Number Of Homogenization Cycles Research Articles

Identifying and optimization of critical process parameters for the modulation of polysaccharide molecular size in Streptococcus pneumoniae serotype-1

Maintaining the molecular size (MS) of Streptococcus pneumoniae capsular polysaccharide within specified range is essential for manufacture of conjugate vaccines, either through physical or acid hydrolysis before use in the conjugation process. Polysaccharide MS typically reduced, with high-pressure homogenization as an approach, for preserving their chemical structure. When the average MS of Pneumococcal capsular polysaccharide serotype-1(CPS1) exceeds 1200 kDa during fermentation, using a high-pressure homogenizer to reduce its MS to 150–250 kDa can become extremely difficult. Even after multiple homogenization cycles, obtaining polysaccharide of the required size can be challenging. Moreover, exceeding a certain number of homogenization cycles can negatively impact the stability, yield, and conjugation efficiency. To control polysaccharide MS, we conducted a design of experiments (DOE) study focused on the optimization of the fermentation process, employing serotype-1 as a represntative case. The successful optimization of these CPPs was achieved in a consistent and reproducible manner. Systematic evaluation by DOE based process optimization has provided valuable insights into precise polysaccharide manufacturing control of polysaccharide MS. Our findings confirm that maintaining Hy-Soy™ at 20-30 g/L and yeast extract at 1–3 g/L in the fermentation media, with a feed concentration of 2–3.5 g/L/H and 0.1–0.5 VVM of air, consistently yields polysaccharide with MS of < 1200 kDa. This strategy that can be extended to other S. pneumoniae serotype polysaccharide production.Graphical abstract

Optimization of a Protocol for Protein Extraction from Calcified Aortic Valves for Proteomics Applications: Development of a Standard Operating Procedure.

The comprehension of the pathophysiological mechanisms, the identification of druggable targets, and putative biomarkers for aortic valve stenosis can be pursued through holistic approaches such as proteomics. However, tissue homogenization and protein extraction are made difficult by tissue calcification. The reproducibility of proteome studies is key in clinical translation of the findings. Thus, we aimed to optimize a protocol for aortic valve homogenization and protein extraction and to develop a standard operating procedure (SOP), which researchers can use to maximize protein yield while reducing inter-laboratory variability. We have compared the protein yield between conventional tissue grinding in nitrogen followed by homogenization with a Potter apparatus with a more advanced bead-beating system. Once we confirmed the superiority of the latter, we further optimized it by testing the effect of beads size, the number of homogenization cycles, tube capacity, lysis buffer/tissue mass ratio, and two different lysis buffers. Optimal protein extraction was achieved with 2.8 mm zirconium dioxide beads, in two homogenization cycles, in the presence of 20 µL RIPA buffer/mg tissue, using 2 mL O-ring cryotubes. As a proof of concept of the usefulness of this SOP for proteomics, the AV proteome of men and women with aortic stenosis was characterized, resulting in the quantification of proteins across six orders of magnitude and uncovering some putative proteins dysregulated by sex.

A New Control Strategy for High-Pressure Homogenization to Improve the Safety of Injectable Lipid Emulsions.

Intravenous lipid emulsions are biocompatible formulations used as clinical nutrition products and lipid-based delivery systems for sparingly soluble drugs. However, the particle-size distribution is associated with risks of embolism. Accordingly, the mean particle diameter (MPD) and particle-distribution tailing (characterized as the pFAT5 value) are critical quality attributes that ensure patient safety. Compliance with the limits stated in the United States Pharmacopoeia is ensured by high-pressure homogenization, the final step of the manufacturing process. The US Food and Drug Administration’s Quality-by-Design approach requires a control strategy based on deep process understanding to ensure that products have a consistent and predefined quality. Here we investigated the process parameters of a jet-valve high-pressure homogenizer, specifically their effect on the MPD, pFAT5 value and droplet count (determined by microscopy) during the production of a Lipofundin MCT/LCT 20% formulation. We provide deep insight into droplet breakup and coalescence behavior when varying the process pressure, emulsion temperature and number of homogenization cycles. We found that high shear forces are not required to reduce the pFAT5 value of the particle distribution. Finally, we derived a control strategy for a rapid and cost-efficient two-cycle process that ensures patient safety over a large control space.

