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The screening process was done using ternary phase diagram studies which were then followed by
the CCD to find the best formulation. The drug content (%) was estimated by the following formula.
The chloroform was evaporated using a rotary evaporator (BUCHI, Rotavapor- RE, Switzerland)
under vacuum conditions, forming a thin-coated film of DOPC at the bottom of the flask. Besides
being resource (cost, experiments, time, manpower)-intensive, the OFAT method cannot estimate
interactions between the variables. Editorial Policies Author Information Peer Review Guidelines
Open Outlook Hot topics Podcasts. However, typical chronic disease drugs are often poorly water-
soluble, have low dissolution rates, and undergo first-pass metabolism, ultimately leading to low
bioavailability and lack of efficacy. Despite the importance of lipid-based formulations, these
systems have some limitations including; stability, complexity during large scale manufacturing
process and limited dosage forms to such as soft gelatin capsule. The presence of either lipid or lipid
with co-surfactant interaction greatly affected the cumulative drug release, as shown by the highest
coefficient, suggesting that the greater amount of drug was accordingly increased. For more
information on the journal statistics, click here. Colloidal silica and dextran were used as a
hydrophobic and a hydrophilic carrier, respectively. The experimental device consisting of a
thermally stable reaction vessel under continuous agitation and a pH-stat with an automated burette
to add NaOH solution is used to mimic the in vivo situation of lipolysis. Published in Carbohydrate
Polymers 2014 Comparison of a solid SMEDDS and solid dispersion for enhanced stability and
bioavailability of clopidogrel napadisilate. Finally, the photostability studies revealed the
substantially enhanced photostability of the MTX-loaded SMEDDS under the forced degradation
and confirmatory conditions. Silver nanoparticle-embedded graphene oxide-methotrexate for
targeted cancer treatment. Setting all the process control settings prior to the production run. Hsieh,
Chien-Ming, Ting-Lun Yang, Athika Darumas Putri, and Chin-Tin Chen. First, the authors conducted
a screening study using a spray drying method with dextran as the solid carrier to obtain a range of
independent parameter values, including inlet temperature, feed rate, and carrier concentration. Paper
should be a substantial original Article that involves several techniques or approaches, provides an
outlook for. Design of experiment (DoE) and risk assessment techniques based on QbD
methodologies are increasingly used in the formulation development of SMEDDS. The authors of
this paper also wish to acknowledge the support provided to this project by the HMSTrust
Laboratory, based at the Monash Institute of Pharmaceutical Sciences. Since SMEDDS belongs to
type IIIb lipid-based formulation, more drugs can be loaded into the formulation when higher
amounts of surfactant are used. To best achieve these objectives, in addition to mechanistic models,
DoE is an excellent tool that allows pharmaceutical scientists to systematically manipulate factors
according to a prespecified design. The concentration distribution map of the FEN-loaded GEL-
based S- SMEDDS formulation was generated from the FEN corresponding highest Raman
intensity bands at 1598 cm-1 and 1648 cm-1 (Figure 3b), where the more reddish area (bright in grey
scale) corresponds to the high concentration and bluish (dark in grey scale) to low concentration
areas. Furthermore, solid SMEDDS ( Figure 3C ) had a relatively smooth surface of calcium silicate
particles, suggesting that liquid SMEDDS is absorbed or coated inside the pores of calcium silicate.
The average of three scattering patterns of the samples were acquired before lipase addition and
subtracted as background. Dilution stability is to evaluate the thermodynamic stability of SMEDDS
upon dilution in water. The outer film coating and packaging in spray drying has shown improved
photostability in various photosensitive drugs. 17. At the same time, the photostability of MTX
powder and MTX-loaded solid SMEDDS was tested by exposing the respective formulations to
daylight for 12 weeks in the confirmatory analysis. Tertiary-phase diagram showing emulsion areas
(in grey color) of the selected masses of the independent variables containing surfactants (i.e.,
PEG400 and Tween 80 (K m )) and oil phases (i.e., ethyl oleate) ( a ). Reduction in Intensity of
Diffraction Peaks from Drugs During Digestion and Correlation to Drug Solubilisation Using HPLC
Synchrotron SAXS can provide insight into three types of processes on drug behaviour during
digestion.
