Appraising Best Poly Ethylene Glycol Carrier for ... · Hemanth et al 356 J Pharm Chem Biol Sci, December 2018 - February 2019; 6(4): 355-364 dispersions using Poly Ethylene Glycol

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J Pharm Chem Biol Sci, December 2018 - February 2019; 6(4):355-364

Journal of Pharmaceutical, Chemical and Biological Sciences

ISSN: 2348-7658 CODEN : JPCBBG

December 2018 - February 2019; 6(4):355-364

Online available at https:/ /www.jpcbs.info

Appraising Best Poly Ethylene Glycol Carrier for Thiocolchicoside Solid

Dispersions

Hemanth A1, Hindustan Abdul Ahad2*, Devanna N2

1Research Scholar, Research and Development, Jawaharlal Nehru Technological University,

Ananthapuramu 515001, AP, India. 2Jawaharlal Nehru Technological University-Oil Technological and Pharmaceutical Research Institute,

Ananthapuramu 515001, AP, India

*CORRESPONDING AUTHOR

Hindustan Abdul Ahad, Jawaharlal Nehru Technological

University-Oil Technological and Pharmaceutical Research

Institute, Ananthapuramu 515001, AP, India

Email: [email protected]

ARTICLE INFORMATION

Received October 17, 2018

Revised December 16, 2018

Accepted December 22, 2018

Published February 17, 2019

INTRODUCTION

In Industry the pharmacist makes so many

trials with the aim to increase the solubility of

drugs which are poorly soluble, in an

inexpensive way. Among the different

techniques of increasing solubility, solid

dispersion technique was attaining the fame [1].

Thiocolchicoside is a colchicoside derivative

(Gloriosa superba) and Colchicum autumnale.

Thiocolchicoside is used as muscle relaxant for

the treatment of painful muscle contractions,

acute and arthritic problems and pains. It is

prescribed in combination with many NSAIDs

[2-5].

Electromagnetic irradiation in microwave oven

is ranged from 0.3 to 300 GHz of infrared and

radio frequencies which resembles to

wavelengths of 1 mm to 1 m. This technique can

be used to get rapid and constant heating even

in materials presenting low heat conductivity

(E.g., polymers), because the transfer of energy

does not trust on heat diffusion [6, 7].

The present exploration was to increase the

solubility of Thiocolchicoside by making solid

Research Article

The work is licensed under

ABSTRACT

The present attempt is to discover the best Poly Ethylene Glycol as solid dispersion carrier by taking

Thiocolchicoside as a model drug. Different Poly Ethylene Glycol bases viz., PEG- 3350, PEG- 4000,

PEG- 6000, PEG- 8000 and PEG- 20000 were evaluated in the study. Thiocolchicoside: PEG in the

ratios ranged from 1:1, 1:2, 1:4 and 1:6 were prepared as solid dispersions by microwave irradiation

method and compressed by 8 station tablet compression machine. The fabricated solid dispersion

tablets were evaluated for physicochemical characteristics and drug release rates. The release of

Thiocolchicoside from the designed solid dispersions were further analyzed by kinetic models. All the

solid dispersion formulations were shown satisfactory physicochemical characteristics and

Thiocolchicoside release. Among the Poly Ethylene Glycol carriers, PEG-6000 was found to be the best

carrier for increasing the solubility and release rate form the solid dispersions of Thiocolchicoside.

KEYWORDS: Thiocolchicoside; Poly Ethylene Glycol; solid dispersions; evaluation

Hemanth et al 356

J Pharm Chem Biol Sci, December 2018 - February 2019; 6(4): 355-364

dispersions using Poly Ethylene Glycol carriers,

viz., PEG- 3350, PEG- 4000, PEG- 6000, PEG-

8000 and PEG- 20000 [8-12] and finding out the

best polymer among them. The solid dispersions

were fabricated by microwave melting method.

