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Pharmaceuticals
Special Issues
Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies
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Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmaceutical Technology".

Deadline for manuscript submissions: closed (25 April 2024) | Viewed by 7575

Special Issue Editors

Dr. Pau Riera

E-Mail Website
Guest Editor
1. Institut d’Investigació Biomèdica Sant Pau (IIB SANT PAU), Barcelona, Spain
2. Pharmacy Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
3. CIBER de Enfermedades Raras (CIBERER), Instituto de Salud Carlos III, Madrid, Spain
Interests: pharmacology; stability studies; precision medicine
Dr. Jan Thomas De Pourcq

E-Mail Website
Guest Editor
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Interests: parenteral nutrition; stability studies; nutrition support
Dr. Noe Garin

E-Mail Website
Guest Editor
1, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
2. Faculty of Health Science, Blanquerna – Universitat Ramon Llull, Barcelona, Spain
Interests: stability studies; pharmacotherapy; pharmaceutical care

Special Issue Information

Dear Colleagues,

Compounding pharmacists have always worked to ensure the stability and safety of the compounds they produce, as well as the effectiveness of drugs administered to patients. Several factors can affect the stability of compounded medications, such as heat, light, oxidation or hydrolysis.

In daily routine, pharmacists face some challenges when they have to assess the stability and/or compatibility of drugs in different vehicles. Sometimes there is a lack of information, particularly for novel drugs or new in-house preparations. In the hospital setting, especially for critical care patients, there may be risky situations when the co-administration of drugs or TPN–drug through the same line is required, and no information about their stability is available.

In this sense, further studies are needed to generate more evidence regarding the abovementioned challenges and to increase the knowledge in this area. In this Special Issue, we aim to compile research from experts in the field that focuses on the concerns affecting preparations.

Dr. Pau Riera
Dr. Jan Thomas De Pourcq
Dr. Noe Garin
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. Pharmaceuticals 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

  • stability
  • sterility
  • drug–TPN and drug–drug compatibility
  • formulation challenges

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Published Papers (6 papers)

