Palatability critically determines pediatric medication adherence, yet the impact of oral cavity dilution and salivary pH on the sensory performance of formulations remains poorly characterized. This study provides the first systematic, biorelevant evaluation of how dilution and physiologically relevant pH affect the palatability of three commercially available hyoscine butylbromide (HBB) syrup brands (X, Y, and Z), extending prior characterization of undiluted formulations. Samples were evaluated using an Alpha Astree II electronic tongue (ChemFET array). Dilution with water and with 2 mL or 5 mL phosphate-buffered saline (PBS) at pH 6.2, 6.8, and 7.4 replicated residual salivary volumes and physiological pH across pediatric and adult populations. Pure HBB API solutions were tested in parallel. Principal component analysis (>85% cumulative variance) confirmed robust discrimination across all conditions. Water dilution increased bitterness across all brands by disrupting excipient matrix integrity, with cellulosic polymer-containing Brands X (HEC) and Y (HPMC) retaining superior taste masking over polymer-free Brand Z. PBS dilution revealed pH-dependent, brand-specific palatability responses: at pH 6.2, 6.8, and 7.4, the hierarchy was consistently Y > X > Z, confirming the robust superiority of Brand Y's HPMC-based taste-masking system across the full physiological salivary pH range. Notably, Brand X exhibited substantially higher ANS sweetness scores than Brand Y at 2 mL pH 7.4 PBS, reflecting differential sweetener system sensitivity to near-neutral PBS ionic conditions. Increasing simulated salivary volume from 2 mL to 5 mL amplified bitterness and attenuated sourness across all brands. Taste-masking strategies that rely solely on sweeteners, without viscosity-building polymers, are inadequate under biorelevant oral conditions. pH-stratified assessment is essential for comprehensive characterization of palatability in pediatric oral liquid formulations.
Background Topical formulations containing cannabis in South Africa must comply with the legal standards of Schedule 0 products with a low CBD content and negligible amounts of THC. A selection of commercially available South African CBD and extemporaneously prepared topicals were evaluated and compared for formulation differences that may affect CBD stability. Methods The stability of CBD in the different topical formulations was assessed under in-use conditions of light exposure and elevated temperature. The physical properties of a selection of commercial and extemporaneously prepared CBD topical forms were characterized. The extemporaneous formulations were oil-in-water (o/w) emulsions with product attributes similar to those of commercially available aqueous cream. CBD content was determined using a validated HPLC method. Results Structural components of the emulsions resulted in high viscosity, particularly for the Pickering emulsion. The spreadability of the topical products was affected by both temperature and formulation type. CBD degraded on exposure to light and increased temperature. The commercially available CBD gel had significantly better stability than other products. Tissue oil exhibited a significant decrease in CBD content, which may lead to poor consumer acceptability. The Pickering emulsion may exhibit better stability of CBD; however, the spreadability at 37°C was lower than that of the other extemporaneously prepared o/w emulsion formulations. Conclusions Storage temperatures and light exposure significantly increase CBD degradation in formulations with fewer antioxidants and lower viscosity among the South African commercial products tested. Excipients such as Aerosil® R974 may be used to produce a Pickering emulsion for a high viscosity o/w emulsion for a CBD topical formulation that has improved CBD stability at 37°C.
Introduction A reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitation of nevirapine (NVP) in bulk drug, commercial tablets, and niosome formulations using an Analytical Quality by Design (AQbD) approach.Methods Critical analytical attributes and method parameters were identified and optimized using a Central Composite Design (CCD), with the retention time and resolution between NVP and internal standard carbamazepine as key responses. Chromatographic separation was achieved on a C18 column using an isocratic mobile phase of water and acetonitrile (57.5:42.5 v/v), a 1.0 mL/min flow rate, and detection at 280 nm. The method was validated per ICH Q2 (R1) guidelines for all parameters including repeatability, intermediate precision, accuracy (recovery/bias), and robustness, in addition to specificity, linearity, LOD and LOQ.Results and Discussion The method demonstrated specificity, linearity (0.5-200 mu g/mL), a detection limit of 0.033 mu g/mL, and quantification limit of 0.5 mu g/mL. The method was precise, accurate, and robust. Stress studies suggested stability-indicating performance under the tested conditions with no observed interference at the analyte retention time at 280 nm. Application to commercial and in-house formulations confirmed its suitability for routine analysis. This work highlights the value of AQbD in developing cost-effective, high-performing analytical methods for pharmaceutical analysis.