Because qualitative evaluation is just as important as the quantitative evaluation in the photostability
study, the samples were visually investigated at the end of the test period for any changes in physical
properties, such as appearance or color, which can imply the existence of photolytic degradation. The
sedimentation phase usually contains calcium soap of fatty acid and precipitated drugs, which can be
used to evaluate the sedimentation velocity of the lipid-based formulation. All Raman spectra (bulk
drugs and mapping of Page 10. Please note that many of the page functionalities won't work as
expected without javascript enabled. The solubility of lipophilic drugs into the formed colloidal
phases can be significantly affected by drug properties, the arrangement of lipids in morphological
structures and the solubilising Page 24. The placement of the new tool, support equipment, and raw
material. Realization that the oral bioavailability of poor water soluble drugs may be enhanced when
co-administered with meal rich in fat has led to increasing recent interest in the formulation of
poorly water soluble drugs in lipids. Adding SMEDDS oil solution to either MTSH or MAS at ratios
of 1:9 has relatively reduced tablets hardness by almost 2 or 4 folds, respectively. In type III
formulations, co-solvents are included to blend with oil and surfactants to form a self-emulsifying
system. The drug-loaded GEL-based S-SMEDDS formulations formed a lamellar phase during
digestion evidenced by three distinct peaks at q of 0.15, 0.30 and 0.45 A-1 in fasted intestinal Page
17. However this preferred route is limited to those drugs molecule that are permeable across the
gastric mucosa and are at least sparingly soluble. We use cookies on our website to ensure you get
the best experience. The removal of the tooling, raw material, and support equipment. Another
simplex lattice design was also employed by Dhaval and coworkers to investigate seven batches of
clofazimine formulations in solid SMEDDS. Expand 38 Save SELF EMULSIFYING DRUG
DELIVERY SYSTEM: A REVIEW Kshitija Khedekar Swati Mittal Medicine, Chemistry 2013
TLDR Present review provides an updated account of advancements in SEDDS with regard to its
composition, evaluation, different dosage forms and newer techniques to convert liquid SED DS to
solid and also various applications. These results verify that the solid SMEDDS enhanced the
dissolution of MTX. AmritRout4 SMEDDS- Self Micro Emulsifying Drug Delivery System.pptx
SMEDDS- Self Micro Emulsifying Drug Delivery System.pptx Tanmai25 SNEDDS.pdf
SNEDDS.pdf amramei677 Basics of self micro emulsifying drug delivery system Basics of self
micro emulsifying drug delivery system Alexander Decker Self emulsifying drug delivery system
Self emulsifying drug delivery system sai9985 Characterization of Self-Microemulsifying Dosage
Form: Special Emphasis on Ze. An emulsion was judged as “good” when introduced droplets
dispersed easily in water and formed a fine emulsion. The longer an article is in the process of
manufacture and the more it is. Additionally, the solid state of the model drugs and distribution of
drugs on the surface of drug-loaded S-SMEDDS systems were quantified using wide-angle X-ray
scattering (WAXS) and Raman spectroscopy, respectively. All formulations were evaluated for
percent transmittance, emulsification time, dispersibility, robustness, and thermodynamic stability.
The AUC and C max were significantly increased in solid SMEDDS. The tendency of this
formulation to emulsify spontaneously and the progress of emulsion droplets were visually observed.
The scattering patterns confirm the crystalline state of model drugs with distinct peaks at q of 0.84,
1.02, 1.14 and 1.18 A-1 for FEN (a) and at q of 0.72, 1.09 and 1.32 A-1 for CINN (b). The scattering
patterns of bulk samples were arbitrarily scaled for the graphing purpose. The drug content in the
samples was quantified at predetermined time intervals by the HPLC method described above. It was
conducted by exposing an excess amount of artificial light using a photostability chamber until
significant degradation had occurred. Oh Young-Joon Park J. Kang C. Yong Han?Gon Choi
Chemistry, Materials Science Drug Delivery 2011 TLDR The flurbiprofen-loaded solid dispersion
would be useful to deliver poorly water-soluble flurbIProfen with enhanced bioavailability without
crystalline change and give higher AUC, Tmax, and Cmax compared to commercial product. The
outer film coating and packaging in spray drying has shown improved photostability in various
photosensitive drugs. 17. You can download the paper by clicking the button above. Comparative
study on solid self-nanoemulsifying drug delivery and solid dispersion system for enhanced
solubility and bioavailability of ezetimibe.
