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Special Issue "Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine"

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A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Clinical Pharmaceutics".

Deadline for manuscript submissions: 31 October 2023 | Viewed by 8340

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Special Issue Editors

Dr. Cristina Manuela Drăgoi

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Department of Biochemistry, Faculty of Pharmacy, Carol Davila University of Medicine and Pharmacy, 6 Traian Vuia Street, 020956 Bucharest, Romania
Interests: biochemistry; nutrition; metabolism; chrononutrition; drug design; drugs’ mechanisms of action; personalized medicine; biological drugs; chronotherapy; chronobiology
Special Issues, Collections and Topics in MDPI journals

Dr. Alina Crenguța Nicolae

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Guest Editor

Faculty of Pharmacy, University of Medicine and Pharmacy “Carol Davila”, 020956 Bucharest, Romania
Interests: biochemistry; pharmacotherapy; antihypertensive agents; blood pressure

Dr. Ion-Bogdan Dumitrescu

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Guest Editor

Faculty of Pharmacy, University of Medicine and Pharmacy “Carol Davila”, 020956 Bucharest, Romania
Interests: pharmaceutical 3D printing; computer-aided design; clinical pharmacy

Special Issue Information

Dear Colleagues,

Modern medicine is going through an extremely important moment in its evolution in relation to the disease–drug–patient axis, gradually progressing from pure drug development, which initiates from the need to prevent or treat certain diseases, to the expansion of coherent therapeutic strategies which are personalized for each individual, in recognition of the fact that each patient is a distinct physio-pathological case. Remarkable advances in recent decades in the prevention strategies, diagnostic procedures and available treatments have paved the way to major improvements in patient care. Personalized medicine is approachable if comprehensive details are known about the pathogenesis; the therapeutic agents developed for the management of the pathology in question; the biochemical mechanisms of action of the drugs; the interactions of the drugs with each other and with other endogenous or exogenous factors; and the genetic and epigenetic background of the patient, their chronobiological, nutritional and socio-demographic characteristics.

In this framework, the aim of this Special Issue on “Emerging strategies in drug development and clinical care in the era of personalized and precision medicine” is to unify the most relevant papers addressing the state-of-the-art knowledge and future directions in drug development, therapeutic strategies, and innovative drug formulations, with a focus on biochemical mechanisms of action and drug design, as well as the relevant preclinical and clinical testing of efficacy, pharmacokinetics and toxicity in the era of precision and personalized medicine.

We welcome articles dealing with all aspects of pharmaceutical and medical care, from basic to clinical research, and invite scientists and drug specialists to publish their original research works, review articles, and communications on this wide health domain.

Dr. Cristina Manuela Drăgoi
Dr. Alina Crenguța Nicolae
Dr. Ion-Bogdan Dumitrescu
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

drug development
therapeutic strategies
preclinical and clinical drug research
drug design
drug–drug interactions
clinical care
toxicological studies
disease risk, disease prognosis and response to therapy
biomarkers identification and application
biochemistry of drug uptake, action, and metabolism
drug target discovery
individualized therapy
pharmacogenomics
novel therapeutics
non-drug-related health interferences
nutritional interventions
chronobiology
medicinal chemistry
phytochemicals
biologics
personalized medicine
precision medicine

Published Papers (7 papers)

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Research

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Open AccessArticle

Toward Stability Enhancement of NTS₁R-Targeted Radioligands: Structural Interventions on [^99mTc]Tc-DT1

Panagiotis Kanellopoulos

Berthold A. Nock

Eric P. Krenning

and

Theodosia Maina

Pharmaceutics 2023, 15(8), 2092; https://doi.org/10.3390/pharmaceutics15082092 - 07 Aug 2023

