Research Articles (School of Pharmacy)

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South African actinobacteria: a treasure trove of novel bioactive metabolites for drug discovery
(Academy of Science of South Africa, 2024) Acquah, Kojo Sekyi; Beukes, Denzil Ronwynne
Although South Africa is known as one of the most biodiverse countries in the world, based on its unique plants and animals, microorganisms have received much less attention. Microorganisms in general and actinobacteria in particular are an underexplored source of new medicines. Recent studies have demonstrated the presence of diverse cultivable actinobacteria from various biomes. However, investigations of the natural product diversity associated with these microorganisms are lacking. We hereby present a review of natural products isolated from South African actinobacteria together with their biological activities. Many of these natural products are structurally novel and include compounds belonging to the following classes: anthraquinones, isoflavonoids, ketolides, macrolides, macrolactams, tripeptides and depsipeptides. They show a wide range of biological activities including antibacterial, antifungal, cytotoxic and antitumour activities.
Progress in Pharmacometrics Implementation and Regulatory Integration in Africa: A Systematic Review
(2024) Ndzamba Bonginkosi S’fiso; Egieyehand Samuel; Fasinu Pius
The availability of clinical trial data, advocacy, and increased funding has facilitated the implementation of pharmacometrics in Africa, resulting in the establishment of additional training programs for pharmacometricians. This study conducted a systematic review to evaluate the progress made from the implementation of pharmacometrics in clinical drug development and its adoption into drug approval by regulatory authorities in Africa. We performed a comprehensive literature search using major databases such as PubMed and Google Scholar. The study included articles published until 2024, with no lower cutoff. Articles were excluded if not addressing the research question or of pharmacometrics studies done outside Africa with no collaboration with African researchers (study setting). For the review, a total of 121 articles were included for analysis. Among the reported pharmacometrics approaches, Population pharmacokinetics modeling approaches are the most used (95 (78.5%)). South Africa and Uganda researchers have the most research output in pharmacometrics in Africa (82 (89.1%) and 7 (7.61%), respectively), with the University of Cape Town (South Africa) producing the highest (71 (78.8%)) of all article in Africa. The most studied conditions are TB (43 (35.5%)), HIV (33 (27.3%), TB and HIV (22 (18.2%)), and malaria (12 (9.92%). Pharmacometrics is gaining momentum in Africa, and the progress made since inception will significantly improve the safety and efficacy of therapeutic agents used to treat HIV, TB, and other emerging conditions.
Clinically relevant metallic nanoparticles in tuberculosis diagnosis and therapy
(John Wiley and Sons Inc, 2024) Akinnawo, Christianah Aarinola; Dube, Admire
Globally 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.
Progress in pharmacometrics implementation and regulatory integration in Africa: A systematic review
(John Wiley and Sons Inc, 2024) Ndzamba, Bonginkosi S'fiso; Egieyeh, Samuel; Fasinu, Pius
The availability of clinical trial data, advocacy, and increased funding has facilitated the implementation of pharmacometrics in Africa, resulting in the establishment of additional training programs for pharmacometricians. This study conducted a systematic review to evaluate the progress made from the implementation of pharmacometrics in clinical drug development and its adoption into drug approval by regulatory authorities in Africa. We performed a comprehensive literature search using major databases such as PubMed and Google Scholar. The study included articles published until 2024, with no lower cutoff. Articles were excluded if not addressing the research question or of pharmacometrics studies done outside Africa with no collaboration with African researchers (study setting). For the review, a total of 121 articles were included for analysis. Among the reported pharmacometrics approaches, Population pharmacokinetics modeling approaches are the most used (95 (78.5%)). South Africa and Uganda researchers have the most research output in pharmacometrics in Africa (82 (89.1%) and 7 (7.61%), respectively), with the University of Cape Town (South Africa) producing the highest (71 (78.8%)) of all article in Africa. The most studied conditions are TB (43 (35.5%)), HIV (33 (27.3%), TB and HIV (22 (18.2%)), and malaria (12 (9.92%). Pharmacometrics is gaining momentum in Africa, and the progress made since inception will significantly improve the safety and efficacy of therapeutic agents used to treat HIV, TB, and other emerging conditions.
Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products
(Frontiers Media, 2024) Dube, Admire; Gwaza, Luther; Chemwolo, Andrew
Having a robust, integrated regulatory system is important for ensuring the availability of safe and efficacious medical products of good quality and for protecting public health. However, less than 30% of countries globally have reached the required regulatory maturity level three, with low- and middle-income countries facing challenges in attracting and retaining qualified staff. World Health Organization (WHO) advocates for systematic workforce development, including competency-based education, to address these gaps. We provide perspectives on a systematic approach to capacity building of medicine regulators based on the experience and lessons learnt in developing and piloting the WHO global competency framework for medicine regulators through three scenarios. A systematic approach to capacity building, such as the human performance technology model, can be used to implement the WHO competency framework as part of organizational performance improvement while ensuring that initiatives are well-defined, targeted, and aligned with organizational goals. The competency framework can be used in different contexts, such as improving organization performance for individual regulatory authorities, strengthening regional collaborations, harmonization and reliance on medical products assessment and joint good manufacturing practices inspections of pharmaceutical manufacturers, and developing learning programs for medicine regulators. A competency-based learning approach for regulatory professionals ensures the transfer of learning to the workplace by integrating real-world practices in learning activities and assessments. Further work is required to develop and validate the assessment instruments, apply the competency framework in other contexts, expanding the learning programmes while continuously providing feedback for further refinement of the competency framework and implementation support tools.
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, Wilna
Transdermal 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.
The In vitro biological activity of biosynthesized silver nanoparticles produced using mangifera indica stem bark extract and properties of Its pharmaceutical gel formulation
(Springer, 2023) Omoteso, Omobolanle A; Adeyemi, Oluwatosin E; Ajala, Tolulope O
This study reports the production of silver nanoparticles using Mangifera indica stem bark (aqueous and methanol) extracts as capping agents and formulation of pharmaceutical gel loaded with the nanoparticles. The extracts were prepared using standard procedures and utilized in biosynthesizing silver nanoparticles. Biosynthesis was ascertained through colour changes, UV–Visible and FTIR spectroscopy. Antioxidant activity of the extracts and biosynthesized nanoparticles were examined by DPPH method. The antimicrobial evaluation was carried out on Pseudomonas aeruginosa and Staphylococcus aureus. Pharmaceutical gels were produced (F1–F5), and loaded with the nanoparticles. Nanoparticles exhibited maximum absorption under UV–visible spectroscopy between 315 and 320 nm. FTIR spectrum showed that alkene and ester functional groups were conferred on the silver nanoparticles by the extracts used. The nanoparticles demonstrated antimicrobial activity against the organisms, which was significantly higher (p < 0.05) than for extracts and reference drug. The antioxidant capacity was in a concentration-dependent manner but significantly lower (p < 0.05) than that of the reference drug. Formulated gels had acceptable organoleptic profiles, pH range of 6.8–7.1, high viscosity, and pseudoplastic flow patterns. The in vitro release profiles of the gels showed was gradual, with t90 higher than 2 h. The release seemed to be influenced by the viscosity of the gel systems. In addition, the release kinetics of the nanoparticle-loaded gel systems followed Higuchi model with r2 ranging from 0.9958 to 0.9980. Mangifera indica extracts were successfully used as bio-reducing agents in the synthesis of silver nanoparticles. The gel formulations had acceptable physical properties and release profiles.
