Current Review on Herbal Pharmaceutical Binders

 

Rupa Bhattacharya, M. Pharm, Shubham Borkar, Ayasha P. Sathawane

Maharashtra Institute of Pharmacy (B. Pharm) Betala, Bramhapuri

*Corresponding Author E-mail: rup22990@gmail.com, shubh221016@gmail.com, ayashasathawane2995@gmail.com

 

ABSTRACT:

Binders are used in the tablet formulation for increasing the cohesiveness between the active pharmaceutical agent and other excipients. Search for new binders as a potential binding agent in tablet dosage form continues to be of interest. This is because different binding agents can be useful in achieving various tablet mechanical strength and drug release properties for different pharmaceutical purpose. Binders impart cohesiveness to granules. Natural polymers are widely used in the pharmaceutical and food industry as excipients and additives due to their low toxicity, biodegradable, availability and low cost. Natural binders like different starches, gums, mucilages, dried fruits possess binding capacity as well as some other properties like disintegrant, filler, sustain release, and modify the performance of dosge form and also increase patient compliance. These natural polymers are much safer and economical than synthetic ones. Different gums like gum arabic, tragacanth, karaya, shellac, xanthen etc shows good potency as a binding agent.

 

KEYWORDS: Natural binder and diluents, Guar gum, Gum Arabic, Karaya, Shellac, Tragacanth, Xanthen.

 

 


INTRODUCTION:

The word excipient was came from Latin word, “excipients” which mean to receive, to gather and to take out. The standard of any dosage form depends on active pharmaceutical ingredient (API), manufacturing processes and the excipients used.[1]

 

An excipient may be defined as any substance mixed with the active pharmaceutical ingredient to give it consistency are used as a vehicle for its administration. It is impossible for any active pharmaceutical ingredient to have properties that allow incorporation in a therapeutic product that meets all the mention requirement therefore every therapeutic product is combination of drug and excipients[2].

 

Many dosage forms formulated as complex system containing many other excipients along with the active pharmaceutical ingredient (API), these compounds are generally added along with the active pharmaceutical ingredients in order to protect, support or enhance stability of the formulation[21].

 

The excipients have the potential to determining the quality of a formulation and in many cases the bioavailability of drug from tablets has received considerable attention. The development of new excipients for potential use as binding agent in tablet formulations continues to be of interest. This is because different binding agents can be useful in achieving various tablet mechanical strength and drug release properties for different pharmaceutical purpose[6].

 

In present days, herbal excipients are replacing the use of synthetic excipients in pharmaceutical industry, because of less toxicity, easily availability and low expenses. And users are also interested in natural/herbal ingredients. Consumers believe that herbal substances are safer in comparison to synthetic one. The modern view is that excipients also enhance the rate of absorption and permeability of formulation. In pharmaceutical industries, Herbal excipients are very popular in these ages. Hence, this review article shows knowledge of herbal excipients which are used in general formulation[1].

 

Plant products are serving as medicinal and additive agents in the pharmaceutical industry as substitutes to the synthetic products for many years and have become an important part of many formulations with the development of pharmacy and different dosage forms, as they are easily available, cheaper and are Eco-friendly in nature[3].

 

To hold various powders together to form a tablet is a binder, fillers usually do not have good binding capacity, binder is either added in dry or mix in granulating liquid, binder form matrix with fillers and drug embedded in it, on drying solid binder forms glue which holds the particles together, the wet binder is the most important ingredient in the wet granulation process, most binders are hydrophilic and most times soluble in water[6].

 

Advantages of natural binders:

1.       Natural polysaccharides are widely used in the pharmaceutical and food industry as excipients and additives due to their low toxicity, biodegradable, availability and low cost.

2.       They can also be used to modify the release of drug, thereby influencing the absorption and subsequent bioavailability of the incorporated drug.

3.       They act as vehicles which transport the incorporated drug to the site of absorption and provide the stability of the incorporated drug, the precision and accuracy of the dosage, and also improve the organoleptic properties of the drugs where necessary in order to enhance patient adherence [21].

