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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

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

Deadline for manuscript submissions: 30 June 2025 | Viewed by 7880

Special Issue Editors

Prof. Dr. Nunzio Denora

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

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.

Prof. Dr. Nunzio Denora
Dr. Antonio Lopalco
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

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

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Published Papers (7 papers)

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Research

14 pages, 3645 KiB  
Article
Toward the Optimal Choice of Gelled Vehicles for Oral Drug Administration in Dysphagic Patients
by Serena Logrippo, Roberta Ganzetti, Matteo Sestili, Diego Romano Perinelli, Marco Cespi and Giulia Bonacucina
Pharmaceutics 2025, 17(2), 251; https://doi.org/10.3390/pharmaceutics17020251 - 14 Feb 2025
Viewed by 491
Abstract
Background/Objectives: Thickened waters are commonly used for dysphagic patients to ensure hydration, facilitate safer swallowing, and administer oral therapies, yet their impact on drug dissolution remains unclear. This study aims to investigate how thickening agents, viscosity, and solid oral dosage form (SODF) [...] Read more.
Background/Objectives: Thickened waters are commonly used for dysphagic patients to ensure hydration, facilitate safer swallowing, and administer oral therapies, yet their impact on drug dissolution remains unclear. This study aims to investigate how thickening agents, viscosity, and solid oral dosage form (SODF) formulations influence drug release in gelled vehicles. Methods: Twelve commercially available thickened waters, including both ready-to-use products and powders for extemporaneous preparation, were used to disperse crushed sodium pravastatin tablets. The resulting preparations were evaluated for their rheological properties and dissolution performance. Results: Thickened water products vary in consistency, with starch-based thickeners providing more consistent results than gum-based ones. Pravastatin release profiles closely matched the original tablets with starch thickeners, while gum-based thickeners showed greater variability, primarily influenced by viscosity. Conclusions: These findings emphasize the importance of selecting the appropriate thickening agent for controlling drug release in thickened water products, highlighting the need to balance patient compliance with the potential impact on drug release during product development. Full article
(This article belongs to the Special Issue Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines)
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16 pages, 480 KiB  
Article
Integrating Analytical Procedures in Routine Practices of Centralized Antiblastic Compounding Units for Valorization of Residual Compounded Drugs
by Rita Patrizia Aquino, Giovanni Falcone, Paola Russo, Fabrizio Dal Piaz, Giulia Auriemma, Ferdinando Maria de Francesco, Stefania Cascone, Eduardo Nava and Pasquale Del Gaudio
Pharmaceutics 2025, 17(1), 101; https://doi.org/10.3390/pharmaceutics17010101 - 14 Jan 2025
Viewed by 760
Abstract
Background/Objectives: Although extemporaneous formulations of anticancer drug products for personalized therapy are produced according to Good Hospital Pharmacy Manufacturing Practice, the lack of knowledge about drug stability under clinical conditions limits the second-time use of these highly costly medications in clinical practice. Therefore, [...] Read more.
Background/Objectives: Although extemporaneous formulations of anticancer drug products for personalized therapy are produced according to Good Hospital Pharmacy Manufacturing Practice, the lack of knowledge about drug stability under clinical conditions limits the second-time use of these highly costly medications in clinical practice. Therefore, the residual compounded drugs are considered waste and a cost item that negatively affects the healthcare system. In the context of the ever-increasing interest of the health system in applying practices in line with personalized medicine and spending review policies, this research aimed to demonstrate the feasibility of incorporating analytical techniques into daily routine practice. Specifically, the present research focused on fast stability analysis of Active Pharmaceutical Ingredients (APIs) in antiblastic residual compounded drugs with the purpose of demonstrating their potentialities as a resource for possible second-time use. Methods: Two different subsets of drug products were analyzed, i.e., medicines containing small molecules and medicines containing monoclonal antibodies. In relation to their different physicochemical properties, two analytical approaches were optimized and involved in the stability investigation: HPLC-DAD for small molecules and a combined approach of LC-MS/MS with size exclusion chromatography for monoclonal antibodies analysis. Results: Results underlined that the stability data, as available in the summary of product characteristics related to each medicine, do not completely describe the physicochemical shelf-life of anticancer compounded drugs. Conclusions: In fact, for all tested products, our results suggested a longer shelf-life in comparison to the datasheet, giving hospital pharmacists the possibility to extend the clinical use of compounded drugs, improving the cost–benefit of anticancer personalized therapy. Full article
(This article belongs to the Special Issue Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines)
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13 pages, 1536 KiB  
Article
Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma
by Chiara Lacassia, Annalisa Cutrignelli, Flavia Maria la Forgia, Sergio Fontana, Antonio Lopalco, Nunzio Denora and Angela Assunta Lopedota
