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Author(s): Anshita Gupta*

Email(s): dr.anshitasoni@gmail.com

Address: Shri Rawatpura Sarkar Institute of Pharmacy, Kumhari, Durg
*Corrosponding author: dr.anshitasoni@gmail.com

Published In:   Volume - 32,      Issue - 1,     Year - 2019


Cite this article:
Gupta (2019), Isolation, Characterization, Evaluation and Establishment of Polymeric Principles from Curcuma Angustifolia as Multitasking Excipient. Journal of Ravishankar University (Part-B: Science), 32 (1), pp. 27-33.



 


Isolation, Characterization, Evaluation and Establishment of Polymeric Principles from Curcuma Angustifolia as Multitasking Excipient

Anshita Gupta*

Shri Rawatpura Sarkar Institute of Pharmacy, Kumhari, Durg

*Corrosponding author: dr.anshitasoni@gmail.com

               

          [Received: 30 January 2019; Revised version: 16 March 2019; Accepted: 28 March 2019]

 

Abstract. In India, Chhattisgarh is famous as Herbal state with its beautiful natural resources of forests and agricultural fields and value addition has been done so far in Chhattisgarh to maintain or improve the quality of the plants before the material reaches the industry. Presently, the herbal industry in Chhattisgarh is not very organized. The plant derived gums, mucilages from natural sources like carrageen an, thaumatin, lard, storax, agar, gum acacia, tragacanth and many more to name comply with many requirements of pharmaceutical excipients. These can be preferred for formulation development as being stable and involving less regulatory issues as compared to their synthetic counter parts. They can also be easily modified to meet the specific needs, thereby being a potent and economic vehicle for delivering active pharmaceutical ingredient in formulation. Thus our concerned and aims of the study is to throw light on the potential of natural excipients which can be proposed to be used as diluent, binder, disintegrant as well as lubricant in various types of formulations as they are biocompatible and capable of giving additional nutrition to the developed dosage form from indigeneous sources of Chhattisgarh state which could serve for cost effective and economical medicament and will enhance the value addition to the proposed herb and herbal species.

 

Key Words: herbal state, diluent, binder, disintegrant, excipients, active pharmaceutical ingredient.

 

Introduction

In India, Chhattisgarh is famous as Herbal state with its beautiful natural resources of forests and agricultural fields and value addition has been done so far in Chhattisgarh to maintain or improve the quality of the plants before the material reaches the industry. Presently, the herbal industry in Chhattisgarh is not very organized. (Kokate et al., 1994) Through the state lead initiatives on In-situ conservation, Ex-situ cultivation and propagation, capacity building of local communities, development of processing technologies and emphasis on value addition on herbal product. In the same lieu arrives the demand and necessity of natural excipients from herbal origin to produce cost effective, standardized, biocompatible and safe drugs. Excipients play a critical role in the creation of medicines, helping to preserve the efficacy, safety, and stability of active pharmaceutical ingredients (APIs) and ensuring that they deliver their promised benefits to the patients. Optimal use of excipients can provide pharmaceutical manufacturers with cost-savings in drug development, enhanced functionality and help in drug formulations innovation. (Kokate et al., 1994; Patel et al., 2015)] Thus our concerned and aims of the study is to throw light on the potential of natural excipients which can be proposed to be used as diluent, binder, disintegrant as well as lubricant in various types of formulations as they are biocompatible and capable of giving additional nutrition to the developed dosage form from indigeneous sources of Chhattisgarh state which could serve for cost effective and economical medicament and will enhance the value addition to the proposed herb and herbal species.

Materials and Methods

Tikhur rhizome was procured from the local market of jagdalpur Chhattisgarh and extracted for starch as mentioned by the procedure of Patel et al. (2015). Extracted starch was used for evaluation of physico chemical and different excipient properties (Patel et al., 2015).

Chemical composition Moisture, crude protein, crude fat and ash content were determined using AACC (2000) standard methods. Starch content in tikhur was determined using IS 4706-2 (BIS, 1978) method. Amylose content in tikhur was measured by the procedure reported by and amylopectin content was calculated using Eq. (1). Amylopectin% = 100 – amylose%

Swelling index

Swelling characteristics swelling characteristics of the starches were studied at different temperatures by microscopic method. The extend of swelling was calculated by finding the ratio between grain size at the maximum temperature and at 35°C (Kumari et al., 2012)

Paste clarity

Paste clarity (% Transmittance at 640 nm) of starch paste was measured using the procedure of Craig et al. (1989). Starch suspension (2%) was heated and stirred in water bath for 30 min at 95 °C. Samples were cooled and stored for 4 d at 4 °C and percent transmittance was measured everyday at 640 nm against water blank using UV – VIS Spectrophotometer (Kumari et al., 2012).