4.       They optimize the performances formulations during in process as well as when patients ingest them [19].

 

Disadvantages of natural binders:

1.       Polymer binders can lead to processing difficulties such as rapid over granulation. Over time they occasionally lead to tablet hardening and a decrease in dissolution performance

2.       When polymer binders are chosen, the addition of strong disintegtants such as super disintegrants is typically required but these are considerably expensive and have a negative effect on product stability as well as film coating appearance of the finished products[6].

 

Binding Agent:

Definition:

A binding agent (or binder) is a substance that holds or draws other material together mechanically, chemically or as an adhesive, to form a cohesive whole.

 

Binders are agents employed to impart cohesiveness to the granules. This ensures the tablet remains intact after compression as well as improving the flow qualities by the formulation of granules of derived hardness and size. The choice of a suitable binder for a tablet formulation requires extensive knowledge of the relative importance of binder properties for enhancing the strength of the tablet and also of the interactions between the various materials constituting a tablet.  To hold various powders together to form a tablet is a binder, fillers usually do not have good binding capacity, binder is either added in dry mix or mix in granulating liquid, binder form matrix with fillers and drug embedded in it, on drying solid binder forms glue which holds the particles together, the wet binder is the most important ingredient in the wet granulation process, most binders are hydrophilic and most times soluble in water.

 

Why natural binder:

·         Synthetic gums used in pharmaceutical industries possess drawbacks of toxic effects and health problems. Natural gums are currently being imported by India from other countries such as Sudan (56 %), Chad (29 %) and Nigeria (10 %).

·         India is the hub of medicinal plants and these are not commercially exploited much. Indian industries depend on the imported gums. Since common man will be involved in collecting the gums the society will be benefited[8].

·         They are biodegradable, biocompatible and non-hazardous polymers showing irregular physical chemical properties and environmentally sustainable features.

·         Carbohydrates represent the most abundant biological molecules, covering a large array of fundamental roles in living things: from the reserve and transport of energy, (starch and glycogen), to the development of structural components (cellulose in plants, chitin in animals), to the linking between intercellular walls (hemicellulose).

·         The great interest with these polysaccharides in aquatic animal feed is strictly related to their gelling properties[9].

 

Classification:

On the basis of their application:

 

1. Solution binders:

are dissolved in a solvent (for example water or alcohol can be used in wet granulation processes). Examples include gelatin, cellulose, cellulose derivatives, polyvinyl pyrrolidone, starch, sucrose and polyethylene glycol.

2. Dry binders:

are added to the powder blend, either after a wet granulation step, or as part of a direct powder compression (DC) formula. Examples include cellulose, methyl cellulose, polyvinylpyrrolidone, and polyethylene glycol[21]

 

Physical properties:

Binding agent such as resins, gum, wax may be tough and possibly elastic but can neither bear compressive nor tensile force. Tensile strength is greatly improved in composite material consisting of resins as the matrix and fiber as a reinforcement. Compressive strength can be improved by adding filling materials.

 

Liquid binders are added to dry substance in order to draw it together in such a way that it maintain a uniform consistency transforming the mixture into a more solid structure for example xanthane and guar gums are plant derived powders used as binding agent in gltuten free baking as replacement for binding action of gluten or in vegan cooking to replace eggs. When they are added to water, it become more viscous and gummy. their binding properties are activated when mixed with other ingredients such as flour.

 

Types of Binders:

Classification on the basis of their source: -

1. Natural polymers: starch, pregelatinized starch, gelatin, acacia, tragacanth and gums.

2. Synthetic polymer: PVC, HPMC, methyl cellulose, ethyl cellulose, PEG.

3. Sugar: glucose, sucrose, sorbitol[21].

 

Application of natural binders:

·       Binder have use in painting where they hold together pigments and sometimes filling material to form paints, plastics, and other material.

·       Binders used include wax, linseed oil, gum arabic, gum tragacanth, methyl cellulose gums, or proteins such as egg white or casein. glue is traditionally made by the boiling of hoofs, bones, or skin of animals and then mixing the hard gelatinous residue with water.

·       Natural gums-based binders are made from substance extracted from plants. Larger amounts of dry substance are added to liquid binder in order to cost or model sculptures and reliefs.

·       In cooking, various edible thickening agent are used as binders. Some of them tapioca flour staches.

·       In explosives, wax or polymer like polyisobutylene or styrene butadiene rubber are often used as binder for plastic explosives[7].


