed Azmi Hassali; Asrul Akmal Shafie; Ahmed Awaisu
Journal:  Health Policy       Date:  2009-12-30       Impact factor: 2.980

6.  Evaluation of hydroperoxides in common pharmaceutical excipients.

Authors:  Walter R Wasylaschuk; Paul A Harmon; Gabriella Wagner; Amy B Harman; Allen C Templeton; Hui Xu; Robert A Reed
Journal:  J Pharm Sci       Date:  2007-01       Impact factor: 3.534

7.  A new tablet disintegrating agent: cross-linked polyvinylpyrrolidone.

Authors:  S S Kornblum; S B Stoopak
Journal:  J Pharm Sci       Date:  1973-01       Impact factor: 3.534

Review 8.  The safety of pharmaceutical excipients.

Authors:  Giorgio Pifferi; Patrizia Restani
Journal:  Farmaco       Date:  2003-08

Review 9.  Pharmaceutical excipients. Adverse effects associated with inactive ingredients in drug products (Part I).

Authors:  L K Golightly; S S Smolinske; M L Bennett; E W Sutherland; B H Rumack
Journal:  Med Toxicol Adverse Drug Exp       Date:  1988 Mar-Apr

10.  Impact of excipients on the absorption of P-glycoprotein substrates in vitro and in vivo.

Authors:  Gilles Cornaire; John Woodley; Philippe Hermann; Alix Cloarec; Cécile Arellano; Georges Houin
Journal:  Int J Pharm       Date:  2004-06-18       Impact factor: 5.875
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  3 in total

1.  Survey to Identify Substandard and Falsified Tablets in Several Asian Countries with Pharmacopeial Quality Control Tests and Principal Component Analysis of Handheld Raman Spectroscopy.

Authors:  Tomoko Kakio; Hitomi Nagase; Takashi Takaoka; Naoko Yoshida; Junichi Hirakawa; Susan Macha; Takashi Hiroshima; Yukihiro Ikeda; Hirohito Tsuboi; Kazuko Kimura
Journal:  Am J Trop Med Hyg       Date:  2018-03-29       Impact factor: 2.345

Review 2.  The pulmonary route as a way to drug repositioning in COVID-19 therapy.

Authors:  Michelle Alvares Sarcinelli; Thalita Martins da Silva; Andressa Daniele Artico Silva; Beatriz Ferreira de Carvalho Patricio; Flávia Costa Mendes de Paiva; Raissa Santos de Lima; Manuela Leal da Silva; Helvécio Vinícius Antunes Rocha
Journal:  J Drug Deliv Sci Technol       Date:  2021-02-24       Impact factor: 5.062

3.  The Biological Fate of Pharmaceutical Excipient β-Cyclodextrin: Pharmacokinetics, Tissue Distribution, Excretion, and Metabolism of β-Cyclodextrin in Rats.

Authors:  Kunqian Mu; Kaiwen Jiang; Yue Wang; Zihan Zhao; Song Cang; Kaishun Bi; Qing Li; Ran Liu
Journal:  Molecules       Date:  2022-02-08       Impact factor: 4.411
  3 in total

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