Pasting properties

Pasting properties of tikhur flour were measured using Rapid Visco-Analyser 4D (RVA) manufactured by M/s Newport Scientific Pvt Ltd., Australia, according to the method described by Yadav et al. (2010). 3.5 g of flour sample with an initial moisture content of 2.63% (wet basis) was dispersed in 25 ml of distilled water and fitted into RVA as per manufacturer’s instructions. The rotating speed of paddle was 160 rev/min except for first 10 sec (960 rev/min). The suspension was equilibrated at 50 °C for 1 min and heated at the rate of 12 °C/min to 95 °C and then held at 95 °C for 2.5 min. The sample was then cooled to 50 °C at the rate of 12 °C/min and then held for 3 min at 50 °C. Peak viscosity, trough viscosity, breakdown viscosity, final viscosity and setback viscosity were recorded in rapid viscosity units (RVU). Pasting temperature (°C) was also recorded and test was replicated thrice (Rani et al., 2012; United State Pharmacopoeia, 1985).

Gel strength

Tikhur starch suspension (prepared with a concentration of 8% starch solids, (db) was heated to 95 °C and held for 30 min and cooled to 4-6 °C for gel formation; Gel strength was determined using Texture Analyzer (TA XT CT 3 Model). The following conditions were used for measurement of gel strength of tikhur starch: pre-test speed: 3.0 mm/s; test speed: 2.0 mm/s post-test speed: 10.0 mm/s; distance: 15 mm; trigger type: Auto – 15 g; data acquisition rate: 400 pps. For gel strength measurement, when a trigger force of 15 g was attained the probe then proceeded to penetrate into the gel at a speed of 2.0 mm/s to a depth of 15 mm. During this penetration, the force was seen to drop at the point where the gel broke thrice (Rani et al., 2012; United State Pharmacopoeia, 1985). Thereafter, the resulting forces were due to continuing penetration up to the required depth. Hardness or gel strength, deformation at target and adhesiveness were obtained through this measurement.

Fourier transform-infrared spectroscopy

Fourier transform infrared spectroscopy (Nicolet-6700, ThermoFisher, United States) was used to determine the functional groups in the wave length range of 4000–400 cm−1 of starch samples. Before taking FT-IR, the sample was blended with KBr (Indian Pharmacopoeia, 1966)

Bulk density

Bulk density (Db) It is ratio of total mass of powder to the bulk volume of powder. 10 gm of drug excipient mixture were taken and transferred into a 50 ml measuring cylinder and the volume was noted. The bulk density of the powder were expressed in gm/ml was determined as follows.

Db = M/Vo

Where, M is the mass of the powder Vo is the bulk volume of the powder.

Scanning electron microscopy

Scanning Electron Microscopy (SEM) is generally used to characterize starch at microstructure level. The results obtained by SEM showed variation in size and shape of starch granules from small to large and oval to polyhedral with the size ranging from 9.75 to 20.43 µm in length and 3.409 to 5.272 µm in width (Nakhat et al., 2004).

Rheological studies

Rheological studies of Starch mucilage Starch mucilage (5% and 10%) of Curcuma angustifolia were prepared. The rheological characteristic of mucilage was evaluated by using Brookfield viscometer (Perez et al., 2015).

Angle of repose

The frictional forces in a loose powder can be measured by the angle of repose, q. This is the maximum angle possible between the surface of a pileof powder and the horizontal plane and it is given as, tan q = h / r,

q = tan-1[h /r]

Where q is the angle of repose, h is the height in cm, r is the radius.

The powder mixture was allowed to flow through the funnel fixed to a stand at definite height. The angle of repose was then calculated by measuring the height and radius of the heap of powder formed.

Test for friability and flow properties of granules

Paracetamol granules prepared with Curcuma angustifolia starch and Corn starch were tested for friability and flow properties [9]. Friability testing was carried out using Roche friabilator. Friability was calculated from the following formula

% Friability = (1-W1/W2) x 100

Where, W1 = weight of granules after test. W2 = weight of granules before test. Flow properties of granules were tested by determining angle of repose.

Statistical data analysis

Experiments were performed three times, and data were analyzed by one sample t-test analysis to determine significant differences at p < 0.05 using SPSS 16.0 statistical software (SPSS, Inc., Chicago, IL, USA).

