Optimization of Formulation and Process Parameters and Product Evaluation of Galactomannan-Borate Complex Based Cream

 

1*Dixit Ashish, 2Jain AK, 1Upadhyay Amit, 1Sharma Naveen, 1Shau Ravish, 3Jain Vimal Kumar and 3Singhai AK

1R.N.S Institute of Pharmaceutical Science and Technology Sitholi, Gwalior (M.P.)

2 Dept. of Pharmacology G.R.Medical College, Gwalior (M.P.)

3lakshmi Narain College of Pharmacy, Bhopal (M.P.)

 

ABSTRACT

Optimization of formulation and process parameters and product evaluation of galactomannan and galactomannan-borate complex based liquid paraffin cream were performed in the present study. The concentrations of galactomannan and borax were optimized. Process parameters of galactomannan and galactomannan-borate complex based liquid paraffin cream were optimized. The product evaluation of galactomannan and galactomannan-borate complex based liquid paraffin cream was performed. The galactomannan and galactomannan-borate based complex was compared with vanishing cream.

 

KEYWORDS: Galactomannan, emulsifying agent, borax.

 

INTRODUCTION

It is the right choice of the emulgent that decides the successful preparation of an emulsion1. There are various classes of emulgents i.e. natural (e.g. acacia, cholesterol), finely divided solids (e.g. bentonite, colloidal silicone dioxide), semi synthetics (e.g. methyl cellulose), surfactants (e.g. tweens, spans) and miscellaneous category (e.g. saponins, carbomer)2. The nonionic emulsifiers like proteins and macromolecular gums stabilize emulsion by forming the interfacial films3.

 

Galactomannan is a natural gum classified under the polysaccharides4. It consists of β- (1-4)- mannose backbone having single α- (1-6)- galactose side chain5. The galactomannans are unique, compared to the more common polysaccharides by differing in spatial dispositions of their OH groups. Mannose and galactose, each have a pair of OH groups on the same side (cis position) of the pyran ring. This cis position offers unique hydrogen binding property by which they reinforce each other6-9.

 

Galactomannan enters in o complex formation with a number of ions like Ca++, Cu++, Al+++, Ti+++ and Sb+++. However the most important interaction takes place with the borate ion, resulting in a considerable increase in viscosity10. But there is a lack of study for establishment of galactomannan and galactomannan-borate complex as an emulsifying agent. So the objective of present study is formulation optimization, process parameter optimization and product evaluation of galactomannan-borate complex based cream11 and comparison with the vanishing cream12-14.

 

MATERIALS AND METHODS (EXPERIMENTAL)

Instrument:

(1) Brookfield Viscometer (DU-II+ pro Brookfield viscometer)

(2) Trinocular microscope (Labomed ATC 2003)

(3) GR 200 Analytical weighing balance (AandD Company).

 

 

Table 1: Viscosities of the different concentration of guar galactomannan and borax

 Borax (% w/v)

Guar  galactomannan (% w/v)

0.25

0.5

0.75

1.0

Viscosities

( cps)

0

60±10

306.67± 40.41

1266.67± 76.3

4516.67±  375.27

0.025

83.33± 5.77

410±40

1533.33± 76.3

5166.67± 425.24

0.05

220±20

1236.67± 90.7

2033.33± 251.6

6550± 726.29

0.075

373.33± 25.1

1983.33± 202.9

3966.67± 351.1

6783.33± 652.56

0.1

686.66± 35.1

3133.33± 251.6

4766.67± 480.4

8216.67± 650.64

Viscosities of galactomannan-borate dispersion were increased as the increase in concentrations of galactomannan and borax.

 

Figure 1: Graph depicting viscosities of Guar Galactomannan and Borax at different concentrations; The graph is plotted using mean± S.D. of triplicate determination

 

Chemical and reagents:

Galactomannan was received as a gift sample from Sunita Mine Chem., Jodhpur, India. Acacia and borax procured from Loba Chemi. Pvt. Ltd. was used as received. Paraffin liquid was of analytical grade.

 

Procedure:

Determination of Rheological Behaviour:

In order to assess the rheological behavior of galactomannan and galactomannan-borate complex, aqueous dispersions of galactomannan were prepared at different concentrations such as 0.25% w/v, 0.5% w/v, 0.75% w/v, and 1.0 % w/v using mortar-pestle. Also 0.025% w/v, 0.05% w/v, 0.075% w/v, 0.1% w/v solutions of borax were prepared. Then 10 ml of each concentration of aqueous dispersions of galactomannan were mixed with 10 ml of each concentration of borax solutions. Then the viscosities of these mixtures were measured using Brookfield viscometer spindle number 4, at an rpm of 20, and temperature of 250C. Viscosities were determined in triplicate determinations. The observations of the study are presented in Table 1 and figure 1.