MATERIALS AND METHODS

Materials

Thiocolchicoside was procured from Yarrow

chemicals. (PEG- 3350, PEG- 4000, PEG- 6000,

PEG- 8000 and PEG- 20000) were obtained from

Amrutha organics, Hyderabad. Microcrystalline

Cellulose, Talc and Magnesium stearate were

acquired from Colorcon, India. Double distilled

water was used when ever desirable.

METHODS

Stability studies

Thiocolchicoside pure drug and excipients (1:1)

compatibility study at stressed storage

conditions i.e., at a temperature of 40°C and RH

of 75% in stability chamber [13] (Classic

Scientific India, Mumbai) was performed.

Hygroscopic studies

The hygroscopic study of Thiocolchicoside pure

drug was done under 33, 53 and 75% RH for 30

days and the weight gain was studied. These

studies were performed in triplicates [14].

Solubility studies

Thiocolchicoside pure drug was tested for

solubility in 0.1N HCl, water, pH 4.5 Acetate

buffer, pH 6.8 and pH 7.4 Phosphate buffers

[15].

Designing of Solid dispersions

The various formulae of Thiocolchicoside solid

dispersions with PEG were shown in table 1.

Table 1: Drug (Thiocolchicoside): Carrier (PEG) ratios in various formulations

Drug: Carrier Ratio Formulation code

TCS: PEG-3350 1:1 TPEG3-1

1:2 TPEG3-2

1:4 TPEG3-3

1:6 TPEG3-4


1:2 TPEG4-2

1:4 TPEG4-3

1:6 TPEG4-4


1:2 TPEG6-2

1:4 TPEG6-3

1:6 TPEG6-4


1:2 TPEG8-2

1:4 TPEG8-3

1:6 TPEG8-4

TCS: PEG-20000 1:1 TPEG20-1

1:2 TPEG20-2

1:4 TPEG20-3

1:6 TPEG20-4

Flow properties

The designed solid dispersions were evaluated

for Micromeritic properties [16-18].

Preparation of solid dispersion tablets

The solid dispersions equivalent to 4 mg of

Thiocolchicoside were fabricated by direct

compression [19] in to tablet dosage form, after

mixing with required amounts of different

ingredients as shown in table 2 by using 8

station tablet compression machine (Karnavati

Engineering, Ahmedabad, India).

Hemanth et al 357


Table 2: Formulation of tablet containing solid dispersions

Ingredients Quantity per tablet

Solid dispersions equivalent

to 4 mg of Thiocolchicoside

125

Lactose 50

Starch 15

Micro Crystalline Cellulose 50

Magnesium stearate 5

Talc 5

Weight of the tablets 250

Evaluation Thiocolchicoside Solid

Dispersions

The following parameters were tested for

Thiocolchicoside solid dispersions [20-24].

Morphological characteristics

In this study, tablets were verified for size and

shape.

Thickness

Tablets were assessed for their thickness using

vernier Calipers (Qumos Enterprises, Mumbai,

India). These trails were made in triplicates.

Hardness

The force required to break the tablets were

noted using Monsanto tablet hardness tester

(Vinsyst Technologies, Mumbai). These tests

were performed in triplicates.

Uniformity in weight

20 tablets from each batch were weighed

individually using an electronic digital balance

(Citizen, CY-104, Mumbai, India) and calculated

the average weight and compared with the

individual tablet weights. From this, percentage

weight difference was calculated and then

checked for IP specifications (Limit ± 7.5% of

average weight).

Friability

It is the occurrence in which tablet surfaces are

injured when subjected to physical tremor or

erosion. This test was performed using Roche

Friabilator. 10 tablets were weighed before the

test (W initial) and moved into a friabilator. The

equipment was run at a speed of 25 rpm for the

period of 4 minutes and the final weight of

tablets (W final) was determined. The loss on

friability was then measured by the following

equation.

Yield

The % recovery of formulated solid dispersion

was resolute after complete removal of moisture.

Thus % recovery calculation involves the weight

of dried Solid dispersion to sum of the weight of

drug and pharmaceuticals required for the

formulation.

