Piyu Shinde Final Project
Piyu Shinde Final Project
BACHELOR OF PHARMACY
CERTIFICATE
This is to certify that Ku. Priyanka Gajanan Shinde, Roll No._______ has
carried out the required project work report on “NANOSPONGES: A RECENT
ADVANCEMENT IN PHARMACEUTICAL FORMULATION” prescribed by Sant
Gadge Baba Amravati University, for the VIIIth Semester of B. Pharm. Course
during the academic year 2023- 2024 & this project work report represents his work
done under my supervision.
I hereby declare that the project work report entitled “NANOSPONGES: A RECENT
ADVANCEMENT IN PHARMACEUTICAL FORMULATION” is based on work carried
out at Laddhad College of Pharmacy Yelgoan, Buldana. I also declare that the matter
embodied in it is a genuine work and the same has not formed the basis for award of any
degree, diploma, of any other university.
This is to acknowledge and express my thanks to all those who directly or indirectly helped me
to make this Project successfully. I wish to express my deepest sense of gratitude to project
guide Proff.Aanand kakde. Proff. of Laddhad College of Pharmacy Yelgaon, Buldana. For
his valuable guidance during the course of the project work without which it would have been
very difficult, rather impossible task for me. He provided precious motivation, constructive
suggestion and critism during the course of dissertation work. His guidance and encouragement
sustained me all a long and help me greatly in his work. I consider it would be my fortune and
honor to work during the guidance of.Proff.Aanand kakde.
2 Introduction 02-03
4 Classifications 05
6 Materials 08
9 15-16
Evaluation parameters
10 17-18
Characterization parameters
11 Factors 19
12 Applications 20
14 Recent patent 22
15 Conclusion 23
16 Reference 24
NANOSPONGES:A RECENT ADVANCEMENT IN PHARMACEUTICAL FORMULATION
1. ABSTRACT:
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2. INTRODUCTION:
Tiny particals
Size-less than 1μm.
Three dimentional network
Solid in nature
Emerging technology
Nanosponges are tiny sponges with a size of about a virus, which can be filled with a wide
variety of drugs. These tiny sponges can circulate around the body until they encounter the
specific target site and stick on the surface and begin to release the drug in a controlled and
predictable manner. Nanosponges (NS) describe insoluble solid porous matter with typical
nanometric porosity and lofty absorption with complexation properties. It is synthesized using
organic or inorganic compounds. . The polymer in the NS has an extended length of the
polyester backbone and cross-linking agents that resemble microscopic grappling hooks to clip
various parts of the polymer together. Polyester degrades gradually in the body since it is
biodegradable. Using different cross-linkers will alter the length and cavity of the NS At this
point, the polymer blocks the drug inside the fissure as the core.
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It serves as a vehicle for delivering proteins, enzymes, vaccines, antibodies, and lipophilic and
hydrophilic compounds to improve the low solubility of poorly water-soluble drugs.
This innovative technology is five times more successful in potential delivering drugs for
breast cancer than traditional approaches, it has the potent completely change how many
diseases are treated (David, 2010). They move towards and bind with a tumor cell’s surface,
wherever they are affixed superficially, and thus start discharging effectively the drug in a
measured and predictable manner.
Nanosponges have a great impetus to develop ongoing research in drug delivery systems. In
several pharmaceutical preparations, concern about the effects and regulation of transporters
on drug effects can significantly contribute to our ability to predict drug variations.
Nanosponges can remove the organic froth from water (Taka et al., 2017). Moreover, NS
exhibits a notable benefit above conventional nanoparticles: indeed, it is readily Regenerable
by a variety of processes, such as washing with efficient and environmentally solvents,
employing relatively inert hot gases for stripping, mild heating, or changing pH or ionic
strength. NS has already been used in a variety of application domains for all these qualities,
including the cosmetic and pharmaceutical industries, flower cultivation, and polymer flame
retardancy.
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NANOSPONGES:A RECENT ADVANCEMENT IN PHARMACEUTICAL FORMULATION
ADVANTAGES:
Non-Irritating, Non-toxic.
DISADVANTAGES:
Nanosponges have only capacity to encapsulating small molecules, not suitable for
larger molecules.
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NANOSPONGES:A RECENT ADVANCEMENT IN PHARMACEUTICAL FORMULATION
CLASSIFICATION:
Carbonate Nanosponges
Modified nanosponges
Carbamate nanosponges
Miscellaneous nanosponges
Ester nanosponges
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Recent discoveries include the NS, organic or inorganic materials constructed of three-
dimensional networks of spherical particles through a porous medium with cavities a few
nanometers across and various dimensions (1 μm or less).