Micro- and Nanofibrillated Cellulose from Annual Plant-Sourced Fibers: Comparison between Enzymatic Hydrolysis and Mechanical Refining.

The current trends in micro-/nanofibers offer a new and unmissable chance for the recovery of cellulose from non-woody crops. This work assesses a technically feasible approach for the production of micro- and nanofibrillated cellulose (MNFC) from jute, sisal and hemp, involving refining and enzymatic hydrolysis as pretreatments. Regarding the latter, only slight enhancements of nanofibrillation, transparency and specific surface area were recorded when increasing the dose of endoglucanases from 80 to 240 mg/kg. This supports the idea that highly ordered cellulose structures near the fiber wall are resistant to hydrolysis and hinder the diffusion of glucanases. Mechanical MNFC displayed the highest aspect ratio, up to 228 for hemp. Increasing the number of homogenization cycles increased the apparent viscosity in most cases, up to 0.14 Pa·s at 100 s−1 (1 wt.% consistency). A shear-thinning behavior, more marked for MNFC from jute and sisal, was evidenced in all cases. We conclude that, since both the raw material and the pretreatment play a major role, the unique characteristics of non-woody MNFC, either mechanical or enzymatically pretreated (low dose), make it worth considering for large-scale processes.

Formulation and optimization of astaxanthin nanoemulsions with marine phospholipids derived from large yellow croaker (Larimichthys crocea) roe

The aim of this work was to investigate the emulsifying capacity of marine phospholipids derived from large yellow croaker roe (LYCRPLs). Initially, conditions for preparing astaxanthin (1% w/w) nanoemulsions with LYCRPLs were optimized based on single-factor experiments, including homogenization pressure, homogenization cycle, emulsifier concentration and corn oil concentration via the response surface methodology. The optimal homogenization pressure was 60 MPa, the optimal number of homogenization cycles was nine, the optimal emulsifier concentration was 4.7%, and the optimal oil concentration was 20%. Under these conditions, the stability, particle size and polydispersity index of nanoemulsions were 0.018 ± 0.0016, 247 ± 4.5 nm and 0.215±0.019, respectively. The droplets of nanoemulsions were characterized by transmission electron microscopy, which revealed that all the droplets were more or less spherical and nonaggregated. In addition, the storage experiments indicated that the nanoemulsions were stable at different temperatures. Therefore, LYCRPLs could be explored as carriers for the delivery of insoluble bioactive compounds in the food industry.

Optimization of Production Parameters for Andrographolide-Loaded Nanoemulsion Preparation by Microfluidization and Evaluations of Its Bioactivities in Skin Cancer Cells and UVB Radiation-Exposed Skin.

Andrographolide (AG) is an active compound isolated from Andrographis paniculata (Family Acanthaceae). Although it possesses beneficial bioactivities to the skin, there is insufficient information of its applications for treatment of skin disorders due to low water solubility leading to complications in product development. To overcome the problem, an AG-loaded nanoemulsion (AG-NE) was formulated and prepared using a microfluidization technique. This study aimed to investigate the effect of pressure and the number of homogenization cycles (factors) on droplet size, polydispersity index and zeta potential of AG-NE (responses) and to determine the effect of AG-NE on skin cancer cells and UVB irradiation-induced skin disorders in rats. Relationships between factors versus responses obtained from the face-centered central composite design were described by quadratic models. The optimum value of parameters for the production of optimized AG-NE (Op-AG-NE) were 20,000 psi of pressure and 5 homogenization cycles. Op-AG-NE showed promising cytotoxicity effects on the human malignant melanoma- (A375 cells) and non-melanoma cells (A-431 cells) via apoptosis induction with a high selectivity index and also inhibited intracellular tyrosinase activity in the A375 cells. Op-AG-NE could reduce melanin index and healed UVB irradiation exposed skin. Op-AG-NE thus had potential for treatment of skin cancers and skin disorders from exposure to UVB radiation.