The experimental parameters were: a 50x Microscope objective, 70% laser power, 8 cm-1 data
interval, 5-s acquisition time, 5 accumulations and each spectrum was the mean of the three
spectrums. Before proceeding with drug-loaded samples, the drug-free S-SMEDDS formulations
were scanned and the spectrum bands were correlated to bulk drugs spectrum bands to confirm the
possible overlapping. In order to evaluate the overall photosensitivity of the formulation, a forced
photodegradation study was performed for 20 days. The syringe tip was removed and the solid
products were pushed out from the syringe, and the uniform size solid pieces were used for further
study. Subsequently, 1 mL of samples were centrifuged at 10,000 g for 10 min (Hanil Science
Industrial Co., South Korea) to separate the undissolved MTX. The calculated percentage of peak
area corresponding (a) FEN diffraction peaks and (c) CINN diffraction peaks plotted in negative
increment against the extent of digestion (left panel) and the concentration of (b) FEN and (d)
CINN in the AP (quantified using HPLC) plotted against the extent of digestion (right panel).
Darwis Medicine, Chemistry Pharmaceutics 2020 TLDR The developed SEDDs of AZM were
proven to be cytocompatible and able to open up the cellular epithelial tight junctions (TJ) and stable
at refrigerator storage conditions, suggesting the developed Seds may enhance the oral delivery of
the drug. The concentration of MTX in the sample was quantified by the HPLC system (Agilent
1260 Infinity, Agilent Technologies, USA) consisting of the Chem Station software, G1311C 1260
Quat Pump, and G1314B 1260 VWD VL detector. The pharmacokinetic parameters are shown in
Table 1. Constantinides Medicine, Chemistry Pharmaceutical Research 2004 TLDR This review
highlights the state-of-the-art in pharmaceutical microemulsions with emphasis on self-emulsifying
systems, from both a physical and biopharmaceutical perspective, primarily focused on their potential
for oral drug delivery and intestinal absorption improvement. For all S-SMEDDS systems, the results
suggest that drugs were still present in crystalline form in suspension after dispersion but they did
not affect the self-assembly behaviour of lipids during digestion. Empty hard gelatin capsules were
filled with either MTX-loaded solid SMEDDS or MTX powder, equivalent to 50 mg of MTX. On
the other hand, calcium silicate was uneven and highly porous surface ( Figure 3B ), which probably
allowed the influx of the aqueous phase into the substance. The average of three scattering patterns
of the samples were acquired before lipase addition and subtracted as background. Therefore, when
oil, surfactant, and co-surfactant are blended all together, the microemulsions occur rather
spontaneously and involve almost no external energy, further indicating a favorable or stable
thermodynamic state. In general, a water-free system not only bears lower solvent effects but also
diminishes the dosing volume and increases drug stability. Note that from the first issue of 2016, this
journal uses article numbers instead of page numbers. The standard digestion buffer solution
consisting Page 7. International Journal of Environmental Research and Public Health (IJERPH).
This point echoes the solubility data in Figure 1 where the small effect of the postprandial state was
additive to that provided by the pre-digested formulation. All articles published by MDPI are made
immediately available worldwide under an open access license. No special. In short, the required
quantity of DOPC was weighed into a round bottom flask and dissolved into 2-3 mL chloroform.
Secondly, the presence of drug diffraction peaks at the start but changes in peak positions during
digestion suggests a polymorphic transformation of the crystalline solid state of the drug. The
appearance of formulations should be transparent and clear without any precipitation. Polarity of the
Lipid Phase The digestion of lipid excipients and drug partitioning in SMEDDS begins in the GI
tract, involving lipid emulsification and solubilization. Application of Design of Experiments in the
Development of Self-Microemulsifying Drug Delivery Systems. Pharmaceuticals 2023, 16, 283.
Thus, the digestion of GMO is expected to produce higher extent of free fatty acids (i.e. oleic acid)
during digestion than GEL. Among them, ethanol has been used traditionally as a co-solvent in oral
solutions, but it may not be suitable for pediatric or other patients who cannot tolerate alcohol. 2.3.
Macroemulsions, Microemulsions and Nanoemulsions Macroemulsion is a thermodynamically
unstable state; therefore, oil-water separation often occurs after storage. The lipid-based formulation
offers tremendous benefits of using versatile excipients and has great compatibility with all types of
dosage forms. Self-microemulsifying drug delivery system (SMEDDS) promotes drug self-
emulsification in a combination of oil, surfactant, and co-surfactant, thereby facilitating better drug
solubility and absorption. In other cases, it is replacing product-specific parts. Powder blends
containing magnesium trisilicate hydrate (MTSH) or magnesium lluminum silicate (MAS) at various
oil loading factors were mixed with MCC with and without various binders and compressed into
tablets using a fixed loading force of approximately of 5 KN.