Uniformity of drug content

5 tablets from each batch were taken and

weighed and crushed in a mortar and pestle. A

weight equal to 4 mg of Thiocolchicoside was

dissolved in 100 ml of Phosphate Buffer solution

(PBS) (pH 7.4). From this 0.2 ml sample was

taken later diluted to 10 ml PBS. The

absorbance was determined [25] at 259 nm with

double beam UV-Visible spectrophotometer (Lab

India, Mumbai). The content uniformity was

calculated from Thiocolchicoside standard

calibration graph.

Thiocolchicoside calibration curve

The process of determining Thiocolchicoside by

UV spectrophotometer at 259 nm was

standardized and the drug was found to obey

Beer-Lambert’s law in 2-10 µg/ml concentration

[26].

Dissolution rate/in-vitro drug release

The dissolution specifications were as below [27]

Apparatus used: USP XXIII dissolution

test apparatus

Dissolution medium: PBS (pH 7.4)

Volume of dissolution medium: 900 ml

Temperature: 37±0.5°C

Speed of basket paddle: 50 rpm

Hemanth et al 358


Sampling intervals: 5 min

Sample withdraws: 10 ml

Absorbance measured at: 259 nm

Kinetic modeling of drug release

The mechanism of the drug release was

analyzed and rate kinetics of the dosage form

was obtained as [28, 29]:

Cumulative percentage drug released

Vs. Time (Zero order plots)

Log cumulative percentage drug

remaining Vs Time (First order plots)

Cube root of drug remaining Vs time

(Hixon Crowell’s plots)

Accelerated Stability studies of

Thiocolchicoside solid dispersions

The prepared Thiocolchicoside solid dispersions

tablets were further subjected to stability

studies for a period of 3 months under stressed

storage conditions [30].

RESULTS

Physical observations were made by storing

Thiocolchicoside with various PEG carriers used,

at stressed storage conditions were tabulated in

table 3.

Table 3: Thiocolchicoside Excipients (1:1) compatibility study physical Observations

Binary

mixture

Initial Storage condition

Room temperature 40°C/75%RH

10

days

20

days

30

days

10

days

20

days

30

days

Thiocolchicoside Pale yellow powder NCC NCC NCC NCC NCC NCC

T+PEG-3350 White waxy

powder

NCC NCC NCC NCC NCC NCC

T+ PEG-4000 White waxy

powder



powder



powder



powder


T+ Lactose Pale yellow powder NCC NCC NCC NCC NCC NCC

T+ Starch Pale yellow powder NCC NCC NCC NCC NCC NCC

T+ MCC Pale yellow powder NCC NCC NCC NCC NCC NCC

T+ MS Pale yellow powder NCC NCC NCC NCC NCC NCC

T+ Talc Pale yellow powder NCC NCC NCC NCC NCC NCC

PEG- Poly Ethylene Glycol; MCC- Micro Crystalline Cellulose; MS- Magnesium Stearate

The hygroscopic study of Thiocolchicoside at room temperature (25±2oC) & humidity conditions was

shown in table 4.

Table 4: Hygroscopicity Data of Thiocolchicoside

Time Interval % Weight Change

33% RH 53% RH 75% RH

Day 0 0.00 0.00 0.00

Day 2 0.00 0.01±0.001 0.01

Day 4 0.00 0.01±0.001 0.01±0.001

All values mentioned as mean ±SD; number of trials (n=3)

The solubility of Thiocolchicoside pure drug in

0.1N HCl, water, pH 4.5 Acetate buffer, pH 6.8

Phosphate buffer and pH 7.4 Phosphate buffer

were shown in fig. 1.

Hemanth et al 359


Fig. 1: Solubility of Thiocolchicoside at various media

The flow properties of fabricated Thiocolchicoside solid dispersions were shown in table 5.