Background/Objectives: Cocrystallisation is a well-established path for altering the physicochemical properties and bioavailability of active pharmaceutical ingredients (APIs). A common side effect of anti-tubercular medicines is the depletion of group B vitamin reserves in TB patients. Co-administration of supplements such as pyridoxine (vitamin B6) during TB therapy may be used to ameliorate the harmful side effects of vitamin B6 deficiency. Methods: Mechanochemical grinding and solvent evaporation experiments using pyridoxine (PN) with 4-aminosalicylic acid (PAS) and separately with pyrazinecarboxylic acid (PCBA) were conducted. The bulk powder and crystal analysis was performed using FTIR, PXRD, DSC, TGA and SCXRD. Results: The isolation and characterization of two multicomponent salts containing pyridoxine, i.e., PN-PAS·H2O and PN-PCBA, were completed. Mechanochemistry is an efficient method for the preparation of cocrystals. Conclusions: The drug–vitamin combinations may be useful for the development of new treatment regimens with potentially improved therapeutic outcomes and reduced adverse effects.
Patient rejection of unpalatable products can adversely affect therapeutic adherence, potentially leading to treatment failure. Taste masking is a goal in pharmaceutical development, particularly when developing formulations for paediatric patients. The use of an electronic tongue (e-tongue) enables rapid, objective, and robust taste evaluation. Its use is gaining traction in the quality assessment of pharmaceutical products. The capability of an Alpha Astree II taste-sensing system to evaluate the palatability of commercially available hyoscine butylbromide (HBB) syrup brands in South Africa, was investigated. Principal component analysis (PCA) was used to process the e-tongue data and the resultant biplots can distinguish between the taste of reference compounds and HBB syrups. The sensor values and taste screening rankings indicate the three brands exhibit a bitter-sweet taste. Brand Z has greater bitterness and sourness than brands, X and Y due to citric acid monohydrate in the formulation. Brand Y included sodium cyclamate and was the most palatable syrup. The findings indicate the e-tongue can differentiate the taste of HBB syrups when different excipients are used to alter taste. Pharmaceutical companies could use these data to improve the palatability of currently available hyoscine syrups. The E-tongue is a complementary instrument to human sensory panels used to inform product development in alignment with customer preferences.
This study investigated the feasibility of using an electronic tongue (E-tongue) as an objective analytical tool for evaluating the taste of commercial liquid milk brands in South Africa. Sixteen samples from four brands were analyzed using a potentiometric E-tongue equipped with cross-selective taste sensors, calibrated to detect sweet, sour, salty, bitter, and umami responses. The effects of storage temperature (2 degrees C-19 degrees C), heat treatment (ultra-pasteurization vs. ultra-high temperature, UHT), lipid content (full-cream vs. low-fat), and storage duration (0-, 3-, 5-, and 45-days post-opening) on taste perception were examined under controlled conditions. Principal Component Analysis (PCA) of multivariate data successfully differentiated milk samples and identified key taste attributes that contribute to variations in palatability. The E-tongue effectively distinguished taste differences between brands, with cumulative variance contributions of 96.007% and 97.898% for PC1 and PC2, respectively, on Days 0 and 45. The results indicate that the E-tongue effectively monitors quality and detects spoilage under various storage conditions and processing methods. UHT milk had a better taste profile than ultra-pasteurized milk, and full-cream variants retained better palatability than low-fat counterparts throughout storage. Refrigerated storage markedly slowed taste deterioration relative to room-temperature conditions. Supporting physicochemical analyses, including pH, viscosity, titratable acidity, particle size, and polydispersity index, confirmed E-tongue results and identified age-gelation in specific samples by Day 45. The Alpha Astree II E-tongue effectively characterized taste profiles and distinguished both inter-and intrabrand differences during storage. The findings demonstrate the potential of the E-tongue as an objective, rapid, and reliable instrument for assessing milk quality, facilitating product development, and improving sensory evaluation methods within the food industry, especially in areas with inconsistent cold-chain infrastructure.
