Editorial Board Members’ Collection Series: New Techniques for Characterization of Drugs and Drug Products

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 5100

Special Issue Editors


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UCIBIO/REQUIMTE, MedTech-Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Rua Jorge Viterbo Ferreira nº 228, 4050-313 Porto, Portugal
Interests: antioxidants; natural products; sunscreens and anti-aging cosmetics; phototoxicity; photostability and photoprotection; mechanical and sensory characterization of topical formulations; patient centric design of topical products; health literacy in cosmetology
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Irma Lerma Rangel College of Pharmacy, Department of Pharmaceutical Sciences, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USA
Interests: formulation development; manufacturing science; process monitoring; drug delivery; immediate and modified release dosage forms; 3D printing; regulatory science; multivariate analysis
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

We are pleased to announce this collection entitled “Editorial Board Members' Collection Series: New Techniques for Characterization of Drugs and Drug Products”. This Special Issue will be a collection of papers by researchers invited by the Editorial Board Members. The aim is to provide a venue for networking and communication between Pharmaceuticals and scholars in the field of new techniques for the characterization of drugs and drug products. All papers will be fully open access upon publication after peer review.

Dr. Isabel Martins De Almeida
Dr. Ziyaur Rahman
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

  • X-ray Micro-CT
  • atomic force microscopy
  • hyperspectroscopy
  • NIR Chemical imaging
  • Raman chemical imaging
  • on-line monitoring tools
  • X-ray powder diffraction
  • single crystal X-ray diffraction
  • small and wide angle X-ray diffraction
  • solid-state NMR

Published Papers (4 papers)