Viewed by 359

Abstract

The neurotensin subtype 1 receptor (NTS₁R) is overexpressed in a number of human tumors, thereby representing a valid target for cancer theranostics with radiolabeled neurotensin (NT) analogs like [^99mTc]Tc-DT1 (DT1, N₄-Gly⁷-NT(8-13)). Thus far, the fast degradation of intravenously injected NT–radioligands by neprilysin (NEP) and angiotensin-converting enzyme (ACE) has compromised their clinical applicability. Aiming at metabolic stability enhancements, we herein introduce (i) DT7 ([DAsn¹⁴]DT1) and (ii) DT8 ([β-Homoleucine¹³]DT1), modified at the C-terminus, along with (iii) DT9 ([(palmitoyl)Lys⁷]DT1), carrying an albumin-binding domain (ABD) at Lys⁷. The biological profiles of the new [^99mTc]Tc–radioligands were compared with [^99mTc]Tc-DT1, using NTS₁R-expressing AsPC-1 cells and mice models without or during NEP/ACE inhibition. The radioligands showed enhanced in vivo stability vs. [^99mTc]Tc-DT1, with [^99mTc]Tc-DT9 displaying full resistance to both peptidases. Furthermore, [^99mTc]Tc-DT9 achieved the highest cell internalization and tumor uptake even without NEP/ACE-inhibition but with unfavorably high background radioactivity levels. Hence, unlike C-terminal modification, the introduction of a pendant ABD group in the linker turned out to be the most promising strategy toward metabolic stability, cell uptake, and tumor accumulation of [^99mTc]Tc-DT1 mimics. To improve the observed suboptimal pharmacokinetics of [^99mTc]Tc-DT9, the replacement of palmitoyl on Lys⁷ by other ABD groups is currently being pursued. Full article

(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine)

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Open AccessArticle

Population Pharmacokinetic Analysis of Perampanel in Portuguese Patients Diagnosed with Refractory Epilepsy

and

Pharmaceutics 2023, 15(6), 1704; https://doi.org/10.3390/pharmaceutics15061704 - 10 Jun 2023

Viewed by 637

Abstract

Perampanel is a promising antiepileptic drug (AED) for refractory epilepsy treatment due to its innovative mechanism of action. This study aimed to develop a population pharmacokinetic (PopPK) model to be further used in initial dose optimization of perampanel in patients diagnosed with refractory epilepsy. A total of seventy-two plasma concentrations of perampanel obtained from forty-four patients were analyzed through a population pharmacokinetic approach by means of nonlinear mixed effects modeling (NONMEM). A one-compartment model with first-order elimination best described the pharmacokinetic profiles of perampanel. Interpatient variability (IPV) was entered on clearance (CL), while the residual error (RE) was modeled as proportional. The presence of enzyme-inducing AEDs (EIAEDs) and body mass index (BMI) were found as significant covariates for CL and volume of distribution (V), respectively. The mean (relative standard error) estimates for CL and V of the final model were 0.419 L/h (5.56%) and 29.50 (6.41%), respectively. IPV was 30.84% and the proportional RE was 6.44%. Internal validation demonstrated an acceptable predictive performance of the final model. A reliable population pharmacokinetic model was successfully developed, and it is the first enrolling real-life adults diagnosed with refractory epilepsy. Full article

(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine)

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Open AccessArticle

Angiotensin II Receptor Blockers Reduce Tau/Aß42 Ratio: A Cerebrospinal Fluid Biomarkers’ Case-Control Study

Antonio José Cañada-Martínez

and

Consuelo Cháfer-Pericás

Pharmaceutics 2023, 15(3), 924; https://doi.org/10.3390/pharmaceutics15030924 - 12 Mar 2023