Taste masking is critical when developing formulations for paediatric patients. Metronidazole (MTZ) was encapsulated in cubosomal gels to mask its bitter, metallic taste. A cubosomal gel using glyceryl monooleate, oleic acid, Poloxamer 407, and polyvinyl alcohol was developed and optimized using Box-Behnken and I-Optimal designs. The optimized nanocarrier particle size was 34.30 nm, Zeta potential -26.6 mV, polydispersity index 0.152, and entrapment efficiency 38.73%. TEM confirmed the formation of a cubic nanostructure, and FTIR was used to monitor stability. The in vitro release was biphasic, with 14% MTZ released within 5 min, followed by sustained release over 12 h. Diffusion-controlled release was confirmed using Higuchi and Korsmeyer-Peppas models. Effective taste masking was determined using an electronic. The system exhibited satisfactory physicochemical stability at 22 °C, over 4 weeks, with PS, PDI, and ZP remaining within acceptable parameters. The EE decreased from 38.73% to 24.75%, indicating hydrophilic-driven MTZ leakage during storage. The cubosomal gel formulation effectively masks unpleasant taste, sustains MTZ release, and maintains acceptable physicochemical properties at 22 °C for four weeks. The EE requires further optimization. These results suggest that cubosomal encapsulation may be a taste-masking strategy for MTZ. Translation to periodontal applications will require evaluation of mucoadhesion, gingival retention, antimicrobial efficacy, and formulation behaviour in gingival crevicular fluid.
The study aimed to develop and optimize chitosan-based mucoadhesive nanomicelles for intranasal delivery of lamotrigine (LTG), to enhance epilepsy treatment, bypass the blood-brain barrier, and potentially improve brain targeting. LTG-loaded nanomicelles were prepared using thin-film hydration and optimized using a central composite design, response surface methodology, and artificial neural networks. The formulation included D-ɑ-tocopheryl polyethylene glycol succinate, Poloxamer 407, chitosan, and glycerol. Critical quality attributes assessed were micelle size (MS), polydispersity index (PDI), Zeta potential (ZP), pH, LTG content, transmittance, in vitro mucoadhesion, LTG release, and 28-day stability. The MS, PDI, ZP, pH, and LTG content of the optimized mucoadhesive nanomicelles was 31.28 ± 0.34 nm, 0.487 ± 0.00, +31.37 ± 1.97 mV, 4.61 ± 0.01, and 2.89 ± 0.01 mg/mL, respectively. The transmittance was 98.50 ± 0.10%, and significant in vitro mucoadhesion, with reduced migration, was observed for mucin-containing gels. LTG release (96.94% at 6 h) followed the Higuchi diffusion model, with sufficient LTG released at 40 min to potentially reach the minimum effective concentration, based on in vitro release data alone. The formulation remained stable for 28 days at 4 °C and 25 °C. Chitosan-based mucoadhesive nanomicelles are a promising intranasal delivery system for LTG, with the potential for brain targeting, controlled LTG release, and improved epilepsy management.
Despite a marked decrease in HIV/AIDS-related mortality, HIV remains one of the leading causes of death in specific populations. Despite concerted efforts to find a cure for HIV, to date, none exists. Current antiretroviral therapy inhibits replication of the virus without completely eradicating it. The successful inhibition of viral replication is only achieved using a combination of antiretrovirals, which inhibit viral replication at different stages of the HIV lifecycle. Efavirenz (EFV), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) is one combination used for HIV management. The development of a novel fixed-dose microemulsion formulation of EFV, FTC, and TDF was undertaken. Microemulsions (ME) were manufactured using phase titration and drug loading, particle size, transparency, Zeta potential, and pH were determined. Transmission Electron Microscopy was used to visualize the microemulsion. In vitro release testing was used to evaluate active pharmaceutical ingredient release behavior. The optimized ME had an average Zeta potential of 33.8 mV and droplet size of 117 nm, determined using Dynamic Light Scattering and confirmed using Transmission Electron Microscopy. Powder X-ray diffraction and Differential Scanning Calorimetry analysis revealed the presence of a molecular dispersion of drugs. These findings demonstrate the potential value of using ME as a fixed-dose combination technology for the delivery of EFV, FTC, and TDF.
