Formulation and Evaluation of Diclofenac Suspension by Using Natural Suspending Agents

Sayad Basha.K*, Sheema Nafees. S, Nethravani. G, Thirumalesh Naik S.B

Department of Pharmaceutics, JNTUA- Oil Technological Research Institute, Ananthapuram, A.P, India.

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

ABSTRACT:

The purpose of this study is to search for cheap and effective natural excipients that can be used as an effective alternative for the formulation of pharmaceutical suspensions. In this research natural suspending agents were selected for the study. Gum acacia, compound tragacanth powder and starch were used. The pharmaceutical oral suspensions were prepared by using diclofenac as a model drug by using potassium chloride as flocculating agent. Diclofenac suspensions were prepared with different concentrations (2%, 3%, and 4%w/v) of each suspending agents like compound tragacanth powder, gum acacia and starch. Characterizations of the suspensions were carried out for sedimentation volume, degree of redispersibility, pH, viscosity and flow rate. As per the obtained results, compound tragacanth powder possesses better characteristics as a suspending agent compared to all other natural suspending agents. The results showed that sedimentation volume and viscosity were found to be directly proportional to the concentration of the suspending agents. The compound tragacanth powder was found to have a promising potential for use as a suspending agent in a concentration range of 2-4%w/v.

KEYWORDS: Gum acacia, starch, redispersibility, sedimentation volume, Tragacanth powder.

INTRODUCTION:

Modern technology has provided the pharmaceutical scientist with a variety of suspending materials for formulating and developing superior suspension. Among these suspending agents, hydro colloids play important role by increasing the viscosity of water. They bind with the water molecules or trap the water molecules between their intertwined macromolecules chain & limit the mobility of water. Suspending agents are used to prevent the sedimentation by affecting the rheological behavior of a suspension.

Ideal suspending agents might have viscosity at low shear. Its viscosity should not be altered by temperature or on aging should be able to tolerate electrolytes and applicable over a wide p^H range ,compatible with other formulation excipients and should be nontoxic. Suspending agents reduces the rate of settling and permits easy redispersion of any settled particulate matter. Both by protective colloidal action and by increasing the consistency of the suspending medium ^(1-3). Suspending agents are 1. In organic materials 2. Synthetic compounds 0r 3.Poly saccharides. Natural gums like acacia, tragacanth, khaya, karaya belong to the latter groups^. Gums have been wildly used as tablet binders, emulgents and thickeners in cosmetics and suspensions as film- forming agents and traditional colloids ⁽⁴⁾_.In this study the suspending properties of compound tragacanth powder and acacia powder was compared with the starch as suspending agents for Diclofenac suspension at a concentration of [2%, 3%, 4% w/v].The evaluation parameters were sedimentation volume, viscosity, flow rate, pH, redispersibility studies.

MATERIALS AND METHODS:

Materials:

Tragacanth and acacia are gift sample by loba chemie, Mumbai, Diclofenac was purchased from Radha Traders Anantapur, Merch, Mumbai, starch, sucrose, potassium chloride, distilled water were sourced locally and were of AR Grades.

Preparation of Diclofenac Suspension:

One gram of Diclofenac was weighed and finally triturated in a mortar with a pestle, natural suspending agents like acacia, tragacanth, starch were taken and is prepared by adding sucrose solution and finally 1gm of potassium chloride was added. This was transferred to 100ml of measuring cylinder and volume was made up to 100ml with water.

Evaluation of Suspension Determination of Sedimentation Volume:

Each suspension of 100ml was stored in a 100ml measuring cylinder for 1hour at room temperature and observations were then made for every 15minutes for one hour. The sedimentation volume was calculated using the following equation ⁽⁵⁾.

Sedimentation volume (F)= H_u ∕ H_o

H_o=initial height of suspension, H_u=ultimate height of suspension

Degree of redispersability:

Less number of taps= stable and good suspension. Fixed volume of each suspension 100ml was kept in a measuring Cylinder which was stored at room temperature for one hour at regular intervals, one measuring cylinder was removed and moved upside, down until there was no sediment at the bottom of cylinder ⁽⁶⁾.

Determination of pH:

P^Hof the prepared oral suspension is determined by using pH meter ⁽⁷⁾.

Viscosity determination:

The viscosity of suspensions was measured at 250°C using Brookfield viscometer, model (Cap 1000+visco) at 900 revolutions per minute. All determinations were made in at least triplicate and the results obtained are expressed as the mean values ⁽⁸⁾.

Flow rate:

The time required for each suspension sample to flow through a 10 ml pipette was determined and the apparent viscosity (ha in mls-1) was calculated using the equation ⁽⁹⁾.

