Drug Loading Methods: Efficiency and Dissolution Performance Analysis

This report explores the influence of different drug loading methods on the efficiency and dissolution performance of mesoporous polymeric carriers, crucial for improving drug bioavailability. It discusses various techniques like spray drying, solvent impregnation, and rotary evaporation, highlighting their impact on drug solid-state stability and release. Key characterization techniques such as confocal microscopy, scanning electron microscopy (SEM), differential scanning calorimetry (DSC), and dissolution testing are mentioned for evaluating drug distribution, microstructure, thermal properties, and solubility. The report references multiple studies, emphasizing advancements in controlled and targeted drug delivery using mesoporous silica nanoparticles (MSNPs) and their modifications for enhanced drug loading, reduced toxicity, and synergistic therapeutic effects in cancer treatment. The overall aim is to optimize drug delivery systems by understanding the relationship between drug loading methods and the resulting performance of mesoporous carriers.

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
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INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
Executive Summary
Mesopore nano molecules are increasingly used in the field of drug production because of its
high bioavailability, biocompatibility and biodegradability. The drug loading efficiency also
needs a revise because of the higher dosage of drug can harm the body. So, newer innovative
techniques are being developed to improve the stability, dissociation rate of the drug so that
little amount of drug can do the needful without causing any harm to the body. There are also
a few characterizing techniques that confirm the efficacy of these particles and it’s stability.

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
Table of Contents
INTRODUCTION......................................................................................................................4
AIM AND OBJECTIVES..........................................................................................................6
RESEARCH QUESTIONS........................................................................................................6
LITERATURE REVIEW...........................................................................................................6
CONCLUSION........................................................................................................................13
REFERENCES.........................................................................................................................15

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
INTRODUCTION
Mesoporous particles can be used as a successful drug delivery system. As the
solubility of drugs remains to be very low, patients need to take medication of higher doses to
meet the therapeutic benefits of a drug. A study was conducted to ensure the extent of the
capability of mesoporous silica nanoparticles (MSNPs) as a drug delivery system.
Mesoporous silica nanoparticles are preferred because of their desirable chemical properties
and thermal stability along with their compatibility with biological tissue. The distinctive
structure of the MSNP allows it to deliver drugs effectively by controlling its slow release
into the body’s target site. The physical and chemical properties of the mesoporous silica
such as the pore size, drug loading capacity and porous nature along with surface properties
can be changed by using additives during the development of MSNP. The altered properties
of the surface of MSNP can make it adhesive to the drugs. The application of MSNP includes
diagnosis, drug delivery into the specific target, uptaking cellular substances and monitoring
body fluids (Bharti et al. 2015).
Drugs that are administered orally should have the property to solubilise and be
absorbed by the intestine to show its therapeutic action but about 40% of drugs that are sold
into the market have low solubility and 70-80% of the newly developed drugs are not sold
into the market because they suffer from low solubility (Le et al. 2019). Solid dispersion
systems can address the solubilization of mesoporous material such as silica which performs
effectively in achieving the delivery of drug molecules within their nanopore structure. There
are various techniques to load the drug into the mesoporous silica including solevent-free and
solvent-dependent techniques. Solvent-based methods are easy to use for amorphisation of
the drug into the mesoporous silica where the drug is dissolved in either ethanol or
impregnated with mesoporous silica followed by removal of the solvent by drying. Spray

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
drying, a solvent-based technique provides greater efficiency in drug loading into
mesoporous silica compared to solvent-free methods (Choudhari et al. 2014).
MSNP confer low toxicity inside various cell lines and to evaluate its safety two
parameters are considered which include surface chemistry and particle size. These two
parameters influence the factors associated with cytotoxicity and biological behaviour that
include particle agglutination, adsorption of protein onto the particle, cellular toxicityparticle
trafficking and nano-bio interface interactions. The MSNP toxicity depends on the size of the
particle and research reveals that native MSNPs possesses more cytotoxicity than the
functional MSNPs. It was reviewed that PEGylation of MSNP decreased its attachment to
serum proteins thereby reducing hemolysis of human blood cells and enhancing blood
compatibility when drugs are injected intravenously (Jafari et al. 2015).
To visualise the physical properties after drug loading through mesoporous silica, the
following techniques can be used which include differential scanning calorimetry (DSC) for
thermal analysis of drug encapsulation into the silica matrix, scanning electron microscope
(SEM) to visualise the size of particles and morphology of the surface of mesoporous silica
and perform dissolution of drug with aqueous solution the drug to check the aqueous
equilibrium solubility of the drug. The drug dissolution will compare the highest saturation
degree and time of drug-loaded silica carriers (Kiwilsza et al. 2015). Confocal microscopy
demonstrated the distribution and location of the nanoparticle containing drug inside the cells
(Costanzo et al. 2016). In this paper, various studies that have already been conducted on this
topic will be discussed elaborately.