Evaluation and establishment of herbal excipient-based formulation (of tablets)

Hardness and friability tablets 

Hardness and Friabilator testing were carried out by using Monsanto hardness tester and Roche friabilator respectively.

Uniformity of weight

The weight variation test of the tablets was performed as per I.P. Twenty tablets of each type were weighed and average weights were calculated (Patel et al., 1994; Nakhat et al., 2004).

Thickness of tablets

The thickness of six tablets was measured using Vernier calipers. The extent to which the thickness of each tablet deviated from ± 5% of the standard value was determined. Six tablets from each batch were selected and evaluated, and the average value with standard deviation was recorded (Indian Pharmacopoeia, 1996).

Disintegration Test

All the six formulations were tested for disintegration time as per method prescribed in I.P. for uncoated tablets. Assay Assays were carried out by using the method prescribed in I.P.10.

Dissolution studies

Dissolution studies were performed as per procedure given in I.P10. The sampling time specified in I.P. The sampling time specified in I.P. was modified instead of withdrawing a single sample after 30 minutes; serial sampling was done at 5, 10,15,20,25 and 30 minutes (Indian Pharmacopoeia, 1996).

Results and Discussion

Physical and chemical characteristics

Physicochemical properties of tikhur starch are presented in Table 1.The average grain size, loss on drying, pH, ash value and angle of response is shown in the table. Swelling characteristics of the starches were studied at different temperatures by microscopic method (Table 2). The extend of swelling was calculated by finding the ratio between grain size at the maximum temperature and at 35°C. Grains of Curcuma angustifolia starch were found to be smaller in size than of Corn starch. They were round, granular in shape. Not much difference was observed in loss on drying, acidity, ash value, pH values of Curcuma angustifolia starch and Corn Starch. The loss on drying and acidity values was well within official limit Table 1. The bulk density, angle of repose and compressibility index of both starches was comparable.

Table 1. Physicochemical properties of tikhur starch

S.No.

Properties

Tikhur Powder

Corn Starch

1.

Average Grain size (micron)

11.86±0.21

23.48 ±0.15

2.

Loss on Drying (%)

10.46±0.3

10.01±0.27

3.

Acidity (ml of 0.01 M NaOH)

0.4

0.43

4.

pH

6.22

6.35

5.

Ash Value (%)

0.260±0.17

0.300±0.21

6.

Bulk Density (g/c/c)

0.65±0.25

0.55±0.28

7.

Angle of repose (Degree)

28.35

35.34

*Corn Starch Taken as Reference, **Tikhur is scientifically known as Curcuma angustifolia powder

 

Table 2.  Swelling characteristics of the starches at different temperature

S.No.

Temperature(°C)

Tikhur Powder

    Corn Starch

 

1.

35

9.86±0.31

23.48±0.16

 

2.

40

10.13±0.11

24.02±0.22

 

3.

50

12.88±0.14

25.31±0.14

 

4.

60

14.45±0.25

26.92±0.11

 

5.

70

16.67±0.21

38.37±0.27

 

6.

80

17.21±0.39

47.68±0.24

 

7.

Swelling Ratio

2.198±0.18

2.023±0.13

 

Bulk density is a measure of heaviness of solid samples, which is important for determining packaging requirements, material handling and application in the pharmaceutical as well as food industry (Singh et al., 2011). Bulk density of tikhur starch is quite lesser than (0.65g/cc) Wheat flour (0.73g/cc). Tikhur starch is not suitable as thickener in food products as it is recommended that flours with high bulk densities (> 0.7 g/mL) are used as thickeners in pharmaceuticals (Akubor and Badifu 2004; Falade and Okafor, 2015).

 

 

 

 

 

 

Table 3.  Hardness and % friability of the tablets

Product

Friability (%)

Hardness (Kg/sq.cm)

 

Paracetamol Granules

 

 

 

 

Tikhur Powder

0.692 ±0.025

3.50±0.325

 

 

 

Corn Starch

0.520± 0.056

3.50±0.436

The friability testing of granules showed that the Corn starch had slightly high binding strength than that of Curcuma angustifolia starch Table 3.

Table 4. Uniformity of Tablets

Product

Average weight

Maximum deviation

(%)

Assay (Percent of

labeled amount)

Paracetamol Tablets

Tikhur Powder

620

+2.8

99.7%

 

 

-3.5

 

Corn Starch

620

+3.6

100.25%

 

 

-2.5

 

In all the cases the values of angle of response were ≤30°, which indicate that both the starches were free flowing. Hardness and % friability of the tablets were found to be well within acceptable limits Table 3. It showed that Curcuma angustifolia starch may exhibit good disintegrating property over corn starch. This disintegrating property may be attributed to the more number of starch grains per mg of sample.

