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DOI: 10.5958/0974-360X.2019.00282.8

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 Research J. Pharm. and Tech. 12(4): April 2019

ISSN 0974-3618 (Print) www.rjptonline.org

0974-360X (Online)

RESEARCH ARTICLE

Impact of Nanoparticulate Drug Delivery System of Herbal Drug in

Control of Diabetes Mellitus
Dr. Senthilnathan. B1, Dr. Vivekanandan. K2, Dr. Bhavya. E3*, Dr. Masilamani1,
Swarna Priya. B1
1
Department of Pharmacy Practice, Jaya College of Paramedical Sciences, College of Pharmacy.
2
Department of Pharmacy Practice, Faculty of Pharmacy, Dr. M.G.R. Educational and Research Institute,
Deemed to be University, Maduravoyal, Chennai-6000095
3.
Department of Pharmacy Practice, School of Pharmaceutical Sciences, VISTAS.
*Corresponding Author E-mail: [email protected]
ABSTRACT:
Aim: The main objective of the current study is to organize and evaluate polymeric nanoparticles for the selected
drug Gymnemic acid, improve the bioavailability of poorly bioavailable gymnemic acid, enhance the anti-
diabetic activity of Gymnemic acid, reduce the dose size of Gymnemic acid by reducing the particle size.
Method and procedure: Gymnemic acid nanoparticles was prepared through emulsion-droplet coalescence
method, by using chitosan polymer (GNP1-GNP5). Based on the invitro drug release profile of Gymnemic acid
nanoparticles formulations (GNP1-GNP5) formulation GNP3 is selected as the best preparation in which the
particle size was 195 nm[1]. Since from ancient times the naturopathic treatment for diseases has been explored
widely and in advance momentum in the present situation, and has several pharmacological significance. Nano
particulate drug delivery systems symbolize a promising drug delivery system [2] in recent years for its prescribed
and targeted drug release. They exists as with a size choice of 10-1000nm, in which the drug or dissolved active
ingredient, encapsulated, entrapped, absorbed or attached to the matrix system. The present research is a
development of nanoparticulate[3,4] drug delivery system for Gymnema sylvestre by ionic gelation method. The
formulation is characterized by particle size, zeta potential, particle morphology and best formulation was
selected for the further studies. Result: The Gymnemic acid nanoparticles [1] were formulated and evaluated for
its invitro drug release profile. The results showed that the in vitro drug release for GNP1, GNP2, GNP3, GNP4
and GNP5 were found 99.55± 0.89, 99.51± 0.34, 99.57± 0.31,78.82± 0.82 and 65.73± 0.62 respectively at the
end of 24hrs. Conclusion: It can be concluded that the newly formulated controlled release nanoparticulate drug
delivery[32] systems of Gymnemic acid may be ideal and effective in the treatment of diabetes mellitus by
allowing the drug to release continuously for 24 hrs.

KEYWORDS: Zeta potential, diabetes mellitus, gymnema sylvestre, phytochemicals.

INTRODUCTION: They exist as particulates or globular dispersions with a

Nanoparticulate drug delivery systems signify a size in the series of 10-1000nm. In nano drug delivery
promising drug delivery system of controlled and systems, the drug or active component is dissolved,
targeted drug release. They are especially designed to entrapped, encapsulated, adsorbed or attached to the
release the drug in the surrounding area of goal tissue. matrix system.
Nano sized materials[5,6] have more advantages over
other dosage forms with larger particle size, as it can
provide more surface area and increased solubility. It
Received on 20.11.2018 Modified on 31.12.2018 also provides the facility to control the drug release
Accepted on 25.01.2019 © RJPT All right reserved along with the ability to deliver the entrapped therapeutic
Research J. Pharm. and Tech. 2019; 12(4): 1688-1694. agents to the desired site of action. Nano drugs are
DOI: 10.5958/0974-360X.2019.00282.8 widely investigated for the oral delivery of drugs. Oral