Levodopa (L-dopa) an effective treatment for Parkinson's disease, but it exhibits low oral bioavailability. Intranasal L-dopa nanosuspensions were manufactured to improve bioavailability using the olfactory and trigeminal delivery routes for direct brain delivery. The development of L-dopa nanocrystals and in vitro characterization was undertaken. Nanosuspensions were optimized using Design of Experiments. The L-dopa nanosuspension was produced at 50 °C using sonoprecipitation and mechanical stirring. Water and ethanol were solvent and antisolvent, and Tween® 80 and cetyltrimethylammonium bromide, stabilizing agents. The critical quality attributes (CQA) monitored were droplet size (PS), polydispersity index (PDI), Zeta potential (ZP), and percent yield (%), pH and osmolarity of the optimized formulation were monitored. SEM, pXRD, DSC, FTIR, and in vitro release were used for further characterization. Short-term stability testing at 4 °C and 22 °C was evaluated for 28 days. The mean PS, PDI, ZP, and % yield of the optimized nanosuspension were 161.4 ± 20.152 nm, 0.383 ± 0.090, +15.45 ± 1.664 mV, and 72.106 ± 0.023%, respectively. In vitro test results for the optimized formulation show the target CQA, had been met. The system may enhance the bioavailability of L-dopa when administered intranasally. In vivo studies are required to confirm nose-to-brain transport.
Sofosbuvir (SOF) is an antiviral compound used alone for the treatment of hepatitis C or in combination with drugs such as ribavirin and ledipasvir (LED). FDA approval as monotherapy was granted in 2013 and for combination treatment of hepatitis C, in 2014. Different studies have been reported the analysis of SOF in bulk and tablet forms. However, a monograph for SOF has not yet been included in official pharmacopoeias. Therefore, no consensus in respect of identification of impurities and concerns relating to safety of the drug exists. A review of the development of stability indicating chromatographic methods for analysis of SOF was undertaken using PubMed and the Google Scholar databases from initial reports to January 2023. Our focus pertained to studies in which a stability indicating chromatographic method had been designed and validated for analysis of SOF in bulk and in tablet form alone and in combination with LED, daclatasvir (DAC), velpatasvir (VEL) and voxilaprevir (VOX) and also reported the use of stress testing. The purpose of this review is to summarize the information reported in different studies in respect of the development of stability indicating methods conducted using stress studies for the analysis of SOF and the results of such stress studies.
Hydrophobic drug delivery via oral or pulmonary routes presents significant challenges for clinical translation, particularly for poorly soluble antiviral drugs. Physiological barriers-such as enzymatic degradation, harsh pH, and rapid transit in the gastrointestinal tract, or mucociliary clearance and alveolar macrophage uptake in the lungs-can severely limit therapeutic efficacy. To address these challenges, we developed a novel lipid nanocapsule (LNC) and chitosan/iota-carrageenan hydrogel composite tailored for sustained delivery of hydrophobic antiviral agents. This composite system was designed to encapsulate and deliver Efavirenz (EFV) under simulated gastrointestinal conditions. EFV was first encapsulated in LNCs, which were subsequently embedded within a mucoadhesive hydrogel matrix to form the EFV-LNC hydrogel composite. The LNCs significantly enhanced EFV solubility compared to water alone (p < 0.0001), and droplet size was controlled (57.4 ± 0.5 nm). The hydrogel composite exhibited an optimized swelling ratio (~ 300 g water per 1 g hydrogel) and achieved an encapsulation efficiency of approximately 53%. Importantly, EFV release from the composite was significantly prolonged under various gastrointestinal pH conditions compared to the unformulated drug (p < 0.0001). Cytotoxicity assays confirmed the composite's cytocompatibility, supporting its potential safety for future mucosal administration. These findings suggest that the LNC-hydrogel composite enhances solubility, enables controlled release, and may improve mucosal retention, supporting its utility as a versatile platform for oral and pulmonary delivery of hydrophobic antiviral drugs.
Multidrug-resistant tuberculosis (MDR-TB) is a significant public health challenge globally, exacerbated by the limited efficacy of existing therapeutic approaches, prolonged treatment duration, and severe side effects. As drug resistance continues to emerge, innovative drug delivery systems and treatment strategies are critical to combating this crisis. This review highlights the molecular mechanisms underlying resistance to drugs in Mycobacterium tuberculosis, such as genetic mutation, efflux pump activity, and biofilm formation, contributing to the persistence and difficulty in eradicating MDR-TB. Current treatment options, including second-line drugs, offer limited effectiveness, prompting the need for innovation of advanced therapies and drug delivery systems. The progression in drug discovery has resulted in the approval of innovative therapeutics, including bedaquiline and delamanid, amongst other promising candidates under investigation. However, overcoming the limitations of traditional drug delivery remains a significant challenge. Nanotechnology has emerged as a promising solution, with nanoparticle-based drug delivery systems offering improved bioavailability and targeted and controlled release delivery, particularly for pulmonary targeting and intracellular delivery to macrophages. Furthermore, the development of inhalable formulations and the potential of nanomedicines to bypass drug resistance mechanisms presents a novel approach to enhancing drug efficacy. Moreover, adjunctive therapies, including immune modulation and host-directed therapies, are being explored to improve treatment outcomes. Immunotherapies, such as cytokine modulation and novel TB vaccines, offer complementary strategies to the use of antibiotics in combating MDR-TB. Personalized medicine approaches, leveraging genomic profiling of both the pathogen and the host, offer promise in optimizing treatment regimens and minimizing drug resistance. This review underscores the importance of multidisciplinary approaches, combining drug discovery, advanced delivery system development, and immune modulation to address the complexities of treating MDR-TB. Continued innovation, global collaboration, and improved diagnostics are essential to developing practical, accessible, and affordable treatments for MDR-TB.