Effect of lignin-containing highly fibrillated cellulose on the adsorption behavior of an organic dye

The morphological properties and particle size characteristics of micro- and nanofibrillated cellulose (NFC) and lignin-containing NFC (LNFC) produced by a microfluidizer processor were investigated. The effects mechanism of lignin-containing on the adsorption of NFC and the stable properties of organic dyes suspension were also studied. The results showed that the preparation process and final performance of NFC were affected by the key factors including lignin, homogenization pressure, and number of homogenization cycles. The increase in the homogeneity of the fibrillated cellulose was minor for the NFC samples, while LNFC samples showed a larger increase in the homogeneity of the particle size distribution. The influence of lignin was reflected both in improved fibrillation efficiency and in the final organic dye dispersion properties achieved by LNFC addition, primarily observed as deceased particle sizes and fibril dimensions. This study indicated that pollution-free dispersion of organic dyes can be realized through the application of lignin-containing NFC.

Quantitative structure property relationship assisted development of Fluocinolone acetonide loaded transfersomes for targeted delivery

Fluocinolone acetonide (FA) is a corticosteroid, synthetic hydrocortisone used to reduce skin inflammation and itching in psoriasis. The present study investigate the formulation of nanotransfersomes containing FA (FA-NTs) using Quantitative Structure Property Relationship (QSPR) and Box–Behnken approach. FA-NTs containing phospholipid, edge activator and cholesterol in definite ratio were prepared by high pressure homogenization and optimized using Box–Behnken design. Based on the QSPR analysis, Phospholipon 90H was selected for nanotransfersome form along with sodium deoxycholate as edge activator. The impact of independent variables Phospholipid concentration (X1), sodium deoxycholate (X2) and number of homogenization cycles (X3) on dependent variables viz., particle size and entrapment efficiency (%EE) were studied. The optimized nanotransfersomal formulation was characterized for FTIR, XRD, DSC, particle size, zeta potential, entrapment efficiency, in-vitro release and ex-vivo permeation studies. FA-NTs batch evidenced 92 ± 4% entrapment efficiency and showed 29.9 nm particle size, 0.264 polydispersity index and −23.72 mV zeta potential. FA-NTs exhibited 68% drug release within 24 h and followed Higuchi release kinetic model (R2 = 0.9902). FA-NTs showed 22.56 μg/cm2/h transdermal flux with 12.40 fold higher than FA dispersion. Biologically, FA-NTs showed hyperproliferation inhibition of differentiated HaCaT cells as evidenced from cell viability, antiproliferative action, nitric oxide production, proinflammatory cytokine measurement, Quantitative Real time PCR and cellular uptake studies. Thus, the present study demonstrates the successful use of QSPR studies and Box–Behnken design in the preparation of nanotransfersomes for efficient delivery of FA in the management of psoriasis.

High-Pressure Homogenization: Principles and Applications Beyond Microbial Inactivation

(Ultra) high-pressure homogenization ((U)HPH) is one of the emerging technologies being studied and developed for various applications in the food industry. (U)HPH was suggested as an effective tool for achieving microbial safety and extending the product shelf life of liquid foods in a continuous process while minimizing some negative attributes of thermal processing. The valve geometry, pressure level, inlet temperature, and the number of homogenization cycles are all factors affecting the level of microbial inactivation and the extent of the techno-functionalities of food biopolymers and matrices. Turbulence, high shear, cavitation, and temperature increase induced by (U)HPH treatments enhance emulsion stability, stabilize proteins in solutions, reduce particle size distributions, and increase the accessibility of health-promoting compounds. This review is a comprehensive and updated overview of the engineering aspects of the (U)HPH process, specifically focusing on (U)HPH modification of food components such as polysaccharides, proteins, and bioactive compounds. A detailed description of the potential applications in food products beyond microbial inactivation is also included.

