Formulation and Evaluation of Dispersible Tablets of Sudarshan, Vyswanara and Panchasakar Churnas

 

Mettu Srikanth Reddy1*, Mallikarjun Setty2

1Department of Pharmaceutics, St Peter’s Institute of Pharmaceutical Sciences, Vidyanagar, Hanamkonda, Warangal – 506001, Andhrapradesh, India.       

2Department of Pharmaceutics, N.E.T Pharmacy College, Raichur – 584103, Karnataka, India.

*Corresponding Author E-mail: srikanthreddymp@gmail.com

 

ABSTRACT:

The dosage uniformity of ayurvedic powders can be increased by formulating them in to tablets. In the present study, dispersible tablets of sudarshan, vyswanara and panchasakar churnas were prepared by wet granulation method. Initially sudarshan, vyswanara and panchasakar churnas were subjected to preformulation studies to test the suitability of direct compression method and was found that the results were not within the standard limits1. So wet granulation method was opted and appropriate formulations were developed. These tablets were evaluated for hardness, weight variation, friability, uniformity of dispersion, disintegration test, diameter of tablet, thickness of tablet, wetting time and stability studies. Here attempts were made to get minimum possible disintegration time by varying the concentrations of superdisintegrants like sodium starch glycolate (SSG), croscarmellose sodium (CCS) and crospovidone (CP) and usage of various diluents like lactose, insoluble starch powder, microcrystalline cellulose (MCC). It was found that concentration of CP at 20% w/w, MCC as diluent and poly vinyl pyrrolidone (PVP) as binder was highly effective in the formulation of dispersible tablets of sudarshan churna.

 

KEYWORDS: Sudarshan churna; vyswanara churna; panchasakar churna; dispersible tablets.

 


1. INTRODUCTION:

Medicinal herbs and minerals have been in use for thousands of years in one form or the other under indigenous system of medicine like Ayurveda, Siddha and Unani in addition to natural products used for their pharmacological actions. There are herbs, which are natural sources of food supplements, taste enhancers, colors and cosmetics2. Different ayurvedic companies manufacture sudarshan3, vyswanara and panchasakar in the form of churnas, which are being widely prescribed by the ayurvedic physicians. They are intended to be dispersed or mixed in liquids like water, milk or water plus honey, etc prior to administration orally. Sudarshan churna, an ayurvedic preparation, contains various active plant materials that include kantakari, shunti, haridra, haritaki, rajani, devadaru etc and is indicated for many complications associated with fever. Especially effective in relieving the problems associated with typhoid and jwar etc. Normal prescribed dose of this preparation is 1 to 2 teaspoonfuls immediately after meals twice a day with water or milk. The main active ingredients of vyswanara churna are: saindhav lavan, jeera, ajmoda, pippali, sonth and hareetaki and it is indicated for rheumatoid arthritis, constipation, piles and abdominal colics.

 

Dose prescribed is 1-3 gms twice or thrice daily with water. Panchasakar churna contains sanai, harre, sonth, anisi, satapuspa, saindhava as the main ingredients. It is indicated for gastrointestinal disorders. Dose prescribed is 2-4 gms at bed time with water. In such cases dose of powders is poorly regulated, as in most of the houses powder measuring devices are different. In addition, the powders (churnas) are difficult to carry and disperse while travelling. Hence, formulation of these powder preparation in to tablet form would be a better approach to overcome these problems. Many elderly persons will have difficulties in taking conventional dosage forms like compressed tablets because of their hand tremors and dysphagia. Swallowing problems are also common in young individuals because of their under developed muscular and nervous system4. The development of dispersible tablets of ayurvedic preparations (churnas) would enhance the patient compliance besides improving the dosage accuracy. One or more dispersible tablets, as required, containing these powders may be simply dispersed in liquid and can be taken orally. The dispersible tablets usually disintegrate in about within 3 minutes5. The faster the drug goes in to solution, the quicker absorption and onset of clinical effect. Though there are innumerable attempts to develop dispersible tablets for allopathic medicines5-10, development of dispersible tablets of ayurvedic powders would be a major initiative. Therefore, the objective of the present study is to develop dispersible tablets of churna (sudarshan, vyswanara and panchasakar) and to optimize the various formulation factors affecting the performance of the tablets.

