Quality by Design Approach in Formulation Development
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".
Deadline for manuscript submissions: 30 April 2026 | Viewed by 2
Special Issue Editors
Interests: pharmaceutical development; preclinical evaluation; nanotechnology; liposomes; polymeric nanoparticles; RNA delivery; smart drug delivery systems; 3D printing; quality by design in formulation and process development
Interests: pharmaceutical development; innovative dosage forms; 3D printing in pharmaceutics; quality by design (QbD); process analytical technology (PAT); multivariate data analysis (MVDA); pharmaceutical product/process optimization
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
The integration of Quality by Design (QbD) principles into formulation development of drug products over the past two decades marked a paradigm shift from the empirical approach, relying on end-product testing, to a systematic, proactive strategy, aimed at building quality into products, based on science and risk assessment strategies. This approach enables product and process understanding and regulatory compliance, and helps achieve the goal of formulation development, which is to obtain safe and effective products that consistently meet the highest quality standards throughout their lifecycle.
During its implementation in pharmaceutical research and practice, QbD has evolved from the regulatory initiative of the International Council for Harmonisation (ICH) and the US Food and Drug Administration (USFDA) in the early 2000s, to a multidisciplinary strategy integrating advanced and diverse tools and methodologies, encompassing risk assessment, design of experiments, process analytical technology, multivariate data analysis, digital tools.
This Special Issue, “Quality by Design Approach in Formulation Development”, aims to highlight the practical applications of QbD principles in the design and optimization of pharmaceutical formulations, with a focus on the cutting-edge applications and trends in this field. We invite contributors from both academia and industry to showcase their innovative contributions to QbD implementation in pharmaceutical formulation and manufacturing process development, with a particular interest in the development of complex, innovative formulations such as biological drug products, nanotechnology-based products, smart drug delivery systems, and non-viral vectors for nucleic acid delivery. We also encourage contributions that go beyond the usual DoE-based strategies, using digital tools, machine learning, and artificial intelligence.
Dr. Alina Porfire
Prof. Dr. Ioan Tomuta
Guest Editors
Manuscript Submission Information
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.
Keywords
- quality by design
- risk analysis
- design of experiments
- multivariate data analysis
- process analytical technology
- innovative formulations
- digital tools
- AI in pharmaceutical development
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