Nanobiotechnological obtaining of liposomal forms of antioxidant preparations based on bioflavonoids

Most pathological conditions are accompanied by lipid peroxidation and accumulation of oxidative stress products. The antioxidant action of natural hydrophobic compounds, such as quercetin, ubiquinone, curcumin, vitamin E, etc. is established. It is also known that these biologically active compounds act on different parts of antioxidant system. However, their use in parenteral drugs is difficult taking into account their hydrophobicity. Nanoparticles, such as liposomes, are used to increase the bioavailability of lipophilic antioxidants and to create water-soluble form of them.The aim of the work is to develop the liposomal preparation with co-encapsulation of two hydrophobic antioxidants, namely curcumin and quercetin.Methods. Technological methods of obtaining liposomes and analytical physicochemical, chromatographic (HPLC, TLC, GLC), methods of determination of particle size, pH were used.Results. As a result of the study, the formulation and technology of obtaining the liposomal form of curcumin and its composition with quercetin were proposed. The effect of fatty acid composition of lipids, the ratio “lipid: active substance and the technological conditions on the liposomes formation and the level of encapsulation of active pharmaceutical ingredients were studied. The dependence of nanoparticle sizes on the pressure value and the number of homogenization cycles was investigated. The lyophilized product with a level of encapsulation of hydrophobic antioxidants at least 85 % was obtained. The physicochemical properties of the samples were observed.Conclusions. The technological scheme for obtaining of сomplex preparation containing curcumin and quercetin, involving the obtaining of lipid film, hydration of components, high-pressure homogenization, sterile filtration and lyophilization is proposed

Development of oil-in-water emulsions based on rice bran oil and soybean meal as the basis of food products able to be included in ketogenic diets

The aim of this work was to develop rice bran oil-in-water emulsions stabilized with proteins and polysaccharides from soybean meal as the basis of food products able to be included in ketogenic diet. The effect of the formulation (ketogenic ratios and oil mass fractions) and the high-pressure homogenization conditions (number of homogenization cycles) on the properties of the resulting O/W emulsions was evaluated. All freshly prepared emulsions showed multimodal particle size distributions and shear-thinning behaviour. At a fixed ketogenic ratio, all emulsions had the same oil to emulsifiers + stabilizers proportion, but increasing their oil mass fraction resulted in systems composed by smaller particles with greater interfacial area, and apparent viscosity. The same effect was observed by increasing the number of homogenization cycles. Meanwhile, increasing the ketogenic ratio (at a fixed oil mass fraction) diminished its apparent viscosity. Most of the studied emulsions were stable for seven days of quiescent refrigerated storage, although some changes in its particle size distributions were observed. Only, the stored emulsions with the highest ketogenic ratio and the lowest oil mass fraction presented gravitational separation but no phase separation. Emulsions prepared after five homogenization cycles presented greater stability to the coalescence than those prepared in one cycle.

Size Reduction Efficiency of Alpha-Mangostin Suspension Using High-Pressure Homogenization.

In this study, we aimed to investigate the effects of stabilizers and processing parameters on the size reduction of alpha-mangostin (AMG) using high-pressure homogenization (HPH). The solubility of AMG in various stabilizers was studied. Selected stabilizers were used to prepare AMG suspensions by HPH under different conditions. After HPH, the particle size of AMG suspensions with stabilizers significantly decreased to microns. Percent size reduction efficiency of all AMG suspensions with each stabilizer increased with the increase in the number of homogenization cycles. Sodium lauryl sulfate and poloxamer188 provided a greater extent of particle size reduction than polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. AMG suspensions with binary stabilizers at higher pressure were also prepared. The use of high pressure increased percent size reduction efficiency.

