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Pharmaceutics
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Advances in Parenteral Formulations
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Advances in Parenteral Formulations

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

Deadline for manuscript submissions: 10 June 2025 | Viewed by 16312

Special Issue Editors

Prof. Dr. Anna Jelińska

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Guest Editor
Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, 60-780 Poznan, Poland
Interests: drug analysis; drug stability; pharmaceutical chemistry
Special Issues, Collections and Topics in MDPI journals
Dr. Maciej Stawny

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Guest Editor
Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, 60-780 Poznan, Poland
Interests: drug interactions; parenteral nutrition; hospital pharmacy; nanotechnology
Special Issues, Collections and Topics in MDPI journals
Dr. Katarzyna Dettlaff

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Guest Editor
Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, 60-780 Poznan, Poland
Interests: drug analysis; drug stability; parenteral nutrition; radiation sterilization

Special Issue Information

Dear Colleagues,

In recent years, there has been great progress in the field of parenteral drugs. This is due to the development of pharmaceutical technology and drug analysis as a response to the emergence of clinical challenges.

The crucial issue in parenteral formulation is chemical, physical, and microbiological stability. One of the biggest problems of the technological process of such drugs is the poor solubility and permeability of most active pharmaceutical ingredients. To overcome this disadvantage, nanotechnology is used, including lipid-based, polymeric, and hybrid nanoparticles. Prolonged drug release formulations are developed, such as in situ implants and drug carriers enabling the drug to reach a critical organ or neoplastic tumor.

Other important issues related to parenteral drugs are their safety, PK/PD interactions, and drug compatibility when administered simultaneously through the same vascular access.

This Special Issue in Pharmaceutics is dedicated to the advantages of parenteral formulations and aims to draw together experts in the fields of pharmaceutical sciences, technology, analytical chemistry, and clinical medicine. Authors are invited to submit original and review articles covering all aspects of this important research field. We look forward to receiving your contributions.

Prof. Dr. Anna Jelińska
Dr. Maciej Stawny
Dr. Katarzyna Dettlaff
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

  • nanoparticle
  • drug interactions
  • nanoemulsions and submicron emulsions
  • drug carriers
  • drug compatibility
  • parenteral nutrition

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Published Papers (5 papers)