Flow rate = ha = Volume of pipette (ml) / Flow time (s)

RESULTS AND DISCUSSION:

Compound tragacanth powder as a suspending agent, was used in a concentration of 2%, 3%, 4% w/v for these studies. Suspensions were prepared containing diclofenac as a model drug with different concentrations of compound tragacanth powder [Table:1] comparisons were drawn with similar concentrations of gum acacia and starch as a conventional suspending agents [2%,3% and 4%w/v]. the suspensions were evaluated for various parameters such as sedimentation volume [figure:1,2 and 3], redispersibility [Table:2] ,pH of solution[Table:3], viscosity, flow rate[Table :4] The results showed that sedimentation volume and viscosity were found to be directly proportional to the suspending agents. Viscosity of the suspension containing low concentration of the tragacanth was low and so the rate of sedimentation was faster. The suspending ability of the suspendants were in the order of compound tragacanth powder >acacia powder> starch. sedimentation volume for the suspensions containg concentration of the tragacanth 3% and 4% w/v was 0.96 and 0.97 respectively at the end of 60 minutes, indicated reasonably good suspend ability and redispersibility of compound tragacanth powder. Hence compound tragacanth powder showed its superior suspending property over gum acacia and starch. The flow rates were inversely proportional to the viscosity of the suspension and were in the order of gum acacia > compound tragacanth powder >starch Since the suspension produces sediment on storage it must be readily dispersible so as to ensure the uniformity of the dose. Inverse relationship was observed between redispersibility and concentration of suspending agents and were in the order of compound tragacanth powder >gum acacia >starch.

Table: 1 Formulation of diclofenac suspension

Ingredients	F1	F2	F3	F4	F5	F6	F7	F8	F9
Diclofenac(g)	1	1	1	1	1	1	1	1	1
Compound tragacanth powder	2%	3%	4%
Gum acacia				2%	3%	4%
Starch							2%	3%	4%
Potassium chloride(g)	1	1	1	1	1	1	1	1	1
Sucrose(mg)	10	10	10	10	10	10	10	10	10
Water q.s to	100 ml	100	100	100	100	100	100	100	100

Table 2: Degree of Redispersibility values for different formulations

No. of strokes	Tragacanth			Acacia			Starch
No. of strokes	F1	F2	F3	F4	F5	F6	F7	F8	F9
No. strokes for redispersibility	60	50	30	70	60	40	70	65	60

Table 3: pH of solution

p^H	Tragacanth			acacia			Starch
p^H	F1	F2	F3	F4	F5	F6	F7	F8	F9
pH of suspension	6.89	6.99	7.01	6.88	6.78	7.02	6.88	6.76	7.02

Figure 1: The comparative sedimentation volume (F) profile for suspensions containing compound tragacanth and other conventional suspending agents at concentration 2% w/v

Figure 2: The comparative sedimentation volume (F) profile for suspensions containing compound tragacanth and other conventional suspending agents at concentration 3% w/v

Figure 3: The comparative sedimentation volume (F) profile for suspensions containing compound tragacanth and other conventional suspending agents at concentration 4% w/v

Table 4: Evaluation of suspensions for viscosity and flow rate

Formulation	Viscosity(cp)( n=3)	Flow rate (m_/S)
F1	22.2±0.89	2.45
F2	46.61±1.38	2.08
F3	66.12±0.98	1.62
F4	15.16±2.3	2.51
F5	25.66±1.41	2.33
F6	43.58±1.36	2.11
F7	71.08±1.2	1.45
F8	138.13±0.95	1.12
F9	201.18±1.15	0.91

CONCLUSION:

By using different ratios of natural suspending agents, Diclofenac suspensions were formulated. In this, the suspending ability of suspend ants were in the order of tragacanth, > acacia > starch. Hence, Tragacanth 4%(w/v) formulation is the best Diclofenac suspension .

REFERENCES:

1. S.G. Banker and C.T. Rhodes In: Modern Pharmaceutics. (3rd Edition) (1998) pp. 30 5-318.

2. R. Lapasin and S. Pricl, “Rheology of Industrial Polysaccharides-Theory and Applications, ”sseds. Aspen Publication, Maryland, (1999) pp. 134 –161.

3. P.A. Williams and G.O. Phillips, “Handbook of Hydrocolloids” 2nd ed. Wood head Publishing Ltd., Cambridge, (2000) pp. 1–22.

4. Liebermann, H., Reiter, M. and Banker, G. (2008). Quality assurance, Pharmaceutical dosage formanddispersesystems.3,pp. 423-424,45,46.

5. Nayak AK., Pal D, Pradhan J, Ghorai T. The potential of Trigonella foenum-graecum L. seed mucilageas suspending agent. Ind J Pharm Edu Res. 2012; 46(4): 311-316.

6. Doharey V, Sharma N, Bindal MC. Assessment of the suspending properties of Cordia gheraf gum on Paracetamol suspension. Scholars Research Library. 2010; 2 (1): 510-517.

7. Mahmud HS, Oyi AR, Allagh TS. Gwarzo M.S. Evaluation of the Suspending Property of Khayasnegalens is gum in Co-Trimoxazole suspensions. Res J Applied Sci Eng and Tech. 2010; 2(1): 50-55.

8. Senthil V, Sripreethi D. Formulation and Evaluation of Paracetamol suspension from Trigonella Foenum Graecum mucilage. J Advanced Pharm Edu Research. 2011; 1(5): 225- 233.

9. Panda M, Patro G, Malpani A, Bhanoji Rao ME. Formulation and evaluation of Norfloxacin Suspension with β-cyclodextrin complexation Int J Pharm Sci Review and Research. 2011; 9 (1):173-177.

Received on 12.01.2016 Modified on 27.01.2016

Res. J. Pharm. Dosage Form. and Tech. 2016; 8(2):119-121.

DOI: 10.5958/0975-4377.2016.00015.X