Evaluation of a New Tablet Binder - Chlorophytum tuberosum

Prithviraj Chakraborty*, Kumar Suresh, Veera Garg and Anu Goyal

¹S.D.College of Pharmacy, Barnala, Punjab, India-148101

ABSTRACT

A preliminary study was carried out for establishing powdered tubers Chlorophytum tuberosum (Roxb.) Baker (Liliaceae) as a tablet binder. The tablets were prepared by wet granulation method using Paracetamol as a drug, Bentonite as a diluent and 3.5% talc as a glidant. A concentration of 0.25% w/w, 0.5% w/w, 0.75% w/w and 1% w/w of the binder were introduced in different formulations. Various physicochemical parameters like thickness, friability, weight variation, hardness, disintegration time, etc. on the tablets prepared with different concentrations of Chlorophytum tuberosum were determined. Dissolution study was carried out for different tablets and comparison was done with the prepared tablets using 5% starch paste as standard binder. The tubers of Chlorophytum tuberosum (Roxb.) Baker (Liliaceae) showed the presence of carbohydrate in it which helped it to act as a binding agent. Amongst the various formulations, the tablets prepared with 0.5% of the above binder showed excellent physicochemical parameters and better drug release pattern. No significant interaction with binder was found in FTIR study. The aim of this study was to suggest that, the tubers of Chlorophytum tuberosum can be used as a tablet binder in a very less concentration and can give an economic means for tablet formulation in Pharmaceutical Industries.

KEYWORDS: Chlorophytum tuberosum, musli, binder, Paracetamol

INTRODUCTION

Binding agents are used to impart the structural strength required during the processing, handling and packaging of tablets. Binders are pharmaceutical excipient that are commonly employed in tablet formulation to impact cohesion on the powder mix and hence improves on the flow properties on the granules. Binders act by causing aggregation of powders thereby forming granules through the process of granulation. They modify the cohesive properties of the granules by promoting the formation of strong cohesive bonds between such particles. A number of plant gums have been used as binding agents in tablet formulations.^{1, 2, 3}They have been found useful in producing tablets with different mechanical strength and drug release properties for different pharmaceutical purposes. The fact that most of the plant materials are non-toxic and widely available has made them of continuing interest.

Musli has been described in ancient Indian literature such as Bhavaprakash nighantu, Rasendra Sarsangrah, Raja Ballabh Nighantu as ‘Vajikaran’ or aphrodisiac which is a special type of immunomodulator. ^4-6 One of the popular and marketed herb under this nomenclature is Chlorophytum tuberosum (Roxb.) Baker (Liliaceae). ^7-10

The tubers of C. tuberosum. are employed as ‘Rasayana’ ^{11, 12} and also because Chlorophytum spp. is a constituent of ‘Chyawanprash’, an outstanding rejuvenator. ^{9, 11}

C .tuberosum (Roxb.) Baker is widely distributed in Bihar, W.B., Kerala, Maharastra and Eastern Himalaya. These species posses the same properties as that of C. arundinaceum Baker i.e. tonic, aphrodisiac and used to treat general debility and in cases of impotency and weakness.¹³

Figure 1: FTIR Spectrum of Paracetamol

Figure 2: FTIR Spectrum of Pure binder

It is also having antioxidant properties.^[14]But no significant work has been reported on Chlorophytum tuberosum for its use as a tablet binder.

In the present work, purified dried powder of roots of Chlorophytum tuberosum has been evaluated as a binding agent in Paracetamol tablet formulations in comparison with a standard binder, starch paste, as a binding agent. Paracetamol was used as the model drug for the present work because of its poor compression properties; hence it needs a binding agent among other excipients to form satisfactory tablets.

MATERIAL AND METHODS:

Fresh tubers of Musli (Chlorophytum tuberosum) were collected from local market and authenticated by Dr. H.B. Singh of National Institute of Science communication and Information Resources (NISCAIR), Delhi, India. Other materials used for the study includes Bentonite, Paracetamol IP. All materials used in this study were of A.R. grade.

Figure 3: FTIR of Formulation

Figure 4: Dissolution profile of Paracetamol tablets using different concentrations of Chlorophytum tuberosum powdered tubers as binding agent

Chemical analysis:

For the detection of the presence of carbohydrates and the reducing sugars, the standard Molisch’s test for carbohydrates ( Trease,2002) and Reduction of Fehling’s solution for reducing sugars (Trease, 2002) were done. In, short, in Molisch’s test the powdered specimen was treated with α-naphthol and concentrated sulphuric acid which gave purple colour. For the detection of the reducing sugar, to the powdered specimen equal quantity of Fehling solution A and B were added. After heating, brick red precipitate was obtained.

Presence of mucilage was tested by treating the powdered specimen with Ruthenium red solution (Trease, 2002). Pink colour with Ruthenium red solution was detected. It confirms the presence of mucilage.

FTIR study:

To study the binder and experimental tablet – excipient interaction, the pure binder (Chlorophytum tuberosum), a mixture of binder and experimental tablet – excipient and Paracetamol IP alone were mixed separately with IR grade KBr in the ratio 100:1 and compressed into pellets in a hydraulic press and scanned over a wave number of 2000-400cm^-1 in IR Spectrophotometer (SHIMADZU, Japan, Model No. FTIR - 8400S).