Preparation and evaluation of pralidoxime-loaded plga nanoparticles as potential carriers of the drug across the blood brain barrier
(Hindawi, 2015) Chigumira, Washington; Maposa, Prosper; Dube, Admire
Pralidoxime is an organophosphate antidote with poor central nervous system distribution due to a high polarity. In the present study, pralidoxime-loaded poly(lactic-co-glycolic acid) nanoparticles were prepared and evaluated as a potential delivery system of the drug into the central nervous system. The nanoparticles were prepared using double emulsion solvent evaporation method. Poly(lactic-co-glycolic acid) (PLGA) in ethyl acetate made the organic phase and pralidoxime in water made the aqueous phase.The system was stabilized by polyvinyl alcohol. Different drug/polymer ratios were used (1 : 1, 1 : 2, and 1 : 4) and the fabricated particles were characterized for encapsulation efficiency using UV-VIS Spectroscopy; particle size distribution, polydispersity index, and zeta potential using photon correlation spectroscopy; and in vitro drug release profile using UV-VIS Spectroscopy. Mean particle sizes were 386.6 nm, 304.7 nm, and 322.8 nm, encapsulation efficiency was 28.58%, 51.91%, and 68.78%, and zeta potential was 5.04 mV, 3.31 mV, and 5.98 mV for particles with drug/polymer ratios 1 : 1, 1 : 2, and 1 : 4, respectively. In vitro drug release profile changed from biphasic to monobasic as the drug/polymer ratio decreased from 1 : 1 to 1 : 4. Stable pralidoxime-loaded PLGA nanoparticles were produced using double emulsion solvent evaporation techniques.
Tandem lc-ms identification of antitubercular compounds in zones of growth inhibition produced by South African filamentous actinobacteria
(MDPI, 2023) Watson, Daniel J.; Wiesner, Lubbe; Beukes, Denzil
Novel antitubercular compounds are urgently needed to combat drug-resistant Mycobacterium tuberculosis (Mtb). Filamentous actinobacteria have historically been an excellent source of antitubercular drugs. Despite this, drug discovery from these microorganisms has fallen out of favour due to the continual rediscovery of known compounds. To increase the chance of discovering novel antibiotics, biodiverse and rare strains should be prioritised. Subsequently, active samples need to be dereplicated as early as possible to focus efforts on truly novel compounds. In this study, 42 South African filamentous actinobacteria were screened for antimycobacterial activity using the agar overlay method against the Mtb indicator Mycolicibacterium aurum under six different nutrient growth conditions. Known compounds were subsequently identified through extraction and high-resolution mass spectrometric analysis of the zones of growth inhibition produced by active strains. This allowed the dereplication of 15 hits from six strains that were found to be producing puromycin, actinomycin D and valinomycin.
New palladium (II) complexes from halogen substituted Schiff base ligands: Synthesis, spectroscopic, biological activity, density functional theory, and molecular docking investigations
(Inorganica Chimica Acta, 2023) Waziri, I; Oselusi, S.O; Yusuf, T.L
Two novel palladium (II) complexes Pd(L1)2 and Pd(L2)2 derived from ON donor bidentate ligands: 2-(((2-bromo-4-chlorophenyl)imino)methyl)phenol (HL1) and 2-(((-bromo-4-methylphenyl)imino)methyl)phenol (HL2) are reported. The structures of the complexes are unequivocally established using 1H NMR, 13C{H}NMR, Fourier transform-infrared, UV–Vis, TGA, elemental analysis (CHN), mass spectrometry (HRMS), and single crystal X-ray diffraction (SCXRD). The SCXRD revealed that the complexes crystallized as a monoclinic system in P2(1)/c space group, in which two ligands coordinated to one Pd(II) center via oxygen and nitrogen atoms of phenolate and imine in a bidentate fashion, resulting in a square planar geometry. The ligands and their complexes were tested for anticancer activity against breast cancer (MCF-7) and colon cancer (HT-29) cell lines, as well as their toxicity profile on HepG-2, a liver cell line, using MTT assays, and compared to 5-fluorouracil (the control). Pd(L1)2 was found to be more active and selective than Pd(L2)2, and it reduced the cancerous cells' viability by more than 70%. Pd(L2)2 reduced the viability of MCF-7 and HT-29 cell lines by more than 50%. However, the ligands were unable to reduce cancerous cell viability by more than 40%. Both complexes had no effect on the HepG-2 liver cell line at lower concentrations. The two complexes had higher antioxidant activity against DPPH radicals, with IC50 values of 33.16 and 38.40 μgmL−1, respectively, than the ligands, which had IC50 values of 50.76 and 60.90 μgmL−1. Hirshfeld surface (HS) analysis was used to investigate the non-covalent interaction (NCI) of the complexes and their ligands. The tendency of a pair of chemical species to form crystal packing interactions is computed, which provides the complexes with good contacts in the crystal packing. The DFT studies were performed for the ligands and their complexes at the M06-2X/6-311G (d,p) and LANL2DZ/6–31 + G (d, p) levels of theory, respectively. The structural characteristics, charges (Mulliken and NPA), global reactivity descriptors, MEP, and dipole moments were investigated using this method. Furthermore, a molecular docking study predicted the interactions in the protein–ligand complex.