Table No.1- List of Natural binder drugs:

Sr. No.

Drug

Synonym

Biological Source

Use

1.

Cruar

Gum

Cyamompsis Tetragonolobus,

Family: Leguminosae

Colon targeted drug delivery microspheres

2.

Gum Arabic

Gum Arabic,

Accacia Arabica Wild (Accacia Senegal)

Family: Leguminosae

Binding agent, Demulcent, Emulsifying agent.

3.

Karaya

Sterculia gum

Sterculiaurense

Family: Sterculiaceae

Mucoadhesive and Buccoadhesive

4.

Shellac

Lacca

Lccifer lacca kerr Order: Homoptera Family: Coccidae

Coating Confection & Medicinal tablet, binder

5.

Tragacanth

Gum tragacanth

Astragalus gumnifer Family: Leguminosae

Suspending agent, Emulsifying agent, Laxative

6.

Xanthen

Xanthen gum

Gram negative bacterium Xanthomonous Campestris

Binder

 


Guar

 

Synonyms: guar gum

 

Biological source: 

Guar gum is galactomannan derived from guar cymompsis tetraganolobus kernels which belong to family leuguminosea.

 

It is also known as cluster bean, guaran, cyamopsis, guarina, clusterbean, culcutta lucern.

 

Geographical source:

It grown abundantly in tropical contries like: Indonesia, India, Pakistan and Africa, in U.S.A., southern westrn regions it was introduced in the year 1900 and its large scale production commenced in early 1950’s [10]

 

Chemistry of Guar Gum:

Guar gum is an uncharged natural gum. It contains 41 % dry weight and acetone insoluble solids of the seeds. At least 75 % of acetone insoluble solids of the endosperm are galactomannose and 12 % being accounted for pentosan, protein, pectin, phytin, ash and dilute acid insoluble residues5. [11]

 

 

 

Chemical structure-

 

Preparation:

First of all the fully developed white seed of guar gum are collected and freed from any foreign substance.

 

The sorted seed are fed to a mechanical ‘splitter` to obtain the bifurcated guar seeds which are then separated into husk and respective cotylendons having the ‘embryo` the gum is found into the endosperm generally the

Endosperm: 35 to 40%

Germ (or embryo): 45 to 50% and

Husk: 14 to 17 %

 

The cotyledons having a distinct bitter taste are separated from the endosperm by the process called winnowing. The crude guar gum i.e. the endosperm is subsequently pulverized by mean of a micro- pulverizes followed by grinding. The relatively softer cotyledons sticking to the endosperm are separated by mechanical ‘sifting` process. Thus the crude drug guar gum is converted to a purified form (i.e. devoid of cotyledons), which is then repeatedly pulverized and shifted for several hour till a final white powder or granular product is obtained.

 

Morphological character:

The guar plant is about 0.6m high and pods are 5-12.5cm long and contain an average 5-6 light brown seeds.

Color - colorless; pale – yellowish white powder.

Odor - characteristic smell.

Taste - mucilaginous

 

Solubility -insoluble in alcohol with water it gives a thick transparent suspension.

 

Guar gum is insoluble in hydrocarbon, fats alcohol, ester, ketone, in fact with a very few exception (eg. Formamide) in organic solvent in general. The only important solvent is guar gum is solvent.

 

Chemical constituents:

It has been found that the water soluble fraction constituent 85% of guar gum and is commonly known as Guaran. It essentially consist of linear chain of (1→4) – β-D-mannopyranosyl units with α -D- galactopyranosyl units attached by (1→6) linkages. However, the ratio of D- galactose to D- mannose is 1:2.

 

Chemical test:

·         On being treated with iodine solution (0.1 N) it fails to give olive green colouration.

·         It does not produce pink colour when treated with ruthenium red solution (distrinction from sterculia gum and agar)

·         A 2% solution of lead acetate gives an instant white precipitate with guar gum (distinction from sterculia gum and acacia)

·         A solution of guar gum (0.25 in 10 ml of water) when mixed with 0.5 ml of benzidine (1% in ethanol) and 0.5 ml hydrogen peroxide produced no blue colouration. (distriction from gum acacia).