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drug delivery is the much favored route of drug 1. Nanospheres, which are polymeric matrix systems
administration[7] due to expediency, better patient which consist of the drug that is dispersed physically
fulfillment and cost-effectiveness. This system has been and uniformly. The polymeric nano sized spherical
also used to increase bioavailability of drugs having poor matrix system provides effective control of the
bioavailability. However, due to the small size, extensive loaded drugs.
research was carried out on administration of these 2. Nanocapsules[8] are those systems containing
systems by various parenteral routes like intravenous, vesicle’s in which the preparation is restrained to a
intra muscular and subcutaneous routes. The drugs cavity enclosed by a polymer membrane. In
loaded in nano drug delivery system were also reported nanocapsules, the polymeric membrane encapsulates
to exhibit improved shelf life and stability. the core material, usually a drug.
MERITS OF NANO DRUG DELIVERY SYSTEMS: Gymnemic acid was cut off from the leaves of
1. They can be enabled with site specific delivery of Gymnema sylvestre (Asclepiadaceae). They are
drugs. sweetness inhibitors. Once the leaves were eaten, sugar
2. Site specific delivery of drugs facilitates enhanced solutions sugar taste similar to water.
therapeutic response and reduction in adverse effects.
3. Drug degradation by enzymatic action can be Chemically, they are triterpenoid glycosides. The
prevented. fundamental configuration is the aglycone
4. Active and passive targeting of drug can be achieved gymnemagenin (C30H50O6). This is decked through a
by manipulating the particle size and surface sugar for example glucuronic acid and by means of
characteristics. assorted ester groups. These variations give rise to the
5. Suitable for incorporation of wide range of different gymnemic acids. More than 20 homologs of
therapeutic agents ranging from inorganic, organic, gymnemic acid are known.
synthetic, semi-synthetic compounds, lipids and
proteins. Gymnemic acid it have the uppermost anti-sweet
6. They can be utilized for administration by oral, nasal, property. It suppresses the sweetness of mainly of the
parenteral and ocular routes. sweeteners as well as strong synthetic sweeteners like
7. Controlled release of drug can be achieved aspartame and natural sweeteners such as thaumatin, a
8. Surface modification using ligands can be made to sweet protein. The anti-sweet activity is reversible, but
improve the specificity of drug targeting. sugarinessrevival on the tongue can acquire more than
DEMERITS: 10 minutes.
1. Aggregation of particles due to their small size and
huge surface area, however, this problem can be The mechanism of the drug is during stimulus in insulin
overcome by adjustment of surface charge (zeta secretion beginning pancreas. It also exerts a parallel
potential) of the nanoparticles by addition of suitable effect by delay the glucose assimilation in the blood.
surface active agents.
2. Difficult to handle in liquid forms (nanosuspensions). Chitosan polymer is used here, which exhibit
Freeze drying (lyophyllisation) had facilitated the Biocompatible, biodegradable, non-toxic, anti-microbial
maintenance of nanoparticles in dry form with and soluble in wide range of solvents.
enhanced stability.
3. Due to their ultra-small size they have limited drug MATERIALS AND METHODS:
loading capacity. Gymnemic acid, chitosan, poloxamer, ethanol,
4. These are susceptible to bursting and leakage of potassium dihydrogen phosphate, orthro phosphoric
drugs. acid.
5. Scaling up problems due to the equipment’s used in
the preparation and need for maintenance of uniform METHODS:
ultrafine size. 1. Preformulation studies:
Calibration graph for Gymnemic acid:
TYPES:
Preparation of calibration curve in pH 1.2, pH 7.4
Nano drug delivery systems are classified based on the
and pH 6.8 buffers:
morphological characters, structure, composition as well
Weigh 100mgs of Gymnemic acid and dissolve it in a
as the arrangement of drug and polymer in the
small volume of buffer solutions in 3 100ml volumetric
formulation:
flask and the volume is made up to 100ml with 1.2 pH
1. Polymeric Nanoparticles: buffer solution in volumetric flask numbered 1, in
The polymeric nanoparticles can be further classified 2ndvolumetric flask 7.4 pH buffer solution was used and
into two types: in the third one 6.8 pH buffer was used to make up the

