The document is a summer training report submitted by Divya Chaturvedi to Amity University regarding preparation and characterization of Decitabine loaded Nanostructural Lipid Carriers (NLCs). It includes an introduction on cancer and myelodysplastic syndromes as well as background on Decitabine. The aim was to develop optimized Decitabine loaded NLCs and characterize them. Materials used included Decitabine, lipids, and instruments like a homogenizer, particle size analyzer, and centrifuge. Characterization techniques involved determining particle size, ultraviolet spectroscopy, and centrifugation to separate particles based on density. The results and discussion section analyzed the optimized formulation and characterization of the Decit

1. Summer Training Report-2019
PREPARATION AND CHARACTERIZATION OF DECITABINE LOADED
NANOSTRUCTURAL LIPID
Submitted to Amity University, Haryana
Project done under the supervision of
Dr. Rahul Shukla
Supervisor
Assistant Professor
Department Of Pharmaceutics
National Institute Of Pharmaceuticals
Education And Research
Raebareli, Lucknow (U.P) 226002, India
Dr. Munindra Ruwali
Co-Supervisor
Assistant Professor
Amity Institute Of Biotechnology
Amity University Haryana
Gurugram (Manesar)-122413
Haryana, India
Submitted by
Divya Chaturvedi
B-Tech Biotechnology, 7th
Semester
A50204116017 (2016-2020)
NIPER
Raebareli

2. 2
Date: 17 July, 2019
BONAFIDE CERTIFICATE
This is to certify that work embodied for project report entitled “Preparation and Characterization
of Decitabin Loaded Nanostructural Lipid Carrier (NLCs)” submitted to National Institute of
Pharmaceutical Education & Research, Raebareli in partial fulfilment of the requirement for the
summer research work in Pharmaceutics is a bonafide record of project work done by Divya
Chaturvedi under our supervision from June 03, 2019 to July 017, 2019.
Dr. Rahul Shukla
Assistant Professor
Department of Pharmaceutics
NIPER-Raebareli, Lucknow

3. 3
DECLARATION
I hereby declare that the work embodied in this project entitled Preparation and Characterization
of Decitabin Loaded Nanostructural Lipid Carrier (NLCs), was carried out by me under the
supervision of Dr. Rahul Shukla, Assistant Professor, Department Of Pharmaceutics, NIPER-
Raebareli, Lucknow.
Divya Chaturvedi
Date: 17 July, 2019
Place: Lucknow

4. 4
ACKNOWLEDGEMENT
I wish to express my sincere thanks to Dr. S.J.S. Flora, Director, National Institute of
Pharmaceuticals Education and Research, Rae Bareli (Uttar Pradesh) for providing me the
opportunity to do my summer training.
I would like to express my heartfelt thanks to Dr. Rahul Shukla (Assistant Professor) and
Dr. Munindra Ruwali (Assistant Professor) for guiding me throughout the project.
I am also thankful to Mayank Handa (PhD) and Master’s students for always helping me out.
I am grateful to my parents and my brothers for always supporting me in all my endeavours.
I perceive this opportunity as a big milestone in my career development. I will strive to use gained
skills and knowledge in the best possible way, and I will continue to work on their improvement, in
order to attain desired career objectives.

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INDEX
S.NO CONTENT PAGE NO.
1. INTRODUCTION 6
2. LITERATURE REVIEW 7-9
3. DRUG PROFILE 10-12
4. AIM & OBJECTIVES 13
5. MATERIALS & EQUIPMENTS 13-14
6. CHARACTERIZATION 14-16
7. PROCEDURE 17-18
8. RESULTS AND DISCUSSION 19-23
9. CONCLUSION AND SUMMARY 24
10. BIBLIOGRAPHY 25-26

6. 6

7. 7
INTRODUCTION
Reduction of the molecule size to the nano scale is one of the significant approaches to upgrade the
oral bioavailability of the drug. There is a need to plan such nano-formulation that could shield
unstable active moieties from acidic condition and discharge in the intestinal medium. Although
some colloidal drug transporters like polymeric nano particles, nano-suspensions, nano-emulsions
have been attempted to overcome the issues like solubility and bioavailability of the numerous drugs
however they have the disadvantages on the mammalian tissue toxic quality because of utilization of
natural solvents, restricted physical stability also, spillage of medication during storage of drug.
Hence, the current focus of the research dependent on the pursuit of bio-good lipids as transporters
for low bioavailability drugs to limit the previously mentioned issues.
NLCs has risen has a potential drug carrier with lower occurrence of tissue damage because of
utilization of bio-compatible and biodegradable lipids. It has reported that lipid secures drug from
acidic degradation, increment intestinal penetrability, advances oral assimilation through lymphatic
transport by reducing first pass digestion and higher amount of drug loading which improves the
available of drug to the systemic circulation .In expansion, NLCs, showed sustained release of drug
from the lipid matrix which results in the prolongation of the drug concentration inside remedial
window. Consequently, NLCs is getting to be one of the best chosen drug delivery frameworks
among the researchers.
Fig. 1: NLCs and its internal structure