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Research

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15 pages, 4140 KiB  
Article
Evaluation of the Impact of Infusion Set Design on the Particulate Load Induced by Vancomycin–Piperacillin/Tazobactam Incompatibility
by Laura Négrier, Bertrand Décaudin, Anthony Treizebré, Marie Guilbert, Pascal Odou and Anthony Martin Mena
Pharmaceuticals 2024, 17(9), 1222; https://doi.org/10.3390/ph17091222 - 17 Sep 2024
Viewed by 362
Abstract
Introduction: Drug incompatibilities are among the most common medication errors in intensive care units. A precipitate can form and block the catheter or cause an adverse event in the patient. Intensive care units have implemented various strategies for limiting the occurrence of these [...] Read more.
Introduction: Drug incompatibilities are among the most common medication errors in intensive care units. A precipitate can form and block the catheter or cause an adverse event in the patient. Intensive care units have implemented various strategies for limiting the occurrence of these incompatibilities, which have already been studied in vitro under standardized conditions. The objective of the present in vitro study was to continue these assessments by determining the impact of the infusion line geometry and the drugs’ position in the infusion set-up on the prevention of vancomycin–piperacillin/tazobactam incompatibility. Methods: Infusion lines with a different common volume, a multilumen medical infusion device, a dilute vancomycin solution, and separate infusions of incompatible drugs were evaluated separately. The infusion line outlet was connected to a dynamic particle counter. Results: Reducing the common volume, using multilumen medical devices, or spacing out the two incompatible drugs on the infusion line did not prevent the occurrence of a significant particulate load. Only dilution of the vancomycin solution was associated with a significantly lower particulate load and the absence of drug incompatibility. Conclusions: Our results show that under specific conditions, it is possible to reduce particulate contamination considerably. Full article
(This article belongs to the Special Issue Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies)
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17 pages, 2155 KiB  
Article
The Infusion of Piperacillin/Tazobactam with an Elastomeric Device: A Combined 24-H Stability Study and Drug Solution Flow Rate Analysis
by Laura Négrier, Anthony Martin Mena, Christian Dupont, Philémon Gamache, Jeanne-Olive Zimbril, Yasmine Abdoune, Youness Karrout, Pascal Odou, Stéphanie Genay and Bertrand Décaudin
Pharmaceuticals 2024, 17(8), 1085; https://doi.org/10.3390/ph17081085 - 19 Aug 2024
Viewed by 723
Abstract
Bacterial respiratory tract infections (e.g., in patients with cystic fibrosis) may be treated with the intravenous infusion of a piperacillin/tazobactam (P/T) solution through an elastomeric device. In the present work, we combined a 24-h drug stability study with an assessment of the drug [...] Read more.
Bacterial respiratory tract infections (e.g., in patients with cystic fibrosis) may be treated with the intravenous infusion of a piperacillin/tazobactam (P/T) solution through an elastomeric device. In the present work, we combined a 24-h drug stability study with an assessment of the drug solution flow rate during an in vitro simulated infusion. Experiments were performed in triplicate with two excipient-free generic P/T solutions and an excipient-containing proprietary P/T solution in saline (all 50/6.25 mg/mL) released from an elastomeric infusion device at 32 °C. The P/T solutions’ stability was assessed by an HPLC-UV assay, pH and osmolality measurements, a visual assessment, and particle counting. Before these analyses, a forced degradation study was performed. To assess the flow rate, a precision scale was used to weigh the solution collected at the infusion line outlet. The stability criteria were <10% degradation and a flow rate within ± 15% of the nominal value over the 24-h infusion period: all three P/T solutions were found to be stable. The actual flow rate was lower than the expected flow rate; this difference was probably due to the drug solution’s high viscosity and must be taken into account in clinical use. Full article
(This article belongs to the Special Issue Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies)
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13 pages, 1328 KiB  
Article
Physicochemical Compatibility of Ceftolozane-Tazobactam with Parenteral Nutrition
by Jan Thomas De Pourcq, Adria Riera, Laura Gras, Noe Garin, Maria Antònia Busquets, Joana Cardenete, Daniel Cardona and Pau Riera
Pharmaceuticals 2024, 17(7), 896; https://doi.org/10.3390/ph17070896 - 5 Jul 2024
Viewed by 827
Abstract
Ceftolozane-tazobactam (CT) is used for the treatment of complicated infections and for multidrug-resistant strains of Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing enterobacteria. In certain cases, simultaneous administration of CT and parenteral nutrition (PN) may be required, but compatibility of Y-site co-administration is unknown. The [...] Read more.
Ceftolozane-tazobactam (CT) is used for the treatment of complicated infections and for multidrug-resistant strains of Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing enterobacteria. In certain cases, simultaneous administration of CT and parenteral nutrition (PN) may be required, but compatibility of Y-site co-administration is unknown. The aim of this study was to analyse the physicochemical compatibility of CT Y-site administered with PN. We evaluated a protocolized PN approach for critical patients in our center. We studied both bolus infusion (2 g ceftolozane/1 g tazobactam in 1 h) and continuous infusion (CI) (6 g ceftolozane/3 g tazobactam) strategies. Samples were visually observed against light, microscopically inspected, and pH was analysed using a pH meter. The mean lipid droplet diameter (MDD) was determined via dynamic light scattering. CT concentration was quantified using HPLC–HRMS. No alterations were observed through visual or microscopic inspection. Changes in pH were ≤0.2, and changes in osmolarity were less than 5%. MDD remained below 500 nm (284.5 ± 2.1 for bolus CT and 286.8 ± 7.5 for CI CT). CT concentrations at t = 0 h and t = 24 h remained within prespecified parameters in both infusion strategies. CT is physiochemically compatible with PN during simulated Y-site administration at the tested concentration and infusion rates. Full article
(This article belongs to the Special Issue Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies)
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23 pages, 4380 KiB  
Article
Insights from Syzygium aromaticum Essential Oil: Encapsulation, Characterization, and Antioxidant Activity
by Naianny L. O. N. Mergulhão, Laisa C. G. Bulhões, Valdemir C. Silva, Ilza F. B. Duarte, Irinaldo D. Basílio-Júnior, Johnnatan D. Freitas, Adeildo J. Oliveira, Marília O. F. Goulart, Círia V. Barbosa and João X. Araújo-Júnior
Pharmaceuticals 2024, 17(5), 599; https://doi.org/10.3390/ph17050599 - 8 May 2024
Viewed by 1428
Abstract
Alginate encapsulates loaded with clove essential oil (CEO) were prepared by ionic gelation, with subsequent freeze-drying. The objective of the present work was to develop a product with the ability to protect CEO against its easy volatility and oxidation. The following techniques were [...] Read more.
Alginate encapsulates loaded with clove essential oil (CEO) were prepared by ionic gelation, with subsequent freeze-drying. The objective of the present work was to develop a product with the ability to protect CEO against its easy volatility and oxidation. The following techniques were used to characterize the formulations: eugenol release, degree of swelling, GC/MS, TGA/DSC, and SEM. The alginate solution (1.0%) containing different concentrations of CEO (LF1: 1.0%; LF2: 0.5%; LF3: 0.1%) was dropped into a 3.0% CaCl2 solution. After lyophilization, the encapsulated samples were wrinkled and rigid, with high encapsulation power (LF3: 76.9% ± 0.5). Three chemical components were identified: eugenol (the major one), caryophyllene, and humulene. The antioxidant power (LF1: DPPH IC50 18.1 µg mL−1) was consistent with the phenol content (LF1: 172.2 mg GAE g−1). The encapsulated ones were thermally stable, as shown by analysis of FTIR peaks, eugenol molecular structure was kept unaltered. The degree of swelling was 19.2% (PBS). The release of eugenol (92.5%) in the PBS solution was faster than in the acidic medium. It was concluded that the low-cost technology used allows the maintenance of the content and characteristics of CEO in the three concentrations tested, offering a basis for further research with essential oil encapsulates. Full article
(This article belongs to the Special Issue Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies)
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12 pages, 2743 KiB  
Article
Exploring Immersion Coating as a Cost-Effective Method for Small-Scale Production of Enteric-Coated Gelatin Capsules
by Beatrice Sabbatini, Diego Romano Perinelli, Giovanni Filippo Palmieri, Marco Cespi and Giulia Bonacucina
Pharmaceuticals 2024, 17(4), 433; https://doi.org/10.3390/ph17040433 - 28 Mar 2024
Viewed by 1291
Abstract
The coating process for solid dosage forms is widely used in the pharmaceutical industry but presents challenges for small-scale production, needed in personalized medicine and clinical or galenic settings. This study aimed to evaluate immersion coating, a cost-effective small-scale method, for enteric-coated gelatin [...] Read more.
The coating process for solid dosage forms is widely used in the pharmaceutical industry but presents challenges for small-scale production, needed in personalized medicine and clinical or galenic settings. This study aimed to evaluate immersion coating, a cost-effective small-scale method, for enteric-coated gelatin capsules using standard equipment. Two enteric coating polymers and different polymer concentrations were tested, along with API solubility. Results were compared with commercially available enteric capsule shells. Successful preparation of enteric coating capsules via immersion necessitates a comprehensive grasp of API and enteric polymer behavior. However, utilizing commercially available enteric capsule shells does not guarantee ease or robustness, as their efficacy hinges on the attributes of the active ingredient and excipients. Notably, coating with Eudragit S100 stands out for its superior process robustness, requiring minimal or no development time, thus representing the best option for small-scale enteric capsule production. Full article
(This article belongs to the Special Issue Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies)
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Review

