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Pharmaceutics
Special Issues
Quality by Design in Pharmaceutical Manufacturing
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Quality by Design in Pharmaceutical Manufacturing

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: 31 October 2025 | Viewed by 721

Special Issue Editors

Dr. Livia Deris Prado

E-Mail Website
Guest Editor
Technological Development Coordination, Instituto de Tecnologia em Fármacos (Farmanguinhos)/Fiocruz, Av. Cmte. Guaranys, 447-Jacarepaguá, Rio de Janeiro 22775-903, Brazil
Interests: formulation; pharmaceutical analysis; drug development; pharmaceutical engineering; solid state characterization
Dr. Yousuf Mohammed

E-Mail Website
Guest Editor
1. Frazer Institute, Faculty of Medicine, The University of Queensland, Brisbane, QLD 4102, Australia
2. School of Pharmacy, The University of Queensland, Brisbane, QLD 4102, Australia
Interests: topical and transdermal drug delivery; penetration enhancement; nanotechnology; skin permeation mechanisms
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Ensuring quality in pharmaceutical manufacturing is essential to producing drug products that meet safety and efficacy standards. The concept of Quality by Design (QbD) offers a comprehensive and systematic approach, integrating quality into every stage of product development and manufacturing from the outset, rather than relying solely on end-product testing. By emphasizing a deeper understanding of the process and identifying critical quality attributes early, QbD enables the control of key variables, ensuring product consistency while minimizing risks to both patients and manufacturers.

As an integrated approach, QbD incorporates analytical tools to design, analyze, and control manufacturing processes throughout the product lifecycle, along with modern methodologies such as modeling and simulation to gain a deeper understanding of the clinical impact of product and process variables.

This Special Issue focuses on exploring the practical application of QbD principles in pharmaceutical manufacturing, highlighting the latest developments and trends in the field. We invite contributions from researchers and industry experts on the implementation of QbD in manufacturing processes, with particular emphasis on studies that demonstrate how QbD enhances process robustness, optimizes product quality, and accelerates the development of new therapeutic solutions. By bridging the gap between scientific research and practical application, this issue aims to showcase how QbD can drive more efficient, sustainable, and patient-centered drug development.

Dr. Livia Deris Prado
Dr. Yousuf Mohammed
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
  • critical quality attributes
  • pharmaceutical technology
  • drug product process development
  • process analytical technologies
  • patient-centric approaches
  • process validation
  • ongoing procedure performance verification
  • analytical quality by design
  • continuous manufacturing
  • design of experiments
  • clinically relevant specification
  • risk assessment

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Published Papers (1 paper)

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Research

23 pages, 3243 KB  
Article
Design of Experiments Leads to Scalable Analgesic Near-Infrared Fluorescent Coconut Nanoemulsions
by Amit Chandra Das, Gayathri Aparnasai Reddy, Shekh Md. Newaj, Smith Patel, Riddhi Vichare, Lu Liu and Jelena M. Janjic
Pharmaceutics 2025, 17(8), 1010; https://doi.org/10.3390/pharmaceutics17081010 - 1 Aug 2025
Viewed by 538
Abstract
Background: Pain is a complex phenomenon characterized by unpleasant experiences with profound heterogeneity influenced by biological, psychological, and social factors. According to the National Health Interview Survey, 50.2 million U.S. adults (20.5%) experience pain on most days, with the annual cost of prescription [...] Read more.
Background: Pain is a complex phenomenon characterized by unpleasant experiences with profound heterogeneity influenced by biological, psychological, and social factors. According to the National Health Interview Survey, 50.2 million U.S. adults (20.5%) experience pain on most days, with the annual cost of prescription medication for pain reaching approximately USD 17.8 billion. Theranostic pain nanomedicine therefore emerges as an attractive analgesic strategy with the potential for increased efficacy, reduced side-effects, and treatment personalization. Theranostic nanomedicine combines drug delivery and diagnostic features, allowing for real-time monitoring of analgesic efficacy in vivo using molecular imaging. However, clinical translation of these nanomedicines are challenging due to complex manufacturing methodologies, lack of standardized quality control, and potentially high costs. Quality by Design (QbD) can navigate these challenges and lead to the development of an optimal pain nanomedicine. Our lab previously reported a macrophage-targeted perfluorocarbon nanoemulsion (PFC NE) that demonstrated analgesic efficacy across multiple rodent pain models in both sexes. Here, we report PFC-free, biphasic nanoemulsions formulated with a biocompatible and non-immunogenic plant-based coconut oil loaded with a COX-2 inhibitor and a clinical-grade, indocyanine green (ICG) near-infrared fluorescent (NIRF) dye for parenteral theranostic analgesic nanomedicine. Methods: Critical process parameters and material attributes were identified through the FMECA (Failure, Modes, Effects, and Criticality Analysis) method and optimized using a 3 × 2 full-factorial design of experiments. We investigated the impact of the oil-to-surfactant ratio (w/w) with three different surfactant systems on the colloidal properties of NE. Small-scale (100 mL) batches were manufactured using sonication and microfluidization, and the final formulation was scaled up to 500 mL with microfluidization. The colloidal stability of NE was assessed using dynamic light scattering (DLS) and drug quantification was conducted through reverse-phase HPLC. An in vitro drug release study was conducted using the dialysis bag method, accompanied by HPLC quantification. The formulation was further evaluated for cell viability, cellular uptake, and COX-2 inhibition in the RAW 264.7 macrophage cell line. Results: Nanoemulsion droplet size increased with a higher oil-to-surfactant ratio (w/w) but was no significant impact by the type of surfactant system used. Thermal cycling and serum stability studies confirmed NE colloidal stability upon exposure to high and low temperatures and biological fluids. We also demonstrated the necessity of a solubilizer for long-term fluorescence stability of ICG. The nanoemulsion showed no cellular toxicity and effectively inhibited PGE2 in activated macrophages. Conclusions: To our knowledge, this is the first instance of a celecoxib-loaded theranostic platform developed using a plant-derived hydrocarbon oil, applying the QbD approach that demonstrated COX-2 inhibition. Full article
(This article belongs to the Special Issue Quality by Design in Pharmaceutical Manufacturing)
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