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
AIM AND OBJECTIVES
The aim of this study is to derive the main differences between the different drug
loading methods, impact of drug loading methods on the loading efficiency and dissolution
performance of mesoporous polymeric carriers.
Objectives:
 To deduce the differences between different drug loading methods.
 To find out the loading efficiency of various drug loading methods.
 To find out the dissolution performance of mesoporous polymeric carriers.
RESEARCH QUESTIONS
Q1. What are the differences between the drug loading methods available?
Q2. State the loading efficiency of the available drug loading method into mesoporous
polymeric carriers.
Q3. State the drug solid-state stability and dissolution performance of mesoporous
polymeric carriers.
LITERATURE REVIEW
Since the last decade, there has been extensive research conducted on mesoporous
polymeric carriers or mesoporous silica nanoparticles (MSN) as it can be used as an
alternative in a drug delivery system. A conducted review sheds light on the advancements
that have been done regarding these particles. The first advancement of MSN is its immediate
and sustained drug delivery system where the drug reaction timing can be set from before,
which might be immediate or sustained. The other advancement of MSN is its controlled and
targeted drug delivery system where the drug reaction can be set to act on a particular target

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
or act in a controlled manner. The researchers also discussed its biotherapeutic agent delivery
efficiency, its bioimaging applications and its capability of tissue regeneration as bioactive
substance. All the results showed the high ability of mesoporous particles (Wang et al. 2015).
A study was conducted to observe if any increase in drug loading and decrease in
drug delivery is possible by changing the surface of mesoporous particle SBA-15. AT first,
the structure of SBA-15 nanoparticles was altered by the addition of 3-aminopropyl
triethoxysilane. Then it was used as a transporter of an anti-inflammatory and non-steroidal
drug after the loading was optimised. The modified version of SBA-15 was characterised by
SEM, XRD and Thermal Analysis. Then by changing the drug loading factors which include
time, stirring rate and temperature loading optimisation was done. It resulted in a significant
increase in drug loading and decrease in the rate of drug delivery (Ahmadi et al. 2014).
Magnetic Resonance Imaging (MRI) is one of the most widely used imaging
procedure (Morris and Slesnick 2018). To get enlarged and clear images of the organs in
MRI, contrast agents are used. Gadolinium is used as the contrast agent, but it has a high risk
of nephrogenic systemic fibrosis. To avoid the usage of this element, researchers conducted
an experiment on mesoporous manganese silicate-coated silica nanoparticle as the contrast
agent in MRI. The results showed it can be used as the contrast agent. However, more
research is required to use as a permanent alternative of gadolinium because the researchers
are sceptical of its efficacy (Li et al. 2016).
Anti-cancer drugs are often not properly delivered at the tumour site and it has quite a
lot of toxic side-effects. To avoid this, researchers conducted an experiment to produce a non-
toxic and target-specific drug delivery system. They took a polyethylene glycol (PEG)
shielding and a tumour microenvironment activating cascade pH-responsive hollow
mesoporous silica nanoparticles (HMSN) drug delivery system and the surface was modified

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
by the addition of 3-(3, 4-dihydroxyphenyl) propionic acid (DHPA) with the help of boronic
acid catechol ester bonds. Different characterising techniques proved the fact of the proper
attachment of DHPA on the surface of HMSN. It was then tested on both in vitro and in vivo
conditions. In vitro test showed that as the compound enters the tumour with increased
permeability and retention effect, PEG was cleaved from Ada in the slightly acidic state of
the tumour microenvironment. On the other hand, the PEG facilitates cellular uptake of
HMSN molecules and leads to apoptosis of tumour cells. The in vivo test showed that the
drug loaded HMSN molecules inhibited the growth of the tumour cells, and it did not even
have any toxic effect (Liu et al. 2016).
Nano-Engineering techniques can make the use of MSNPs in many ways. In this
study, the researchers proved this again by synthesising three MSNP molecules of different
sizes: 48nm, 72nm and 100nm with PEG incorporated in its surface. Then by the help of
cleavable disulphide bonds, amino-β-cyclodextrin was added to block the rugs inside the
mesopore. Then active folate ligand was incorporated into the MSNPs, creating PEG-
MSNPs48-CD-PEG-FA leading to improvement and selective uptake of these nanoparticles
inside the tumour. It was seen that these MSNP nanoparticles were able to inhibit the growth
of breast cancer tumours in mice much more effectively (Zhang et al. 2014).
MSNPs hve the ability to change their physical forms. To explore this ability,
scientists conducted an experiment in which they heavily doped MSNPs with
photosensitising chlorin e6. Heavy doping led to the change of shape in these nanoparticles
from spherical to rod-shaped. It was then seen that these rod-shaped nanoparticles have the
ability to emit singlet oxygen molecules that are used in photodynamic therapy and these
molecules also have high drug loading capability. Owing to it’s larger aspect ratio than the
spherical molecules, it can uptake the cancer cells much faster. This was further tested with