Cited by 1 | Viewed by 1154

Abstract

(1) Background: The role of antihypertensives in Alzheimer’s Disease (AD) prevention is controversial. This case-control study aims to assess whether antihypertensive medication has a protective role by studying its association with amyloid and tau abnormal levels. Furthermore, it suggests a holistic view of the involved pathways between renin-angiotensin drugs and the tau/amyloidß42 ratio (tau/Aß42 ratio); (2) Methods: The medical records of the participant patients were reviewed, with a focus on prescribed antihypertensive drugs and clinical variables, such as arterial blood pressure. The Anatomical Therapeutic Chemical classification was used to classify each drug. The patients were divided into two groups: patients with AD diagnosis (cases) and cognitively healthy patients (control); (3) Results: Age and high systolic blood pressure are associated with a higher risk of developing AD. In addition, combinations of angiotensin II receptor blockers are associated with a 30% lower t-tau/Aß42 ratio than plain angiotensin-converting enzyme inhibitor consumption; (4) Conclusions: Angiotensin II receptor blockers may play a potential role in neuroprotection and AD prevention. Likewise, several mechanisms, such as the PI3K/Akt/GSK3ß or the ACE1/AngII/AT1R axis, may link cardiovascular pathologies and AD presence, making its modulation a pivotal point in AD prevention. The present work highlights the central pathways in which antihypertensives may affect the presence of pathological amyloid and tau hyperphosphorylation. Full article

(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine)

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Open AccessArticle

Kinin B₁ and B₂ Receptors Contribute to Cisplatin-Induced Painful Peripheral Neuropathy in Male Mice

Gabriela Becker

Maria Fernanda Pessano Fialho

Indiara Brusco

and

Sara Marchesan Oliveira

Pharmaceutics 2023, 15(3), 852; https://doi.org/10.3390/pharmaceutics15030852 - 06 Mar 2023

Cited by 1 | Viewed by 1103

Abstract

Cisplatin is the preferential chemotherapeutic drug for highly prevalent solid tumours. However, its clinical efficacy is frequently limited due to neurotoxic effects such as peripheral neuropathy. Chemotherapy-induced peripheral neuropathy is a dose-dependent adverse condition that negatively impacts quality of life, and it may determine dosage limitations or even cancer treatment cessation. Thus, it is urgently necessary to identify pathophysiological mechanisms underlying these painful symptoms. As kinins and their B₁ and B₂ receptors contribute to the development of chronic painful conditions, including those induced by chemotherapy, the contribution of these receptors to cisplatin-induced peripheral neuropathy was evaluated via pharmacological antagonism and genetic manipulation in male Swiss mice. Cisplatin causes painful symptoms and impaired working and spatial memory. Kinin B₁ (DALBK) and B₂ (Icatibant) receptor antagonists attenuated some painful parameters. Local administration of kinin B₁ and B₂ receptor agonists (in sub-nociceptive doses) intensified the cisplatin-induced mechanical nociception attenuated by DALBK and Icatibant, respectively. In addition, antisense oligonucleotides to kinin B₁ and B₂ receptors reduced cisplatin-induced mechanical allodynia. Thus, kinin B₁ and B₂ receptors appear to be potential targets for the treatment of cisplatin-induced painful symptoms and may improve patients’ adherence to treatment and their quality of life. Full article

(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine)

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Open AccessArticle

Clinical and Electrophysiological Changes in Pediatric Spinal Muscular Atrophy after 2 Years of Nusinersen Treatment

Cristina Manuela Drăgoi

Alina Crenguța Nicolae

and

Daniela Adriana Ion

Pharmaceutics 2022, 14(10), 2074; https://doi.org/10.3390/pharmaceutics14102074 - 29 Sep 2022