 

2. MATERIALS AND METHODS:

Sudarshan, vyswanara and panchasakar churnas were purchased from an established local supplier (Baidynath), SSG, CCS and CP were gift samples from Concertina Pharma (p) ltd, Hyderabad and other materials used in the study such as lactose, insoluble starch powder, MCC, talc, sodium lauryl sulfate (SLS) and PVP were purchased from S.D fine chemicals, Mumbai.

 

2.1. Preparation of dispersible tablets:

The dispersible tablets of sudarshan, vyswanara and panchasakar churnas were prepared by conventional wet granulation method using the following superdisintegrants namely SSG, CCS and CP at 5, 10 and 20% w/w levels. The composition of each formulation is given in table 2. Aqueous solution of 1% w/w PVP was used as binder for all the formulations. The granules were prepared by passing the damp mass through sieve no: 16. The wet granules were dried at 50 0C in hot air oven for 1 hr and later blended with other ingredients thoroughly by tumbling in a polythene bag. Earlier to compression of granules in to tablets, tabletting properties1, such as angle of repose, Carr’s index and Hausner’s ratio were determined for all the formulations. The granules were compressed in to tablets using a ten station rotary punch tableting machine using 12 mm standard concave punches set at a hardness of 3.5-4.5 kg/cm2.

 

2.2. Evaluation of dispersible tablets:

Dispersible tablets were evaluated for weight variation, hardness, friability, diameter of tablet, thickness of tablet and disintegration time11, wetting time12-15, uniformity of dispersion16, and stability studies. Twenty tablets were selected at a random and average weight was determined using Shimadzu balance. Then individual tablets were weighed and was compared with average weight. The Pfizer hardness tester and the Roche friabilator were used to test hardness and friability respectively. Disintegration time was determined using USP tablet disintegration test apparatus using distilled water (900 ml) as medium. Uniformity of dispersion was tested as per official method (IP). Two tablets of each formulation were placed in 100ml of water and stirred slowly. A smooth dispersion produced was passed through a sieve no: 22. The diameter and thickness of tablet were determined by using vernier calipers. The wetting time was done to measure tablet-wetting time. A piece of tissue paper was folded twice and is placed in a small petridish containing sufficient water. A tablet was put on the paper, and the time for complete wetting was measured. The stability study for optimal formulations with respect to disintegration time was carried out by storing the tablets at a room (30 ± 2oC/60 ± 5% RH) and elevated temperature (40 ± 2oC/75 ± 5% RH) for two months. At the end of each month tablets were evaluated for disintegration time.

3. RESULTS AND DISCUSSION:

Initially sudarshan, vyswanara and panchasakar churnas were subjected to preformulation study. Table 1 shows the values of angle of repose, % compressibility and Hausner’s ratio. It is observed that the angle of repose values were high (36.56, 35.16 and 35.28 sudarshan, vyswanara and panchasakar churnas respectively) suggesting that these churnas have poor flow properties. % Compressibility values for sudarshan, vyswanara and panchasakar churnas are 58.92, 52.45 and 51.93 % respectively, indicating that the flow properties of these churnas are very poor. Hausner’s ratio values for sudarshan, vyswanara and panchasakar churnas are 1.59, 1.57 and 1.58 respectively. These high Hausner’s ratio values also indicate that all these churnas are not free flowing powders. With an intention to reduce the cohesiveness and improve the flow properties, lubricant (talc) and glidant (SLS) were incorporated to churna powders. It was found that there is no improvement in the angle of repose, % compressibility and Hausner’s ratio values for all the three churnas with the addition of lubricant and glidant to the churnas as shown in table 1. Hence the preparation of tablets by direct compression was dropped out.