 

Optimization of the formulation for preparation of the Galactomannan-borate based liquid paraffin cream

In the formulation optimization of creams following concentration of 0.2%w/v, 0.4%w/v, 0.8%w/v and 1%w/v of galactomannan and 0.16%w/v, 0.2%w/v, 0.3%w/v, 0.4%w/v and 0.5%w/v solutions of borax were used.

 

Likewise, for optimization of formula for preparing creams, a total of 4´5=20 creams were prepared and compared with the prepared vanishing cream as the standard. The formulations that yielded a product with

 

desired quality attributes using appearance, globule size, Globule size distribution, number of globules/cc, rheogram, specific gravity, pH neutral were selected. For comparison and selection of formulations, an arbitrary scale ranging from 0-5 was devised. Each of the prepared formulations was assigned a number value depending upon their closeness to achieving the desired attributes. Results of this study are presented in table 2 and 3.

 

Optimization of the process parameter for preparation of galactomannan-borate based liquid paraffin cream.

For optimization of speed of silverson mixer and time of homogenization, based on the factorial design, 2´3(speed´time) = 6 emulsions of liquid paraffin using acacia as the emulsifying agent were prepared, one additional emulsion was prepared in mortar-pestle and it was not homogenized (control).

After the respective treatments, globule sizes of the emulsions were determined in triplicate. The data so obtained was statistically treated using ANOVA followed by studentized range test for multiple comparisons.  The results are presented in Table 4

 

Product evaluation parameters of   galactomannan-borate based liquid paraffin cream.

Having optimized the formulation and process parameter for cream, the galactomannan-borate based products were evaluated and compared with the standard i.e. vanishing cream.

The quality control tests parameters included for evaluation of the product and the method employed are presented in table 6.

 

Five replicate determinations were made for each of the parameter for evaluating the creams respectively.. The results of the evaluation of cream are presented in table 5.

 

RESULTS AND DISCUSSION:

The viscosity determinations of galactomannan-Borate dispersion with different concentrations are presented in Table 1 and Figure 1.

 

Optimization of the formulation for preparation of the Galactomannan-borate based liquid paraffin cream

Number values assigned depending on the quality attributes of the prepared creams are depicted in Table 2

 

Table 2: Number values assigned depending on the quality attributes of the prepared creams

Borate Ion conc.

(% w/v)

Galactomannan conc. (% w/v)

0.2

0.4

0.8

1.0

0.16

0

2

3

3

0.2

1

2

3

3

0.3

1

2

3

4

0.4

1

2

4

5

0.5

1

2

5

5

 

The formula as optimized for preparation of galactomannan/ galactomannan-borate based cream are given in Table 3

 

Table 3- Results for formulation optimization of cream

 

             Concentration of

Galactomannan        Borax

For cream

1.0% w/v

0.8 % w/v

0.4 % w/v

0.5 % w/v

Internal phase: liquid paraffin; Concentration: 20% v/v

 

In this study concentrations of the galactomannan and borax were optimized at 1% w/v, 0.8 % w/v for galactomannan and 0.4 % w/v, 0.5 % w/v for borax.

 

Optimization of the process parameter for preparation of galactomannan and galactomannan-borate based liquid paraffin emulsion.

The result of the optimization of the critical process variables are presented in Table 4

 

Table 4: Result of process optimization of cream

Critical process variables

Optimized level

Rate of addition of internal phase

0.6±0.05 ml/min

Speed

High

Time

20 Minutes

 

As per the data analysed (Table 8), it is seen that there is statistically (p<0.05) significant reduction in the globule size of emulsions after homogenization using Silverson mixer. Further the globule size after homogenization at high speed for 30 minutes is lower (8.46±0.32 mm) as compared to the globule size after homogenization at high speed for 20 minutes (9.46± 0.15 mm), but since the difference is statistically insignificant (p < 0.05), the time parameter at the lower level of 20 minutes was selected.

 

Product evaluation parameters of both galactomannan and galactomannan-borate based emulsion.

The results of evaluation of the galactomannan/ galactomannan-borate based cream are shown in Table 5.