NLCs as a potential carrier system for transdermal delivery of forskolin.

Nanostructured lipid carriers (NLC) composed of the substances generally recognized as safe (GRAS) were obtained by using a hot high-pressure homogenization technique (HPH). The influence of the number of homogenization cycles and concentration of a decyl glucoside surfactant on the NLC properties were studied. The system's stability was assessed by macroscopic observation, light backscattering and zeta potential measurements. NLC particle size was measured using dynamic light scattering (DLS). The kinetically stable formulations were loaded with forskolin and selected for in vitro drug permeation study using the Franz cell method. Concentration of forskolin in the receptor solution (i.e. ethanol/PBS mixture) was analyzed with high performance liquid chromatography (HPLC) with UV detection. The obtained results have shown that NLC formulations could be used as effective carriers for forskolin permeation through the skin.

Development of a palm olein oil-in-water (o/w) emulsion stabilized by a whey protein isolate nanofibrils-alginate complex

An oil-in-water (o/w) emulsion is a system where the oil droplets are dispersed within a watery phase. The most important function of emulsions is their ability to incorporate lipophilic components into food matrices. Thus, it is crucial to develop an emulsion that is highly stable. This work was aimed at developing a palm olein o/w emulsion stabilized by a whey protein isolate nanofibrils-alginate complex, as well as evaluating the influence of oil load and the homogenization process (both pressure and cycle) on the characteristics of the o/w emulsions. Emulsions were analyzed for droplet size, zeta potential, viscosity, creaming stability, and morphology. The results showed that an increase in oil load led to a larger droplet size, less negative zeta potential, and emulsions that were more viscous and less stable. On the other hand, increasing homogenization pressure and the number of homogenization cycles resulted in a smaller droplet size, more negative zeta potential, and emulsions that were less viscous and more stable. Emulsions with a smaller droplet size and better stability resulted from lower oil load, high homogenization pressure and more homogenization cycles.

Development of olmesartan medoxomil optimized nanosuspension using the Box–Behnken design to improve oral bioavailability

The aim of the present investigation was to enhance the oral bioavailability of olmesartan medoxomil by improving its solubility and dissolution rate by preparing nanosuspension (OM-NS), using the Box–Behnken design. In this, four factors were evaluated at three levels. Independent variables include: concentration of drug (X1), concentration of surfactant (X2), concentration of polymer (X3) and number of homogenization cycles (X4). Based on preliminary studies, the size (Y1), zeta potential (ZP) (Y2) and % drug release at 5 min (Y3) were chosen as dependent responses. OM-NS was prepared by high pressure homogenization method. The size, PDI, ZP, assay, in vitro release and morphology of OM-NS were characterized. Further, the pharmacokinetic (PK) behavior of OM-NS was evaluated in male wistar rats. Statistically optimized OM-NS formulation exhibited mean particle size of 492 nm, ZP of –27.9 mV and 99.29% release in 5 min. OM-NS showed more than four times increase in its solubility than pure OM. DSC and XRD analyses indicated that the drug incorporated into OM-NS was in amorphous form. The morphology of OM-NS was found to be nearly spherical with high dispersity by scanning electron microscopic studies. The PK results showed that OM lyophilized nanosuspension (NS) exhibited improved PK properties compared to coarse powder suspension and marketed tablet powder suspension (TS). Oral bioavailability of lyophilized NS was increased by 2.45 and 2.25 folds when compared to marketed TS and coarse powder suspension, respectively. Results of this study lead to conclusion that NS approach was effective in preparing OM formulations with enhanced dissolution and improved oral bioavailability.