8. 8
LITERATURE REVIEW
CANCER
Cancer is a group of more than 100 different diseases. It can develop almost anywhere in the body.
Cells are the basic units that make up the human body. Cells grow and divide to make new cells as
the body needs them. Usually, cells die when they get too old or damaged. Then, new cells take their
place. Cancer begins when genetic changes interfere with this orderly process. Cells start to grow in
uncontrolled manner. These cells may form a mass called a tumour. A tumour can be cancerous or
benign. A cancerous tumour is malignant, meaning it can grow and spread to other parts of the body.
A benign tumour means the tumour can grow but will not spread. Some types of cancer do not form
a tumor. These include leukemias, most types of lymphoma, and myeloma.
Types of cancer
Cancer is divided into four types based on where it began. Four main types of cancer are:
 Carcinomas: A carcinoma begins in the skin or the tissue that covers the surface of
internal organs and glands. Carcinomas usually form solid tumors. They are the most
common type of cancer. Examples of carcinomas include prostate cancer, breast
cancer, lung cancer, and colorectal cancer.
 Sarcomas: A sarcoma begins in the tissues that support and connect the body. A sarcoma
can develop in fat, muscles, nerves, tendons, joints, blood vessels, lymph vessels,
cartilage, or bone.
 Leukemias: Leukemia is a cancer of the blood. Leukemia begins when healthy blood
cells change and grow uncontrollably. The four main types of leukemia are acute
lymphocytic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia,
and chronic myeloid leukemia.
 Lymphomas: Lymphoma is a cancer that begins in the lymphatic system. The lymphatic
system is a network of vessels and glands that help fight infection. There are two main
types of lymphomas: lymphoma and non-Hodgkin lymphoma.
As a cancerous tumor grows, the bloodstream or lymphatic system may carry cancer cells to other
parts of the body. During this process, known as metastasis, the cancer cells grow and may develop
into new tumors. One of the first places a cancer often spreads is to the lymph nodes. Lymph nodes

9. 9
are tiny, bean-shaped organs that help fight infection. They are located in clusters in different parts
of the body, such as the neck, groin area, and under the arms. Cancer may also spread through the
bloodstream to distant parts of the body. These parts may include the bones, liver, lungs, or brain.
Even if the cancer spreads, it is still named for the area where it began. For example, if breast cancer
spreads to the lungs, it is called metastatic breast cancer, not lung cancer.
Myelodysplastic disorders (MDS)
Myelodysplastic syndromes are a group of disorders caused by poorly formed blood cells or ones
that don't work properly. Myelodysplastic syndromes result from something amiss in the spongy
material inside your bones where blood cells are made (bone marrow). Treatment for
myelodysplastic syndromes usually focuses on reducing or preventing complications of the disease
and its treatments. In some cases, treatment might involve chemotherapy or a bone marrow
transplant.
Causes: In a healthy person, bone marrow makes new, immature blood cells that mature over time.
Myelodysplastic syndromes occur when something disrupts this process so that the blood cells don't
mature. Instead of developing normally, the blood cells die in the bone marrow or just after entering
the bloodstream. Over time, there are more immature, defective cells than healthy ones, leading to
problems such as fatigue caused by anemia, infections caused by leucopenia, and bleeding caused by
thrombocytopenia. Some myelodysplastic syndromes have no known cause. Others are caused by
exposure to cancer treatments, such as chemotherapy and radiation, or to toxic chemicals, such as
tobacco, benzene and pesticides, or to heavy metals, such as lead.
The World Health Organization divides myelodysplastic syndromes into subtypes based on the type
of blood cells — red cells, white cells and platelets involved.
Risk factors
Factors that can increase your risk of myelodysplastic syndromes include:
 Older age: Most people with myelodysplastic syndromes are older than 60.
 Treatment with chemotherapy or radiation: Chemotherapy or radiation therapy, both of
which are commonly used to treat cancer, can increase your risk of myelodysplastic
syndromes.