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Research

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19 pages, 4713 KiB  
Article
Evaluation of Strategies for Reducing Vancomycin-Piperacillin/Tazobactam Incompatibility
by Anthony Martin Mena, Laura Négrier, Anthony Treizebré, Marie Guilbert, Lucille Bonnaire, Valentine Daniau, Gabie Leba Bonki, Pascal Odou, Stéphanie Genay and Bertrand Décaudin
Pharmaceutics 2023, 15(8), 2069; https://doi.org/10.3390/pharmaceutics15082069 - 1 Aug 2023
Cited by 4 | Viewed by 1947
Abstract
Background: Drug incompatibility is defined as a physical-chemical reaction between two or more injectable drugs and that results mainly in precipitation or insolubility. Several strategies for reducing incompatibilities have been implemented empirically in intensive care units. However, these strategies have never been compared [...] Read more.
Background: Drug incompatibility is defined as a physical-chemical reaction between two or more injectable drugs and that results mainly in precipitation or insolubility. Several strategies for reducing incompatibilities have been implemented empirically in intensive care units. However, these strategies have never been compared directly (and particularly in terms of the particulate load and drug mass flow rate) under standardized conditions. The objective of the present in vitro study was to evaluate the impact of various strategies for preventing incompatibility between simultaneously infused vancomycin and piperacillin/tazobactam. Methods: An in-line filter, a dilute vancomycin solution (5 mg/mL), and an alternative saline administration line were evaluated separately. The infusion line outlet was connected to a dynamic particle counter. The antibiotic concentration was measured in an HPLC-UV assay. Result: The use of an in-line filter and an alternative saline administration route did not significantly reduce the particulate load caused by vancomycin-piperacillin/tazobactam incompatibility. Dilution of the vancomycin solution was associated with a significantly lower particulate load and maintenance of the vancomycin mass flow rate. Discussion: It is important to systematically compare the efficacy of strategies for preventing drug incompatibility. The use of diluted vancomycin solution gave the best results in the case of vancomycin-piperacillin/tazobactam incompatibility. Full article
(This article belongs to the Special Issue Advances in Parenteral Formulations)
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12 pages, 1860 KiB  
Article
Y-Site Compatibility Studies of Ketoprofen with Parenteral Nutrition Admixtures for Central and Peripheral Administration
by Katarzyna Dettlaff, Aleksandra Gostyńska, Natalia Ziółkowska and Maciej Stawny
Pharmaceutics 2022, 14(12), 2570; https://doi.org/10.3390/pharmaceutics14122570 - 23 Nov 2022
Cited by 6 | Viewed by 2172
Abstract
Ketoprofen (KTF) is often used in hospital wards, especially in its intravenous form. According to the literature review, the compatibility of ketoprofen with parenteral nutrition (PN) admixtures has not yet been investigated. For this reason, we aimed to provide data contributing to physical [...] Read more.
Ketoprofen (KTF) is often used in hospital wards, especially in its intravenous form. According to the literature review, the compatibility of ketoprofen with parenteral nutrition (PN) admixtures has not yet been investigated. For this reason, we aimed to provide data contributing to physical compatibility to ensure the safe co-administration of these medications. In this study, we examined the compatibility of KTF with eight selected commercial PN admixtures intended for central (Lipoflex Special, Omegaflex Special, Kabiven, SmofKabiven) and peripheral (Lipoflex peri, Omegaflex peri, Kabiven Peripheral, Olimel Peri N4E) administration. The KTF solution for infusion was combined in three different volume ratios with studied PN admixtures reflecting the conditions in clinical practice. The evaluation of undesirable physical destabilization of oil-in-water system or precipitate formation involved the visual inspection and the determination of mean droplet diameter, zeta potential, pH, and turbidity changes. The results of compatibility of KTF with eight commercial PN admixtures showed that three of them: Kabiven, SmofKabiven, and Kabiven Peripheral, are incompatible with KTF and should not be concomitantly administered. Full article
(This article belongs to the Special Issue Advances in Parenteral Formulations)
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17 pages, 1581 KiB  
Article
Behavior of Regular Insulin in a Parenteral Nutrition Admixture: Validation of an LC/MS-MS Assay and the In Vitro Evaluation of Insulin Glycation
by Heloise Henry, Jean-François Goossens, Mostafa Kouach, Damien Lannoy, David Seguy, Thierry Dine, Pascal Odou and Catherine Foulon
Pharmaceutics 2022, 14(5), 1081; https://doi.org/10.3390/pharmaceutics14051081 - 18 May 2022
Cited by 3 | Viewed by 2759
Abstract
Parenteral-nutrition (PN)-induced hyperglycemia increases morbidity and mortality and must be treated with insulin. Unfortunately, the addition of insulin to a ternary PN admixture leads to a rapid decrease in insulin content. Our study’s objective was to determine the mechanistic basis of insulin’s disappearance. [...] Read more.
Parenteral-nutrition (PN)-induced hyperglycemia increases morbidity and mortality and must be treated with insulin. Unfortunately, the addition of insulin to a ternary PN admixture leads to a rapid decrease in insulin content. Our study’s objective was to determine the mechanistic basis of insulin’s disappearance. The literature data suggested the presence of a glycation reaction; we therefore validated an LC-MS/MS assay for insulin and glycated insulin. In a 24-h stability study, 20 IU/L of insulin was added to a binary PN admixture at pH 3.6 or 6.3. When the samples were diluted before analysis with a near-neutral diluent, insulin was fully stable at pH 3.6, while a loss of around 50% was observed at pH 6.3. Its disappearance was shown to be inversely correlated with the appearance of monoglycated insulin (probably a Schiff base adduct). Monoglycated insulin might also undergo a back-reaction to form insulin after acidic dilution. Furthermore, a second monoglycated insulin species appeared in the PN admixture after more than 24 h at high temperature (40 °C) and a high insulin concentration (1000 IU/L). It was stable at acidic pH and might be an Amadori product. The impact of insulin glycation under non-forced conditions on insulin’s bioactivity requires further investigation. Full article
(This article belongs to the Special Issue Advances in Parenteral Formulations)
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13 pages, 4216 KiB  
Article
Sodium Valproate Incompatibility with Parenteral Nutrition Admixtures—A Risk to Patient Safety: An In Vitro Evaluation Study
by Ludwika Piwowarczyk, Szymon Tomczak, Patryk Antkowiak, Anna Jelińska and Maciej Stawny
Pharmaceutics 2022, 14(2), 371; https://doi.org/10.3390/pharmaceutics14020371 - 7 Feb 2022
Cited by 9 | Viewed by 3222
Abstract
Epilepsy is defined as a group of concerning problems related to the nervous system; its defining feature is a predisposition to epileptic seizures. The frequency of seizures in intensive care units (ICU) ranges from 3.3% to 34%, and ICU antiepileptic treatment is routine [...] Read more.
Epilepsy is defined as a group of concerning problems related to the nervous system; its defining feature is a predisposition to epileptic seizures. The frequency of seizures in intensive care units (ICU) ranges from 3.3% to 34%, and ICU antiepileptic treatment is routine practice. The administration of drugs through the same infusion line is not recommended but is common clinical practice, especially in ICU. Incompatibilities between parenteral drugs and between drugs and parenteral nutrition admixtures (PNAs) are common medical errors and pose risks to patient safety. The co-administration of drugs must always be confirmed and clearly defined. The simultaneous infusion of sodium valproate (VPA, drug used to treat seizures and epilepsy) with parenteral PNAs has not yet been studied. During the experiment reported in this study, a visual control, pH, osmolality, zeta potential, particle size, polydispersity index, and turbidity were measured. The conducted research shows that the lipid emulsion composition has a significant influence on drug–PN (drug–parenteral nutrition) compatibility. The acceptance criteria were met only for PNs containing omega-3-acid-triglycerides (Omegaflex special and peri). The second fraction of particles above 1000 nm was observed for most of the tested PNAs (Lipoflex special, Lipoflex peri, Kabiven, SmofKabiven, Kabiven Peripheral, and Olimel Peri N4E), which disqualifies their simultaneous administration with VPA. Full article
(This article belongs to the Special Issue Advances in Parenteral Formulations)
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Review