 

Initially, concentration (5-20% w/w) of superdisintegrants (SSG, CCS and CP) was optimized using 1% w/w aqueous solution of PVP as binder and MCC as diluent   (i.e S1-S9 formulations). Table 3 shows that sudarshan churna granules produced were free flowing and there was no significant variation in the values of angle of repose (23.30-24.13), % compressibility (19.75-21.24 %) and Hausner’s ratio (1.15-1.23) with the increase in the concentration of superdisintegrants. Granules (S1-S9) were compressed in to tablets in a ten station rotary punching machine Rimek (12 mm punch and die set). Table 4 shows that tablets passed weight variation (649.0-651.4 mg), hardness (3.5-4.5 kg/cm2) and friability tests (0.12-0.42 %) as per the standard limits11. Thickness and diameter of the tablets after compression did not show any changes with the variables. Tablets also produced uniform dispersion in water. However, both disintegration time (4.84-0.32 min) and wetting time (4.76-0.38 min) decreased with increase in the concentration of superdisintegrants (table 4). All the dispersible tablets (except S1 and S4) disintegrated within 3 minutes fulfilling the official requirement for dispersible tablets. The rapid water uptake into the tablet causes the disintegrant particles to swell17,18, which results in a significant disintegrating force inside the tablet, causing rupture of the tablet structure19,20. Thus, it can be said that 20% of the superdisintegrant can produce desired effect in dispersible tablets.

 

Further, to study the effect of diluents, MCC was replaced with starch (S10) and lactose (S11) by keeping 20% superdisintegrant (CP) in sudarshan churna tablet.

 

Preformulation studies (Table 3) showed that angle of repose values were excellent and % compressibility and Hausner’s ratio values were within the limits of a free flowing material1.


Table 1: Angle of repose, % Compressibility and Hausner’s ratio of sudarshan, vyswanara and panchasakar churna powders and preformulations characteristics after adding lubricant (talc) and glidant (SLS).

Parameters

Sudarshan churna

Vyswanara churna

Panchasakar churna

Sudarshan churna + talc + SLS

Vyswanara churna + talc + SLS

Panchasakar churna + talc + SLS

Mean

(±SD, n=3)

Mean

(±SD, n=3)

Mean

(±SD, n=3)

Mean

(±SD, n=3)

Mean

(±SD, n=3)

Mean

(±SD, n=3)

Angle of repose

36.56(0.42)

35.16(0.29)

35.28(0.82)

33.92(0.32)

32.76(0.58)

32.14(0.24)

% Compressibility

58.92(0.61)

52.45(1.11)

51.93(0.32)

55.43(0.52)

50.08(0.14)

49.93(0.63)

Hausner’s ratio

1.59(0.02)

1.57(0.01)

1.58(0.02)

1.43(0.06)

1.48(0.07)

1.51(0.04)

 

Table 2: Formulation chart of sudarshan, vyswanara and panchasakar churnas dispersible tablets by wet granulation

INGREDIENTS

S1

S2

S3

S4

S5

S6

S7

S8

S9

S10

S11

V1

V2

V3

P1

P2

P3

S/V/P

500

500

500

500

500

500

500

500

500

500

500

500

500

500

500

500

500

SSG

32.5

65

130

---

---

---

---

---

---

---

---

130

---

---

130

---

---

CCS

---

---

---

32.5

65

130

---

---

---

---

---

---

130

---

---

130

---

CP

---

---

---

---

---

---

32.5

65

130

130

130

---

---

130

---

---

130

LACTOSE

---

---

---

---

---

---

---

---

---

---

3.75

---

---

---

---

---

---

STARCH POWDER

---

---

---

---

---

---

---

---

---

3.75

---

---

---

---

---

---

---

MCC

101.25

68. 75

3.75

101.25

68. 75

3.75

101.25

68. 75

3.75

---

---

3.75

3.75

3.75

3.75

3.75

3.75

PVP

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

TALC

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

6.5

SLS

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

3.25

Total wt of tablet

650

650

650

650

650

650

650

650

650

650

650

650

650

650

650

650

650

*All weights are given in mg, S = sudarshan churna, V = vyswanara churna , P = panchasakar churna

 

Table 3: Tabletting properties

Formulation code

Angle of repose () (±SD, n=3)

% Compressibility  (±SD, n=3)

Hausner’s ratio (±SD, n=3)

S1

24.05(0.46)

