Formulation and Evaluation of Directly Compressible Dispersible Tablets of Hingashtak churna.

 

Mahale AM*, Sakarkar DM, Wanare RS, Masirkar VJ, Mantri RH, Tayade AM and Jadhav JK

Department of Industrial Pharmacy, Sudhakarrao Naik Institute of Pharmacy, Pusad, Dist. Yavatmal, 445 204.

*Corresponding Author E-mail: arunpatil81@rediffmail.com

 

ABSTRACT:

Formulation of ayurvedic powder preparations into tablets may increase dosage uniformity. Application of direct compression method to ayurvedic preparations can be regarded as a major advance. In the present study, dispersible tablets of Hingashtak churna were prepared by direct compression method. Hingashtak churna was subjected to preformulation studies to test the suitability of direct compression method and appropriate formulations were developed. These formulations were further evaluated for hardness, friability, weight variation, uniformity of dispersion, disintegration test and stability studies. Attempts were made to get minimum possible disintegration time by varying the concentrations of sodium starch glycolate and starch. It was found that, use of mixture of both the disintegrating agents was highly useful in the formulation of dispersible tablets of . The study further Hingashtak churna r revealed the usefulness of direct compression method to formulate dispersible tablets of ayurvedic preparations.

 

KEYWORDS: Hingashtak churna, constipation, anorexia, appetizer

 


INTRODUCTION:

A number of ayurvedic preparations are used in the form of powders many of these are intended to be mixed in liquid prior to administration1. In such cases, dosage is poorly regulated. Formulation of these preparations into tablet form would be better approaches to maintain dosage uniformit1y. Since higher temperature and moisture level of wet granulation may be harmful to active principle of plant products, direct compression method would be useful for development of tablet for ayurvedic preparation2. Though there are innumerable attempt to developed tablets using direct compression method for allopathic medicine, application of this technology to ayurvedic preparation would be a major initiative in direction2. Hingashtak churna, an ayurvedic preparation, contains various active plant materials that include a great combination of Appetizer herbs3. Ingredients-Shunthi (Zingiber officinale), Maricha (Piper nigrum), Pippali (Piper longum),Ajmoda (Trachyspermum ammi),Saindhava lavana, Jiraka (cumin seeds- both white and black), Hingu (Asafoetida) and indicative for many GIT disturbances like anorexia, indigestion, flatulence, constipation, dyspepsia, and belching4. Normal prescribed dose of these preparations is half a teaspoon with water 2-3 times a day. In present work, an attempt has been made to developed dispersible tablet of Hingashtak churna by direct compression method5.

 

MATERIALS AND METHOD:

Hingashtak churna was obtained from zandu pharmaceutical, dicalcium phosphate (DCP, directly compressible grade, Emcompress), sodium starch glycolate (SSG), potato starch IP, talc IP magnesium stearate IP.

 

Preparation of tablet6, 7, 8:-

Six tablet formulations were developed by keeping the proportion of HC and DCP constant and altering composition of disintegrating agent. Each tablet contained half teaspoonful of HC. The average weight of HC equivalent to one teaspoonful quantity was determined by measuring and weighing HC ten times with three different teaspoons, which was divided by 2 to get average weight for half teaspoon quantity of HC. Prior to compression into tablets, tableting properties such as flowability, compressibility index and bulk density for HC alone and blend of HC and DCP in different proportion were determined. After careful study, an optimum proportion was selected for compression. The results of the tableting properties are depicted in table 1. Finally accurately weighed ingredients were compressed into tablet with single punch tableting machines using 13mm biflat punches.

 

Various evaluation test for tablets such as hardness [using a Pfizer hardness tester], friability, weight variation, uniformity of dispersion and disintegration test were studied using standard methods.


TABLE NO 1: TABLETING PROPERTIES OF HINGASHTAK CHURNA (HC)

Proportion of HC and DCP

Angle of repose

Compressibility index (%)

Bulk density

PL alone [1:0]

29.41±0.25

36.11±0.21

0.72±0.01

1:0.1

25.15±0.29

32.81±0.28

0.73±0.01

1:0.2

24.07±0.24

31.10±0.41

0.78±0.00

1:0.3

23.16±0.19

29.58±0.48

0.81±0.01

1:0.4

22.02±0.16

28.98±0.29

0.88±0.01

1:0.5

20.26±0.21

26.92±0.39

0.97±0.00

1:0.1+1% talc +1%mg stearate

23.92±0.23

28.30±0.15

0.76±0.00

Tableting properties of Hingashtak churna (HC) alone and along with other excipients (DCP) =Dicalcium phosphate, Talc and Magnesium stearate were determine in triplicate. Mean values ±Standard error mean (SEM) are of a sample n=3

 

TABLE NO 2: RESULTS OF EVALUATION TEST FOR TABLETS

Formula

Composition of Disintegrants %

Hardness (kg/cm2)

Friability (%)

Disintegration time(second)

Disintegration time after 3 months (sec.)

 

Starch

SSG

 

 

 

Room temp.

