Natural Polymers in Fast Dissolving Tablets

 

 Ratnaparkhi M.P.*, Karnawat G.R., Andhale R.S.

Dept. of Pharmaceutics, Marathwada Mitra Mandal’s College of Pharmacy, Thergaon (Kalewadi),

Pune - 411033 India.

 

ABSTRACT:

Oral route is most preferable route of administration for various drugs, because it is convenient, economical, safest route. Fast dissolving tablets are popular nowadays, as they disintegrated in mouth within a few seconds without using water for swallow. Problems like Dysphagia in pediatric and geriatric patients have been overcome by formulating Fast dissolving tablet. Natural polymers are preferable because they are chemically inert, nontoxic, less expensive, biodegradable, and available easily than synthetic polymers. Natural polymers are obtained from the natural origin so they are devoid of any side effect. It is proved from the previous studies that Natural polymers are more-safe and effective than the synthetic polymers. Natural polymers improve the properties of tablet and they are used as binder, diluent, superdisintegrant, they also enhance the solubility of poorly water-soluble drug, decrease the disintegration time and provide nutritional supplement. The aim of the present article is to study various natural polymers used in fast dissolving tablets.

 

 

 

INTRODUCTION:

Fast Dissolving Tablets are a solid dosage form, which disintegrate or dissolve within 1 min when placed in the mouth without drinking of water or chewing. “Fast dissolving tablets” are also known by various synonyms like, RapiMelt, Quick Disintegrating, Mouth Dissolving, Orally Disintegrating, Oro-Dispersible, Quick Dissolve, Melt-in Mouth, porous tablets, etc. Recently fast dissolving tablet technology has been approved by the United State Pharmacopoeia (USP), Centre for Drug Evaluation and Research (CDER). This formulation is convenient for the patients suffering from Dysphagia (Difficulty in swallowing), risk of choking, and hand tremors. FDTs are usually beneficial for geriatric, pediatric and bedridden, nauseous or noncompliant patients. FDTs have more bioavailability than conventional tablets, quick onset of action as its absorption is very fast with in few seconds, better in taste and hence the palatability of the tablet is improved, it also improve the patient compliance.

 

The polymers obtained from the natural origin are preferred over synthetic polymers because they are more-effective and safe. Natural polymers are used in most of the formulations. Natural polymers are economical and easily available in the sufficient quantity. They are non-toxic so do not cause any harmful side effects on the body. Natural polymers are environmental friendly, they are biodegradable in nature, and they do not cause any pollution. Natural polymers have more patient compliance, they provide nutritional supplement and are renewable. Synthetic polymers have certain drawbacks viz high cost because they are prepared by different procedures or reactions by using costly instruments and equipment’s and it require a lot of time to form a synthetic polymer. Synthetic polymers are non-renewable sources they have more side effects as they are prepared by different reactions using different chemicals which can interact with the body components and cause allergic reactions in the body, they can cause toxicity in the body, synthetic polymer cause environmental pollution during their synthesis, synthetic polymers are non-biodegradable and patients generally do not prefer synthetic polymers because of their side effects so these are less patient compliant.

 

The aim of this review is to study different natural polymers and their pharmaceutical action which are used in fast dissolving tablets, and comparison of the properties of tablet improved by using natural polymers over synthetic polymers. Natural polymers improve the tablet disintegration time, as the tablet gets disintegrated rapidly within few seconds because of the use of natural polymer as superdisintegrant. Natural polymers used are like Soy Polysaccharide, Gellangum, dehydrated banana powder etc., they increase the porosity of the granules so that the tablet formed is easily get dissolved without the use of water in the mouth, the drug get rapidly released from the tablet by the action of natural polymer. Natural polymers have appreciable effects on hardness and friability.^1,2

 

Ideal properties of natural polymers:

The polymer should have following properties to be used in Fast dissolving tablets formulation.

§  Polymer should be non-toxic, non-irritant and devoid of leachable impurities

§  It should have good wetting and spread ability property

§  The polymer should exhibit sufficient peel, shear and tensile strengths

§  The polymer should be readily available and should not be very expensive

§  It should not aid in cause secondary infections in the oral mucosa/ dental region

§  It should have a good mouth feel property

§  The polymers employed should have good shelf life

§  It would be ideal to have a polymer that would have local enzyme inhibition action along with penetration enhancing property^3,4

 

List of natural polymers:

1.     Chitin and Chitosan.

2.     Guar Gum.

3.     GumKaraya

4.     Agar and Treated Agar.

5.     Fenugreek Seed Mucilage.

6.     Soy Polysaccharide

7.     Gellan Gum

8.     Mango Peel Pectin.

9.     Lepidiumsativum Mucilage.

10. Plantagoovata Seed Mucilage.

11. Aeglemarmelos Gum

12. Locust Bean Gum.

13. Mangiferaindica Gum (MIG).

14. Hibiscus Rosa Sinensis Mucilage and Treated Agar.

15. Dehydrated Banana Powder (DBP).

16. Cassia fistula gum

17. Cucurbita Maximum

18. Ocimum Americanum Seed Mucilage

19. Pullulan

20. Rosin

21. Ocimumbasilicum seeds

22. Xanthan gum

23. Maltodextrin

24. Sodium alginate

25. Gum acacia

26. Gum tragacanth

27. Gum Carrageenan

 

1.     Chitin and Chitosan:

Chitin is a long chain polymer of 𝛽-(1→4)-N-acetyl-D-glucosamine. It is a natural polysaccharide obtained from crab and shrimp shells. It has amino group covalently linked to acetyl group as compared to liberate amino group in chitosan. Chitosan is cationic polysaccharide derived from the N-deacetylation of Chitin, which is the structural element in the exoskeleton of crustaceans (such as crabs and shrimp) and cell walls of fungi. It is the most abundant natural and non-toxic polymer in nature. Chitosan products are highly viscous, resembling natural gums.^5,6

 

2. Guar Gum:

Guar gum is natural high molecular weight polysaccharides (approximately 50, 000-8, 000, 000), commonly used in cosmetics, food products and in pharmaceutical formulations. It is made up of galactomannans units combined through glycosidic linkages and obtained from the endosperm of the seed of the guar plant, Cyamopsistetragonoloba (L) Taub. It also known by various synonyms like Galactosol, guar flour, jaguar gum, meprogat, meyprodor. It is used as stabilizer, thinner, and emulsifier in many pharmaceutical preparations. The seeds of Guar are de-husked, milled and screened to obtain the guar gum. It is produced as a free-flowing, off-white powder. Guar gum solutions are stable in the pH range of about 1.0–10.5. It dissolves rapidly in cold as well as in hot water. It is insoluble in organic solvents, its economical nature makes it popular in gums and stabilizers industry. In pharmaceuticals, guar gum is used in solid-dosage forms as a binder and disintegrant, and in oral and topical products it is used as a suspending, thickening, and stabilizing agent, and also as a controlled-release carrier.^7,8

 

3. GumKaraya:

Gum karaya is a complex polysaccharide of high molecular weight, obtained from the exudation of trees of the ‘genus Sterculia’, Family-Sterculiaceae. Its synonyms are Karaya, gum karaya, Sterculia, gum sterculia, Kadaya, Katilo, Kullo, Kuterra. Chemically, gum karaya is an acid anionic polysaccharide and composed of the sugarslike, containing 43%. D-galacturonic acid, 13% D-galactose and 15% L-rhamnose. Gum karaya is compatible with proteins, carbohydrates and plant hydrocolloids. It is used as a adhesive, binding agent in pharmaceuticals. The colour of a gum karaya powder ranges from off white to pink to tan. It can be used as a alternative for gum tragacanth. The gum has ability to absorb water and its wells to 70–100 times greater than its original volume. The high viscosity nature of gum limits its uses as binder and disintegrant in the development of conventional dosage form^9,10,11

 

4.Agar and Treated Agar:

Agar is adried gelatinous complex polysaccharide which is mainly extracted from the species of Gelidium, Gracilaria, Acantkopeltis, Ceramium, and Pterocladia. Agar is mainly composed of two fractions, agarose and agaropectin. Agarose is responsible for gel vigor and agaropectin is responsible for the viscosity of agar solutions. Agar is widely used due to its gelling and stabilizing properties.). Agar is colourless, odourless having mucilaginous taste. It is available in the form of strips, sheet flakes or coarse powder. Agar can form stiff gel at low concentrations, typically between 0.5% and 2%.^12,13

 

5. Fenugreek Seed Mucilage:

An herbaceous plant, Trigonella Foenum-graceum, of leguminous family commonly known as Fenugreek. It has found wide applications as a food, a food additive, and as a traditional medicine in every region. The polysaccharide mucilage obtained from Fenugreek Seeds. Mucilage is cream yellow colored amorphous powder. This is quickly dissolves in warm water to form viscous colloidal solution. Its physicochemical parameters are studied and found to have 22.25^oC, 0.64g/cc, 15.20% values as angle of repose, bulk density and compressibility index respectively. The mucilage of Fenugreek does not dissolve in water, when it is exposed to fluids, it forms a viscous gummy mass. Fenugreek seed mucilage can be used as super-disintegrating agent in the formulation of various fast dissolving tablets compared to synthetic superdisintegrants.^14,15,16