19.75(0.56)

1.19(0.01)

S2

23.83(0.51)

20.17(1.99)

1.23(0.05)

S3

23.62(0.73)

21.24(0.45)

1.15(0.03)

S4

23.98(0.79)

20.47(0.01)

1.22(0.02)

S5

23.79(0.72)

19.84(0.65)

1.16(0.01)

S6

23.30(0.29)

20.46(1.26)

1.21(0.13)

S7

23.91(0.11)

20.89(1.04)

1.22(0.10)

S8

24.01(0.26)

20.75(0.39)

1.17(0.01)

S9

24.13(0.12)

19.86(2.37)

1.23(0.01)

S10

23.72(1.64)

20.24(0.67)

1.18(0.18)

S11

23.89(1.76)

18.98(0.66)

1.24(0.02)

V1

22.22(0.92)

20.18(0.53)

1.16(0.18)

V2

22.42(1.57)

20.10(0.55)

1.24(0.04)

V3

24.35(1.13)

19.68(0.62)

1.17(0.08)

P1

22.21(1.78)

19.71(0.57)

1.21(0.12)

P2

22.96(1.54)

20.70(0.51)

1.11(0.13)

P3

23.14(0.59)

21.46(0.14)

1.24(0.01)

 

Table 4: Evaluation data of dispersible tablets

Formulation code

Wt variation (mg) (±SD, n=3)

Hardness (kg/cm2) (±SD, n=3)

Friability (%) (±SD, n=3)

DT (min)

(±SD, n=3)

Wetting time (min)

(±SD, n=3)

S1

649.2(2.08)

4.25(0.35)

0.21(0.08)

4.84(0.41)

4.76(0.33)

S2

651.4(3.21)

3.50(0.00)

0.42(0.16)

1.78(0.35)

2.95(0.57)

S3

650.6(2.51)

4.25(0.35)

0.24(0.16)

0.55(0.02)

1.91(0.47)

S4

650.3(1.15)

4.25(0.35)

0.12(0.01)

3.18(0.16)

1.52(0.03)

S5

650.5(4.72)

4.00(0.00)

0.25(0.01)

1.36(0.05)

1.12(0.05)

S6

649.0(0.57)

4.00(0.00)

0.23(0.04)

0.48(0.03)

1.03(0.04)

S7

650.2(1.00)

4.50(0.00)

0.15(0.01)

1.33(0.04)

0.87(0.41)

S8

650.4(1.53)

4.00(0.00)

0.41(0.01)

0.54(0.03)

0.54(0.01)

S9

649.5(0.57)

4.00(0.00)

0.25(0.02)

0.32(0.01)

0.38(0.04)

S10

649.9(1.15)

3.75(0.35)

0.21(0.01)

0.51(0.03)

0.41(0.02)

S11

650.0(1.00)

4.25(0.35)

0.19(0.01)

0.53(0.00)

0.51(0.04)

V1

649.9(1.15)

3.75(0.35)

0.21(0.01)

10.61(0.32)

11.78(0.63)

V2

650.0(1.00)

4.25(0.28)

0.20(0.06)

8.33(0.28)

1.47(0.06)

V3

650.3(2.31)

4.25(0.16)

0.17(0.04)

1.08(0.03)

0.21(0.01)

P1

650.4(1.53)

4.00(0.70)

0.27(0.22)

50.50(2.12)

30.26(1.53)

P2

650.4(1.00)

3.75(0.35)

0.47(0.06)

36.50(0.71)

4.67(0.57)

P3

650.6(3.05)

3.75(0.19)

0.31(0.03)

9.85(0.51)

3.83(0.42)


Table 4 shows that tablets S10 and S11 pass the weight variation, hardness, friability tests and were uniform in thickness and diameter. These tablets have also produced uniform dispersion in water. As MCC was replaced with starch (S10), although little, the disintegration time increased (from 0.32 to 0.51 min). When MCC was replaced with lactose (S11), although little, the disintegration time increased (from 0.32 to 0.53 min). With these results, it appears that tablets prepared with MCC as diluent shows comparatively better disintegration and wetting times.