Zinc(II) complex of (Z)-4-((4-nitrophenyl)amino)pent-3-en-2-one, a potential antimicrobial agent: synthesis, characterization, antimicrobial screening, DFT calculation and docking study
(Bulletin of the Chemical Society of Ethiopia, 2023) Waziri, I; Oselusi, S.O; Wahab, O. O
Herein, the synthesis and characterizations of (Z)-4-((4-nitrophenyl)amino)pent-3-en-2-one (HL) ligand and its Zn(II) complex are reported. The compounds were characterized using elemental and thermogravimetric (TGA) analysis, electrochemical studies, FTIR, UV-Vis, 1H and 13C{H}NMR, HRMS, and PXRD techniques. Antimicrobial activity was screened on some Gram-positive and Gram-negative bacteria. DFT predictions were achieved using B3LYP, ωB97XD and M06-2X functional with 6-31+G(d,p) and LANL2DZ basis sets for nonmetallic and metallic atoms, respectively. The therapeutic potentials of the compounds were evaluated based on protein binding affinity, ADME/T and drug-likeness properties. The experimental results revealed the formation of a complex in which two ligands coordinated to the zinc ion in a tetrahedral arrangement through their carbonyl and amino groups. The antimicrobial study showed that the complex possesses higher antimicrobial activity than free ligand and the control (Streptomycin). B3LYP emerged as the best performing functional having yielded the best IR spectra and geometrical parameters relative to the experimental data. The density functional theory (DFT) predictions revealed that the complex is more active than the ligand, and its formation is thermodynamically feasible and exothermic. The docking results revealed that the binding affinities of the compounds are in agreement with the in-vitro data, and they possess drug-like properties.
Synthesis of ester-linked ursolic acid-based hybrid compounds: Potential antibacterial and anticancer agents
(Wiley, 2023) Khwaza, Vuyolwethu; Oyedeji, Opeoluwa O.; Oselusi, Samson O.
The molecular hybridization of two or more drugs into a single molecule is an effective drug design approach to reduce pill burden and improve patient treatment adherence. Ursolic acid-based hybrid compounds were synthesized and characterized followed by molecular docking studies. In vitro studies against various bacterial strains and human cancer cells (MDA-MB-231, HeLa, and MCF-7) were performed. Compounds 14–19, 21, 34, 31, and 30 demonstrated significant antibacterial activities with MIC values of 15.625 μg/ml. Compounds 29 and 34 were more cytotoxic than ursolic acid, with IC50 values of 46.99 and 48.18 μg/ml. Compounds 29 and 34 in the docking studies presented favourable binding interactions and better docking energy against the Epidermal Growth Factor Receptor (EGFR) than the parent compound, ursolic acid. The findings revealed that the ursolic acid scaffold is a promising precursor for the development of molecules with promising anticancer and antimicrobial activities. However, more studies are needed to fully understand their mode of action.
Documentation of antipsychotic-related adverse drug reactions: An educational intervention
(AOSIS, 2019) Purcell, Gregory; McCartney, Jane; Boschmans, Shirley-Anne
Antipsychotic agents are associated with harmful adverse reactions which impact negatively on patient adherence and clinical management. Accurate and complete documentation of signs and symptoms in the clinical notes is an important means of communication between healthcare providers, and an essential component in the management of antipsychotic-induced adverse drug reactions. To determine the impact of an educational intervention on the incidence and extent of antipsychotic-induced adverse drug reaction documentation in patient medical records.
