Browsing by Author "Dube, Admire"
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Item A Comprehensive Study on the Global Regulatory Requirements for the submission of a Post-Approval Change, specifically a Change in Manufacturing Site(University of the Western Cape, 2017) Hoey, Barbara; Dube, AdmireRegulatory requirements for post-approval changes vary for different countries around the world. It is a challenging and costly process for pharmaceutical companies to manage changes to the approved regulatory dossier over the lifecycle of the product when it is registered in many countries. In practice the process can be complex, unpredictable and time consuming because of regional differences and frequent changes in regulatory procedures, requirements and timelines. The global regulatory requirements for the submission of a post-approval change, specifically a change in manufacturing site, were reviewed for six jurisdictions for this study. These include United States of America (US), Europe (EU), South Africa, Brazil, Russia and China. The study centred on the differences in the documentation required when submitting a post-approval change for a change in manufacturing site in these countries. The study compared and contrasted the differences and similarities between the jurisdictions. An analysis of the challenges for implementation of the change was performed. The study also examined what resources a company may need in order to meet the requirements. Some notable similarities but also many differences in the post-approval submission requirements between the countries were identified. Some of the similarities included classification of the type of variation, the submission application process, and the requirement to provide supportive stability data and updates to the common technical dossier (CTD). Differences highlighted were the types of application forms required, the amount of stability data required to support the change and the time lines for review of post-approval changes in each jurisdiction. The challenge for pharmaceutical companies arises in the effective management of these differences. Investment in a robust regulatory change management team is an essential resource requirement for pharmaceutical companies. Adoption of a QbD approach and careful consideration of the global requirements during the product development phase could potentially be of use in strategic planning within a company in order to ensure continued product access globally.Item Antimicrobial, anticancer and catalytic activities of green synthesized Avocado seed extract-gold nanoparticles(University of the Western Cape, 2019) Ngungeni, Yonela; Madiehe, Abram; Dube, AdmireNature through billions of years of trial and error has produced an immeasurable amount of natural systems like plants, birds and animals. The intelligence of nature is hidden in these natural systems and researchers are turning towards “Nature’s intelligence” to find inspiration and advance novelty in the development of nanomaterials. Gold nanoparticles (AuNPs) have unique optical, electronic and physicochemical features which has gained them popularity and widespread exploitation in various applications. The conventional methods used for AuNPs synthesis employs toxic chemicals which makes these NPs unsafe for biomedical applications. Hence, there is a search for new, ‘green’ and more cost effective methods for AuNPs synthesis. Plant extracts are regarded as a highly desirable system for nanoparticle synthesis due to their tremendous capability to produce a wide range of phytochemicals that can act as reducing agents. The main goal of this study was to synthesize AuNPs in a cost effective manner without the use of toxic chemicals in the synthesis process. Avocado seeds which are an agricultural waste by-product were used for the biosynthesis of AuNPs. The study reports on the synthesis optimization, characterization and activities of the biogenic AuNPs. The avocado seed extract mediated - AuNPs (AvoSE-AuNPs) were optimized by varying reaction parameters and characterized by UV-visible, Dynamic Light Scattering (DLS) and High Resolution Transmission Electron Microscopy (HRTEM), Zetasizer and Fourier Transform Infrared Spectroscopy (FTIR). The formation of AvoSE-AuNPs had an absorption maximum at 534 nm. HRTEM and DLS confirmed that the NPs were polydispersed and present in different shapes. The presence of phytochemical constituents on the AvoSE-AuNPs were confirmed by FTIR. Their potential antibacterial activity was tested on bacterial strains known to exhibit resistance to a number of current antibiotics. The catalytic activity of AvoSE-AuNPs was also assessed as a means to contribute to the development of new methods aimed at alleviating organic pollutants such as nitrophenols in the environment. The AvoSE-AuNPs demonstrated excellent catalytic activity in the reduction of 4-NP by NaBH4 as shown by the rapid decrease in the nitrophenolate absorption band at 400 nm and the appearance of new absorption band at 298 nm, revealing the formation of the 4-aminophenol. Furthermore, the rate constants calculated demonstrated that the reaction occurs faster in the presence AvoSEAuNPs. The AvoSE-AuNPs showed low significant cytotoxicity. Cell cycle analysis was conducted to further