Cited by 2 | Viewed by 1425

Abstract

In the new therapeutic era, disease-modifying treatment (nusinersen) has changed the natural evolution of spinal muscular atrophy (SMA), creating new phenotypes. The main purpose of the retrospective observational study was to explore changes in clinical evolution and electrophysiological data after 2 years of nusinersen treatment. We assessed distal compound motor action potential (CMAP) on the ulnar nerve and motor abilities in 34 SMA patients, aged between 1 and 16 years old, under nusinersen treatment, using specific motor scales for types 1, 2 and 3. The evaluations were performed at treatment initiation and 26 months later. There were registered increased values for CMAP amplitudes after 2 years of nusinersen, significantly correlated with motor function evolution in SMA type 1 patients (p < 0.005, r = 0.667). In total, 45% of non-sitters became sitters and 25% of sitters became walkers. For SMA types 1 and 2, the age at the treatment initialization is highly significant (p < 0.0001) and correlated with treatment yield. A strong negative correlation (r = −0.633) was observed for SMA type 1 and a very strong negative correlation (r = −0.813) for SMA type 2. In treated SMA cases, the distal amplitude of the CMAP and motor functional scales are important prognostic factors, and early diagnosis and treatment are essential for a better outcome. Full article

(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine)

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Review

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Open AccessReview

DNA and RNA Molecules as a Foundation of Therapy Strategies for Treatment of Cardiovascular Diseases

Ljiljana Rakicevic

Pharmaceutics 2023, 15(8), 2141; https://doi.org/10.3390/pharmaceutics15082141 - 15 Aug 2023

Viewed by 468

Abstract

There has always been a tendency of medicine to take an individualised approach to treating patients, but the most significant advances were achieved through the methods of molecular biology, where the nucleic acids are in the limelight. Decades of research of molecular biology resulted in setting medicine on a completely new platform. The most significant current research is related to the possibilities that DNA and RNA analyses can offer in terms of more precise diagnostics and more subtle stratification of patients in order to identify patients for specific therapy treatments. Additionally, principles of structure and functioning of nucleic acids have become a motive for creating entirely new therapy strategies and an innovative generation of drugs. All this also applies to cardiovascular diseases (CVDs) which are the leading cause of mortality in developed countries. This review considers the most up-to-date achievements related to the use of translatory potential of DNA and RNA in treatment of cardiovascular diseases, and considers the challenges and prospects in this field. The foundations which allow the use of translatory potential are also presented. The first part of this review focuses on the potential of the DNA variants which impact conventional therapies and on the DNA variants which are starting points for designing new pharmacotherapeutics. The second part of this review considers the translatory potential of non-coding RNA molecules which can be used to formulate new generations of therapeutics for CVDs. Full article

(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine)

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Open AccessReview

Applications of Exosomes in Diagnosing Muscle Invasive Bladder Cancer

Jillian Marie Walker

Padraic O’Malley

and

Mei He

Pharmaceutics 2022, 14(10), 2027; https://doi.org/10.3390/pharmaceutics14102027 - 23 Sep 2022

Cited by 3 | Viewed by 1735

Abstract

Muscle Invasive Bladder Cancer (MIBC) is a subset of bladder cancer with a significant risk for metastases and death. It accounts for nearly 25% of bladder cancer diagnoses. A diagnostic work-up for MIBC is inclusive of urologic evaluation, radiographic imaging with a CT scan, urinalysis, and cystoscopy. These evaluations, especially cystoscopy, are invasive and carry the risk of secondary health concerns. Non-invasive diagnostics such as urine cytology are an attractive alternative currently being investigated to mitigate the requirement for cystoscopy. A pitfall in urine cytology is the lack of available options with high reliability, specificity, and sensitivity to malignant bladder cells. Exosomes are a novel biomarker source which could resolve some of the concerns with urine cytology, due to the high specificity as the surrogates of tumor cells. This review serves to define muscle invasive bladder cancer, current urine cytology methods, the role of exosomes in MIBC, and exosomes application as a diagnostic tool in MIBC. Urinary exosomes as the specific populations of extracellular vesicles could provide additional biomarkers with specificity and sensitivity to bladder malignancies, which are a consistent source of cellular information to direct clinicians for developing treatment strategies. Given its strong presence and differentiation ability between normal and cancerous cells, exosome-based urine cytology is highly promising in providing a perspective of a patient’s bladder cancer. Full article

(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine)

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