 

Uses:

About 1% mucilage of guar gum possesses similar viscosity to that of mucilage of acacia and a 3% mucilage similar to mucilage of tragacanth. it has 5to 8 times thickening power than starch. it is used as a protective colloid, a binding and disintegrating agent, bulk laxative, appetite depressant and in peptic ulcer therapy. Guar gum is good emulsifying agent. Industrially, this is used in paper manufacturing, printing, polishing, textile and also in food and cosmetic industries[10].

 

Guar gum is used in colon-delivery systems due to its drug release retarding property and susceptibility to microbial degradation in the large intestine. Selective delivery of 5–ASA to the colon can be achieved using guar gum as a carrier in the form of a compression coating over the drug core.

 

Guar gum, in the form of three-layer matrix tablets, is a potential carrier in the design of oral controlled drug delivery systems for highly water-soluble drugs such as trimetazidine dihydrochloride[11].

 

Gum Arabic

 

Synonym:

Gum Arabic, gum acacia, babul.

 

Biological source:

It consists of dried gummy exudation obtained from the stem and branches of Acacia Arabica wild (acacia Senegal)

 

Family:

Leguminosea

 

 

Geographical source:

It is found in Sudan, India, morocco, Shrilanka and Africa. In India, it occur in Punjab, Rajasthan and Western ghats. About 85 % of world supply of gum acacia is from Sudan.

 

Morphological character:

Colour- tears are cream – brown to red in colour, while powder is light brown.

Odour- Odorless

Taste- bland and mucilaginous.

Size and Shape – irregular brown tears of varying size.

 

Solubility – it is soluble in water, the watery solution is viscous and acidic. it is insoluble in alcohol.

 

Chemical constituent:

Polysaccharide arabin (mixture of calcium, magnesium and potassium salt of arabic acid) Arabic acid on hydrolysis group give D- galactose, L-arabinose, L- rhamnose, and D- glucuronic acid. Also contain enzyme oxidase and peroxidase[12].

 

The quality of GA are evaluated based on the parameters like color, odor, moisture content, viscosity, pH, specificrotation, tannins, and concentration of several metals. Mineral generally found are Ca, Na, K, P, and traces of Pb, Co, Cu, Zn, Ni, Cd, Cr, and Mn. If the quality of GA conforms well to international standards, only then are they exported. So, the proportions of the constituents are important parameter in quality regulation[13].

 

Chemical test:

1. Solution of lead sub acetate gelatinises the aqueous solution of Indian gum.

 

2. It does not produced a pink colour with the solution of ruthenium red.

 

Uses:

It is good binding agent is used in the preparation of lozenges, pastilles and compressed tablet. It is a gum of choice, as it is compatible with other plant hydrocolloids, as well as, starches and carbohydrates in the combination with gelatin, it is used to form coaceryates for micro capsulation of drug[12].

 

Karaya gum:

 

Synonyms:

Steralia gum

 

Biological source:

Gum karaya is dried gummy exudate obtained from the tree sterculia urens

 

Famil: Sterculiaceae.

Geographical source: sterculia urens is wide spread in India, especially in north centre part[14].

 

Cultivation collection:

Sterculia trees can grow up to 10 meter tall depending on the species and it can be used near of five times during its life time, with a total yields between 1-5 Kg by season. A very important fact is that the gum production is handcraft process. Local population obtained the gum by incisions or tapping of the trunks and the exudation begins immediately and continues for several days, the bulk exudes is dried in hot and dry climate, broken, cleaned to remove bark and foreign matter and classified according to the quality and stored. The highest quality of raw gum is collected during the hot months of April, May and June. The grades used in international trade are superior (No.1, 2 and 3) and siftings. Superior No. 1 gum is used in food and pharmaceutical preparations because have high viscosity, clear color, good solubility and moisture retention. The gum is offered as granules or powder. World production is around 3000 tons by year, near of half comes from India and the rest comes from North Africa. The major imported countries are USA, France and UK[15].

 

Morphological character:

Colour - white, pink or brown in colour

Odour – slight odour resembling acetic acid.

Taste - bland and mucilaginous taste.