investigate the apparent exhibited toxicity of the AvoSE-AuNPs. The results showed that in both cell lines treated with AvoSE-AuNPs and AvoSE there was a ii | P a g e disruption in the regulation of cell cycle. Cell cycle analysis helped improve understanding of the low cytotoxicity observed by the MTT assay results. The results presented in this study clearly demonstrate the feasibility of using AvoSE for the synthesis of AuNPs. This study demonstrated that AvoSE mediated AuNPs synthesis is a greener alternative as it abides by the green chemistry principles. Furthermore, the study outcomes contributed to minimizing environmental pollution by finding use for agricultural waste and thus ultimately adding value to the field.Item Clinically relevant metallic nanoparticles in tuberculosis diagnosis and therapy(John Wiley and Sons Inc, 2024) Akinnawo, Christianah Aarinola; Dube, AdmireGlobally a significant burden of tuberculosis (TB) is faced, which is difficult to eradicate due to patients' non-adherence, and drug-resistant strains that are spreading at an alarming rate. Novel approaches are required to improve diagnosis and treatment. Metallic nanoparticles (MNPs) have demonstrated potential as sensor probes and in combination therapy, which combines MNPs with antimycobacterial drugs to develop new treatment and theranostic approaches. To strengthen the theoretical foundation toward the clinical application of TB nanomedicine, this review focuses on the properties and effectiveness of therapeutically relevant MNPs. It also elaborates on their antimycobacterial mechanisms. This review aims to analyze the body of literature on the topic, pinpoint important empirical findings, and identify knowledge gaps that can provide a basis for future research endeavors and translation of the technologies. Current data suggest that MNPs are potential systems for efficient diagnosis and treatment although additional pre-clinical and clinical research is needed to bring these technologies to the clinic.Item Comparative study on the topical and transdermal delivery of diclofenac incorporated in nano-emulsions, nano-emulgels, and a colloidal suspension(Springer, 2022) Dube, Admire; Louw, Estelle-Vionè; Liebenberg, WilnaTransdermal delivery of active pharmaceutical ingredients (APIs) can be challenging, since the skin possesses a rate-limiting barrier, which may be overcome when APIs possess certain ideal physicochemical properties. The lack thereof would require that APIs be included in drug delivery vehicles to enhance skin permeation. Hence, diclofenac was incorporated into various drug delivery vehicles (i.e., nano-emulsions, nano-emulgels, and a colloidal suspension containing drug-loaded nanoparticles) to investigate the transdermal delivery thereof, while nano-emulsions and nano-emulgels had varying concentrations of evening primrose oil (EPO). The aim of the study was to compare the topical and transdermal diclofenac delivery from the different types of vehicles and to investigate the influence the different EPO concentrations had on diclofenac delivery. After characterization, membrane release studies were performed (to determine whether the API was successfully released from the vehicle) followed by in vitro skin diffusion studies and tape stripping (to establish whether the vehicles assisted the API in reaching the target site (transdermal delivery)). Lastly, cytotoxicity studies were conducted via methyl thiazolyl tetrazolium (MTT) and neutral red (NR) assays on human keratinocyte (HaCaT) cells. Results showed minimal cytotoxic effects at concentrations equivalent to that which had permeated through the skin, while the membrane release and in vitro skin diffusion studies indicated that the nano-emulsions and the 10% EPO vehicles increased API release and diffusion when compared to the other vehicles. However, the colloidal suspension had the highest concentrations of API within the skin. Hence, all the vehicles were non-toxic and effectively delivered diclofenac through the transdermal route.Item Design and evaluation of fast dispersible tablets of lamivudine using selected natural superdisintegrants(University of the Western Cape, 2018) Noutchang, Yves Roland Tchakounte; Samsodien, Halima; Dube, AdmireFast dispersible tablets (FDTs) are solid single-unit dosage forms that are placed in the mouth and allowed to disperse or dissolve in the saliva without the need of water. The basic approach to formulating FDTs consists of adding a superdisintegrant to a tablet formulation. These tablets offer both the advantages of conventional tablets and liquid dosage forms along with distinctive properties which include accurate dosing, ease of administration, quick onset of action, enhanced bioavailability, and increased patient adherence. FDTs have been found to be effective in remedying therapeutic in-adherence caused by dysphagia (swallowing difficulties) particularly in paediatric and geriatric subjects. There is a strong correlation between therapeutic success and patient adherence especially with HIV/AIDS treatment regimens, consequently the dosage form should be patient friendly and devoid of unappealing characteristics. This study aimed at developing a cost effective fast dispersible tablet of lamivudine using alternative excipients and conventional