 

Table 5. disintegration time of paracetamol (tablets (n=6)

Product 

% Disintegrant

Disintegration Time

 

 

(Sec.)

 

Paracetamol tablets

 

Tikhur Powder

10.0

145±2.012

 

5.0

 

 

2.5

215±1.784

 

 

355±3.462

Corn Starch

10.0

154±1.036

 

5.0

260±2.565

 

 

 

 

 

 

 

 

 

 

 

 

Scanning electron microscopy

Scanning Electron Microscopy (SEM) is generally used to characterize starch at microstructure level. The results obtained by SEM showed variation in size and shape of starch granules from small to large and oval to polyhedral with the size ranging from 9.75 to 20.43 µm in length and 3.409 to 5.272 µm in width.

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                                            

 

 

 

Figure 1. Scanning electron microscopy of Tikhur Powder

Water absorption characteristics represent the ability of a product to associate with water under conditions where water is limiting. The water and oil absorption capacity of tikhur starch was 2.32 + 0.18 g/g and 1.92 + 0.04 g/g respectively. The maximum water absorption was about 40% for starches. Higher water absorption of starch helps in maintaining water soluble delivery system. Oil absorption capacity reflects the emulsifying capacity. The correlation coefficient between water and oil absorption capacity was 0.29 stipulating that amylose can form complexes with lipids also.

Paste clarity

Clarity is a key parameter in starch paste quality because it gives shine and opacity to product colour. Percent transmission of tikhur starch decreased gradually from 54.6 to 50.4% on 4 th day. Decrease in light transmittance of starch pastes with the increase in storage time is attributed to recrystallization of starch (Shah et al., 2016). But it is generally higher than percent transmittance of cassava (50.6%) and potato starch (42.2%) as outlined by Nuwamanya et al. (2011)

Gel Strength

 A number of factors have been suggested to be responsible for the strength of starch paste. Intrinsic interaction of the starches which is governed by their relative hydrophilicity/hydrophobicity, ability to form complex, relative content of amylose/amylopectin, rearrangement of the amylose chains which led to increase in the porosity of the matrix and presence of nonstarch polysaccharides which may hinder hydrogen bond formation could affect the paste strength.

Conclusion

Tikhur is a unique starch with therapeutic benefits suitable for use in different sweets as it imparts no after taste. The medium amylose content, clarity and good solubility in water. There is an excellence scope for Curcuma angustifolia starch. Hence newer natural substance must be studied for its pharmaceutical application. Curcuma angustifolia starch could be used as a promising pharmaceutical excipient in tablet technology as, it showed adequate binding and disintegrating properties.

Acknowledgement

Author wants to thanks the Dr.Chanchal Deep Kaur, Principal SRIP, Kumhari for providing necessary facilities to carry out the work.

References

Kokate, C.K. (1994) Practical Pharmacognosy, 4 Edition, Vallabh Prakashan, New Delhi

Patel, S., Tiwari, S., Pisalkar, P.S., Mishra, N.K., Naik, R.K., Khokhar, D. (2015). Indigenous processing of Tikhur (Curcuma angustifolia Roxb.) for the extraction of starch in Baster, Chhattisgarh. Indian Journal of Natural Products and Resources, 6: 213-220.

Kumari, R., Shrivastava, S.L., Mishra, H.N.  (2012) Optimization of Khoa and Tikhur mix preparation of Khoa-jalebi sweet. Open Access Scientific Reports. 1:1-4.

Rani. A., Chawhaan, P.H. (2012). Extraction and scanning electron microscopic studies of Curcuma angustifolia Roxb. starch. Indian Journal of Natural Products Resources, 3:407-10.

The United State Pharmacopoeia (1985) USP XXI, NF XVI, Mack Publishing Co, Easton.

Indian Pharmacopoeia (1966) 2nd Edition, Government of India, Ministry of Health and Family Welfare, New Delhi

Nakhat, P.D., Yeole, P.G. (2004) Studies on Panicum Miliaceum Starch as a Pharmaceutical Excipient, International Journal of Pharmaceutical Excipients, 21-24.

Perez, E., Lares, M. (2005). Chemical composition, mineral profile and functional properties of canna (canna edulis) and arrow root (maranta spp) starches, Plant Foods Human Nutrition. 60: 113-116.

Treatise, G.E., Evens, W.C., A Text book of Pharmacognosy, Elsevier science.

Indian Pharmacopoeia (1996). Government of India, Ministry of Health and Family Welfare.

 

 



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