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Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with...
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Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines, 2nd Edition

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: 31 May 2026 | Viewed by 879

Special Issue Editors

Dr. Antonio Lopalco

E-Mail Website
Guest Editor
Department of Pharmacy-Pharmaceutical Sciences, University of Bari “Aldo Moro”, 70125 Bari, Italy
Interests: drug delivery systems; stability; preformulation; paediatric formulation
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Nunzio Denora

E-Mail Website
Guest Editor
Department of Pharmacy-Pharmaceutical Sciences, University of Bari “Aldo Moro”, 70125 Bari, Italy
Interests: drug delivery; drug targeting; TSPO; imaging; tumors
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Extemporaneous pharmaceutical formulations refer to customized medications prepared on demand by pharmacists or healthcare professionals to meet specific patient requirements, constituting a personalized medicine. These formulations offer flexibility in terms of dosage, ingredients, and administration routes, and are tailored to individual patient needs. Moreover, advancements in compounding techniques and technology enhance the quality, safety, and consistency of the preparations.

Key factors driving innovation in extemporaneous formulations include advancements in pharmacotherapy, regulatory frameworks accommodating compounding practices, and collaborations between healthcare professionals and pharmaceutical stakeholders. Additionally, patient-centric approaches and personalized medicine trends further promote the adoption of extemporaneous formulations in clinical practice.

Despite the potential benefits, challenges such as standardization, quality control, and scalability need to be addressed to ensure widespread adoption and acceptance. Overall, innovation in pharmaceutical compounding represents a promising avenue for filling the void left by the absence of industrial medicines, particularly in underserved regions, thereby improving access to essential healthcare interventions and promoting better health outcomes for diverse patient populations.

In the realm of pharmaceuticals, the absence of industrially manufactured medicines poses significant challenges, especially in regions with limited access to healthcare infrastructure. However, innovation in pharmaceutical compounding emerges as a promising solution to bridge this gap.

This Special Issue explores the landscape of custom medications as a viable alternative to address the unmet medical needs resulting from the absence of commercial pharmaceuticals.

We welcome original research, reviews, opinion papers, editorials, or short communications on the following topics:

  • Extemporaneous formulations;
  • Off-label use;
  • Orphan drugs;
  • Dosage forms and excipients;
  • Stability and compatibility;
  • Compounding technologies;
  • Compounding legislation and regulation;
  • Quality control.

Dr. Antonio Lopalco
Prof. Dr. Nunzio Denora
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 250 words) can be sent to the Editorial Office for assessment.

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

  • extemporaneous
  • compounding
  • pharmaceutical
  • formulation
  • personalized
  • pharmacy

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Related Special Issue

Published Papers (1 paper)

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24 pages, 662 KB  
Article
Quality-by-Design Compounding of Semisolids Using an Electronic Mortar and Pestle Device for Compounding Pharmacies: Uniformity, Stability, and Cleaning
by Hudson Polonini, Carolina Schettino Kegele, Savvas Koulouridas and Marcone Augusto Leal de Oliveira
Pharmaceutics 2026, 18(2), 205; https://doi.org/10.3390/pharmaceutics18020205 - 4 Feb 2026
Viewed by 330
Abstract
Background/Objectives: Manual preparation of semisolid formulations (creams, ointments, gels) is prone to variability in mixing energy and time, which may compromise uniform API distribution. This study aimed to evaluate an Electronic Mortar and Pestle (EMP; Unguator™) as a standardized compounding tool, with [...] Read more.
Background/Objectives: Manual preparation of semisolid formulations (creams, ointments, gels) is prone to variability in mixing energy and time, which may compromise uniform API distribution. This study aimed to evaluate an Electronic Mortar and Pestle (EMP; Unguator™) as a standardized compounding tool, with objectives to: (i) validate stability-indicating UHPLC methods; (ii) assess content uniformity across jar strata; (iii) quantify the impact of mixing time and rotation speed via design of experiments (DOE); and (iv) verify cleaning effectiveness and cross-contamination risk. Methods: Five representative formulations were compounded: urea 40%, clobetasol 0.05%, diclofenac 2.5% in hyaluronic acid 3% gel, urea 10% + salicylic acid 1%, and hydroquinone 5%. UHPLC methods were validated per ICH Q2(R2) and stress-tested under acid, base, oxidative, thermal, and UV conditions. Homogeneity was assessed by stratified sampling (top/middle/bottom). A 32 factorial DOE (time: 2/6/10 min; speed: 600/1500/2400 rpm) modeled effects on % label claim and RSD. Cleaning validation employed hydroquinone as a tracer, with swab sampling pre-/post-use and post-sanitization analyzed by HPLC. Results: All UHPLC methods met specificity, linearity, precision, accuracy, and sensitivity criteria and were stability-indicating (Rs ≥ 1.5). Formulations achieved 90–110% label claim with strata CV ≤ 5%. DOE revealed speed as the dominant factor for clobetasol, urea, and diclofenac, while time was more influential for salicylic acid; gels exhibited curvature, indicating diminishing returns at high rpm. Model-predicted optima were implementable on the Unguator™ with minor rounding of rpm/time. Cleaning validation confirmed post-sanitization residues below LOQ and <10 ppm acceptance. Conclusions: The Unguator™ provides a practical, parameter-controlled route for compounding pharmacies to standardize semisolid preparations, achieving reproducible layer-to-layer content uniformity within predefined criteria under the evaluated conditions through programmable set-points and validated cycles. DOE-derived rpm–time relationships define an operational design space within the studied ranges and support selection of implementable device settings and set-points. Importantly, the DOE-derived “optima” in this study are optimized for assay-based content uniformity (mean % label claim and strata variability). Cleaning validation supports a closed, low-cross-contamination workflow, facilitating consistent routines for both routine and complex formulations. Overall, the work implements selected QbD elements (QTPP—Quality Target Product Profile; CQA—Critical Quality Attribute definition; CPP—Critical Process Parameter identification; operational design space; and a proposed control strategy) and should be viewed as a step toward broader lifecycle QbD implementation in compounding. Full article
(This article belongs to the Special Issue Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines, 2nd Edition)
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