 

Table 5- Results of evaluation of galactomannan/ galactomannan-borate based creams

Evaluation parameter

Emulgent used ( Concentration)

Triethanolamine

Stearic acid

(0.7/1.8 % w/v)

Galactomannan-Borate

(1/0.4 % w/v)

Galactomannan-Borate

(0.8/0.5 % w/v)

Appearance

White free from bubbles

White free from bubbles

White free from bubbles

pH

9.3±0.25

10.7±0.25

11.5±0.25

Rheogram

Shown in figure 3

Shown in figure 4

Shown in figure 5

Globule size

15.9±0.2a

14.65±0.2a

15.5±0.2a

Globule size distribution

Shown in figure 2

 

 

Data indicates mean±S.D. of five replicate determinations. Date analysed using ANOVA followed by Studentized range test for multiple comparisons; a =not significantly different at p < 0.05

 

Table 6- Quality control tests /evaluation of galactomannan-borate based cream

Quality control tests /Evaluation parameter

Method employed

Appearance

visual Inspection

pH

using pH electrode

Globule size

by microscopy

Globule size distribution

by microscopy

Rheogram (for creams)

by placing 1cc of cream between two glass slides and application of variable stress on the top slide by way of a pulley-arrangement and determining the resultant shearing rate

 

 

Figure 2: Graph depicting the globule size distribution of vanishing cream and galactomannan-borate cream

       

Figure 3: Rheogram of the Vanishing Cream

 

  Figure 4: Rheogram of the GG-B based Cream (1.0/0.4% w/v)

 

Figure 5: Rheogram of the GG-B based Cream (0.8/0.5% w/v)

 

CONCLUSION:

Based on the present study, it can be said that galactomannan-borate complex has a potential application to be used as an emulgent for the preparation of cream.

The optimization of formulation and process parameters for preparation galactomannan-borate based cream was successfully worked out.

 

REFERENCE:

1.        Rawlins EA. Bentley’s Textbook of Pharmaceutics, 1988, eighth edition, 256-257, English language Book Society, London.

2.        Aulton ME., Pharmaceutics: The Science of Dosage Forms Design, 2003, second edition, 345-356, Churchill Livingstone, New York.

3.        Jain NK, Sharma SN., Textbook of Professional Pharmacy, 1994, third edition, 236-243,  Vallabh Prakashan, Delhi.

4.        Govt. of India; Ministry of Health and Family Welfare. Pharmacopoeia of India, 4th ed. Controller of Publications. 1996. p.356.

5.        Issarani R, Nagori BP. FTIR-spectrum of galactomannan extracted from Trigonella foneum-graceum, IJPS. 2004 May-June, 63(3): 358-360.

6.        Tayler VE, Brandy LR, Robbers JE., Pharmacognosy, 1981, eighth edition,  53-54, Lea and Febiger Publication, Philadelphia

7.        Evans WC. Trease and Evans, Pharmacognosy, 2002, fifteenth edition, 209 W.B.Saunders, New York.

8.        Wallis TE., Textbook of Pharmacognosy, 1989, fifth edition, 224-225, CBS Publishers and Distributers; Delhi

9.        Finar IL., Stereochemistry: The Chemistry of Natural Products, 1994, fifth edition, part-II, 342, ELBS with Longman Scientific and Technical, London.

10.     Kok SM, Nill ES, Mitchell RJ. Viscosity of galactomannan during high temperature processing influencing of degradation and solubilization. Food Hydrocolloids. 1999 Nov; 13(6): 535-542.

11.     Garti N, Madar Z, Aserin A, Sternheins B. Fenugreek galactomannan as food emulsifier. L-wissenschaft and Techlogie. 1997 May; 30(3): 305-11.

12.     Garti N, Madar Z, Aserin A, Sternheins B. Effect of galactomannan on rheological properties, food hydrocolloids.2003 May; 17(3): 229-236.

13.     Rayment P, Murphy RB Simons, Eillis RP. Rheological Properties of guar galactomannan and rice starch mixture II creep measurements, Carbohydrate Polymers. 1998 Jan-Feb; 35(1-2): 55-63.

14.     Pezron AR, Leibler L. Rheology of galactomannan- borax gels. Journal of Polymer     Science, Part B: Polymer Physics. 2003 March; 28(13): 2245-2461.

 

Received on 13.05.2009

Accepted on 10.06.2009        

© A&V Publication all right reserved

Research Journal of Pharmaceutical Dosage Forms and Technology. 1(3): Nov. – Dec. 2009, 229-232