10. 10
 Exposure to certain chemicals: Chemicals linked to myelodysplastic syndromes include
tobacco smoke, pesticides and industrial chemicals, such as benzene.
 Exposure to heavy metals: Heavy metals linked to myelodysplastic syndromes include lead
and mercury.
Symptoms
Myelodysplastic syndromes rarely cause signs or symptoms in the early stages. In time,
myelodysplastic syndromes might cause:
 Fatigue
 Shortness of breath
 Unusual paleness (pallor) which occurs due to a low red blood cell count (anaemia)
 Easy or unusual bruising or bleeding which occurs due to a low blood platelet count
(thrombocytopenia)
 Pinpoint-sized red spots just beneath your skin caused by bleeding (petechiae)
 Frequent infections which occurs due to a low white blood cell count (leukopenia)

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DRUG PROFILE
Table 1: Physicochemical properties of Decitabine
NAME Decitabine
IUPAC Name
4-amino-1-[(2R,4S,5R)-4-hydroxy-5-
(hydroxymethyl)oxolan-2-yl]-1,2-dihydro-1,3,5-
triazin-2-one
Molecular Weight 228.208 g/mol
Empirical Formula C8H12N4O4
Physical Description
5-Aza-2’-deoxycytidine is a fine white
crystalline powder. Used as a drug.
Solubility Sparingly soluble in water
Melting point 200℃
Mechanism of action
Decitabine acts by conversion of decitabine
triphosphate, where the drug directly
incorporates into DNA and inhibits DNA
methyltransferase resulting in hypomethylation
of DNA and cellular differentiation or apoptosis.
Decitabine is cell cycle specific and acts
peripherally in the S phase of the cell cycle. It
does not inhibit the progression of cells from the
G1 to S phase
Drug interactions
Drug interaction studies with decitabine have not
been conducted. In vitro studies in human liver
microsomes suggest that decitabine is unlikely to
inhibit or induce cytochrome P450 enzymes. In
vitro metabolism studies have suggested that
decitabine is not a substrate for human liver
cytochrome P450 enzymes. As plasma protein

12. 12
binding of decitabine is negligible (<1%)
interactions due to displacement of more highly
protein bound drugs from plasma proteins are
not expected.
Dosage form and route of
administration
For Injection: DACOGEN (decitabine) for
Injection is supplied as a sterile, lyophilized
white to almost white powder, in a single-dose
vial, packaged in cartons of 1 vial. Each vial
contains 50 mg of decitabine.
Pharmacodynamics
Decitabine has been shown to induce
hypomethylation both in vitro and in vivo.
However, there have been no studies of
decitabine-induced hypomethylation and
pharmacokinetic parameters.
Fig. 2: Structure of Decitabine

13. 13
Fig. 3: Mechanism of action of Decitabine
AIM: Preparation and Characterization of Decitabine Loaded Nanostructural Lipid Carrier
(NLCs)
Objective: 1) Formulation of optimized Decitabine loaded NLCs.

14. 14
2) Characterization of optimized Decitabine loaded NLCs.
MATERIAL AND METHODS
Table 2: Materials used in preparation of NLCs
Table 3: Instruments used in experimentation of NLCs
S.No. EQUIPMENTS USED SOURCE
1 Magnetic stirrer AREX-6 DIGITAL
2 Homogeniser OMNI International
3 Probe Sonicator MISONIX Ultrasonic liquid processors
4 pH meter Eutech Instruments Pvt.Ltd, New Delhi
5 Bath Sonicator PCI Analytics, India
6 UV-Visible Spectrophotometer Lab India Analytical UV 3000+ Mumbai,
S.No. NAME OF MATERIALS SOURCE
1. Decitabine Micro Labs, Bangalore
2 Glycerol Monostearate Loba Chemie Pvt. Ltd. Mumbai, India.
3 Oleic acid Merck Limited. Mumbai , India
4. Poloxamer 407 Sigma Aldrich India
5 Soya Lecithin Himedia, Mumbai, India.
6 Mannitol Himedia, Mumbai, India.
7 Methanol Merck Limited. Mumbai , India
8 Hydrochloric acid Himedia, Mumbai, India.