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19 pages, 556 KiB  
Review
A Narrative Review: Analysis of Supplemental Parenteral Nutrition in Adults at the End of Life
by Francisco Rivas García, Rafael Jesús Giménez Martínez, Felipe José Huertas Camarasa, Joan Carles March Cerdá, Fuensanta Lloris Messeguer and Margarita López-Viota Gallardo
Pharmaceuticals 2024, 17(1), 65; https://doi.org/10.3390/ph17010065 - 30 Dec 2023
Viewed by 1913
Abstract
“End of life” is a stage defined by the existence of an irreversible prognosis that ends with a person’s death. One of the aspects of interest regarding end of life focuses on parenteral nutrition, which is usually administered in order to avoid malnutrition [...] Read more.
“End of life” is a stage defined by the existence of an irreversible prognosis that ends with a person’s death. One of the aspects of interest regarding end of life focuses on parenteral nutrition, which is usually administered in order to avoid malnutrition and associated complications. However, parenteral nutrition can be adapted to specific circumstances and evolve in its functionality through supplementation with certain nutrients that can have a beneficial effect. This narrative review aims to carry out a situation analysis of the role that could be adopted by supplemental parenteral nutrition in attenuating alterations typical of end of life and potential improvement in quality of life. Full article
(This article belongs to the Special Issue Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies)
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