Pharmaceutics 2025, 17(1), 83; https://doi.org/10.3390/pharmaceutics17010083 - 10 Jan 2025
Viewed by 732
Abstract
Background/Objectives: Since 2008, following clinical studies conducted on children that revealed the ability of the β-adrenergic antagonist propranolol to inhibit capillary growth in infantile hemangiomas (IHs), its oral administration has become the first-line treatment for IHs. Although oral propranolol therapy at a [...] Read more.
Background/Objectives: Since 2008, following clinical studies conducted on children that revealed the ability of the β-adrenergic antagonist propranolol to inhibit capillary growth in infantile hemangiomas (IHs), its oral administration has become the first-line treatment for IHs. Although oral propranolol therapy at a dosage of 3 mg/kg/die is effective, it can cause systemic adverse reactions. This therapy is not necessarily applicable to all patients. Topical skin applications could help maintain a high drug concentration at local sites and also represent a characteristically easy method of administration for pediatric patients. Because no topical propranolol dosage forms are commercially available, such formulations may be prepared at hospitals and pharmacies. Methods: In the present study, we identified a simple method for preparing topical propranolol hydrochloride formulations at 1% w/w with five commercial ready-to-use bases and evaluated the pharmaceutical profiles. The physical stability of the extemporaneous formulations was predicted by performing an accelerated centrifuge test and assessed by visual inspection after one month storage at 25 °C. The chemical stability of the drug in the five formulations was assessed by using a high-performance liquid chromatography (HPLC) method. In vitro drug-release and permeability experiments were conducted through synthetic membranes and the outer pavilion of a pig’s ear by utilizing Franz-type diffusion cells. Results: The results indicated that the release of the drug was significantly influenced by the internal structure and physicochemical properties of each base. Conclusions: Specifically, the formulations prepared with the hydrophilic bases could be easily prepared and yield satisfactory results, representing a potential effective therapy for IHs in pediatric patients. Full article
(This article belongs to the Special Issue Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines)
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23 pages, 5870 KiB  
Article
Development of an Adaptable Qualification Test Set for Personnel Involved in Visual Inspection Procedures of Parenteral Drug Products Manufactured Under Good Manufacturing Practice Conditions in Hospital Pharmacy Compounding Facilities
by Tessa van den Born-Bondt, Harmen P. S. Huizinga, Koen R. Kappert, Hans H. Westra, Jacoba van Zanten, Herman J. Woerdenbag, Jacoba M. Maurer and Bahez Gareb
Pharmaceutics 2025, 17(1), 74; https://doi.org/10.3390/pharmaceutics17010074 - 7 Jan 2025
Viewed by 864 | Correction
Abstract
Objectives: Parenteral drug products manufactured under GMP conditions should be visually inspected for defects and particulate contamination by trained and qualified personnel. Although personnel qualification is required, no practical protocols or formal guidelines are available for the development of qualification test sets (QTSs) [...] Read more.
Objectives: Parenteral drug products manufactured under GMP conditions should be visually inspected for defects and particulate contamination by trained and qualified personnel. Although personnel qualification is required, no practical protocols or formal guidelines are available for the development of qualification test sets (QTSs) used for qualification procedures. The current practice is to either procure a standardized QTS from a commercial supplier or amass sufficient manufacturing rejects during visual inspection procedures to compile in-house QTSs. However, both strategies inherently possess disadvantages and limitations. The objective of this study was to develop a manufacturing protocol for an optimal and adaptable QTS for training and qualification procedures. Methods: We combined the results of a literature search, survey of five Dutch hospital pharmacy compounding facilities, semi-structured personnel interviews, and extensive pre-GMP formulation studies to develop an optimal and adaptable QTS manufacturing protocol. Results: The literature search did not identify a manufacturing protocol for an optimal and adaptable QTS, but did identify specifications and requirements for optimal QTSs. The survey among hospital pharmacy compounding facilities revealed considerable variability in the qualification procedures and used QTSs. Semi-structured personnel interviews and pre-GMP formulation studies demonstrated that defects encountered during routine productions could be realistically simulated with pharmaceutical-grade excipients. As a proof-of-concept, we manufactured two different QTSs under GMP conditions and assessed these for formal GMP training and qualification purposes, which were considered a significant improvement compared to using manufacturing rejects. Conclusions: To the best of our knowledge, this is the first study presenting these data and our adaptable protocol, which is provided in the Supplemental Materials, may aid compounding facilities in the standardization, training, and qualification of personnel involved in visual inspection procedures. Full article
(This article belongs to the Special Issue Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines)
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15 pages, 2802 KiB  
Article
Development and Characterization of Trihexyphenidyl Orodispersible Minitablets: A Challenge to Fill the Therapeutic Gap in Neuropediatrics