 

In the case of vyswanara churna, three formulations were prepared (V1, V2 and V3) by keeping MCC as diluent, 1% w/w aqueous solution of PVP as binder and by varying the superdisintegrants (20% SSG, 20% CCS and 20% CP). The vyswanara churna granules produced were free flowing and the angle of repose, % compressibility and the Hausner ratio values were within the standard limits as shown in table 3. Granule formulations were compressed in to tablets. Table 4 shows that tablets passed weight variation, hardness and friability tests as per the standard limits. Thickness and diameter of the tablets after compression did not show any changes with the variables. Tablets also produced uniform dispersion in water. However, both disintegration time (10.61-1.08 min) and wetting time (11.78-0.21 min) decreased with variation in the superdisintegrant as shown in table 4. Among the tablets V1, V2 and V3, only V3 disintegrated within 3 minutes fulfilling the official requirement for dispersible tablets.

 

In the case of panchasakar churna, three formulations were prepared (P1, P2 and P3) by keeping MCC as diluent, 1% w/w aqueous solution of PVP as binder in common and by varying the superdisintegrants (20% SSG, 20% CCS and 20% CP). The panchasakar churna granules produced were free flowing and the angle of repose, % compressibility and the Hausner ratio values were within the standard limits as shown in table 3. Granule formulations were compressed in to tablets. Table 4 shows that tablets passed weight variation, hardness and friability tests as per the standard limits. Thickness and diameter of the tablets after compression did not show any changes with the variables. Tablets also produced uniform dispersion in water. However, both disintegration time (50.50-9.85 min) and wetting time (30.26-3.83 min) decreased with variation in the superdisintegrant as shown in table 4. Among the tablets P1, P2 and P3, none of the tablet showed disintegration time below 3 minutes. The inherent gummy/adhesive characters of panchasakar churna might have increased the cohesiveness and hence, delayed the disintegration of tablets. It can be concluded that dispersible tablets for panchasakar churna cannot be prepared by varying the superdisintegrants.

 

3.1. Stability studies:

One of the objectives of the work was to carry out the stability studies on the dispersible tablets of churna (sudarshan). The stability studies were carried out for all those tablets (S2-S11 (except S1 and S4) and V3 which have showed the promising results with disintegration test (disintegration time below 3 minutes). Table 5 and 6 shows results of stability studies conducted at 30 ± 2 oC/60 ± 5% RH and 40 ± 2 oC/75 ± 5% RH for sudarshan churna tablets.

 

The results indicate that there was no significant change in disintegration time after stability studies. Thus, it can be concluded that, the dispersible tablets prepared in this study are stable.

 

4. CONCLUSION:

Ayurvedic medicines are available in the form of tablets, pills, powders, fermentation products (asva-arishta), decoctions, medicated fats, drops, lotions, liniments, extracts etc. Most of the ayurvedic solid medicines are in the form of churnas, bhasmas etc. The problems associated with churnas such as, dose measurement, difficulty in carrying and disperse during travelling, administration to pediatric and geriatric patients can be overcome by formulating in to tablets.

 

Sudarshan, vyswanara and panchasakar churnas have been widely used in fever, enlargement of liver and spleen, fatigue, nausea, rheumatoid arthritis and indigestion. In this study, an attempt has been made to develop and evaluate the dispersible tablets of these churna.

 

Initially, preformulation studies (angle of repose, % compressibility and Hausner’s ratio) are carried on churna powders to find out the suitability of churna for direct compression in to tablets. The preformulation results revealed that churnas are not free flowable and found not fit for direct compression. To improve the flowability of the churna, directly compressible diluents like avicel PH 101, fast flo lactose and emcompress were included in the formulations. However, incorporation of directly compressible diluents did not show any improvement in the flow properties of churnas. Therefore, it was decided to use the wet granulation technique to prepare the tablets.

