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 "Clinical Pharmaceutics".

Deadline for manuscript submissions: 31 December 2024 | Viewed by 2567

Special Issue Editors


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Department of Pharmacy-Pharmaceutical Sciences, University of Bari “Aldo Moro”, 70125 Bari, Italy
Interests: drug delivery systems; stability; preformulation; paediatric formulation
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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

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Keywords

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

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Published Papers (2 papers)

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Research

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 778
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
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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
Viewed by 1341
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
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