Granular or crystal gums having a particle size ranging between 6 to 30 mesh and powdered gum having particle size of 150 mesh

 

Chemical constituent:

It is partially acetylated polysaccharides containing about 8% acetyl group and about 37% uranic acid residue it undergoes hydrolysis in an acidic medium to produce (+) galactose, (-)-rhamnose, (+)- galacturonic acid and a trisaccharide acidic substance. It contain a branched hetropolysaccharides moiety having a major chain of 1,4-linked a –(+) galacturonic acid along with 1,2 linked (-) -rhamnopyranose units with short (+)- glucopyranosyluronic acid containing sid chain attached 1-3 to the main chain i.e. (+) – galactouronic acid moieties.

 

Chemical test:

It readily produce a pink colour with a solution of ruthenium red.

Substituent/adulterant:

It is used as substitute for gum tragacanth.

 

Uses:

It is employed as a denature adhesive, paper industry, it is also employed as a thickening agent for dyes in the textile industry and bulk laxatives[10].

 

The fact that the gum is naturally available, inexpensive and non-toxic has also fostered the interest in developing the gum for pharmaceutical use. Further work has also shown its potential as a directly compressible matrix system in the formulation of controlled release tablets[14].

 

Toxicity:

Karaya gums are generally recognized as safe (GRAS) the FDA recognizes it as safe after the realization of toxicological, teratogenic and mutagenic studies. demonstrated that karaya gum have no harmful significant effects in vital organs or biochemical alterations in a study performed on male and female rats[15].

 

Shellac:

 

Lac resin thus obtained is known as stickle. It contains number of nonresinous impurities like wood particles, insect body, wax, dye etc., which are to be removed. The resin thus obtained is called seedlac which is further refined and converted into commercially acceptable form, known as shellac[16].

 

Synonyms:

Lacca

 

Biological source:

It is the resinous excretion of the insect loccifer (tachardia) lacca kerr, order homoptera belonging to family coccidae.

 

Geographical source:

It is produced in Burma, Assam and India.

 

Preparation:

It is found most abundantly on smaller branches and twings. These are broken off and the excretion is scraped from the twings with the help of curved knives. It is ground and the colouring matter extracted with water or dilute alkali solution, the exhausted shellac in dried from is known as seed lac. These alkaline extract on dryness gives lac dye. The seed lac is melted in along sousage shaped bag suspended over a charcoal fire and the lac is squeezed out. It is cooled and then stretched into a large sheet it is broken up to give flake shellac of commerce. Sometimes the shellac is poured into circular moulds and on cooling, stamped with the maker’s name. This form of shellac known as Button lac. When the shellac is dissolved in hot alkaline solution, bleached with chlorine or sulphurous acid, precipitated with acid, collected by filtration and pulled underwater into sticks, it is known as bleached shellac. When the shellac is kept under water, it is soluble in alcohol, but the solubility decreases on exposure.

 

Morphological character:

They occur in thin, very brittle, yellowish translucent sheets or powder. It is soluble in alcohol, ether, benzene and petroleum ether, sparingly soluble in oil of turpentine and in soluble in water.

 

Chemical Constituent:

It contain wax, red colouring matter, laccaic acid, resin, hydrolysis of the resins gives a complex mixture of aliphatic and alicylic hydroxyl acid and their polysters.

 

Uses:

 It is used for coating confections and medicinal tablets, finishing lather, in lacquers and varnishes, to manufacturing buttons, griding wheels, seeling wax, cements, inks, records, paper, for stiffing hats, in electrical machines, and in polishes[17].

 

Tragacanth

 

Synonyms:

gums tragacanth.

 

Biological source:

This gum is obtained from the branches of astragalus gummifer belong to family – leguminosae.

 

Geographical source:

It is native of southern and eastern Europe. The plant is widely distributed in iron, Afghanistan, Iraq, Syria and India. In India, few species of astagalus are available in garnwal, Shimla, and Kashmir and hilly region of kumaon[22].

 

Tragacanth when used as the carrier in the formulation of 1-and 3-layer matrices produced satisfactory release prolongation either alone or in combination with other polymer[4].

 

 

Morphological character:

Form – flatted lamellate, tough ribbon shaped pieces of horny structure, more or less curved or controlled.

Colour – white or faint yellow

Size – about 2.5 cm length.

Fracture -short

Odour – none

Taste – insipid and mucilaginous.