techniques. Only conventional tablets and oral liquid dosage forms of lamivudine are available on the South African market. Two natural polymers reported to have superdisintegrating properties were selected to serve as multipurpose excipients in this study. The polymers were identified, characterised and compared using thermal, spectroscopic and micromeritic analytical tools. The polymer that displayed the best characteristics in terms of micromeritic, tableting and disintegrating properties was retained and used for the optimum formulation. The optimum formulation was composed of 150 mg of lamivudine, 23% w/w unripe banana powder and 2% w/w magnesium stearate. FDTs of lamivudine were obtained using the compression technique with and without wet granulation. The tablets were assessed as per the United States Pharmacopoeia (USP) guidelines and other evaluation procedures pertaining to FDTs. The wet granulated tablets were found to be less friable and thus more resilient than the directly compressed tablets. In-vitro disintegration of the wet granulated tablets occurred within 50±3 sec in deionised water (pH 7) and 35±2 sec in a phosphate buffer solution (pH 6.8). Consequently, the innovative tablets fulfilled the core requirement of FDTs i.e. rapid disintegration. Drug release studies were carried out by analysing dissolution aliquots of the innovative tablets using a validated High Performance Liquid Chromatography (HPLC) method, and comparing them to Aspen Lamivudine®, a conventional tablet of lamivudine presently on the South African market. Complete dissolution in deionised water (pH 7) was attained within 10 minutes and 30 minutes for the innovative tablets and Aspen Lamivudine® respectively.Item The design, preparation and evaluation of Artemisia Afra and placebos in tea bag dosage form suitable for use in clinical trials(University of the Western Cape, 2006) Dube, Admire; Syce, James A.; School of Pharmacy; Faculty of ScienceArtemisia Afra, a popular South African traditional herbal medicine is commonly administered as a tea infusion of the leaves. However, clinical trials proving it safety and efficacy are lacking mainly due to the absence of good quality dosage forms and credible placebos for the plant. The objectives of this study were to prepare a standardized preparation of the plant leaves and freeze-dried aqueous extract powder of the leaves, in a tea bag dosage form and to design and prepare credible placebos for these plant materials.Item The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges(Frontiers in medicine, 2023) Ncube, Bakani Mark; Dube, Admire; Ward, KimIntroduction: In 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States. Methods: This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of Anglophone and Francophone AU Member States. The heads of NRAs and a senior competent person were contacted to complete self-administered questionnaires. Results: The perceived benefits of model law implementation include enabling the establishment of an NRA, improving NRA governance and decision-making autonomy, strengthening the institutional framework, having streamlined activities which attract support from donors, as well as enabling harmonisation, reliance, and mutual recognition mechanisms. The factors enabling domestication and implementation are the presence of political will, leadership, and advocates, facilitators, or champions for the cause. Additionally, participation in regulatory harmonisation initiatives and the desire to have legal provisions at the national level that allow for regional harmonisation and international collaboration are enabling factors. The challenges encountered in the process of domesticating and implementing the model law are the lack of human and financial resources, competing priorities at the national level, overlapping roles of government institutions, and the process of amending/repealing laws being slow and lengthy. Conclusion: This study has enabled an improved understanding of the AU Model Law process, the perceived benefits of its domestication, and the enabling factors for its adoption from the perspective of African NRAs. NRAs have also highlighted the challenges encountered in the process. Addressing these challenges will result in a harmonised legal environment for medicines regulation in Africa and be an important enabler for the effective operation of the African Medicines Agency.Item The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges(Frontiers Media, 2023) Ncube, Bakani Mark; Dube, Admire; Ward, KimIn 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States.Item Electronic nicotine delivery systems : approach to regulation in South Africa(University of the Western Cape, 2015) Omarjee, Momeena; Dube, AdmireBackground: The explosion in the popularity and use of e- cigarettes over the last decade has raised concerns and incited intense discussions over their safety, efficacy and potential public health impact. Globally there is dramatic variation in the approach to regulation, with certain jurisdictions attempting to regulate e-cigarettes either as tobacco products, medicines, consumer products or poisons whilst others have banned their use and sale. The aim of this study was to review the e-cigarette regulatory strategies adopted by the