by Camila Olivera, Oriana Boscolo, Cecilia Dobrecky, Claudia A. Ortega, Laura S. Favier, Valeria A. Cianchino, Sabrina Flor and Silvia Lucangioli
Pharmaceutics 2025, 17(1), 5; https://doi.org/10.3390/pharmaceutics17010005 - 24 Dec 2024
Viewed by 722
Abstract
Background: Trihexyphenidyl (THP) has been widely used for over three decades as pediatric pharmacotherapy in patients affected by segmental and generalized dystonia. In order to achieve effective and safe pharmacotherapy for this population, new formulations are needed. Objective: The aim of this work [...] Read more.
Background: Trihexyphenidyl (THP) has been widely used for over three decades as pediatric pharmacotherapy in patients affected by segmental and generalized dystonia. In order to achieve effective and safe pharmacotherapy for this population, new formulations are needed. Objective: The aim of this work is the development of trihexyphenidyl orodispersible minitablets (ODMTs) for pediatric use. Methods: Six different excipients were tested as diluents. The properties of powder mixtures were evaluated before direct compression and pharmacotechnical tests were performed on the final formulation. The determination of the API content, uniformity of dosage, and physicochemical stability studies were analyzed by an HPLC-UV method. Results: The developed ODMTs met pharmacopeia specifications for content, hardness, friability, disintegration, and dissolution tests. The physicochemical stability study performed over 18 months shows that API content remains within 90.0–110.0% at least for this period. Conclusions: These ODMTs will allow efficient, safe, and high-quality pharmacotherapy. Full article
(This article belongs to the Special Issue Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines)
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15 pages, 2077 KiB  
Article
Oral Gels as an Alternative to Liquid Pediatric Suspensions Compounded from Commercial Tablets
by Monika Trofimiuk, Małgorzata Sznitowska and Katarzyna Winnicka
Pharmaceutics 2024, 16(9), 1229; https://doi.org/10.3390/pharmaceutics16091229 - 20 Sep 2024
Viewed by 1262
Abstract
The aim of the study was to propose pharmacy-compounded oral gels as a new and alternative dosage form that is attractive to children as having a better masking taste than syrups and reducing the risk of spilling. The application and physical properties of [...] Read more.
The aim of the study was to propose pharmacy-compounded oral gels as a new and alternative dosage form that is attractive to children as having a better masking taste than syrups and reducing the risk of spilling. The application and physical properties of the gels prepared with cellulose derivatives (hydroxyethylcellulose and carmellose sodium) or carbomers were evaluated. The results of the study showed the most suitable consistency, viscosity, and organoleptic properties for gels prepared with carbomer and cellulose derivatives at concentrations of 0.75% and 2.0%, respectively. The microbial stability of the gels was guaranteed by the use of methylparaben and potassium sorbate. VAL (valsartan) and CC (candesartan cilexetil) tablets, often used off-label in children, were pulverized and suspended in the hydrogel bases, resulting in final drug concentrations of 4 mg/g and 1 mg/g, respectively. There was no significant change in viscosity and consistency parameters when the pulverized tablets were added, and only small changes in viscosity and consistency were observed during 35 days of storage, especially in the gels with sodium carmellose and candesartan. On the basis of the drug assay, an expiry date of 25 °C was recommended: 35 days for valsartan and 14 days for candesartan preparations. Full article
(This article belongs to the Special Issue Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines)
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15 pages, 3504 KiB  
Article
Liquid- and Semisolid-Filled Hard Gelatin Capsules Containing Alpha-Lipoic Acid as a Suitable Dosage Form for Compounding Medicines and Dietary Supplements
by Jelena Jovičić-Bata, Nemanja Todorović, Veljko Krstonošić, Ivan Ristić, Zorana Kovačević, Milana Vuković and Mladena Lalić-Popović
Pharmaceutics 2024, 16(7), 892; https://doi.org/10.3390/pharmaceutics16070892 - 4 Jul 2024
Cited by 1 | Viewed by 2137
Abstract
Liquid-filled hard gelatin capsules may have pertinent advantages both for therapeutic effect and extemporaneous preparations of medicines. Alpha lipoic acid is a substance used in medicines and dietary supplements and there is a need for creating an appropriate formulation which would be suitable [...] Read more.
Liquid-filled hard gelatin capsules may have pertinent advantages both for therapeutic effect and extemporaneous preparations of medicines. Alpha lipoic acid is a substance used in medicines and dietary supplements and there is a need for creating an appropriate formulation which would be suitable for each individual patient or consumer. Based on its biopharmaceutical and physical chemical characteristics, eight different capsule formulations were designed and characterized. Silicon dioxide was added to form a semisolid content and prevent leakage. The formulation filled with alpha lipoic acid solution in polyethylene glycol 400 showed the best performance. Although the addition of silicon dioxide to the formulation with polyethylene glycol 400 led to a change in both flow character and viscosity, the release rate did not show a statistically significant decrease (more than 85% of content was released after 5 min testing). Applied technique is a simple and an appropriate approach for compounding and could be used for other substances with similar properties. Full article
(This article belongs to the Special Issue Extemporaneous Formulations: Filling the Gap in the Pharmaceutical Industry with Personalized Medicines)
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