 

In the formulations S1 to S9, the concentration of three superdisintegrants was varied between 5-20% by keeping the MCC as diluent and 1% w/w PVP as binder. These granules were found to be free flowing as the angle of repose, % compressibility and Hausner’s ratio values were within the standard limits. These granules were compressed in a ten station rotary punching machine (12 mm punch and die set). Evaluation of tablets indicated that hardness, weight variation, friability, thickness and diameter of the formulations did not vary significantly with the concentration of superdisintegrants. However, disintegration and wetting times were comparatively lower with tablets containing 20% of superdisintegrants. Therefore, further studies were carried out by using 20% superdisintegrants in the formulations.

 

In the next set of formulations, S10-S11, suitability of two other diluents, insoluble starch powder and lactose was analysed. These granules were found to be free flowing as the angle of repose, % compressibility and Hausner’s ratio values were within the standard limits.



Table 5: Stability studies of optimized sudarshan and panchasakar churna tablets at   30 ± 2 C/60 ± 5% RH.

Formulation code

Initial (DT)(min)

30thday (DT)(min)

60thday (DT)(min)

S2

1.78

1.80

1.82

S3

0.55

0.56

0.59

S5

1.36

1.38

1.40

S6

0.48

0.50

0.53

S7

1.33

1.36

1.39

S8

0.54

0.57

0.60

S9

0.32

0.34

0.37

S10

0.51

0.53

0.54

S11

0.53

0.54

0.56

V3

1.08

1.09

1.11

 

Table 6: Stability studies of optimized sudarshan and panchasakar churna tablets at 40 ± 2 C75± 5%RH.

Formulation code

Initial (DT)(min)

30thday (DT)(min)

60thday (DT)(min)

S2

1.78

1.79

1.83

S3

0.55

0.56

0.58

S5

1.36

1.39

1.41

S6

0.48

0.51

0.53

S7

1.33

1.35

1.38

S8

0.54

0.54

0.61

S9

0.32

0.33

0.36

S10

0.51

0.52

0.55

S11

0.53

0.54

0.57

V3

1.08

1.10

1.12

 

These granules were compressed in a ten station rotary punching machine (12 mm punch and die set). Evaluation of tablets indicated that hardness, weight variation, friability, thickness and diameter of the formulations did not vary significantly with the change of diluent. However, the disintegration and wetting times were more compared to that of tablets containing MCC as diluent.

 

In the case of vyswanara and panchasakar churnas, the granules produced were found to be free flowing as the angle of repose, % compressibility and hausner ratio values were within the standard limits. These granules were compressed in a ten station rotary punching machine (12 mm punch and die set). Evaluation of tablets indicated that hardness, weight variation, friability, thickness and diameter of the formulations did not vary significantly with the change of superdisintegrant. However, disintegration and wetting times decreased with the change of superdisintegrant in the order of SSG > CCS > CP.

 

The above results indicated that disintegration and wetting times are lower with tablets containing 20% superdisintegrants (SSG, CCS and CP). The disintegration time values of sudarshan churna tablets are less than 3 min (except formulations S1 and S4), indicating that disintegration time is as per the IP limits. In case of vyswanara churna tablets, the tablets containing crospovidone (20%) and 1% PVP as binder (V3) showed disintegration time less than 3 min, while vyswanara churna tablets containing sodium starch glycolate and croscarmellose sodium showed more disintegration time (i.e > 3 min). In case of panchasakar churna tablets, none of superdisintegrants was effective as the disintegration time was more than 3 min.

Stability studies were performed on the optimized formulations at 30 ± 2o C/60    ± 5% RH and 40 ± 2 oC/75 ± 5 % RH for 60 days .The formulations were found to be stable at the end of 60 days.

 

Thus, it can be concluded that, dispersible tablets of sudarshan and vyswanara churnas could be prepared using CP (20%) as superdisintegrant, MCC as diluent and 1% w/w PVP as binder.

 

5. REFERENCES:

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2.        Hedge SV. Cosmetics in Ayurved. 7th ed. Bangalore: AyurvedLine; 2004. p. 12-15.

3.        Brahmananda NED. AyurvedLine. 7th ed. Bangalore: AyurvedLine; 2004.p. 28-30.

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Received on 07.09.2010          Modified on 16.09.2010

Accepted on 22.09.2010         © RJPT All right reserved

Research J. Pharm. and Tech. 4(3): March 2011; Page 380-384