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volume. A categorization of standard containing the Particle size and Surface charge:
concentration ranges from 10 to 50 µg/ml of Gymnemic Using Malvern-Zeta size the zeta- potential is calculated
acid were prepared for 1.2 pH buffer, 7.4 pH buffer and the significance in surface charge of adhesion and
solution and 6.8 pH buffer solution individually, interaction of particle with cells is noted. The prepared
absorbance were calculated at 290nm and calibration nanoparticles[16,17] was evaluate for their particle size and
graph was plotted by means of concentration against surface charge by photon correlation spectroscopy (PCS)
absorbance. by means of zeta sizer and diluted to 1:1000 with the
aqueous phase of the formulation to obtain a suitable
2. Drug-excipient compatibility study by DSC: kilo counts per second (kcps) and then it is analyzed at
Differential scanning calorimetry (DSC): 25°C with an angle of detection of 90° six replicates was
Samples of individual components in addition to each in use for the measurement.
drug-excipient be weighed (Mettler Electronic balance)
unswervingly in pierce aluminum crucible pans (5-10 Drug content: [18]
mg) and scanned in the 50-300°C range below static air, Weigh 1gm of gymnemic acid nanoparticles exactly
with heating rate of 10ºC/min, using Shimadzu DSC-60 transfer into a 25ml volumetric standard flask and
equipment. dissolve 5 ml with pH 6.8 phosphate buffer solution
then dilute 1 ml to 25 ml of buffer solution and Then the
METHOD OF PREPARATION [9-14] usual and sample absorbance was measured at 290 nm
Table 1. Formula used for the preparation of Gymnemic acid using a UV-Visible spectrophotometer. The percentage
nanoparticles of drug content was calculated.
S. FORMULA- DRUG CHITOSAN TWEEN
NO TION (mg) (%V/V) (%V/V)
1. GNP-1 100mg 0.5 5
2. GNP -2 100mg 1.0 5
3. GNP -3 100mg 1.5 5
4. GNP -4 100mg 2.0 5
Entrapment efficiency:
5. GNP -5 100mg 2.5 5 The drug infused nanoparticles are centrifuged at 15000
rpm for about 30 mins. 1ml of the separated supernant
METHOD: solution was diluted with water and the absorbance was
Emulsion -droplet coalescence method: noted at 290 nm and calculated for the quantity of
• Dissolve Chitosan particles with 1% acetic acid and gymnemic acid entrapped was calculated by subtracting
100mg of Gymnemic acid in phosphate buffered the sum of untapped[19,20] from the total gymnemic acid
saline. This solution is added to 10ml of liquid used for the preparation.
paraffin contain 5% v/v tween 20. The mixture was
The entrapment efficiency was calculated based on the
homogenized 3 minutes to form water in oil (w/o)
formula given below
emulsion.
• The resultant Gymnemic acid nanoparticles[9] were
centrifuged at 3000 rpm for 60 mts and washed with
ethanol and water, consecutively to eliminate residual
liquid paraffin and surfactant. In vitro release:
• afterward on they were dried in air for 3 hour Using Franz diffusion cell the invitro study was
followed by hot air oven at 50° for 4 hour and store performed for about 24 hrs using a dialysis membrane.
in a desiccator The equipped gymnemic acid nanoparticles[21,22] are kept
• Some batches namely (GNP1, GNP2, GNP3, GNP4, inside the membrane and it is immersed in phosphate
and GNP5) be prepared by varying the drug and buffer with pH of 6.8 and the sample was withdrawn at
polymeric ratio and the result of polymer programmed time interval and the quantity of gymnemic
concentration on the encapsulation effectiveness and acid released was determined by measured using UV-
the drug loading capacity was studied. Visible spectrophotometer at 290 nm absorbance. Based
on the absorbance results a cumulative % of drug release
CHARACTERIZATION STUDIES: was calculated and the results were discussed.
• Drug content
• Particle size and zeta potential RESULTS AND DISCUSSION:
Preformulation studies[23]:
• Drug content
Preparation of calibration graph for Gymnemic acid:
• Encapsulation efficiency
Standard calibration data of Gymnemic acid in pH 1.2,
• In vitro drug release [15]
7.4 and 6.8 buffers at 285 nm

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Table 2. Absorbance of Gymnemic acid in buffer solutions characteristic color change and there is no significant
Absorbance changes in the chemical evaluation this indicates that the
S. No Concentration
pH 1.2 pH 7.4 pH 6.8
1 10 0.025 0.031 0.101
drug and ingredients added are compatible with each
2 20 0.052 0.063 0.204 other.the results are given below in the table 3
3 30 0.076 0.095 0.302
4 40 0.104 0.122 0.406 Table 3 Physical characteristics of Gymnemic acid
5 50 0.124 0.155 0.505 S.No Physical parameter Results
1 Description Dark brown colour powder
2 Melting point 198.80C
3 Loss on drying 0.08%
4 Assay 99.58%