 

Chemical constituent:

It contain a complex polysaccharide carbohydrate. Water soluble tragacanth (30-40%) water insoluble barsorin (60-70%).

 

Tragacanth in turn consist of a) tragacanthic acid + (galacturonic acid + xylose +fructose + galactose) and (b) arabinogalactan +carabinose +galactose +galacturonic + rhamnose in small quantities) It is also contain 3 % starch and cellulose.

 

Chemical test

Solubility – partially soluble in water (distinction from acacia and agar).

 

Uses:

It is used as demulcent, suspending agent, binding agent, emulsifying agent, laxative.

 

It is used in adhesive and it is used in textile industry[22].

 

Xanthan

 

Synonyms:

gum xanthan, polysaccharide B -1459.

 

Biological source:

The polysaccharide gum is produced by the bacterium xanthomonascompestric on certain suitable carbohydrate[19].

 

Chemical Structure -

 

The primary structure of this naturally produced cellulose derivative contains a cellulosic backbone (β-D-glucose residues) and a trisaccharide side chain of β-D-mannose-β-D glucuronicacid-α-D-mannose attached with alternate glucose residues of the main chain. The terminal D-mannose residue may carry a pyruvate function, the distribution of which is dependent on the bacterial strainand the fermentation conditions. The non-terminal D-mannose unit in the side chain[4].

 

Preparation:

One of the latest techniques of biotechnology recombinant DNA technology, has been duly exploited for the commercial production xanthan gums.

 

Methodology:

First of all the genomic banks of xanthomonnus campestris meticulossly made in Escherichia coli by strategically mobilizing the broad host range cosmids being used as the vector. Subsequently, the conjugal transfer of the genes takes place from the E-coli into the nonmucoid x. compestris. Consequently, the wild types genes are duly separated by virtue of the unique ability to restore mucoid phenotype. as a result, a few of the cloned plasmid incorporated in the wild type strains of x. comprestic shall affrord an increase the production xanthan gum.

 

Interestingly, the commercial xanthan gum are available with different genetically controlled composition molecular weights and as their respective sodium, potassium or calcium salts.

 

Morphological character:

It is a cream coloured, odourless, and free flowing powder it dissolve swiftly in water on shaking and yields a highly viscous solution at relatively low concentration. the aqueous solution are extremely pseudo plastic in character. It give rise to a strong film an evaporation of its aqueous solution it is fairly stable and resistant to thermal degradation. The viscosity is independent of temperature between 10 to 70◦c. it is fairly compatible with variety of salts.

 

Chemical constituents:

Xanthan gum is composed of chiefly D- glucosyl, D -mannosyl, and D -glucosylluronic acid residue along with variant quatum of O – acetyl and pyruvicacid acetal. The primary structure essential comprises of a cellulose backbones with trisaccharide side chain and the repeating moiety being a pentasaccharide.

 

Uses:

Its potentially in chemically enhanced oil recovery is well known.

 

The inherent pseudo plastic property of its aqueous solution rendered both toothpaste and ointment. In enabling them to hold their shape and also to spread rapidly. It is extensively employed in pharmaceutical due to its superb suspending and emulsifying characteristics features[19].

 

CONCLUSION:

There are large numbers of natural polymers have been used in the development of dosage form such as starches, mucilages, gums and also dried fruits can be used as bindung agents. They also possess properties like disintegrating agents, fillers sustain releasing agent. Natural binder shown good binding property in wet granulation process they also modify the release of drug.

 

Furthermore they act as a vehicle for incorporated drug they transport the drug to the site of absorption and influence the bioavailability of drug and also provide the stability to the drug. Natural binders allow accuracy and precision in the dosage form. They also improve organoleptic properties of drug in order to enhance patient compliance. Optimize dosage performance during manufacturing process.

 

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13.      Patel S., and Goyal A., Application of natural polymer gum Arabic, International Journal of food properties 5- February 2015.

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15.      Gabriel A.L-M., Janeth N., Karaya gum – general topic and application, MMAJI,9(4), 2013[111-116].

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Received on 30.10.2019         Modified on 25.11.2019

Accepted on 18.12.2019       ©A&V Publications All right reserved

Res.  J. Pharma. Dosage Forms and Tech.2019; 11(4):288-295.

DOI: 10.5958/0975-4377.2019.00048.X