Co-encapsulating solid lipid nanoparticles for multifunctional therapeutics: Preparation and characterization

One of the most favored features of using nanoparticulate delivery systems such as solid lipid nanoparticles (SLNs) is their capability to encapsulate multi-agents of different chemical structures to achieve simultaneous delivery to the site of action. The present work has been carried out to elaborate a convenient methodology for the loading of the drug combination efficiently and with high drug content. Thus, two representatives of the naturally occurring flavonoids (FLs) with a broad spectrum of biological functions, i.e., fisetin (FIS) or myricetin (MYR), along with the indocyanine-type photosensitizer IR-780 were co-loaded in the cetyl palmitate (CP) matrix of the phosphatidylcholine-based solid lipid nanoparticles (SLNs) by means of the high pressure homogenization method (HPH). The HPH process – optimized in regard to different ratios of combination drugs, particle components content as well as variable parameters as pressure and number of homogenization cycles – provided physically stable and fairly monodisperse FL+IR-780-loaded SLN dispersions (with polydispersity indices below 0.3). The sizes of the studied nanosystems along with the size distribution were determined by dynamic light scattering (DLS), while shape and morphology – by atomic force microscopy (AFM). The physical state of the studied co-loaded SLNs was characterized by Fourier transform infrared (FT-IR) spectroscopy, differential scanning calorimetry (DSC) and thermogravimetric analysis (TG-DTA). Both FLs and IR-780 preserved their structural state and were thoroughly dispersed in the CP-matrix during the HPH procedure. Our synthetic methodology enabled to perform remote loading of two drugs (FIS or MYR and IR-780) in the SLN – type nanocarriers having desirable chemical and colloidal stability, making them useful for therapeutic and diagnostic applications or combination therapies.

Optimization of homogenization-evaporation process for lycopene nanoemulsion production and its beverage applications.

Lycopene is a natural antioxidant which has several health benefits. Undesirable oxidation of lycopene compromises its health benefits and also affects the sensory quality of food products containing lycopene. Health benefits associated with lycopene in food preparations can be enhanced by preventing its degradation by incorporating it into the oil phase of an oil-in-water nanoemulsion. In this study, lycopene nanoemulsions were prepared from a low-concentration lycopene extract using an emulsification-evaporation technique. The effects of the concentrations of the lycopene extract (0.015 to 0.085 mg/mL) and emulsifier (0.3 to 0.7 mg/mL), and the number of homogenization cycles (2 to 4) on the droplet size, emulsification efficiency (EE), and nanoemulsion stability were investigated and optimized by statistical analysis using a Box-Behnken design. Regression analysis was used to determine the 2nd-order polynomial model relationship of independent and dependent variables, with multiple regression coefficients (R(2)) of 0.924, 0.933, and 0.872, for the droplet size, EE, and nanoemulsion stability, respectively. Analysis of variance showed that the lycopene extract concentration has the most significant effect on all the response variables. Response surface methodology predicted that a formulation containing 0.085 mg/mL of lycopene extract and 0.7 mg/mL of emulsifier, subjected to 3 homogenization cycles, is optimal for achieving the smallest droplet size, greatest emulsion stability, and acceptable EE. The observed responses were in agreement with the predicted values of the optimized formulation. This study provided important information about the statistical design of lycopene nanoemulsion preparation.

Effect of four different size reduction methods on the particle size, solubility enhancement and physical stability of nicergoline nanocrystals