Table 4 Physical characteristics of individual drug and

excipients[21]
Final
S.No Sample ID Initial description
description
1. Gymnemic acid Dark brown colour No changes
powdered
2. Chitosan Off-white powder No changes

Table 5 Physical characteristics of drug-excipient mixture

Final
S.No Sample ID Initial description
description
1. Gymnemic acid Dark brown colour No changes
Fig. 1. Calibration curve of Gymnemic acid in pH 1.2, 7.4 and
powdered
6.8buffers
2 Gymnemic acid+ Brown colour No changes
Chitosan powders
Standard calibration curve of Gymnemic acid was
carried out in 1.2 pH, 7.4 pH and 6.8 pH buffer at 220 Table 6 Chemical characteristics of drug-excipient mixture
nm. The r2 value in the entire medium shows nearly 1, Final assay
S.No Sample ID Initial assay (%)
(%)
which signifies linearity. 1. Gymnemic acid 99.58%±0.26 99.54%±0.21
2. Gymnemic acid+ 99.55%±0.64 99.51%±0.43
DSC analysis: Chitosan
The melting point of gymnemic acid and the physical n = 3; Mean ± S.E.M.
mixture of other ingredients showed a similarity index in Table 7 Drug content and entrapment efficiency Particle size and
thermogram graph DSC analysis. Hence from the DSC zeta potential of Gymnemic acid nanoparticle.
study, it was found no interaction between Gymnemic Trial Zeta Particle Entrapment Drug
acid and other excipients used in the formulation. potential size(nm) Efficiency Content(%)
(mV) (%)
GNP1 17.9 190.1 58.67 99.53
The DSC thermogram be given in the Fig. 2 and 3 GNP 2 16.7 192.6 68.73 99.51
GNP 3 15.6 195.0 85.71 99.57
Drug –Excipients compatibility analysis - Physical GNP 4 14.2 196.5 86.24 99.54
observation and assay: GNP 5 13.6 197.3 86.71 99.52
Based on the study the material of drug-excipient has no
DSC
mW DSC of Gymnemic acid

20.00

Detector: DSC-60
Sam pl e Wei ght:
0.100[m g]
Cel l : Al um i num
Atm osphere: Ni trogen
Fl ow Rate: 10[m l /m i n]
Annotati on: Drug- Exci pi ents com pati bi l i ty study
Gymnemic acid
0.00

Peak 198.88 x10

C
0

Onset 198.28 x10

C
0

Endset 200.51 0
C
x10
Heat -11.15 x10
mJ
0

-111.50 x10
J/g
0
-20.00

-40.00

100.00 200.00
Temp [C]

Fig. 2

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DSC
mW
DSC of Gymnemic loaded acid chitosan nanoparticles
0.00
De te cto r: DSC-6 0
Sa m p l e We i g h t:
0 .1 0 0 [m g ] Peak 198.91 x10
C
0
Ce l l : Al u m i n u m Gymnemic acid
Atm o sp h e re : Ni tro g e n Onset 192.29 x10
C
0

An n o ta ti o n : Dru g - Exci p i e n ts co m p a ti b i l i ty stu d y Endset 204.94 x10

C
0

Heat -0.92 x10

mJ
0

-5.00 -9.20 x10

J/g
0

-10.00

-15.00

100.00 150.00 200.00 250.00

Temp [C]

Fig. 3
Fig. 2 and 3 DSC Thermogram of Gymnemic acid and Gymnemic acid nanoparticles

Fig. 4 Particle size of optimized Gymnemic acid loaded Chitosan nanoparticles (GNP3)

Fig. 5 Zeta potential of optimized Gymnemic acid loaded Chitosan nanoparticles (GNP3)

• As a result, the zetapotential rate for GNP3 was concentration.

obtained maximum of 19.6 mV. • This is because of elevated quantity of availability of
• The particle size has no changes [24]. Chitosan to encapsulate the drug, in the lead increase
• Particle size and entrapment efficiency of the the Chitosan concentration, number of layers coated
Gymnemic acid nanoparticles(GNP1- GNP5) were the drug was improved, thus results in increased
greater than before with increasing Chitosan particle size and entrapment efficiency[25].