Table 5: Flow character specifications

Formulation Flow properties

Angle of repose (0) LBD TBD CI HR

TPEG3-1 34.53±0.02 0.654±0.03 0.704±0.05 7.102±0.02 1.076±0.01

TPEG3-2 29.19±0.03 0.758±0.01 0.789±0.08 3.929±0.03 1.041±0.08

TPEG3-3 29.30±0.04 0.528±0.05 0.584±0.04 9.589±0.05 1.106±0.04

TPEG3-4 29.05±0.06 0.625±0.03 0.689±0.02 9.288±0.03 1.102±0.03

TPEG4-1 26.54±0.09 0.452±0.07 0.498±0.01 9.236±0.01 1.101±0.01

TPEG4-2 31.21±0.06 0.235±0.04 0.255±0.03 7.843±0.05 1.085±0.01

TPEG4-3 31.56±0.08 0.255±0.03 0.269±0.03 5.204±0.03 1.054±0.01

TPEG4-4 29.49±0.06 0.366±0.06 0.389±0.02 5.912±0.08 1.062±0.07

TPEG6-1 26.31±0.08 0.268±0.08 0.274±0.02 2.189±0.07 1.022±0.05

TPEG6-2 30.50±0.06 0.365±0.01 0.387±0.01 5.684±0.04 1.060±0.01

TPEG6-3 29.15±0.02 0.854±0.02 0.878±0.03 2.733±0.04 1.028±0.03

TPEG6-4 27.30±0.04 0.524±0.04 0.564±0.05 7.092±0.03 1.076±0.01

TPEG8-1 29.06±0.06 0.254±0.08 0.268±0.03 5.223±0.05 1.055±0.01

TPEG8-2 28.30±0.01 0.625±0.06 0.635±0.09 1.574±0.03 1.016±0.04

TPEG8-3 30.24±0.06 0.369±0.05 0.389±0.07 5.141±0.03 1.054±0.05

TPEG8-4 30.56±0.08 0.582±0.03 0.595±0.05 2.184±0.08 1.022±0.01

TPEG20-1 31.50±0.06 0.565±0.04 0.578±0.03 2.249±0.09 1.023±0.06

TPEG20-2 26.19±0.04 0.485±0.01 0.496±0.03 2.217±0.03 1.022±0.01

TPEG20-3 31.32±0.02 0.258±0.03 0.269±0.01 4.089±0.07 1.042±0.01

TPEG20-4 26.05±0.08 0.569±0.03 0.584±0.03 2.568±0.04 1.026±0.02


The fabricated Thiocolchicoside tablets were

observed to have uniform in size, shape, off

white in colour, odourless with smooth surface.

The thickness of prepared formulations,

uniformity of weight, hardness, friability,

percent yield and drug content uniformity were

shown in table 6.

Table 6: Physical Characteristics of Prepared solid dispersions

Formulation Physical parameter

Uniformity of

weight (mg)

Hardness

(cm2)

Thickness

(mm)

Friability (%) Yield (%) Assay

(%)