450

T-1

5

-

2.74±0.05

0.96±0.06

286.00±1.68

297.6±0.33

301.00±0.51

T-2

10

-

2.94±0.02

0.99±0.60

109.02±1.22

106.05±0.43

116.66±0.88

T-3

5

4

2.81±0.06

0.99±0.01

60.22±0.33

61.66±0.67

68.50±0.41

T-4

10

4

2.89±0.07

0.91±0.07

57.96±o.34

56.09±0.56

67.46±0.82

T-5

5

8

3.08±0.04

0.88±0.02

51.78±0.58

52.00±0.52

69.89±0.77

T-6

10

8

2.98±0.05

0.84±0.04

45.98±0.55

44.33±1.12

55.66±0.55

Prepared tablet formulations (T-1, T-2, T-3, T-4, T-5, and T-6) were evaluated for various quality control tests such as Hardness, Friability, Disintegration time and Disintegration time after storage for 3 months following reported methods in triplicate. Means values   ±Standard error mean (SEM) are of a sample n=3  are reported. SSG= sodium starch glycolate

 

 


Stability study with respect to disintegration time for 3 months was carried out by storing the tablets at room and elevated temperature [45oC]. At the end of each month, tablets were evaluated for disintegration time.

 

RESULTS AND DISCUSSION:-

The average weight of HC equal to half a teaspoon full quantity was found to be 1.12±0.02 g, which was incorporated in each tablet. Since, tableting properties of HC alone very poor, DCP was blended in different proportion. As proportion of DCP was increase, angle of repose and compressibility index were decrease (table1). 1:0.1 Proportion of HC and DCP was selected for compression in to tablets which had optimum tableting properties and with this proportion; weight of tablet could also be kept less.

 

All prepare formulations passed the friability (%friability was within 1%) weight variation (%deviation was within ± 5%) and uniformity of dispersion test .tablet hardness range from 2.7-3.0 Kg/cm2.

 

Initially, disintegration time of formula T-1 was evaluated to know whether 5% starch alone could provide desire rate. However, these tablets failed the disintegrations test. With intention for reducing the disintegration time, the amount of starch was increase to 10% in the formulation T-2. These tablets, even though passed the disintegration test, took nearly two minutes (106sec) to disintegrate. In order to further improve the disintegration property, super disintegrating agent, SSG (4%) was used along with 5% starch in T-3. Disintegration time was lower to 60.33 sec, which was found satisfactory. The aim was to formulate dispersible tablet of HC minimum possible disintegration time. Hence an attempt was made to reduce the disintegration time further by altering the concentration of starch and SSG. The result of disintegration test of T-3, T-4, T-5 have indicated that, disintegration time was not lowered significantly with the rise in concentration of any one of disintegrants used. But the disintegration test of T-6(disintegration time is 44.33± 0.66sec) revealed that, an increase in concentration of both the disintegrants has lowered the disintegration time significantly. This may be due to combined effect of both disintegrants at higher proportion.

 

After storage for three months, the disintegration time was remained unchanged at room temperature; whereas at elevated temperature [450c], disintegration time was slightly increased. This is in conformity with the report that SSG has tendency to increase the disintegration time of tablets, when stored at elevated temperature and humidity.

 

In conclusion, the results have indicated that either SSG or starch alone failed to reduce disintegration time satisfactorily. The use of this combination can be considered as highly beneficial in the preparation of tablet of HC. It is evident from the present study that direct compression method can be successfully applied to formulate dispersible tablet of ayurvedic powder preparation. Results are shown in table 2.      

 

ACKNOWLEDGMENTS: -

We are thankful to our institute, Sudhakarrao Naik Institute Of pharmacy, Pusad, for providing the facilities to carry out research work. We are also thankful to our Principal Dr. D. M. Sakarkar.

 

REFERENCES:

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2.        Dr. K.M. Nadkarni’s, INDIAN MATERIA MEDICA: vol. 1, popular prakashan, 1976, pp: 279-1314

3.       Chaudhari, R.D., Herbal drug industry: 1996; 1st ed: pp:150-575

4.       Cave A., and Hatton C.K., pharmacognosy, phytochemistry, medicinal plant: 1993; 2nd ed:  pp: 613-698.

5.       Carter, S.G., Eds., in, Tutorial pharmacy Cooper and Gunns: CBS publishers and distributors, Delhi, 1986; 6th ed:  pp: 225.

6.       Lachmann, L, Liberman, H.A. and Kanig, J.L., in, the Theory and Practice of Industrial pharmacy: Varghese Publishing house, Bombay, 1987; 3rd ed:  pp: 293.

7.       Liberman, H.A., Lachmann,L., and Schwartz,J.B.,Eds., Pharmaceutical dosage forms: Tablets, 1.,Marcel Dekker Inc., New York,1989; 2nd  vol: pp:109.

8.       Indian Pharmacopoeia, controller of publication, Ministry of Health and Family Welfare, 1996; 4th ed: pp: 736-740.

9.       Indian Pharmacopoeia, controller of publication, Ministry of Health and Family Welfare, 1996. 4th ed: pp: 736.

 

 

 

Received on 02.03.2010       Modified on 10.04.2010

Accepted on 29.04.2010      © RJPT All right reserved

Research J. Pharm. and Tech.3 (4): Oct.-Dec.2010; Page 1288-1290