Polymers and cross-linkers are the chief ingredients in the formulation of NS. The polymer used
can influence the content and development of NS. It can bind to specific ligands, and an agent
such as Crosslinker will rely on the polymer structure and the drug formulation.
The porous NS particles are nontoxic, will not solubilize in organic solvents and will stable up
to 300°C. NS formulations can be stabilized at temperatures of up to 130°C and a pH range of 1
to 11.Nanosponges can provide sustainable prolonged release as well as enhance the drug
molecules bioavailability, thus modifying the pharmacokinetic parameter.
Poly-valerolactone Disocyanate
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Patient pliability during dosage form administration and subsequent repeated-dose therapy
regimen is a crucial difficulty in vaginal drug delivery. Gels have essential advantages over
conventional formulations, including adaptability, safety, high bioavailability, and cost-
effectiveness.
Different drug loading capabilities have been observed for para-crystalline NS. As drug
carriers, intriguing results have already been attained by utilizing a compound of an active
carbonyl molecule, such as carbonyldimiidazole, triphosgene, diphenyl carbonate (DPC), or
organic dianhydrides.
Nanosponge will offer a perfect drug release profile and a longer retention period at the
specific target site profile of encapsulated drug moieties for improved and good efficient
therapy to treat various cancers, including breast and colon cancer. The current review was
undertaken for the drug delivery of NS, preparation methods, characterization, mechanism of
drug release, and applications.
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a) Solvent method
b) Emulsion solvent diffusion method
c) Ultrasound assisted synthesis.
d) Solvent evaporation method
e) Melt method
f) Bubble electrospinning
g) Synthesis by the use of microwave radiation
Solvent method:
Dissolve the polymers in suitable solvent.
Add excess quantity of cross-linkers.
Reflux the mixture foe 48 hours at Temperature 100c.
Allow this solution to cool at room temperature.
Add excess quantity of distilled water and filter the product.
Then purified by Soxhlet extraction with ethanol.
Dry the product and grind in mechanical mill to get homogenous powder.
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Melt method:
The Crosslinker and β-CDs are fused when using the melting technique.
The remaining fixings are finely homogenized and added to a 250 ml jar preheated
to 100°C.
The reaction is then carried out for 5 hours by magnetic mixing.
The reaction mixture is allowed to cool.
After which the result is broken down and repeatedly washed well with suitable
solvents, i.e., ethanol, to eliminate the excipients and byproducts that have not
reacted completely.
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Bubble electrospinning:
A syringe, syringe pump, high-voltage power, and a grounded collector are the main
components of a standard electrospinning setup, as outlined in several pieces of
literature.
The amount of nanofibers production is one of the key restrictions that restrict their
applicability.
PVA can also be utilized as a polymer in the bubble electrospinning technique.
The solution of polymer (10%) was organized by adding distilled water, it was then
stirred at 80°C–90°C for 2 hours to produce a one-phase mixture.
The polymer solution was then allowed to cool before making Nanosponges fibers.
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NANOSPONGES:A RECENT ADVANCEMENT IN PHARMACEUTICAL FORMULATION
In this method, the drug carrier for delivering the drug was β-Cyclodextrin.
Nanosponges was prepared by means of reacting β-Cyclodextrin and employing a
cross-linker.
Its Synthesis can be in the nature of neutral or acidic forms.
It have a mean diameter of lesser than 1 µm, but fractions of particles below 500 nm.
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Physical Examination:
o Prepared nanosponges inspected visually for their color, homogeneity and
consistency.
o It should have pleasant appearance with respect to color.
Determination of PH:
o PH can be determined by using digital PH meter.
o 1gm of gel was dissolved in 100ml of distilled water and store foe 2 hours.
Viscosity Measurement:
o Determination of viscosity using Brookfield viscometer.
o With sample adapter, spindle no.64.
Stability studies:
o It provide a quality of drug product varies with time under the influence of
different parameters such as Temperature, humidity, shelf life and storage
condition.
