INTRODUCTION:

Binding agents are used to impact the structural strength during the processing, handling and packaging of tablets. A number of plant gums have been used as binding agents in tablet formulations. The fact that these gums are non-toxic and widely available has made them of continuing interest. ^{(1, 2, 3)}

Guggul is the oleogum resin obtained by making incisions at the basal part of stem bark of Commiphora mukul (Fam. Burseracea). Extracts of oleogum resin includes compounds guggulosterones, d-α- phellandrene, d- limonene, (o) – bornyl acetate, 1,8- cineole, (o)-linalol, methylchavicol, α- terpineol (2)-5 – tricosene-1, 2, 3, 4- tetracol and (2) – 5- tetracosene-1, 2,3,4- tetracol, α- pinene, myrcene, eugenol, cadinene, geraniol, methyl heptanoate.

Gum of Commiphora mukul after acid hydrolysis yields an aldobiuronic acid, 6- o – (4 – o – methyl – β D- glucopyranosyl acids D- galactose and D- galactose. ^{(4, 5)}

Gum obtained from oleogum resin of Commiphora mukul has benn used as an active pharmaceutical ingredient and also as a binding agent. Traditionally Commiphora mukul is used as anti-inflammatory, antispasmodic, carminative, diaphoretic, diuretic, hypoglycaemic, expectorant, thyroid stimulant, antiseptic, demulscent, sedative, stomachic, liver tonic, deterent, diuretic etc. ⁽⁶⁾

In the present work, Guggul gum has been evaluated as a binding agent in paracetamol tablet formulations. Paracetamol was used as the model drug for present work because of its poor compression properties; it needs a binding agent among other excipients to form satisfactory tablets.

MATERIALS AND METHODS:

Collection of Guggul Drug

The guggul was purchased from local market in Pune region. The guggul was separated from adultrants and used for further procedures.

Isolation of gum:

Guggul was extracted by Soxhlet extraction using ethylacetate as solvent. The filtrate contains soluble resins (30%) and the residue containing insoluble gum (60 %) was collected.

Purification of Guggul Gum:

After collection of guggul gum was well dried. The dried drug was powdered in mortar and passed through sieve number 120. 120 gm of guggul gum was solubilised in 240 ml distilled water. The concentrated solution was precipitated in 310 ml ethanol. The precipitate was separated and dried at 60 º C. The dried gum was powdered and stored in tightly closed container. (Yield obtained was 20.26% w/v).

Standardization of guggul gum:

The guggul gum was standardized for following properties.

Loss on drying: 5 gm gum was dried at 100 + 5º C till the constant weight of gum was obtained.

The loss on drying was found to be 9 % w/w.

Ash value: 1 gm of gum was accurately weighed and evenly distributed it in the crucible. It was dried at 105 º C for one hour and ignited in muffle furnace at 600 + 25º C. Percentage ash content was found to be less than 10% w/w.

pH: Guggul gum was analysed for 2 to 8 % w/w gum solutions with pH found to be 6.

Preparation and Evaluation of Granules:

Wet granulation method was used to prepare granules. The formulation was developed by using paracetamol IP as a model drug. Binder solution of gum was prepared by dissolving it in distilled water. The binder concentrations used were 2, 4, 6, 8 % w/w in solution. Binder level was adjusted by lowering the level of microcrystalline cellulose in the formula. All the ingredients were dry mixed manually in mortar. Binder solution was slowly added into the mixture. The wet mass was granulated by passing them manually through number 12 mesh sieve. Granules were dried at 50º C in oven and again resieved through number 1 mesh sieves. The granules were evaluated for percentage of fineness and particle sizes. Granules were mixed with 3 % talc and evaluated for flow property ^{7, 8}. The tablet formulation was developed as shown in Table No. 1.

Preparation and Evaluation of Tablets:

Tablets were compressed by using cad mach single punch tablet machine fitted with flat faced punches. The batch size prepared was of 100 tablets. The prepared tablets were stored in closed container for 15 days. No evidence of chemical changes was observed. The tablets were evaluated for content uniformity, hardness, friability, disintegration time and dissolution study ^9-12.

Dissolution study was carried out in 900 ml 0.1 N HCL medium using paddle type dissolution apparatus. The dissolution was carried out at 37 ºC. 10 ml of sample has withdrawn at 10 min interval and 10 ml dissolution medium was added into dissolution chamber as a replacement for sampling after each interval. Absorbance was measured at 243 nm using UV spectrophotometer.^{10, 12}

RESULTS AND DISCUSSION:

P H of binder gum isolated was 5.5 – 6.5. The prepared granules were evaluated for percentage of fines, particle size and flow properties. The flow property of granules was determined by angle of repose and values were between 28– 30^o. All batches showed good flow properties. Granule size was distributed between 0.65 – 0.70 mm. as mentioned in table 2.

Three batches of tablets of each binder concentration were prepared. The prepared tablets were evaluated for hardness, content uniformity, friability, disintegration results are shown in table 3. Dissolution study showed that the drug release from the tablets was more than 90 % in 70 min. the drug release from tablets decreased with increase in binder concentration. All the evaluation parameters were found to be within pharmacopoeial limits at binder concentration 6 – 8 %w/w. guggul gum exhibited good binding properties for uncoated tablets.

Table no. 1 Formulations containing guggul gum binder

	Quantity (% w/w)
	2 %	4 %	6 %	8 %
Paracetamol	80	80	80	80
Microcrystalline Cellulose	11	11	11	11
Binder (Guggul gum)	2	4	6	8
Talc	7	5	3	1

Table no. 2 Evaluation of granules prepared by using guggul gum

	Binder concentration (% w/w)
	2 %	4 %	6 %	8 %
Particle size	0.66	0.68	0.64	0.70
Angle of repose (º C)	28.15	27.56	24.43	29.16
Content Uniformity %	93.26	93.69	94.21	95.98

Table no. 3 Evaluation of tablets

	Binder concentration (% w/w)
	2 %	4 %	6 %	8 %
Hardness	6	6	7	7
Content Uniformity (%)	97.05	97.81	98.11	99.65
Friability	1.3	1.28	1.1	0.9
Disintegration	10min. 30sec.	12min.	15min. 35sec.	20min.

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9. Chukwu A. and Okpalaezinne P. Preliminary evaluation of cissus root gum as a binder in sodium salicylate formulations. Drug Dev. Ind. Pharm. 1989; 15 (2): 325-330.

10. Indian pharmacopoeia, Vol. II, Ministry of Health and Family Welfare, Govt. of India, 1996, 556.

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Received on 15.09.2012 Modified on 09.10.2012

Research J. Pharm. and Tech. 6(3): March 2013; Page 238-239