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21 pages, 774 KiB  
Review
Y-Site Compatibility Studies of Parenteral Nutrition and Other Intravenous Medications in Neonatal and Pediatric Patients: A Review of the Literature Evidence
by Aleksandra Gostyńska, Tomasz Przybylski and Magdalena Ogrodowczyk
Pharmaceutics 2024, 16(2), 264; https://doi.org/10.3390/pharmaceutics16020264 - 12 Feb 2024
Cited by 2 | Viewed by 4228
Abstract
Background: Polytherapy in neonatal and pediatric patients requiring parenteral nutrition (PN) administration is a challenging task. Due to limited intravenous access, the Y-site administration of medication with PN admixtures is sometimes inevitable. Aim: This review aims to summarize the evidence on the compatibility [...] Read more.
Background: Polytherapy in neonatal and pediatric patients requiring parenteral nutrition (PN) administration is a challenging task. Due to limited intravenous access, the Y-site administration of medication with PN admixtures is sometimes inevitable. Aim: This review aims to summarize the evidence on the compatibility of the Y-site of intravenous medications and PN admixtures in neonatal and pediatric settings. Methods: A literature review of the PubMed database was conducted. Articles published between January 1995 and November 2023 concerning the compatibility of intravenous medications in pediatric-dose PN admixtures or with intravenous lipid emulsions only were included. Studies concerning the compatibility/stability of the ingredients of PN admixtures and those concerning unapproved medications were excluded. Based on the methodology used, the quality of the research was assessed. Results: A total of fifteen studies were explored. Among fifty-five different drug substances assessed in the research reviewed, 56% (31/55) were found to be compatible, 13% (7/55) were assigned as incompatible, and for 31% (17/55), the data were ambiguous. None of the studies demonstrated an “A” grade (very high quality), and the grades “B”, “C”, and “D” were assigned to four, six, and five studies, respectively. The compatibility data are presented in two tables, the first concerning the simultaneous administration of medications with 2-in-1 PN formulations (without lipids) and the second, with 3-in-1 formulations (with lipids) and lipid emulsions. Conclusions: This review presents data on compatibilities between intravenously administered medications and PN mixtures intended for neonates and pediatric patients found in the PubMed database. It should be highlighted, however, that this work has some limitations. The clinical decisions on the simultaneous administration of intravenous medication with PN admixtures should be based not only on this review (including assessment of the quality of evidence) but also on manufacturer data, available electronic databases, and incompatibility data for PN admixtures dedicated to adult patients. Full article
(This article belongs to the Special Issue Advances in Parenteral Formulations)
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