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
doxorubicin a chemotherapy drug, and it resulted in dual action including chemotherapy as
well as photodynamic therapy. Thus, it resulted in having much better efficiency of inhibiting
cancer cells in both in vitro and in vivo conditions (Yang et al. 2015).
Saint-Cricq et al. (2015) researched and prepared a thermally disintegrable drug
delivery nanoparticle that set to work when required on exposing it to a magnetic field. The
mesopores of the nanoparticles are blocked at first at body temperature by applying an azo
functionalized PEG so that the drug inside can not leak out. Azo-PEG allows the drug to
escape from the pores when exposed to a narrow range of temperature by breaking the
covalent bonds present. Then it was subjected to heat by a magnetic field in nanoscopic level
so that the surrounding tissues are not destroyed. The result showed that it did not cause any
cytotoxicity on fibroblasts and thus can be used to deliver drugs and various other
therapeutics, making it a safer choice for drug delivery system in different treatment
procedures.
A study was conducted to investigate the synergistic effects of using mesoporous
molecules. The synergistic therapy included various ways of treatments including magnetic
hyperthermia, photothermal therapy and controlled drug release. The system used magnetic
mesoporous silica nanoparticles (MMSN) as magnetic thermoseeds and drug carriers and
Graphene Quantum Dots (GQD) as caps along with photothermal generators. The experiment
results showed that these nanoparticles could release drugs doxorubicin when present in low
pH range. It also showed that MMSN/GQD nanoparticles could emit heat at an alternating
magnetic field to the hypothermic temperature range. 4T1 cells of breast cancer were taken as
a model system to study the effects in more details, and it showed that the combined impact
of chemo-magnetic hyperthermia therapy and chemo-photothermal therapy along with

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
doxorubicin resulted in an increased number of cancer cell death than the therapies applied
alone (Yao et al. 2017).
Another technique was developed and studied to reduce the effect of doxorubicin by
producing biodegradable and enzyme responsive mesoporous silica nanoparticles with
tumour specificity. For blocking the mesopore to prevent the leakage of drugs, the
researchers used α-cyclodextrin and alkoxysilane tether. Further treatments and modifications
were done with cathepsin B- responsive functions and GFLGR7RGDS with tumour target and
membrane penetration so that the blocking material gets more potent and can prevent the exit
of the drug doxorubicin from the mesopores. Then the normal and tumour cells were
incubated with the prepared drug loaded MSNPs. This resulted in the action of surface RGDS
along with the seven arginine molecules to target and penetrate the membrane and enter the
tumour cells. It was also seen that cathespsin B gets poverexpressed in lysosomes and
endosomes of tumour cells and thus can hydrolyse the GFLG part. It further led to
observations that the doxorubicin loaded mesopores released about 80% drug within a day
and resulted in an increase in apoptosis rate. It was also observed that the drug loaded
MSNPs profoundly inhibited the growth of αvβ3-positive HeLa cells that causes cancer
(Cheng et al. 2015).
Another research was conducted to reduce the side effects or toxic effects of cancer
drugs. In this research, the scientists produced a redox responsive nanoparticle for triplex
therapy of tumour. The mesopores were sealed with cytochrome c on the MSNP molecules
by disulphide bonds for intracellular drug delivery in a redox-sensitive way. To ease the
process of drug targetting, AS1411aptamer was attached to the MSNPs. The structure was
then confirmed and checked by TEM, fluorescence spectroscopy and BET/BJH analysis. This
process led to the observation that the drug secretion from the nanoparticle could be done by