The design and evaluation of ciprofloxacin-loaded nanoformulations using Ipomoea batatas starch nanoparticles
(SpringerOpen, 2023) Ajala, Tolulope O.; Omoteso, Omobolanle A.; Awe, Oladotun M.
Starch nanoparticle derivatives are gaining popularity as drug delivery vehicles because of their biocompatibility, better mechanical characteristics, heat stability properties, impediment qualities, permeability capabilities, and flexibility to be changed for specific predetermined functions. The effect of techniques and processing time on the physiochemical and drug release characteristics of sweet potato (Ipomoea batatas) starch nanoparticles and their ciprofloxacin-loaded nanoformulations was studied. Scanning electron microscopy confirmed that the treated starch formed nanoparticles and also revealed significant changes in the morphology of the treated starches. The water absorption capacity of chemically treated starch nanoparticles (CTSN)-3 days was the highest, whereas CTSN-6 days had the maximum solubility. The functional groups present in the starch nanoparticles were confirmed by Fourier transform infrared spectroscopy and Raman. The thermal characteristics of starch nanoparticles were established using hot-stage microscopy, differential scanning calorimetry, and thermogravimetric analysis.
Sub-analysis of cyp-guides data: Assessing the prevalence and impact of drug-gene interactions in an ethnically diverse cohort of depressed individuals
(Frontiers Media, 2022) Crutchley, Rustin D.; Keuler, Nicole
Minority groups are underrepresented in pharmacogenomics (PGx) research. Recent sub-analysis of CYP-GUIDES showed reduced length of stay (LOS) in depressed patients with CYP2D6 sub-functional status. Our primary objective was to determine whether PGx guided (G) versus standard treatment (S) influenced LOS among different race/ethnic groups. Secondary objectives included prevalence of drug-gene interactions (DGIs) and readmission rates (RAR). Retrospective sub-analysis of CYP-GUIDES data comprising CYP2D6 phenotypes was reclassified using standardized CYP2D6 genotype to phenotype recommendations from the Clinical Pharmacogenetics Implementation Consortium (CPIC) and Dutch Pharmacogenetics Working Group (DPWG).
The validation of a simple, robust, stability-indicating rp-hplc method for the simultaneous detection of lamivudine, tenofovir disoproxil fumarate, and dolutegravir sodium in bulk material and pharmaceutical formulations
(Hindawi, 2022) Omoteso, Omobolanle Ayoyinka; Milne, Marnus; Aucamp, Marique
An effective analytical method is requisite to ensure the accurate identification and quantification of drug(s), either in bulk material or in complex matrices, which form part of finished pharmaceutical products. For the purpose of a pharmaceutical formulation study, it became necessary to have a simple, yet robust and reproducible reversed-phase HPLC method for the simultaneous detection and quantification of lamivudine (3TC), tenofovir disoproxil fumarate (TDF), and dolutegravir sodium (DTG) in bulk form, complex polymeric matrices, and during drug release studies. A suitable method was developed using a Kinetex® C18, 250 × 4.6 mm column as stationary phase and a mobile phase consisting of 50 : 50 v/v methanol and water with 1 mL orthophosphoric acid, with a flow rate of 1.0 mL/min and column temperature maintained at 35°C. A detection wavelength of 260 nm and an injection volume of 10 μL were used. ,e method was validated according to the International Conference on Harmonization (ICH) guideline Q2 (R1), and the parameters of linearity and range, accuracy, precision, specificity, limit of detection (LOD), limit of quantification (LOQ), robustness, and stability were all determined. Acceptable correlation coefficients for linearity (R2) of >0.998 for each of the three drugs were obtained. ,e LOD was quantified to be 56.31 μg/mL, 40.27 μg/mL, and 7.00 μg/mL for 3TC, TDF, and DTG, respectively, and the LOQ was quantified as 187.69 μg/mL, 134.22 μg/mL, and 22.5 μg/mL for 3TC, TDF, and DTG, respectively. In relation to all the determined validation parameters, this method proves to be suitable for the accurate identification and quantification of the three ARVs, either alone or in combination, as well as when incorporated into polymeric matrices. Furthermore, the method proves to be suitable to detect degradation of the compounds.