15. 15
India
7 Master Sizer ZS 90, Malvern, Worcestershire, UK.
8 Dissolution Test Apparatus Lab India Instrument Pvt Ltd, Mumbai
9 FTIR Spectrometer Bruker, USA.
Instrumentation employed in characterization of prepared NLCs:
1. Ultraviolet (UV) Spectroscopy
Development of a simple and accurate analytical method for the quantitative estimation of the drug
is a definite step in pre-formulation studies. Ultra-violet spectroscopy involves the spectroscopy of
photons in the ultra-violet region as the molecules undergo electronic transitions.
Stock solutions of the drug were prepared (1 mg/ mL) in different media such as methanol and 0.1 N
Hydrochloric acids. The stock solutions were further diluted to the concentration of 100 µg/ mL and
10 µg/ mL. The solutions were scanned spectrophotometrically to determine the λmax of the drug.
2. Particle size (Mastersizer)
Malvern Mastersizer uses laser diffraction techniques to measure the size of particles. These could
be suspensions of solid particles, emulsions droplets, or even dry powders. The size of particles in a
lubricant can have a significant impact on the performance. A commonly encountered example is
the size of emulsions droplets in an emulsion-based metal working fluid (MWF). In rolling oil the
emulsion droplets (oil-in-water) need to plate out at the roll bite and their size is an important
contribution to how well they do this. If the droplets are too large they will not be able to enter the
roll bite; if they are too small they will enter pass straight through and not plate out. In either case
the lubricant contained in the droplets will not be delivered. The ideal case is a narrow distribution
centred on a desired mean of radius. Malvern Mastersizer uses the principle of static light scattering
(SLS) and Mie theory to calculate the size of particle in a sample. The basic principle is that small
particles will scatter light at large angles and large particles will scatter light at small angles.

16. 16
Fig. 4: Graph of Mastersizer
3. Homogenizer:
Homogenizer is equipment that assists in the process of homogenizing. The main job of a
homogenizer is to form a uniform structure of all solid materials present in novel delivery system. A
homogenizer also breaks down large water particles into small homogenous structure, resulting in an
emulsion consisting of water molecules spread evenly throughout the whole liquid.
4. Centrifugation:
Centrifugation is a process used to separate or concentrate materials suspended in a liquid medium.
The theoretical basis of this technique is the effect of gravity on particles (including macromolecules)
in suspension. Two particles of different masses will settle in a tube at different rates in response to
gravity. More dense components of the mixture migrate away from the axis of the centrifuge, while
less-dense components of the mixture migrate towards the axis. Centrifugation works on the principle
for separating particles from a solution according to their size, shape, density, viscosity of the medium
and rotor speed. In a solution particles whose density is higher than that of solvent sink (sediment)
and particles that are lighter than it float to the top. The greater the difference in density, the faster
they move. If there is no difference in density, the particles stay steady.
5. Lyophilization
Lyophilization /freeze drying is a method of extracting the water from Biological samples, foods and
other products so that foods or products remain stable and are easier to store at room temperature.
Biological materials should be dried to stabilize them for storage, preservation and shipping. In
many cases this drying can cause damage and some loss of cellular or protein activity.

17. 17
Lyophilization significantly reduces damage to biological samples. Lyophilization is based on a
simple principle of physics called “Sublimation”. Sublimation is the process of transition of a
substance from solid to the vapor state without passing through an intermediate liquid phase. The
process of lyophilization consists of:
 Freezing of the product to convert the water in the product to ice form,
 Sublimation of ice directly into water vapor under vacuum.
 Drawing off the water vapor
 Once the ice has been sublimated, the products are freeze-dried and can be removed from
machine.
6. Fourier Transform Infrared spectroscopy
Infrared spectroscopy is widely used for identification of all types organic and several types of
inorganic compounds as well as functional groups present in an organic compound. The FTIR spectra
of pure drug was taken on IR spectrophotometer (60 MHz Varian EM 360 Perkin Elmer, USA) using
Potassium bromide pellets of drug in the scanning range 4000-400 cm-1. The peaks obtained from
the spectrum were interpreted and compared to the spectrum given in Indian Pharmacopoeia.