The morphology of the solid SMEDDS formulation revealed well dispersed particles with a smooth
surface. This includes the necessary adjustments required after the first. According to the length of
the fatty acid chain, it could be divided into medium-chain triglycerides (MCT) and long-chain
triglycerides (LCT). For the all studied S-SMEDDS formulations, the drug diffraction peaks did not
completely disappear but peaks intensities reduced significantly during digestion over time. The
scattering data is then compared to the corresponding solubilisation profiles obtained using HPLC
(Figure 7b and Figure 7d). Since surfactant is mixed with co-solvent in type IV formulations, it
provides better solvent capacity on dilution than using co-solvent alone. 2.2. The Compositions of
Lipid-Based Formulations and Their Role in Enhancement of Bioavailability 2.2.1. Triglycerides and
Mixed Glycerides Used as Lipid Phase in Lipid-Based Formulations Triglyceride is an ester in which
three molecules of fatty acid are linked to the alcohol glycerol. Visit our dedicated information
section to learn more about MDPI. This is associated with the several challenges and difficulties that
may be encountered during the SMEDDS preparation and administration process. You can download
the paper by clicking the button above. The dissolution medium-containing vessel was surrounded by
an outer water-bath in order to maintain the specific temperature. Although they are regarded as the
most appropriate method to increase drug solubility and bioavailability in oral drug administration,
there are still few available products on the pharmaceutical market formulated as SMEDDS. The
first-order model is attributed to a well-modeled response with the factors by linear correlation of the
factors. There are several actions that could trigger this block including submitting a certain word or
phrase, a SQL command or malformed data. Here, the solubilisation behaviour of two poorly water-
soluble lipophilic drugs, FEN and CINN, is described for the first time during digestion of S-
SMEDDS formulations. Three levels of three-factors (3 3 ) BBD were used thereafter to generate a
factorial combination of these independent parameters on responses to evaluate powder
characteristics, including %moisture, %yield, drug content, and particle size. In addition, the higher
concentration of BS and PL leads to the swelling of micelles, further boosting the solubilisation
capacity. In addition, the low molecular weight polar molecules present in lipid formulations may
penetrate and plasticize gelatin capsule shells, restricting the concentration of propylene glycol and
related co-solvents that can be used, resulting in reduced efficacy of the formulation. The
experimental parameters were: a 50x Microscope objective, 70% laser power, 8 cm-1 data interval, 5-
s acquisition time, 5 accumulations and each spectrum was the mean of the three spectrums. Before
proceeding with drug-loaded samples, the drug-free S-SMEDDS formulations were scanned and the
spectrum bands were correlated to bulk drugs spectrum bands to confirm the possible overlapping. In
order to evaluate the overall photosensitivity of the formulation, a forced photodegradation study
was performed for 20 days. The chemical map of the drug-loaded solid formulations was generated
using SpectrumImage software (PerkinElmer, United Kingdom) from high-intensity Raman bands
corresponding to drugs, using bulk Raman Spectra as a reference spectrum. The three diffractograms
of bulk model drugs and prepared S-SMEDDS formulations were acquired at an X-ray wavelength
of 1.127 A (energy 11 keV) for bulk drugs and 0.954 A (energy 13 keV) for S-SMEDDS
formulations. A similar trend was found in drug release of pH 6.8 results. Therefore, the authors then
concluded to use a high proportion of surfactant to later obtain greater cumulative drug release in the
batches studies. Zeta potential is the electrical potential in the interfacial double layer of a dispersed
particle or droplet versus a point in the continuous phase away from the interface. To browse
Academia.edu and the wider internet faster and more securely, please take a few seconds to upgrade
your browser. Illustration of microemulsions and nanoemulsions prepared from the similar elements
of oil, water, and surfactant, giving the relatively similar structures with each other. Therefore, it is
necessary to consider the criterion of lipid selection during SMEDDS formulation. The prepared
SMETs have acceptable tableting properties (flowability, compressibility, and compactibility) and
were able to preserve self microemulsifying properties of entrapped SMEDDS formulation. Expand
46 2 Excerpts Save Fabrication and evaluation of pH-modulated solid dispersion for telmisartan by
spray-drying technique. Some APIs or excipients might be sedimented when SMEDDS is stored at
low temperatures. This analysis revealed that MTX powder ( Figure 3A ) had an even surfaced and
angulated crystals in shape.