Table 1: Formulation containing 0.5% w/w of powdered tubers of Chlorophytum tuberosum as binding agent

Ingredients

Quantity (% w/w)

Paracetamol

Bentonite

Binder( powdered Chlorophytum tuberosum tuber )

Talc

15.0

0.5

3.5

Formulation Development:

Formulation was developed by conventional technique. In short, wet granulation technique was done by using sieve no 18. Then drying was done in hot air oven at 45°C for 30 minutes and air dried granules were kept for two days. Again granules were sieved through sieve no 18. Talc (3.5% w/w) as lubricating agent was mixed with granules for preparation of compressed tablets for each batch. The standard starch paste (5% w/w) was also used as binder with the other excipients in another batch as standard control.

Hardness:

Hardness study was conducted by following the guidelines of the USP (The United State Pharmacopoiea). For this Six Tablets of each batch were taken and hardness of each tablet of each batch was measured by Monsanto Type hardness tester.

Thickness study:

The study of thickness was conducted by following the guidelines of the USP. For these fifteen tablets were taken for each batch and thickness were measured by using Mitutoyo micrometer.

Friability:

Friability testing was done by using 6 tablets for each batch by using Friability test apparatus.

Weight variation:

Weight variation study was conducted by following guidelines of USP. In short, 20 tablets were taken and individual weight difference from the mean of total weight of 20 tablets was calculated.

Disintegration:

Disintegration test was carried out taking 6 tablets in each batch using USP tablet disintegration test apparatus following USP guidelines. The temperature was controlled at 37.5°C.

Dissolution study:

Dissolution study was carried out in 900ml 0.1 N Hcl media using paddle type Dissolution Test Apparatus. The dissolution was carried out at 37±1°C and 50 rpm paddle speed. The 10ml samples were withdrawn at 15min intervals, 10ml dissolution media was replaced after each interval. Absorbance was measured at 243nm using UV Spectrophotometer (Systronic).¹⁵

RESULT AND DISCUSSION:

Upon various chemical tests for carbohydrates, the tubers showed the presence of carbohydrate in it. Formation of brick red precipitate on reduction of Fehling’s solution indicates that the tubers contain reducing sugar. Pink coloration with Ruthenium red confirms the presence of mucilage in the tubers. Figure 1 depicts the FTIR spectrum of Paracetamol, Figure 2 shows the spectrum of the pure binder and Figure 3 demonstrates the spectrum of the formulation. When the figures were compared it was found that there were no major changes. In all the figures wave numbers i.e. 1690cm^-1, 1780cm^-1 are the stretching zone of C=C(Aromatic), C=O(Aldehydes and Ketones) and wave numbers i.e. 1570 cm^-1, 1500 cm^-1,770 cm^-1are the deformation of N-H(Amines), C-H (Alkanes), O-H(Alcohols).

The formulation patter of the tablet is shown in Table no 1. The prepared tablets were evaluated for hardness, thickness, friability, weight variation and disintegration time and compared amongst the various formulations. The results are indicated in Table no 2. All the batches of tablets exhibited a good uniformity of content. The hardness of the tablets increased with increase in percentage of binding agent. The friability values decreased with increase in binder concentration. Tablets of each batch shows good uniformity in thickness and are within the pharmacopoeial limits. The disintegration time also increased with increase in binder concentration. In vitro dissolution profile of the Paracetamol tablets prepared with different concentration of Chlorophytum tuberosum powdered tubers is given in Figure no 4. Dissolution study reveals that drug release from the tablets containing 0.25- 0.75 % w/w binder was more than 80% in 70 min. Tablets at 0.05 % w/w concentration shows more optimum results as tablet binder. The drug release from tablets retards with increase in binder concentration. The comparative dissolution profile of the optimized tablet and tablet prepared with standard starch paste is shown in Figure 5. The comparative dissolution profile of Paracetamol tablets prepared with 0.5% w/w Chlorophytum tuberosum and standard 5% starch paste as binding agent reveals that 0.5 %w/w powder of Chlorophytum tuberosum tuber can give optimum drug release.

CONCLUSION:

From the study it can be concluded that powdered tubers of Chlorophytum tuberosum (Musli) can be suitable and cheaper option as a tablet excipient in particular, as a tablet binder. It is effective in a very low amount as compared to the standard tablet binders used. Moreover, as the plant is available chiefly in Asia, this could provide an economic means for the tablet production.

ACKNOWLEDGEMENT:

The authors also wish to thank The Managing committee, SDCMC; Barnala for providing laboratory facilities to carry out the present work.

Table 2: Various experimental physicochemical parameters of the formulations using different concentration of Chlorophytum tuberosum as binding agent

Characteristics

Binder concentration % w/w

0.25

0.50

0.75

1.0

Hardness (kg/cm²)

Content Uniformity (%)

Friability (%)

Thickness (mm)

Disintegration time

Weight variation

2.6

98.0

1.12

3.21±0.13

9 min 20 sec

0.147±0.011

3.1

98.65

0.66

3.27±0.24

13min 32 sec

0.142±0.012

4.9

98.53

0.54

3.20±0.092

28min 42 sec

0.176±0.053

6.6

97.98

0.21

3.36±0.19

37min 32sec

0.208± 0.009

± Standard deviation

Figure 5: Dissolution profile of Paracetamol tablets using different binding agent (Chlorophytum tuberosum 0.5% w/w and Standard Starch paste 5.0 % w/w)

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