Nicergoline, a poorly soluble active pharmaceutical ingredient, possesses vaso-active properties which causes peripheral and central vasodilatation. In this study, nanocrystals of nicergoline were prepared in an aqueous solution of polysorbate 80 (nanosuspension) by using four different laboratory scale size reduction techniques: high pressure homogenization (HPH), bead milling (BM) and combination techniques (high pressure homogenization followed by bead milling HPH + BM, and bead milling followed by high pressure homogenization BM + HPH). Nanocrystals were investigated regarding to their mean particles size, zeta potential and particle dissolution. A short term physical stability study on nanocrystals stored at three different temperatures (4, 20 and 40 °C) was performed to evaluate the tendency to change in particle size, aggregation and zeta potential. The size reduction technique and the process parameters like milling time, number of homogenization cycles and pressure greatly affected the size of nanocrystals. Among the techniques used, the combination techniques showed superior and consistent particle size reduction compared to the other two methods, HPH + BM and BM + HPH giving nanocrystals of a mean particle size of 260 and 353 nm, respectively. The particle dissolution was increased for any nanocrystals samples, but it was particularly increased by HPH and combination techniques. Independently to the production method, nicergoline nanocrystals showed slight increase in particle size over the time, but remained below 500 nm at 20 °C and refrigeration conditions.

Nanoemulsions produced with varied type of emulsifier and oil content: An influence of formulation and process parameters on the characteristics and physical stability

The aim of the present study was to prepare oil-in-water nanoemulsions stabilized with a novel natural alkyl polyglucoside surfactant and to compare them with corresponding lecithin/polysorbate 80 - based nanoemulsions in terms of physicochemical properties and physical stability. Nanoemulsions were prepared by high pressure homogenization, using 20, 30 and 40% (w/w) medium chain triglyceride as oil phase, and 4, 6 and 8% (w/w) lecithin/polysorbate 80 mixture (1/1) or caprylyl/capryl glucoside as emulsifiers. The influence of emulsifier type, emulsifier concentration and oil content was investigated with respect to changes in particle size, particle size distribution, surface charge and physical stability. The influence of production parameters (number of homogenization cycles, type of homogenization process, homogenization pressure) on particle size was also investigated. Analysis was performed by photon correlation spectroscopy, laser diffraction, zeta potential, pH and electrical conductivity measurements. All formulations produced revealed a small droplet size ranging from 147 to 228 nm and a very narrow size distribution (polydispersity index range 0,072-0,124). Zeta potentials were about -20 mV and -50 mV for nanoemulsions stabilized with lecithin/polysorbate 80 and caprylyl/capryl glucoside, respectively. The results obtained during the stability studies (6 months at 25?C and 1 month at 40?C) indicated that nanoemulsion stability was influenced by their composition. Acquired results also suggested the most appropriate production parameters: 9 homogenization cycles, homogenization pressure of 500 bar and discontinuous process of homogenization.

“Vitamin E” fortified parenteral lipid emulsions: Plackett–Burman screening of primary process and composition parameters

The objective of this study was to screen the effect of eight formulations and process parameters on the physical attributes and stability of “Vitamin E”-rich parenteral lipid emulsions. Screening was performed using a 12-run, 8-factor, 2-level Plackett–Burman design. This design was employed to construct polynomial equations that identified the magnitude and direction of the linear effect of homogenization pressure, number of homogenization cycles, primary and secondary emulsifiers, pre-homogenization temperature, oil loading, and ratio of vitamin E to medium-chain triglycerides (MCT) in the oil phase on particle size, polydispersity index, short-term stability, and outlet temperature of manufactured emulsions. The viscosity of vitamin E was reduced from 3700 (100%) to 64 mPa.s (30%) by MCT addition. As viscosity is critical for efficient emulsification, vitamin/MCT ratio was the most significant contributor for the stability of emulsions. Particle size increased from 236 to 388 nm, and percentage vitamin remaining emulsified after 48 h dropped from 100 to 73% with increase in vitamin/MCT ratio from 30/70 to 70/30. Significant decrease in particle size and PI, and an increase in outlet temperature were also observed with increase in homogenization pressure and number of homogenization cycles. Emulsifiers and oil loading, however, had insignificant effect on the responses. Overall, stable submicron emulsions at vitamin/MCT ratio of 30/70 could be prepared at 25,000 psi and 25 cycles in ambient conditions. The identification of these parameters by a well-constructed design demonstrated the utility of screening studies in the “Quality by Design” approach to pharmaceutical product development.