The highly aggressive and invasive glioblastoma (GBM) tumour is the most malignant lesion among adult-type diffuse gliomas, representing the most common primary brain tumour in the neuro-oncology practice of adults. With a poor overall prognosis and strong resistance to treatment, this nervous system tumour requires new innovative treatment. GBM is a polymorphic tumour consisting of an array of stromal cells and various malignant cells contributing to tumour initiation, progression, and treatment response. Cannabinoids possess anti-cancer potencies against glioma cell lines and in animal models. To improve existing treatment, cannabinoids as functionalised ligands on nanocarriers were investigated as potential anti-cancer agents. The GBM tumour microenvironment is a multifaceted system consisting of resident or recruited immune cells, extracellular matrix components, tissue-resident cells, and soluble factors. The immune microenvironment accounts for a substantial volume of GBM tumours. The barriers to the treatment of glioblastoma with cannabinoids, such as crossing the blood–brain barrier and psychoactive and off-target side effects, can be alleviated with the use of nanocarrier drug delivery systems and functionalised ligands for improved specificity and targeting of pharmacological receptors and anti-cancer signalling pathways. This review has shown the presence of endocannabinoid receptors in the tumour microenvironment, which can be used as a potential unique target for specific drug delivery. Existing cannabinoid agents, studied previously, show anti-cancer potencies via signalling pathways associated with the hallmarks of cancer. The results of the review can be used to provide guidance in the design of future drug therapy for glioblastoma tumours.
Ophthalmic drops for ocular delivery exhibit inadequate residence time, which often requires multiple daily dosing that may result in patient non-adherence. In this study, the development of a once-daily-dosed chitosan-coated metronidazole (MTZ)-loaded solid lipid nanoparticles (SLNs) for ocular delivery was undertaken. Melt emulsification and ultrasonication were used to manufacture MTZ-loaded SLN, which were subsequently coated with chitosan (CS) by mechanical stirring using a 0.1% w/v solution. Gelucire® 48/16 and Transcutol® HP were used as the solid lipid and synthetic solvent, respectively, with Tween® 20 included as a stabilizing agent. The critical quality attributes (CQA) of the optimized CS-coated SLN that was monitored included particle size, polydispersity index, Zeta potential, % entrapment efficiency, % MTZ loading, pH, and osmolarity. The optimized coated nanocarriers were evaluated using laser Doppler anemometry (LDA) and were determined to be stable, with particle sizes in the nanometre range. In vitro mucoadhesion, MTZ release and short-term stability, in addition to the determination of the shape of the optimized CS-coated SLN, were undertaken. The mucoadhesive properties of the optimized CS-coated MTZ-loaded SLN demonstrated increased ocular availability, which may allow dose reduction or longer intervals between doses by improving precorneal retention and ocular availability. Overall, our findings suggest that CS-coated MTZ-loaded SLNs have the potential for clinical application, to enhance ocular delivery through the release of MTZ.
Opportunities for developing innovative and intelligent drug delivery technologies by targeting the endocannabinoid system are becoming more apparent. This review provides an overview of strategies to develop targeted drug delivery using the endocannabinoid system (ECS). Recent advances in endocannabinoid system targeting showcase enhanced pharmaceutical therapy specificity while minimizing undesirable side effects and overcoming formulation challenges associated with cannabinoids. This review identifies advances in targeted drug delivery technologies that may permit access to the full pharmacotherapeutic potential of the ECS. The design of optimized nanocarriers that target specific tissues can be improved by understanding the nature of the signaling pathways, distribution in the mammalian body, receptor structure, and enzymatic degradation of the ECS. A closer look at ligand-receptor complexes, endocannabinoid tone, tissue distribution, and G-protein activity leads to a better understanding of the potential of the ECS toolkit for therapeutics. The signal transduction pathways examine the modulation of downstream effector proteins, desensitization, signaling cascades, and biased signaling. An in-depth and overall view of the targeted system is achieved through homology modeling where mutagenesis and ligand binding examine the binding site and allow sequence analysis and the formation of libraries for molecular docking and molecular dynamic simulations. Internalization routes exploring receptor-mediated endocytosis and lipid rafts are also considered for explicit signaling. Furthermore, the review highlights nanotechnology and surface modification aspects as a possible future approach for specific targeting.