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Spreadability studies:
o Spreadability means extent of area to which the gel readily spreads on application
to the skin.
o The Spredability was calculated using following equation,
Spreadability =M x L/T
Where,
M= mass in grams
L= distance traveled by gel
T=time
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Zeta potential:
o Surface charge is measured by the zeta potential.
o Additional electrode in particle size measurement equipment can be used to
determine it.
o After being diluted with 0.1 mol/l KCl, NS samples were put in an electrophoretic
cell with an electric field of roughly 15 V/cm for zeta potential analysis.
o The solid-state inclusion complex was detected by using the Powder X-ray
diffractometry technique.
o A complex formation is indicated by a variation in the diffraction pattern.
o If drug compounds are in a solid state, a comparison study between the
mechanical combination of the drug/polymer molecules and the assumed complex
of the diffractogram must be done.
o The diffraction patterns will alter if the drug and the NS form a complex and
change the drug’s crystalline nature.
o The complex formation of a compound indicates that the existing peaks will
become sharper, a few new peaks will appear, and the exact peaks will move.
Infra-red spectroscopy:
Polydispersity index:
o The PDI measures variance or dispersion within the particle size distribution.
o A sample is considered monodisperse if the PDI value is lower, whereas a sample
is considered polydisperse if the PDI value is higher and displays a wider range of
particle sizes.
o To calculate the polydispersity index using formula,
PDI = ∆d
DAvg
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Where,
(d) =width of the distribution marked by SD
(D Avg)= average particle size denoted by MV (nm)
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Type of polymer:
Type of drugs:
Complex drug molecules with certain characteristics are listed below,
Temperature:
o Temperature change play a vital role in nanosponge’s complexation.
o The complex of molecules decreases with increased temperature.
Method of preparation:
o Nanosponges can be prepared by different types of methods.
o Drug/Nanosponge complexation can be affected by the method of loading the
drug into the nanosponge.
o The nature of the drug, polymer, and temperature can also affect the method of
preparation.
Degree of substitution:
o The complex of Nanosponges form ability which may be affected by molecule
number, position and substituent.
o Number of substituents increases, probability of cross-linkling increases.
o Due to a higher degree of cross-linking, highly porous nanosponges can be
obtained.
o This result in the formation of a mesh-type of network.
Solubility Studies:
o It is the most important and widely used approach for complexation which
scrutinizes the effect of a nanosponge on the solubility of the drug.
o Nanosponges are confirmed or find by insolubility in water and organic solvents.
Examples: DMF (Dimethyl Formamide) and DMSO (Dimethyl Sulfoxide).
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APPLICATIONS OF NANOSPONGES:
Solubility enhancement
Drug delivery
Protein delivery
Enzyme immobilization
Diagnostic Tool
Cosmetics
Cancer therapy
Antifungal therapy
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There are several NS-based formulations on the market and some drugs like Prostavastin,
brexin, glymesason, mena-gargle, and other formulations are in clinical studies Some of the
marketed formulations of NS are listed,
Novel techniques like solvent evaporation and bubble electrospinning are additionally being
updated and developed. The new trends supporting mass production quickly include higher
yields, cost-effective manufacturing, and repeatability.
The recent trends that will help mass production quickly include higher yields, cost Effective
manufacturing, and repeatability
It might be used as a basic water filter in the future. Lowering production costs is a crucial
Concern, which calls for creating innovative polymers, crosslinkers, and new manufacturing
techniques.
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RECENT PATENTS:
New patents in NSs were recently submitted, authorized, and used to improve the
making process more efficiently.
Patents cover toxin absorption agents, growth preservation, enzyme release, and
biocatalyst investigations, demonstrating promise as anticancer agents.
The authorities have also granted patents that will assist in shifting demand to NSs as
a breakthrough pharmaceutical delivery technology.
Which involves patent number, applicant, and title.
3. US9574136B2 Kun Lian for Nanoparticles, NS, methods of synthesis, and methods
of use.
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CONCLUSION:
Nanosponges are useful carrier for the delivery system, including prolonged delivery, target
drug delivery, and increased therapeutic efficacy of various pharmaceutical drugs.
NS are adaptable drug delivery systems that form compounds of inclusion and non-inclusion in
the hydrophilic (gentamicin) compounds they carry and medications that are hydrophobic
(dexamethasone). Drugs can be transported by Nanosponges. By a variety of methods,
including parenteral, rectal, topical, and oral a predictable manner to the designated location. Β-
Cyclodextrin Nanosponges has outstanding applicability in various specialized medication
delivery systems. In addition, it makes biopharmaceutical class II medications more soluble.
That the recent advancement covers NS, their synthesis techniques, and a number of types,
characterization techniques, formulation development, and applications like investigations of in
vitro cytotoxicity, patents are covers in this recent advancement.
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REFERENCES:
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