18. 18
Method of Preparationof NLCs:
Weighed amount of Decitabine (DCB) was taken. Solublize DCB in methanol by keeping it on bath
Sonication for 2 mins. Weighed amount of solid lipid (Glycerol Monostearate), liquid lipid (Oleic
acid) was taken in another vial. Mix both the lipids phase in a beaker (100ml). Weighed amount of
Surfactant (Poloxamer 407) and Co surfactant (Soya lecithin). Mix both aqueous phases in 30 mL of
triple distilled water; keep in refrigerator for 10 mins to obtain clear solution. Now, keep lipid phase
on heating mantle at 70℃ until it gets melt, and place aqueous phase on magnetic stirrer with
continuous stirring at 70℃. After lipids phase get melted, add drug solution drop wise with the help
of injection, slowly. This will evaporate organic solvent (methanol). Now remove lipid phase from
heating mantle and place it on magnetic stirrer for same temperature. Drop wise add aqueous phase
in the lipid phase with the help of syringe slowly, so that no coagulation occurs. Keep the
formulation beaker in the homogenizer for 4-5 mins. Now probe sonicate it for 20 mins process time
at 25 amplitude and 1 sec pulse off and on time, by placing formulation beaker in the ice filled bowl.
Fig. 5: Illustrative representation of procedure followed for preparation of NLCs

19. 19
Table 4: Various process parameters for optimization of NLCs
Batch
No.
Solid lipid
(in mg)
Liquid lipid
(in mg)
Surfactant
(in mg)
Co-surfactant
(in mg)
Drug
(in mg)
Probe sonication
time (mins)
F1 700 300 250 50 15 20
F2 600 400 250 50 15 20
F3 800 200 250 50 15 20
F4 900 100 250 50 15 20
Fig. 6: Different batches of NLCs

20. 20
RESULTS AND DISCUSSION
1. Ultra violet spectroscopy:
Stock solution of drug was prepared (1 mg/mL) in distilled water. The stock solution was further
diluted to the concentration of 100 µg/mL. With this aliquot of 10 µg/mL to further dilute it to 4
µg/mL, 6 µg/mL, 8 µg/mL, 10 µg/mL, 12 µg/mL, 14 µg/mL, 16 µg/mL and 25 µg/mL. The
solutions were scanned spectrophotometrically to determine the λmax of the drug. The obtained
particle size is the following one along with its calibration curve and equation. λmax was
determined at 242 nm.
Table 5: Result of UV-Spectroscopy
Concentration (µg/ml) Mean Absorbance ± S.D % RSD
4 0.173 ± 0.000577 0.333
6 0.246 ± 0.000577 0.243
8 0.332 ± 0.000577 0.173
10 0.422 ± 0 0
12 0.424 ± 0.0011 0.271
14 0.498 ± 0.001 0.2008
16 0.534 ± 0.001 0.187
25 0.847 ± 0.000577 0.0681
Fig. 7: Calibration graph and equation of the drug obtained through UV

21. 21
2. Particle size, Entrapment efficiency and Drug loading of the NLCs:
The entrapment efficiency and drug loading capacity of the NLCs formulation was
determined by measuring the amount of the unentrapped drug by using centrifugal filter units
and was qualified using UV-spectroscopy method. For this 1 mL formulation was diluted
with 4 mL of diluents to dissolve any un-loaded drug particles. The diluted sample was kept
in upper compartment of ultra centrifuge tube and centrifuged at 12,000 rpm for 40 mins at
5℃. The free drug in the aqueous phase moves to lower chamber through the semi permeable
membrane, whereas drug entrapped in the nano-particles retained in upper chamber. The
collected sample in the lower chamber was measure and entrapment efficiency and drug
loading was determined by following equation.
Entrapment Efficiency = Estimated % drug content
Theoretical % drug content
Drug loading = Weight of drug in nano-particles
Weight of nano-particles
Table 6: Various parameters of prepared batches of NLCs
Batch no. Drug loading Entrapment
efficiency
Particle size PDI
F1 8.92 91.78% 104 nm 0.283
F2 7.46 86.45% 120 nm 0.213
F3 9.13 92.45% 140 nm 0.196
F4 9.35 93.56% 136 nm 0.184
3. Drug Release:
In-vitro drug release study of the plain DCB solution and NLCs was performed using dialysis bag
technique in the phosphate buffer solution (PBS) pH 7.4 as well as pH 5.5. The dialysis bag was
x 100
x 100