Situation analysis on the regulation of nanomedicines in Southern Africa
(Frontiers Media, 2023) Mudyiwenyama, Linda G.; Khoza, Star; Dube, Admire
Medical products incorporating nanoparticle drug delivery systems (nanomedicines) are therapeutic or imaging agents, which comprise a delivery system within the nanometer size range (1 – 1000 nm). As medical products, nanomedicines meet definitions of medicines according to various national legislations for regulation of medicines. However, for the regulation of nanomedicines, additional assessments including toxicological issues have to be considered. These complexities require extra regulatory effort. In the resourcelimited context of low- and middle-income countries, many National Medicines Regulatory Authorities (NMRAs) lack resources and capacities to effectively assure the quality of medicinal products in their countries. With emerging trends in innovative technologies, including nanotechnology, this burden is worsened. The need to overcome regulatory challenges drove the formation of a work sharing initiative in the Southern African Development Community (SADC), ZaZiBoNA in 2013. Regulatory agencies participating in this initiative cooperate in the assessment of applications for registration of medicines.
Treating urinary tract infections in public sector primary healthcare facilities in Cape Town, South Africa: A pharmaceutical perspective
(South African Medical Association, 2022) Keuler, Nicole Leanne; Johnson, Y; Coetzee, Renier
Antibiotic resistance is a global healthcare burden complicating the management of infections. Urinary tract infections (UTIs) are commonly treated in primary care. Managing UTIs appropriately in primary care can combat antibiotic resistance. The treatment practices for UTIs in primary care in Western Cape Province, South Africa, are not well described. To describe treatment of UTIs in adults in primary care in the Cape Town metropole public sector of the Western Cape. A retrospective multicentre medical records review of patients diagnosed with UTIs was conducted during 1 October 2020 - 28 February 2021. Six public sector primary healthcare facilities were included in the study through random selection from three of the four substructures in the Cape Town metropole. Medical records of adult patients diagnosed with UTIs, through clinical diagnosis or microbiological testing, were identified via a selective sampling process. Data were collected from medical records using a standardised data collection tool.
Zinc(ii) complex of (z)-4-((4-nitrophenyl)amino)pent-3-en-2-one, a potential antimicrobial agent: Synthesis, characterization, antimicrobial screening, dft calculation and docking study
(Chemical Society of Ethiopia, 2023) Waziri, Ibrahim; Wahab, Olaide O.; Oselusi, Samson Olaitan
Herein, the synthesis and characterizations of (Z)-4-((4-nitrophenyl)amino)pent-3-en-2-one (HL) ligand and its Zn(II) complex are reported. The compounds were characterized using elemental and thermogravimetric (TGA) analysis, electrochemical studies, FTIR, UV-Vis, 1H and 13C{H}NMR, HRMS, and PXRD techniques. Antimicrobial activity was screened on some Gram-positive and Gram-negative bacteria. DFT predictions were achieved using B3LYP, ωB97XD and M06-2X functional with 6-31+G(d, p) and LANL2DZ basis sets for nonmetallic and metallic atoms, respectively.
Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022
(Springer, 2023) Moeti, Lerato; Litedu, Madira; Joubert, Jacques
Various regulatory authorities are experiencing backlogs of applications which result in delayed access to medicines for patients. The objective of this study is to critically assess the registration process utilised by SAHPRA between 2011 and 2022 and determine the fundamental root causes for the formation of a backlog. The study also aims to detail the remedial actions that were undertaken which resulted in the development of a new review pathway termed the risk-based assessment approach for regulatory authorities experiencing backlogs to implement. A sample of 325 applications was used to evaluate the end-to-end registration process employed for the Medicine Control Council (MCC) process between 2011 and 2017; 129 applications were used for the backlog clearance project (BCP) between 2019 and 2022; 63 and 156 applications were used for the risk-based assessment (RBA) pilot studies in 2021 and 2022, respectively. The three processes are compared, and the timelines are discussed in detail.

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