World Health Organisation, Australia, European Union and United States in an attempt to identify feasible approaches to the regulation of e-cigarettes in South Africa within the context of existing institutional regulatory frameworks. Methods: The principles of an explorative comprehensive literature-based review using a thematic qualitative approach were employed. The primary method of data collection was documentation, collected and selected using document review and analysis. Results: The strategies between jurisdictions studied vary significantly in their approach to e-cigarette regulation with each equally facing challenges and massive criticism. The South African approach to the medicalisation of e-cigarettes when evaluated against the WHO FCTC regulatory objectives was found to be ineffective and warrants a change in strategy. Within the existing medicine and tobacco product regulatory frameworks, SA has the option to regulate e-cigarettes as: (1) medicine; (2) tobacco products; or (3) an amalgam of the two approaches. Conclusion: The most expeditious way for SA to regulate e-cigarettes immediately, in the absence of robust scientific data would be to implement a hybrid approach - regulation as a medicine when marketed for therapeutic use and as tobacco products when used recreationally.Item Establishment of the African Medicines Agency: Progress, challenges and regulatory readiness(Springer Nature, 2021) Ncube, Bakani Mark; Dube, Admire; Ward, KimInsufcient access to quality, safe, efcacious and afordable medical products in Africa has posed a signifcant challenge to public health for decades. In part, this is attributed to weak or absent policies and regulatory systems, a lack of competent regulatory professionals in National Medicines Regulatory Authorities (NMRAs) and inefective regional collaborations among NMRAs. In response to national regulatory challenges in Africa, a number of regional harmonisation eforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the AU Model Law on Medical Products Regulation. The goals of the model law include to increase collaboration across countries and to facilitate the overall regional harmonisation process. The AMRH initiative is proposed to serve as the foundation for the establishment of the African Medicines Agency (AMA). The AMA will, as one of its mandates, coordinate the regional harmonisation systems that are enabled by AU Model Law domestication and implementation. In this paper, we review the key entities involved in regional and continental harmonisation of medicines regulation, the milestones achieved in establishing the AMA as well as the implementation targets and anticipated challenges related to the AU Model Law domestication and the AMA’s establishment. This review shows that implementation targets for the AU Model Law have not been fully met, and the AMA treaty has not been ratifed by the minimum required number of countries for its establishment. In spite of the challenges, the AU Model Law and the AMA hold promise to address gaps and inconsistencies in national regulatory legislation as well as to ensure efective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level. Furthermore, this review provides recommendations for future research.Item Evaluation of the effect of polyethylene glycol incorporation on the performance of poly(lactic-co-glycolic acid) nanoparticles(University of the Western Cape, 2016) Samkange, Tendai; Dube, AdmireNanoparticle drug delivery is challenged by the binding of proteins in blood which result in their rapid removal from the circulatory system. Nanoparticles engineered to delay protein binding have shown to have extended circulatory times. One such engineering technique is PEGylation, which is the coating of nanoparticles with polyethylene glycol (PEG). PEG shields the nanoparticle from adhesive interactions with proteins. However, the optimal PEG content required to impart this "stealth" property onto poly(lactic-co-glycolic acid) (PLGA) nanoparticles, is unknown. Moreover, the effect of PEGylation on drug release has not been thoroughly investigated.Item Formulation and evaluation of the biocompatibility of chitosan-dextran nanoparticles using a blood-brain barrier model(University of the Western Cape, 2018) Ntwatwa, Ziphozihle; Dube, AdmireCentral nervous system (CNS) infections are a therapeutic challenge. This is partly due to insufficient drug penetration across the blood-brain barrier (BBB). The BBB is a specialized, highly selective, metabolically active physiological barrier that regulates the movement of molecules into-and-out of the brain. As a result, large hydrophilic antibiotics such as colistin poorly penetrate to the CNS. Colistin is an old 'last line of defence'; a gram-negative antibiotic that has seen its clinical re-emergence due to the surge of multidrug resistance (MDR) infections. However, owing to systemic toxicity, increasing the intravenous dosage, in order to obtain higher CNS penetration, is inimical. Chitosan (CS) based nanoparticles (NPs) have been proposed as drug delivery systems across the BBB. CS is a cationic, natural polysaccharide that has the ability to be complexed with multivalent polymers like dextran (DS) thus forming CS-DS NPs. Naturally, CS has remarkable inherent features such as