22. 22
activated as per procedure and was soaked in the dissolution medium for 24hrs. 2ml DCB solution
and NLCs was taken in pre-activated dialysis bag and both ends were tied with thread then, kept in
the beaker containing 50 mL of PBS. After this beaker was placed in the magnetic stirrer with
continuous stirring at 100 rpm maintained at 37℃. The samples were withdrawn at predetermined
time interval and replenished with same quantity of fresh PBS. So obtained samples were diluted
with distilled water and analyzed on UV-spectroscopy. As observed from the data depicted in Table
7 which clearly states that release of free drug is for 12 h in comparison to controlled release of
NLCs for 36 h. Further, release of NLCs is higher at pH 5.5 in comparison to release profile at ph
7.4 as seen in Figure 8; because it simulates to tumor environment.
Table 7: % Cumulative drug release v/s Time
Time (h) Free drug ± S.D NLCs at pH 7.4 ± S.D NLCs at pH 5.5 ± S.D
0
0 0 0
15
7.51 ±0.223 5.283157 ±0.263 6.184387 ±0.152113
30
17.24 ±0.330 8.40 ±0.116 8.64 ± 0.0219
45
29.40 ±0.263 11.88 ±0.184 12.44 ± 0.073
60
42.43 ±0.402 15.73 ±0.301 17.16 ± 0.256
120
54.14 ±0.223 22.04 ±0.390 24.01 ± 0.223
240
68.37 ±0.183 31.74 ±0.625 33.29 ± 0.295
360
79.38 ±2.232 40.26 ±3.750 41.64 ± 3.042
480
86.93 ±2.566 47.16 ±5.115 49.32 ± 2.566
600
93.02 ±2.531 53.49 ±2.224 56.26 ± 3.677
720
96.92 ±1.838 56.49 ±1.511 58.84 ± 2.191
1200 59.14 ±0.730 61.67 ± 2.348
1560 59.75 ±1.521 62.03± 1.116
2160 60.16 ±1.461 62.64 ± 1.461
2880 60.50 ±1.116 62.93 ± 0.730

23. 23
Fig. 8: % Cumulative Release v/s Time (hrs)
3. Infra-red Spectra
Infrared Red Spectroscopy is the technique used for the identification of different functional
groups in the organic compounds. Infrared spectra may be regarded as the fingerprint of a
molecule as no two compounds except optical isomers have the same IR spectra.
Characterized peaks of Decitabine are at 1680 of amide followed by 2952 of C-H stretch and
3110 of O-H stretch. Glycerol Monostearate has peaks at 3306 with O-H stretch, C-H stretch
(asymmetric) at 2913,C-H stretch (symmetric) at 2848, C-O-C stretch at 1176 and C=O stretch
at 1729. Poloxamer 188 has peaks of aldehydic with C-H stretch at 2864, C-O-C stretch at
1099 and O-H stretch at 3742. Mannitol has peaks of C-H stretch 2803, O-H stretch 3615.
Oleic acid has peaks of C=H stretch at 2922, C-H at stretch 2855 and C=O stretch at 1708.
Lyophilized formulation have characterized peaks of Glycerol Monostearate C-H stretch
(asymmetric) at 2913 and C-H stretch (symmetric) at 2848 followed by oleic acid peaks of has
peaks of C=H stretch at 2922, C-H at stretch 2855 and C=O stretch at 1708 and stabilizer
Poloxamer 188 has peaks C-O-C stretch at 1099 followed by Mannitol has C-OH stretch at
1017. Here we can see that there is no peak of Decitabine can be characterized in Lyophilized
NLCs. This concludes that drug Decitabine is entrapped in the GMS and Oleic acid based
NLCs.

24. 24
Decitabine
GMS
Oleic acid
Poloxamer
Mannitol
Physical Mixture
Lyophilized
Fig. 9: FT-IR Peaks graph

25. 25
Summary and Conclusion
Present work is emphasised on Decitabine loaded nano-structured lipid carriers preparation for
obtaining controlled release of drug. Various techniques were used for characterization of NLCs.
NLCs of DCB were prepared by the precipitation technique using high speed homogenization
technique followed by probe sonication. Glyceryl Monostearate and Oleic acid as the solid and
liquid lipid respectively was used for preparation of NLCs. The formulation was optimized and
characterized for various parameters like particle size, entrapment efficiency and uniformity. The
optimized batch was prepared using 7:3 lipids, 1:5 surfactant and co-surfactant and final batch have
104 nm particle size, 8.92% drug loading and 91.78% entrapment efficiency. 0.283 PDI. No peak of
Decitabine was characterized in Lyophilized NLCs which confirmed that effective encapsulation of
Decitabine in lipids. In vitro release studies of optimized NLCs at pH 7.4 and 5.5 was compared with
free drug. Controlled release pattern was obtained in case of NLCs in comparison to immediate
release of free drug. In case of NLCs it was observed that control release was followed for 48 h in
comparison to immediate release of 12 h in free drug.

26. 26
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