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
a redox reaction and thus can initiate in vitro apoptosis. On performing various tests like HE
staining assays and TUNEL staining it showed that the nanoparticle exhibited high tumour
targeting property and triplex therapy which inhibited the growth of tumours (Zhang et al.
2014).
There quite a few processes by which drug loading can be done which include spray
drying, rotary evaporation, solvent impregnation, and for testing the character or end product
techniques like differential scanning calorimetry, scanning electron microscopy and
dissolution testing can be used (Sharma 2016).
Spray drying can be defined as the technique used to prepare amorphous solid
dispersion that can be used effectively to deliver the group of drugs that are not water-soluble
(Singh and Van den Mooter 2016). An experiment was conducted using the spray drying
technique to produce monodisperse mesoporous silica. The particles showed a hexagonal
structure, and the size could be altered from 50 to 100 μm by altering the content of initial
solute and by bringing a change in the temperature of drying. It was observed that the amount
of water and the ratio between surfactant and silica affected the ordering degree by self-
assembly of the surfactant-silica micelles. The mesoporous molecules produced from spray
drying were seen to have larger sizes and had a higher speed of synthesis than the
conventional methods of production (Singh and Van den Mooter 2016).
An attempt was taken to increase the dissolution and solubility of a drug named
lapatinib ditosylate using hot melt extrusion and solvent rotary evaporation. A broad study
was done based on the solid liquid equilibrium to find the interaction between drug and
polymer. Thus, nine formulas of the drug were derived and were characterised by powder X-
Ray diffraction, SEM, differential scanning calorimetry, dissolution and solubility. This study
resulted in finding out that process parameter that included extrusion temperature and

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
physical attributes that included solid state and drug loading made effects on the dissolution
and solubility of the drug. One of the formulas was identified as the best one. Thus, formula
prepared by solvent rotary evaporation can help to determine the amorphicity, and therefore
the dissolution and solubility can be found out from that (Hu, Lou and Hageman 2018).
There is an increased demand for optimised and effective drug loading and delivery
system for improved biocompatibily and bioavailability, and thus, various microdevices are
being prepared for storage of ingredients that are insoluble in water. These microdevices are
synthesised in such a way that it can prevent deactivation of the drug inside it and allow the
drug to release whenever the necessity arises. This is when the solvent impregnation
technique came into the play. Here, the insoluble or poorly soluble drug is put into the micro
containers by dual application of supercritical fluid impregnation and inkjet printing. The
scientists took polyvinyl pyrolidine solutions and inserted it in the micro containers by inkjet
printing technique. This process is followed by impregnation of ketoprofen by supercritical
carbon dioxide as the loading medium. This technique proved to be much beneficial as these
micro containers exhibited a faster rate of drug dissolution and loading, and tbhus the release
of drug can be regulated. This technique thus allows much higher fabrication of the
microdevices delivery of oral drugs safely (Mariza et al. 2014).
Marin, Mallepally and McHugh (2014) conducted an experiment by using silk fibroin
derived from Bombyx mori as a medium for drug loading because of its bioavailability and
biodegradability. Silk fibroin aerogels were loaded with Ibuprofen, an anti-inflammatory drug
by superficial carbon dioxide impregnation technique. Then it was characterised under
Differential Scanning Calorimetry and the result indicated of it being amorphous. Scanning
Electron Microscopy was also used for the identification of textural and morphological
properties. When this is analysed in vitro, it was found that ibuprofen got released from the

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
aerosol at the temperature of 37°C and pH of 7.4 and took about 6 hours time to release
completely and the dissolution took about 15 minutes proving it to be a worthy procedure to
follow.
The increase in concern for the non-solubility of active pharmaceutical drugs has to
lead to the shelving of many potent molecules. From a review done by Grohganz et al.
(2014), it came to the vision that amorphous drugs are extremely unstable and thus it has to
be stabilised before use. But, it was also seen that the amorphous counterpart of the drug is
much more stable than the crystalline counterpart. To stabilise the amorphous forms,
polymer-based solid dispersion technique is used. Thus, various other methods are also used
to form amorphous counterparts which are much more stable by maintaining in situ
condition.
Another research was conducted to understand the effect of pH on drug release and
functioning. Metformine hydrochloride tablets were taken and by using the USP I test basket
apparatus at 100 rotations per minute, the dissolution was conducted. The result showed that
the tablets dissolved in HCl of pH 6.8 faster than in HCl of pH 4.5 (Desai et al. 2015).
ICH Stability Testing is a set of guidelines that are used and followed to test the
stability of any new drugs and the drugs with improved versions. It is also used to test
thresholds for different impurities present in the drug. This test is compulsory before making
any drug available in the market (Teasdale, Elder and Nims 2017).
CONCLUSION
From this study, it can be concluded that there is a considerable chance of newer
discoveries in this field of production of newer varieties of mesopore molecules which can
facilitate the working of a large variety of drugs. The different characterising techniques

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
available can also help in the production of optimised and effective mesopore molecules with
high drug loading and delivering efficiency.

INFLUENCE OF DRUG LOADING, EFFICIENCY AND DISSOLUTION
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