biocompatibility, biodegradability, ability to encapsulate poorly soluble drugs and it is favourable for endothelial cell uptake. However, polymeric NPs (even those derived from natural polysaccharides) have limited use due to toxicity. Considering the vital role of the BBB, toxicity would denote dire effects on CNS functioning. Therefore, treatment of CNS infections fringes on a deeper understanding of the interactions between drug delivery systems and the BBB.Item Insights into innovative therapeutics for drug-resistant tuberculosis: Host-directed therapy and autophagy inducing modified nanoparticles(Elsevier, 2022) Khoza, Leon J.; Kumar, Pradeep; Dube, AdmireTuberculosis (TB) remains one of the deadliest communicable dis- eases caused by Mycobacterium tuberculosis (Mtb) since its discovery in the 1880s (Cambau and Drancourt, 2014; Singh et al., 2020). Over 1 billion mortalities have been recorded to date due to TB, and it was the leading cause of death from a single infectious agent before the COVID- 19 pandemic, with an estimated 10.4 million new cases and an average of 1.7 million deaths yearly (Gagneux, 2018; Barberis et al., 2017; Scriba et al., 2020; Allu ́e-Guardia et al., 2021; Organization, 2021). Further, about 25% of the world’s population are latently ill or infected, providing a substantial pool for future cases of active TB (Gagneux, 2018). The World Health Organisation (WHO) reported that in 2019 an average of 10 million new cases were recorded, with 1.2 million cases being children and an estimated total of 1.4 million mortalities (Orga- nization, 2019).Item Medicines regulatory science expertise in Africa: workforce capacity development and harmonisation activities towards the establishment of the African medicines agency(Adis, 2022) Dube, Admire; Ncube, Bakani Mark; Ward, KimThe medicines regulatory landscape in Africa is undergoing transformation with at least two countries having National Medicines Regulatory Authorities (NRAs) that operate at World Health Organization (WHO) maturity level 3. However, this represents the exception as over 90% of African NRAs have limited capacity to perform core medicine regulatory functions, have a shortage of competent regulatory professionals, have high staff turnover, lack diversity of scientific expertise, and have staffing shortages relative to the high workload. A systematic approach to developing the regulatory workforce is therefore crucial to addressing the existing shortfalls in regulatory capacity, particularly at this time when efforts are underway to operationalise the African Medicines Agency (AMA). In this article, initiatives that are building African NRAs’ regulatory capacity and developing their workforce are reviewed in preparation for work to be conducted by the AMA. We found that the African Medicines Regulatory Harmonisation (AMRH) initiative has been at the forefront of capacity building and workforce development mainly through the designation of specialised Regional Centres of Regulatory Excellence and the implementation of medicines regulatory harmonisation initiatives in regional economic communities. In addition, some NRAs within high-income countries and trusted institutions have been supporting regulators in low-income countries with registration assessments and facilitating access to quality-assured medical products through their stringent review procedures (SRPs). Capacity building has subsequently been facilitated through this active involvement of African regulators in SRPs. This article also provides recommendations for further capacity building and workforce development. © 2022, The Author(s), under exclusive licence to Springer Nature Switzerland AG.Item Nanomedicines for infectious diseases(Springer Nature, 2019) Dube, AdmireInfectious diseases continue to pose a significant threat to global health. Over 200 infectious diseases are currently known to man. Fortunately, only a handful are responsible for significant morbidity and mortality. HIV/AIDS, tuberculosis (TB) and malaria top the list of deadly infectious diseases, and worldwide, these three diseases combined, are responsible for over 3 million deaths every year (1). Outbreaks of infectious diseases are also not uncommon and examples in recent history include the Ebola virus, Zika virus and Avian flu outbreaks which originated in West Africa, South America and Asia, respectively, before spreading to other parts of the world (2–4). This further emphasizes the global concern over infectious diseases.Item Nanostructured immunosensor for low level detection of waterborne cryptosporidium(University of the Western Cape, 2022) Siwak, Andrea Martha; Dube, AdmireA major causative agent of gastrointestinal disease is Cryptosporidium, a protozoan waterborne parasite identified in over 70 countries. Cryptosporidium infection is a cause of high disease morbidity in children and the immunocompromised, with limited treatment options available for patients at risk of severe illness. The hardy nature of the organism leads to the persistence of its oocyst form in drinking water sources, with standard water treatment procedures such as chlorine disinfection and activated sludge proving inefficient for its removal from effluent water.Item Ongoing development of guidelines for biosimilar medicines assessment