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Pharmaceuticals
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Impacts of Constituent Material Variability on the Performance and Quality...
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Impacts of Constituent Material Variability on the Performance and Quality of Pharmaceutical Dosage Forms

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

Deadline for manuscript submissions: closed (30 November 2021) | Viewed by 5520

Special Issue Editor

Dr. Abina Crean

E-Mail Website
Guest Editor
University College Cork, Cork, Ireland
Interests: formulation science; dosage form design; quality by design; material characterisation, process development; process control; process analytical technology (PAT); process modelling; continuous processing

Special Issue Information

Dear Colleagues,

The performance and quality of pharmaceutical dosage forms are dependent on both the properties of constituent materials (API and excipients) and the manufacturing process. Investigation of the physical and chemical relationships between pharmaceutical materials, process factors and drug product performance is necessary to achieve the level of process understanding required to inform robust quality control strategies. Understanding the impact of material variability on dosage form performance and identifying critical material attributes are central to the quality by design (QbD) approach to drug development. Monitoring critical material attributes and adjusting process parameters to compensate for material variability, by the application of process models, is a key aspect of Quality by Control (QbC) during drug product manufacture. The advent of drug product continuous manufacture, together with the pharmaceutical sector’s evolution towards QbC and Pharma 4.0, has increased the need for an advanced understanding of how the variability of constituent material properties impacts drug product performance and quality. This Special Issue aims to summarize the latest advances in Process Analytical Technology (PAT) techniques to study variability in constituent pharmaceutical materials, present the latest findings highlighting the impact of material variability on drug product performance as well the design of process models to control for material variability and finally elucidate future directions.

Dr. Abina Crean
Guest Editor

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

  • dosage form
  • drug product
  • drug substance
  • excipient
  • critical material attributes
  • quality by design
  • process control
  • process analytical technology (PAT)
  • process modelling

Published Papers (2 papers)

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Research

14 pages, 6815 KiB  
Article
The Investigation of Thymol Formulations Containing Poloxamer 407 and Hydroxypropyl Methylcellulose to Inhibit Candida Biofilm Formation and Demonstrate Improved Bio-Compatibility
by Enas Al-Ani and Wayne Heaselgrave
Pharmaceuticals 2022, 15(1), 71; https://doi.org/10.3390/ph15010071 - 05 Jan 2022
Cited by 5 | Viewed by 1474
Abstract
The aim of this study was to investigate the potential of thymol to inhibit Candida biofilm formation and improve thymol biocompatibility in the presence of hydroxypropyl methylcellulose (HPMC) and poloxamer 407 (P407), as possible drug carriers. Thymol with and without polymers were tested [...] Read more.
The aim of this study was to investigate the potential of thymol to inhibit Candida biofilm formation and improve thymol biocompatibility in the presence of hydroxypropyl methylcellulose (HPMC) and poloxamer 407 (P407), as possible drug carriers. Thymol with and without polymers were tested for its ability to inhibit biofilm formation, its effect on the viability of biofilm and biocompatibility studies were performed on HEK 293 (human embryonic kidney) cells. Thymol showed a concentration dependent biofilm inhibition; this effect was slightly improved when it was combined with HPMC. The Thymol-P407 combination completely inhibited the formation of biofilm and the antibiofilm effect of thymol decreased as the maturation of Candida biofilms increased. The effect of thymol on HEK 293 cells was a loss of nearly 100% in their viability at a concentration of 250 mg/L. However, in the presence of P407, the viability was 25% and 85% using neutral red uptake and sulforhodamine B assays, respectively. While, HPMC had less effect on thymol activity the thymol-P407 combination showed a superior inhibitory effect on biofilm formation and better biocompatibility with human cell lines. The combination demonstrates a potential medical use for the prevention of Candida biofilm formation. Full article
(This article belongs to the Special Issue Impacts of Constituent Material Variability on the Performance and Quality of Pharmaceutical Dosage Forms)
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21 pages, 2896 KiB  
Article
In Situ-Forming Microparticles for Controlled Release of Rivastigmine: In Vitro Optimization and In Vivo Evaluation
by Mohamed Haider, Ibrahim Elsayed, Iman S. Ahmed and Ahmed R. Fares
Pharmaceuticals 2021, 14(1), 66; https://doi.org/10.3390/ph14010066 - 14 Jan 2021
Cited by 13 | Viewed by 3485
Abstract
In this work, sucrose acetate isobutyrate (SAIB) and polylactic co-glycolic acid (PLGA) were used alone or in combination as a matrix-former (MF) to prepare long-acting injectable rivastigmine (RV) in situ-forming microparticles (ISM). RV-ISM were prepared by the emulsification of an internal [...] Read more.
In this work, sucrose acetate isobutyrate (SAIB) and polylactic co-glycolic acid (PLGA) were used alone or in combination as a matrix-former (MF) to prepare long-acting injectable rivastigmine (RV) in situ-forming microparticles (ISM). RV-ISM were prepared by the emulsification of an internal phase, containing the drug and the matrix former(s), into an external oily phase containing a stabilizer. The statistical design, Central Composite Design (CCD), was adopted as a quality by design (QbD) approach to optimize the formulation of RV-ISM systems. The fabricated RV-ISM systems was designed to minimize the initial burst drug release and maximize the sustainment of RV release from the ISM and ease of injection. The influence of critical formulation variables such as the matrix-former to drug (MF/D) ratio and SAIB to PLGA (S/P) ratio in the internal phase with respect to critical quality attributes (CQAs), such as the percentage drug release within the first day (Q1), the time required for 50% drug release (T50%) and the rate of injection, were studied using the CCD. The optimal RV-ISM system with the highest desirability value (0.74) was predicted to have an MF/D ratio of 11.7:1 (w/w) and an S/P ratio of 1.64:1 (w/w). The optimal RV-ISM system was assessed for its release profile, injectability, rheological properties, morphology, effect on cell viability, tolerance to γ-sterilization and in vivo performance in male albino rabbits. In vitro release studies revealed that the optimal RV-ISM system released 100% of its drug content throughout a release period of 30 days with only 15.5% drug release within the first day (Q1) and T50% of 13.09 days. Moreover, the optimal system showed a high injection rate of 1.012 mL/min, pseudoplastic flow, uniform spherical globules with homogenous particle size, minimal cytotoxicity and high tolerability to γ-sterilization. In vivo pharmacokinetic (PK) studies revealed that the rate of absorption of RV from the optimal RV-ISM system was controlled compared to a drug solution following either intramuscular (IM) or subcutaneous (SC) injection. Furthermore, the optimal RV-ISM was found to follow flip-flop PK with poor correlation between in vitro release and in vivo findings. These findings suggest that the optimal RV-ISM is a promising tool to achieve a sustained release therapy for RV; however, further investigation is still required to optimize the in vivo performance of RV-ISM. Full article
(This article belongs to the Special Issue Impacts of Constituent Material Variability on the Performance and Quality of Pharmaceutical Dosage Forms)
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