TPEG3-1 253.1±0.01 4.5±0.04 4.51±0.01 0.59±0.05 96.3±0.06 96.3±1.27

TPEG3-2 254.3±0.01 5.2±0.05 4.53±0.04 0.60±0.05 98.5±0.06 96.9±3.25

TPEG3-3 255.2±0.01 6.3±0.01 4.50±0.01 0.53±0.05 97.9±0.06 99.4±1.21

TPEG3-4 255.2±0.02 5.3±0.01 4.51±0.02 0.45±0.02 99.8±0.06 97.2±0.11

Hemanth et al 360


TPEG4-1 255.1±0.02 4.5±0.05 4.53±0.04 0.51±0.03 90.5±0.06 96.8±0.86

TPEG4-2 250.9±0.01 5.2±0.03 4.50±0.02 0.72±0.03 91.5±0.06 99.2±0.15

TPEG4-3 252.3±0.01 6.3±0.05 4.51±0.07 0.11±0.01 98.3±0.06 97.2±0.35

TPEG4-4 253.8±0.02 5.3±0.05 4.53±0.05 0.25±0.02 97.8±0.06 96.3±0.01

TPEG6-1 250.5±0.02 4.5±0.05 4.50±0.03 0.56±0.04 94.5±0.06 99.1±1.29

TPEG6-2 250.1±0.01 5.2±0.01 4.51±0.04 0.09±0.01 96.5±0.06 100.6±4.25

TPEG6-3 254.2±0.02 6.3±0.05 4.53±0.01 0.50±0.05 98.7±0.06 97.3±0.96

TPEG6-4 252.2±0.01 5.3±0.04 4.50±0.03 0.25±0.02 98.2±0.06 96.4±3.25

TPEG8-1 251.3±0.01 4.5±0.04 4.51±0.01 0.53±0.07 90.3±0.06 99.2±1.25

TPEG8-2 252.3±0.02 5.2±0.02 4.53±0.04 0.68±0.04 91.8±0.06 100.6±0.82

TPEG8-3 251.2±0.01 6.3±0.04 4.50±0.02 0.50±0.03 95.6±0.06 97.1±0.66

TPEG8-4 250.2±0.01 5.0±0.03 4.51±0.02 0.25±0.01 94.4±0.06 96.4±0.72

TPEG20-1 250.2±0.02 4.5±0.07 4.53±0.05 0.59±0.04 95.6±0.06 99.2±0.89

TPEG20-2 251.2±0.02 5.2±0.04 4.50±0.04 0.66±0.01 98.8±0.06 100.9±2.31

TPEG20-3 250.1±0.01 6.6±0.05 4.51±0.02 0.50±0.04 96.5±0.06 97.2±1.55

TPEG20-4 252.1±0.01 5.4±0.03 4.53±0.07 0.21±0.02 98.7±0.06 96.1±0.44


The solubility of prepared tablets was found

good in distilled water and 0.1N HCl. These

values were shown in figure 2 to 6.

Fig. 2: Solubility of Thiocolchicoside and

solid dispersions with

PEG-3350 in various media









-8000 in various media

Hemanth et al 361





The estimation of Thiocolchicoside was

determined by plotting calibration curve of

Thiocolchicoside (fig. 7).

Fig. 7: Calibration curve for the estimation

of Thiocolchicoside

The dissolution of prepared tablets was found

good in formulations containing

Thiocolchicoside: PEG ratios 1:6. These were

shown in figs. 8 to 12.

Fig. 8: In vitro drug dissolution plots of

Thiocolchicoside and

PEG-3350 solid dispersions













Hemanth et al 362


The drug release mechanism from prepared

tablets formulations was determined by kinetic

treatment of in vitro drug dissolution data. The

correlation (r2) values were shown in table 7.

First order and Hixon Crowell’s plots were

shown in fig. 13 and 14.

Fig. 13: First order plots for TPEG tablets

Fig. 14: Hixson Crowell’s plots for TPEG-4 tablets

Table 7: Correlation coefficients (R2) for different release kinetics of Thiocolchicoside solid

dispersions

Formulation Correlation (R2)

Zero order First order Hixson

Crowell’s

TPEG3-4 0.9738 0.9936 0.9979

TPEG4-4 0.5025 0.9885 0.9868

TPEG6-4 0.8823 0.9494 0.9206

TPEG8-4 0.9785 0.9868 0.9860

TPEG20-4 0.9738 0.9666 0.9804

DISCUSSION

The compatibility study between

Thiocolchicoside and the polymer carriers used

revealed that Thiocolchicoside was found to be

compatible with the excipients used.

The hygroscopic study of Thiocolchicoside at

room temperature (25±2oC) & humidity

conditions proves that Thiocolchicoside was non-

hygroscopic (% weight gain < 0.2%).

Thiocolchicoside shown good solubility of

0.2958±0.0065 µg/ml in 0.1N HCl and

0.2019±0.0024µg/ml in water. The solubility of

Thiocolchicoside was found to be 0.2698±0.0095,

0.1054±0.0024 and 0.1924±0.0058 µg/ml in pH

4.5 Acetate buffer, pH 6.8 Phosphate buffer and

pH 7.4 Phosphate buffer respectively. The

solubility data indicates that drug has very poor

solubility.