in Uganda: Critical evaluation and recommendations for inclusion(University of Western Cape, 2020) Nantongo, Eva; Dube, AdmireA Biosimilar is defined as a biologic product that is similar but not identical to the reference/originator biologic product. Biologic products have raised hopes of improving the quality of life especially in the treatment of chronic non-communicable diseases (NCDs). Of all the major health threats to emerge since the start of this century, none has challenged the very foundations of public health as profoundly as the rise of NCDs. However, the increasing cost of treatment of biologic products has raised many questions regarding its access in the context of multiple inequalities. The arrival of the patent cliff in this sector has given rise to biosimilars. The emergence of biosimilars is expected to go a long way in reducing the cost of care of NCDs. The use of biosimilars is based on the assumption that they are of assured quality and of the same pharmaceutical standard as the reference biologicals. Their quality should therefore be rigorously controlled and assured. Uganda has had biologicals on its market that are claimed to be copies of the originator biologicals also known as biosimilars. Most of these products have not been approved through a biosimilar approval procedure, but have instead been licensed (by the Uganda National Drug Authority (NDA)) using the same requirements as generics or small molecule medicines. According to the World Health Organization (WHO) Guidelines on the Evaluation of Similar Biotherapeutic Products, a biosimilar that has not been demonstrated to be similar to a reference product through head-to-head comparisons should not be described as similar or be called a biosimilar. Although these products are on the Ugandan market, based on the above, they cannot be referred to as biosimilars. In November 2017 however, NDA embarked on the process of developing guidelines for assessment of biologics, and a specific guideline for assessment of biosimilars.Item Perceptions of the pharmaceutical industry and regulators in South Africa towards registration harmonisation in the Southern African Development Community (SADC)(University of the Western Cape, 2021) Dhanraj, Keshnee; Dube, Admire; Ward, KimMedicines have to be regulated in an effort to monitor their quality, safety, and efficacy. The process of medicines registration is lengthy, costly, and document-heavy. Many countries have limited expertise and resources at national medicines regulatory authorities (NMRAs) and some countries have adopted unified approaches to medicines registration legislation. Harmonised guidelines and initiatives have been adopted in South Africa and the Southern African Development Community (SADC). However, there are no studies that have identified the effects of these initiatives and guidelines on major stakeholders such as the pharmaceutical industry and regulators.Item Permeation challenges of drugs for treatment of neurological tuberculosis and HIV and the application of magneto-electric nanoparticle drug delivery systems(MDPI, 2021) Fisher, David W.; Tchoula Tchokonte, Moise B.; Dube, Admire; Mhambi, SinayeThe anatomical structure of the brain at the blood-brain barrier (BBB) creates a limitation for the movement of drugs into the central nervous system (CNS). Drug delivery facilitated by magneto-electric nanoparticles (MENs) is a relatively new non-invasive approach for the delivery of drugs into the CNS. These nanoparticles (NPs) can create localized transient changes in the permeability of the cells of the BBB by inducing electroporation. MENs can be applied to deliver antiretrovirals and antibiotics towards the treatment of human immunodeficiency virus (HIV) and tuberculosis (TB) infections in the CNS. This review focuses on the drug permeation challenges and reviews the application of MENs for drug delivery for these diseases. We conclude that MENs are promising systems for effective CNS drug delivery and treatment for these diseases, however, further preclinical and clinical studies are required to achieve translation of this approach to the clinic. © 2021 by the authors. Licensee MDPI, Basel, SwitzerlandItem A perspective on nanotechnology and covid-19 vaccine research and production in south africa(MDPI, 2021) Egieyeh, Samuel; Dube, AdmireAdvances in nanotechnology have enabled the development of a new generation of vaccines, which are playing a critical role in the global control of the COVID-19 pandemic and the return to normalcy. Vaccine development has been conducted, by and large, by countries in the global north. South Africa, as a major emerging economy, has made extensive investments in nanotechnology and bioinformatics and has the expertise and resources in vaccine development and manufacturing. This has been built at a national level through decades of investment. In this perspective article, we provide a synopsis of the investments made in nanotechnology and highlight how these could support innovation, research, and development for vaccines for this disease. We also discuss the application of bioinformatics tools to support rapid and cost-effective vaccine development and make recommendations for future research and development in this area to support future health challenges.