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Research

16 pages, 3412 KiB  
Article
Evaluation of the Ejection Pressure for Tracking Internal Cracks during Compaction in Bilayer Tablet Formulations Using Experimental and Finite Element Methods
by Sun Ho Kim, Su Hyeon Han, Jong-Seok Oh, Dong-Wan Seo and Myung Joo Kang
Pharmaceuticals 2024, 17(3), 330; https://doi.org/10.3390/ph17030330 - 02 Mar 2024
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Abstract
This study aimed to evaluate the ejection pressure and the correlation of the findings with the occurrence of internal cracks within bilayer tablets (BLTs) consisting of metformin HCl (MF) and evogliptin tartrate (EG). Then, the mechanism of tablet failure was provided by the [...] Read more.
This study aimed to evaluate the ejection pressure and the correlation of the findings with the occurrence of internal cracks within bilayer tablets (BLTs) consisting of metformin HCl (MF) and evogliptin tartrate (EG). Then, the mechanism of tablet failure was provided by the finite element method (FEM). The ejection pressure and the difference in diameter depending on MAIN-P were evaluated to understand the correlation between ejection pressure and change in the BLT internal structure. The ejection pressure and the difference in diameter increased as the MAIN-P increased, then steeply decreased from 350 MPa to 375 MPa of MAIN-P, despite there being no pattern in compaction breaking force and porosity. The mechanical integrity at the BLT interface was weakened by internal cracks, reducing ejection pressure. The stress distribution analysis during the compression revealed that crack formation caused by entrapped air located at the center of the BLT interface may not propagate due to concentrated stress, which promotes a tight bond at the edge of the BLT. Furthermore, complete delamination can occur in the ejection process due to localized and intensive shear stresses at the BLT interface. These findings indicate that the mechanisms of internal cracking and delamination were successfully confirmed by FEM simulation. Moreover, measuring ejection pressure before BLT manufacturing can prevent invisible tablet cracks without damaging the tablets. Full article
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13 pages, 4466 KiB  
Article
Application of NIR Spectroscopy for the Valorisation of Cork By-Products: A Feasibility Study over the Screening and Discrimination of Chemical Compounds of Interest
by Ricardo N. M. J. Páscoa, Cláudia Pinto, Liliana Rego, Joana Rocha e. Silva, Maria E. Tiritan, Honorina Cidade and Isabel F. Almeida
Pharmaceuticals 2024, 17(2), 180; https://doi.org/10.3390/ph17020180 - 30 Jan 2024
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Abstract
Quercus suber is considered a sustainable tree mainly due to its outer layer (cork) capacity to regenerate after each harvesting cycle. Cork bark is explored for several application; however, its industrial transformation generates a significant amount of waste. Recently, cork by-products have been [...] Read more.
Quercus suber is considered a sustainable tree mainly due to its outer layer (cork) capacity to regenerate after each harvesting cycle. Cork bark is explored for several application; however, its industrial transformation generates a significant amount of waste. Recently, cork by-products have been studied as a supplier of bioactive ingredients. This work aimed to explore whether near infrared spectroscopy (NIRS), a non-destructive analysis, can be employed as a screening device for selecting cork by-products with higher potential for bioactives extraction. A total of 29 samples of cork extracts were analysed regarding their qualitative composition. Partial least squares (PLS) models were developed for quantification purposes, and R2P and RER values of 0.65 and above 4, respectively, were obtained. Discrimination models, performed through PLS-DA, yielded around 80% correct predictions, revealing that four out of five of samples were correctly discriminated, thus revealing that NIR can be successfully applied for screening purposes. Full article
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16 pages, 3332 KiB  
Article
The Effect of Compression Pressure on the First Layer Surface Roughness and Delamination of Metformin and Evogliptin Bilayer and Trilayer Tablets
by Sun Ho Kim, Jung Han Kook, Dong-Wan Seo and Myung Joo Kang
Pharmaceuticals 2023, 16(11), 1523; https://doi.org/10.3390/ph16111523 - 26 Oct 2023
Cited by 1 | Viewed by 1332
Abstract
The objectives of this study were to evaluate the delamination of convex-shaped metformin HCl (MF) and evogliptin tartrate (EG) multi-layer tablets depending on the pre-compression and main compression pressures and simultaneously correlate these results with those of a surface roughness analysis. Free-flowing MF [...] Read more.
The objectives of this study were to evaluate the delamination of convex-shaped metformin HCl (MF) and evogliptin tartrate (EG) multi-layer tablets depending on the pre-compression and main compression pressures and simultaneously correlate these results with those of a surface roughness analysis. Free-flowing MF and EG (median diameters of 38.3 and 44.7 μm, respectively) granules prepared using the wet granulation method were pre-compressed and subsequently compressed into bilayer and trilayer tablets using a universal testing machine. The compaction force required to break the tablets increased linearly as the main compression pressure increased (30–150 MPa). Conversely, the interfacial strength and compaction breaking force decreased as the pre-compression pressure increased (10–110 MPa). A surface roughness analysis employing a profilometer revealed that the first layer (MF) roughness drastically decreased from 5.89 to 0.51 μm (Ra, arithmetic average of profile height deviations from the mean line) as the pre-compression pressure increased from 10 to 150 MPa in the bilayer tablet. Accordingly, the decrease in the roughness of the first layer reduced the inter-penetration at the interface, as observed via energy dispersive spectrometer (EDS)-equipped scanning electron microscopy, decreasing the interfacial bonding strength and causing delamination of the MF/EG multi-layer tablets. These findings indicate the significance of roughness control in the actual preparation of multi-layer tablets and the usefulness of profilometer- and EDS-based surface analyses for interpreting the delamination of multi-layer tablets. Full article
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11 pages, 2497 KiB  
Article
Coupling of NIR Spectroscopy and Chemometrics for the Quantification of Dexamethasone in Pharmaceutical Formulations
by Alessandra Biancolillo, Claudia Scappaticci, Martina Foschi, Claudia Rossini and Federico Marini
Pharmaceuticals 2023, 16(2), 309; https://doi.org/10.3390/ph16020309 - 16 Feb 2023
Cited by 2 | Viewed by 1850
Abstract
Counterfeit or substandard drugs are pharmaceutical formulations in which the active pharmaceutical ingredients (APIs) have been replaced or ingredients do not comply with the drug leaflet. With the outbreak of the COVID-19 pandemic, fraud associated with the preparation of substandard or counterfeit drugs [...] Read more.
Counterfeit or substandard drugs are pharmaceutical formulations in which the active pharmaceutical ingredients (APIs) have been replaced or ingredients do not comply with the drug leaflet. With the outbreak of the COVID-19 pandemic, fraud associated with the preparation of substandard or counterfeit drugs is expected to grow, undermining health systems already weakened by the state of emergency. Analytical chemistry plays a key role in tackling this problem, and in implementing strategies that permit the recognition of uncompliant drugs. In light of this, the present work represents a feasibility study for the development of a NIR-based tool for the quantification of dexamethasone in mixtures of excipients (starch and lactose). Two different regression strategies were tested. The first, based on the coupling of NIR spectra and Partial Least Squares (PLS) provided good results (root mean square error in prediction (RMSEP) of 720 mg/kg), but the most accurate was the second, a strategy exploiting sequential preprocessing through orthogonalization (SPORT), which led (on the external set of mixtures) to an R2pred of 0.9044, and an RMSEP of 450 mg/kg. Eventually, Variable Importance in Projection (VIP) was applied to interpret the obtained results and determine which spectral regions contribute most to the SPORT model. Full article
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