The fabricated Thiocolchicoside solid dispersions

showed good flow properties (26.05±0.08 to

34.53±0.02o). The compressibility Index was

between 1.574±0.03 to 9.589±0.05, indicating

good compression properties while tableting. The

fabricated Thiocolchicoside tablets were

Hemanth et al 363


observed to have uniform in size, shape, off

white in colour, odourless with smooth surface.

The prepared tablets were found to have

uniform thickness (4.5 mm) and weight. The loss

on friability was less than 1% and the hardness

was more than 4 Kg/cm2 indicating that the

prepared tablets having good mechanical

strength. The uncoated tablets disintegrated

within 15 min, the yield was found to good

(>90%) and the drug content was also found to

be uniform.

The formulations TPEG3-1, TPEG3-2, TPEG3-3

and TPEG3-4 showed good solubility in distilled

water (up to 1.25±0.01µg/ml) and in 0.1 N HCl

(up to 1.13±0.02 µg/ml). TPEG4-1, TPEG4-2,

TPEG4-3 and TPEG4-4 showed good solubility

in 0.1 N HCl (up to 0.63±0.01 µg/ml) and in

distilled water (up to 0.52±0.01 µg/ml). TPEG6-

1, TPEG6-2, TPEG6-3 and TPEG6-4 showed

good solubility in 0.1 N HCl (up to 0.61±0.01

µg/ml) and in distilled water (up to 0.57±0.01

µg/ml). TPEG8-1, TPEG8-2, TPEG8-3 and

TPEG8-4 showed good solubility in distilled

water (up to 0.58±0.01 µg/ml), in 0.1 N HCl (up

to 0.56±0.03µg/ml). The formulations TPEG20-

1, TPEG20-2, TPEG20-3 and TPEG20-4) showed

good solubility in 0.1 N HCl (up to 0.74±0.02

µg/ml) and in distilled water (up to 0.68±0.01

µg/ml).

Thiocolchicoside followed Beer’s Lamberts law at

the concentration of (2 to 10 µg/ml). The

regression (R2 value was found to be 0.9998 with

the slope of 0.0743x+0.0149.

The dissolution of prepared tablets was found

good in formulations containing

Thiocolchicoside: PEG ratios 1:6 with all carriers

viz., PEG- 3350, PEG- 4000, PEG- 6000, PEG-

8000 and PEG- 20000. The regression (R2 value

was found to be 0.9936, 0.9885, 0.9494, 0.9868

and 0.9666 for first order plots and 0.9979,

0.9868, 0.9206, 0.9860 and 0.9804 for Hixson

Crowell’s models for formulations TPEG3-4,

TPEG4-4, TPEG6-4, TPEG8-4 and TPEG20-4.

Accelerated stability studies for the optimized

formulation (TPEG6-4) revealed that these

formulations were retained their physical

parameters even after stressed storage

conditions.

CONCLUSION

In the investigation of finding best PEG carrier

for preparing solid dispersions by taking

Thiocolchicoside as a model drug. The

formulation TPEG6-4 in the ratios 1: 6 was

found to have good solubility and drug

dissolution characteristics. And among the PEG-

3350, PEG-4000, PEG-6000, PEG-8000 and

PEG-20000, Poly Ethylene Glycol 6000 was

found to be best PEG among the tested one as

solid dispersion.

CONFLICT OF INTEREST

The authors declare no conflict of interest in this

research article.

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Cite this article as:

Hemanth A, Hindustan Abdul Ahad, Devanna N. Appraising Best Poly Ethylene Glycol Carrier for

Thiocolchicoside Solid Dispersions. J Pharm Chem Biol Sci 2018; 6(4):355-364

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Appraising Best Poly Ethylene Glycol Carrier for ... · Hemanth et al 356 J Pharm Chem Biol Sci, December 2018 - February 2019; 6(4): 355-364 dispersions using Poly Ethylene Glycol