BioMed Research International

Modern Approaches to Quality Assurance of Drug Formulations


Publishing date
06 Feb 2015
Status
Published
Submission deadline
19 Sep 2014

1University of Veterinary and Pharmaceutical Sciences Brno, Brno-Královo Pole, Czech Republic

2Callum Consultancy, Devon, USA

3Midwestern University, Downers Grove, USA

4University of Macau, Macau, China


Modern Approaches to Quality Assurance of Drug Formulations

Description

Developments in pharmaceutical sciences have resulted in sophisticated systems to modify drug action by delaying its onset, slow the rate of delivery to reduce side effects, or maintain constant plasma levels to sustain drug action. More novel modes of delivery have also gained prominence. These may provide, for example, transdermal drug delivery and time-based (chronotherapeutic) release or may target specific organs, tissues, or cellular structures as in cancer therapy. Numbers of biopharmaceutical products have also increased greatly in recent times and will probably continue to do so.

Novel systems, therapeutic agents, and evolving paradigms on quality assurance present many challenges. At the same time they afford opportunities for developing and propounding new philosophies and technologies for assuring quality and performance. In particular, they promise reduced emphasis on end product testing if dosage form design and manufacture is appropriate, with testing of input materials and in-process testing/monitoring largely replacing end product testing. The same principles apply to quality assurance of devices used for sophisticated delivery because these too may influence parameters such as amount, rate, and possibly time of drug delivery.

With these considerations in mind we invite authors to submit original research or review articles related to these developments. Articles might concern but need not be restricted to:

  • The active pharmaceutical ingredient
  • Dosage form design
  • The process for product manufacture
  • Assurance of product quality and performance

Topics can include analytical as well as process technologies and how these might complement each other.

Potential topics include, but are not limited to:

  • Development and testing of novel/innovative dosage forms
  • Development and testing of multifunction excipients
  • Preparation, characterization, formulation, and testing of nanoparticles
  • Preparation, characterization, and utilization of pharmaceutical cocrystals and solid dispersions
  • Innovative analytical techniques and their applications in process monitoring, analysis, and control
  • Dynamic dissolution approaches, in vitro-in vivo correlation
  • Quality assurance/control of active pharmaceutical ingredients, excipients, packaging, devices, and finished dosage forms
  • Solid state forms of drugs and excipients: analytical assessment and consequences for process and quality attributes
  • PAT applications in manufacture
  • Regulatory acumen
  • Drug counterfeiting and how to counteract it

Articles

  • Special Issue
  • - Volume 2015
  • - Article ID 126478
  • - Editorial

Modern Approaches to Quality Assurance of Drug Formulations

Josef Jampilek | Patrick J. Crowley | ... | Kin Tam
  • Special Issue
  • - Volume 2015
  • - Article ID 790720
  • - Research Article

Antimicrobial Properties of Microparticles Based on Carmellose Cross-Linked by Cu2+ Ions

Martina Kejdušová | Jakub Vysloužil | ... | Vratislav Košťál
  • Special Issue
  • - Volume 2015
  • - Article ID 892671
  • - Research Article

Formulation of Novel Layered Sodium Carboxymethylcellulose Film Wound Dressings with Ibuprofen for Alleviating Wound Pain

Lenka Vinklárková | Ruta Masteiková | ... | Jurga Bernatonienė
  • Special Issue
  • - Volume 2015
  • - Article ID 328628
  • - Research Article

Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from “Golem”: A Novel Apparatus

Martin Čulen | Paweł K. Tuszyński | ... | Jiří Dohnal
  • Special Issue
  • - Volume 2015
  • - Article ID 670420
  • - Review Article

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

Tzu-Wei Li | Pei-Weng Tu | ... | Shiow-Ing Wu
  • Special Issue
  • - Volume 2015
  • - Article ID 812673
  • - Research Article

Preparation of Silica Nanoparticles Loaded with Nootropics and Their In Vivo Permeation through Blood-Brain Barrier

Josef Jampilek | Kamil Zaruba | ... | Pavel Suchy
  • Special Issue
  • - Volume 2015
  • - Article ID 608435
  • - Research Article

Modern Evaluation of Liquisolid Systems with Varying Amounts of Liquid Phase Prepared Using Two Different Methods

Barbora Vraníková | Jan Gajdziok | David Vetchý
  • Special Issue
  • - Volume 2015
  • - Article ID 109563
  • - Research Article

Preparation and Characterization of Solid Dispersions of Artemether by Freeze-Dried Method

Muhammad Tayyab Ansari | Altaf Hussain | ... | Ghulam Murtaza
  • Special Issue
  • - Volume 2014
  • - Article ID 929248
  • - Research Article

Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

Erika Bojnanska | Michal Kalina | ... | Josef Jampilek
  • Special Issue
  • - Volume 2014
  • - Article ID 179568
  • - Research Article

Evaluation of the Influence of Formulation and Process Variables on Mechanical Properties of Oral Mucoadhesive Films Using Multivariate Data Analysis

Hana Landová | David Vetchý | ... | Zdeněk Knotek
BioMed Research International
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Acceptance rate31%
Submission to final decision67 days
Acceptance to publication30 days
CiteScore3.600
Impact Factor2.276
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