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• Further increase in the Chitosan concentration Above 1.5% w/v of Chitosan concentration[28], reduction
(GNP4-GNP5), has no more augment in the in drug release was observed as in the case of trial GNP4
entrapment efficiency because the accessibility of the and GNP5. The maximum percentage drug release for
drug to be included is small which is not enough for GNP4 and GNP5 were found to be 78.82± 0.82 and
further encapsulation of drug by Chitosan. 65.73± 0.62 respectively at the end of 24h was obtained.

In- vitro drug release: From the records obtained from in vitro drug release for
Table 8 In vitro release studies of Gymnemic acid nanoparticles GNP1- GNP5, it was concluded that increase in
S. Time PERCENTAGE CUMULATIVE DRUG
Chitosan concentration slows down the drug liberate due
No in RELEASE
(Hrs) to improved particle size and decresed surface area of
GNP1 GNP2 GNP3 GNP4 GNP the prepared nanoparticles.
5
1. 0.5 35.86± 30.25± 21.74± 12.75± 8.88± From all the above formulations, GNP3[28] was preferred
0.47 0.55 0.33 0.19 0.24
2 1 50.81± 41.37± 36.85± 23.18± 17.63
as best formulation due to its ideal particle size (195
0.22 0.23 0.56 0.27 ± nm), high entrapment efficiency (85.71%) and desirable
0.92 drug release (99.57± 0.31% at the end of 24 h).
3 6 88.72± 72.36± 43.82± 32.15± 25.74
0.19 0.42 0.72 0.56 ±
0.34 4. SUMMARY AND CONCLUSIONS:
4 12 99.51± 85.74± 56.89± 43.81± 32.81 The active pharmaceutical ingredient Gymnemic acid
0.34 0.19 0.18 0.15 ± was evaluated for its organoleptic properties and
0.17 solubility. The results obtained were satisfactory.
5 16 99.52± 97.32± 71.73± 57.93± 42.72
0.67 0.74 0.88 0.31 ±
0.35 Gymnemic acid nanoparticles were prepared by
6 20 99.53± 99.49± 84.88± 66.48± 51.95 emulsion -droplet coalescence method[30] and the
0.17 0.11 0.24 0.71 ± polymer concentrations were optimized by various trials
0.73
7 24 99.55± 99.51± 99.57± 78.82± 65.73
0.89 0.34 0.31 0.82 ± In the present study Chitosan nanoparticles containing
0.62 Gymnemic acid was prepared. The effect of increase in
mean±S.D, n=3 Chitosan[31] concentration in various parameters like
particle size and invitro release profile were studied.

The Gymnemic acid nanoparticles were formulated and

evaluated for its invitro drug release profile[33]. The
results showed that the in vitro drug release for GNP1,
GNP2, GNP3, GNP4 and GNP5 was found to be 99.55±
0.89, 99.51± 0.34, 99.57± 0.31,78.82± 0.82 and 65.73±
0.62 respectively at the end of 24hrs.

Based on the in vitro study profile of Gymnemic acid

nanoparticles formulations[34] (GNP1-GNP5)
formulation GNP3 was selected as finest formulation in
which the particle size was 195 nm.

FIG. 6. Effect of Chitosan concentration on Invitro drug release of The % in vitro study of GNP3 formulation was 99.57±
Gymnemic acid nanoparticles 0.31 and it was found to be suitable formulation to
manage the condition of diabetes mellitus. Hence it can
From the in vitro drug release [26] study results, the
be concluded that the newly formulated controlled
highest drug release (99.57± 0.31) and at the closing
release nanoparticulate drug delivery[35] systems of
stages of 24hwas observed with trial GNP3 which
Gymnemic acid may be ideal and effective in the
contains 1.5% w/v of Chitosan.
treatment of diabetes mellitus by allowing the drug to
Below 1.5% w/v of Chitosan concentration as in the case release continuously for 24 hrs.
of trials GNP1 and GNP 2 the maximum percentage
drug release 99.51± 0.34 and 99.49± 0.11 were obtained 5. CONFLICT OF INTEREST:
at the end of 12 and 20hrs respectively which was not The authors declare no conflict of interest.
desirable[27].

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