Despite their incredible contribution to fighting viral infections, antiviral viral resistance is an increasing concern and often arises due to unfavorable physicochemical and biopharmaceutical properties. To address this kind of issue, lipid nanocapsules (LNC) are developed in this study, using efavirenz (EFV) as a drug model. EFV solubility was assessed in water, Labrafac Lipophile and medium chain triglycerides oil (MCT oil). EFV turned out to be more soluble in the two latter dissolving media (solubility > 250 mg/mL); hence, given its affordability, MCT oil was used for LNC formulation. LNC were prepared using a low-energy method named phase inversion, and following a design of experiments process. This one resulted in polynomial models that predicted LNC particle size, polydispersity index and zeta potential that were, respectively, around 50 nm, below 0.2 and below −33 mV, for the optimized formulations. Once synthesized, we were able to achieve an encapsulation efficacy of 87%. On the other hand, high EFV release from the LNC carrier was obtained in neutral medium as compared to acid milieu (pH 4) with, respectively, 42 and 27% EFV release within 74 h. Other characterization techniques were applied and further supported the successful encapsulation of EFV in LNCs in an amorphous form. Stability studies revealed that the developed LNC were quite stable over the period of 28 days. Ultimately, LNCs have been demonstrated to improve the biopharmaceutical properties of EFV and could therefore be used to fight against antiviral resistance.
This study is focused on proposing a new design and setup for electromembrane extraction. A new cap was designed and conductive vials of different shapes were fabricated using three-dimensional printing. The new cap holds three fibers to enhance electromembrane extraction recovery. Conductive vials can simultaneously perform as electrodes therefore, there is no need to include an electrode in sample solutions. Phenobarbital and phenytoin were used as model compounds to assess the setup performance. Under optimal conditions, these analytes were extracted from the sample solution at pH = 9 to the acceptor solution at pH = 13 with a voltage of 40 V for 20 min, while 1-octanol was employed as the supported-liquid-membrane. The influence of conductive vials geometry on the recovery was examined and the effects of different shapes were studied by performing numerical simulation to establish electric potential distribution. Of the vials tested with circular, triangular, and floral-like cross-sections the latter exhibited the best voltage distribution. The circular vial had the highest recovery attributed to its better hydrodynamic shape, which allows rapid fluid sample transport and therefore enhanced system recovery. The extraction recovery and relative standard deviation of the circular vial with three fibers were 33.0 and 7.6 for phenobarbital and 42.2 and 10.4 for phenytoin.
Nevirapine (NVP) is used for the management of HIV/AIDS but must be dosed frequently, exhibits unpredictable bioavailability and a side effect profile that includes hepato- and dermo-toxicity. Niosomes are a colloidal drug delivery system that may be used to overcome the low bioavailability, side effect profile and frequent dosing needed when using conventional drug delivery systems. The compatibility of NVP with sorbitan esters, polysorbate, cholesterol and dihexadecyl phosphate (DCP) was investigated using Differential Scanning Calorimetry (DSC), Scanning Electron Microscopy (SEM), Fourier Transform Infra-red Spectroscopy (FTIR) and X-ray Powder Diffraction (XRPD). Screening studies were undertaken to identify potential excipients that would produce niosomes with target critical quality attributes (CQA) viz, a particle size (PS) < 1000 nm, a polydispersity index (PDI) < 0.500 and an entrapment efficiency >90%. The results revealed that sorbitan esters in combination with cholesterol and 5 μmol DCP produced niosomes with the best CQA and Zeta potential (ZP) < -30 mV which suggests good stability of the niosomes on storage. Sorbitan esters produced the smallest niosomes of < 400 nm diameter with a PDI < 0.400 and an entrapment efficiency > 78% without cholesterol. The addition of cholesterol and DCP was essential to form niosomes with target CQA.