 

6. Soy Polysaccharide:

Soy polysaccharide is a high molecular weight water soluble polysaccharide, which is obtained from soy beans. This is used as a disintegrant in formulation of tablets made by direct compression method using lactose and dicalcium phosphate dihydrate as fillers. Soy polysaccharides does not contain sugar or starch, therefore it can be used in nutritional products. Soy Polysaccharides mainly contains cellulose, arabinogalactan, arabinan, and an acidic polysaccharide complex.¹⁷

 

7. Gellan Gum:

Gellan Gum is obtained from bacterium, Pseudomonas elodea. It is a high molecular weight water soluble linearanionic polysaccharide, biodegradable polymer mainly composed of a repeating unit of tetrasaccharide, that are two residues of D-glucose and one of each residues of D-glucuronic acid and L-rhamnose. It is manufactured by fermentation process. It is available in two forms-High acyl (HA) and Low acyl (LA). Gellan Gum is used as a tablet superdisintegrant, as they swells rapidly when comes in contact with water with owing to its high hydrophilic nature. In current study, the complete disintegration of tablet was observed within 4 minutes with Gellan gum concentration of 4 % w/w and 90 % of drug dissolved within 23 minutes.^{18,19, 20}

 

8. Mango Peel Pectin:

Mango peel contains 20–25% of the mango processing waste which is good source for the extraction of pectin. This pectin is of good quality and felicitous for the preparation of Film and Gelly. Pectin is a structural heteropolysaccharide which is a hydrophilic colloid. Mango peel pectin utilized as a superdisintegrant, due to its good solubility and higher swelling index, it may be used in the formulation of fast dispersible tablets. This pectin is composed of Anhydrogalactouronic acid and methoxyl contents.^21,22

 

9. Lepidiumsativum Mucilage:

Lepidiumsativum known as garden cress ora Saliyo, belongs to Cruciferae family. Lepidiumsativum Seeds contain a large proportion of mucilage, dimeric imidazole alkaloidslepidine B, C, D, E and F and two imidazole alkaloids semilepidinoside A and B. Mucilage of Lepidiumsativum has various properties like binding, disintegrating, gelling etc. The mucilage can be extracted from seeds by different procedures. The extracted mucilage is used for formulation of fast dissolving tablets. Mucilage is found to be a brownish white powder which decomposes above 200°C and have pungentodor. On its various physicochemical characteristics, the values of swelling index, angle of repose, bulk density and tapped density are estimated as following 18, 32oC, 0.58g/cc and 0.69g/cc respectively.^{23,24, 25}

 

10. Plantagoovata Seed Mucilage:

Ispaghula mucilage consists of Epidermis of the dried seeds of Plantagoovata contains mucilage. Plantagoovata seed mucilage is obtained by grinding off the husk. Mucilage of Plantagoovata has characteristics like binding, disintegrating, and sustaining properties. Fast disintegrating tablets of prochlorperazine maleate were formulated with use of PlantagoOvata (2-8% w/w) as superdisintegrant by direct compression method to improve the patient compliance^26,27,28

 

11. Aeglemarmelos Gum (AMG):

Aeglemarmelos Gum is obtained from the fruits of Aeglemarmelos belonging to the family Rutaceae. This disintegrated faster and consistently than the croscarmellose sodium. The ripened fruit pulp is red in color which having mucilaginous and astringent taste. The pulp contains carbohydrates, proteins, vitamin C, vitamin A, angelenine, marmeline, dictamine, o-methyl fordinol and isopentylhalfordinol. AMG is prepared by heat treatment technique. It increases the solubility of poorly soluble drugs, increases glucose level and glycosylated hemoglobin in diabetic patients, decreases plasma insulin and liver glycogen in diabetic patient, decreases lipid peroxidation, stimulates macrophage functioning, and causes significant deviation in the GSH (glutathione) concentration in liver, kidney, stomach, and intestine. Purified gum Polysaccharide contains D-galactose, D-galacturonicacid, L-Rhamnose and L-arabinose.²⁹

 

12. Locust Bean Gum:

It is known as carob bean gum. Locust bean gum is a galactomannan vegetable gum extracted from the seeds of the carob tree, It is a galactomannan vegetable gum extracted from the seeds of carob tree (Ceretoniasiliqual) found in Mediterranean region. Locust bean gum is used as gelling and thickening agent, bio adhesive, and it also enhances the solubility. The gum is a white to yellowish-white in color and odorless powder. It is insoluble in most organic solvents. It is dispersible in either hot or cold water, forming a sol having a pH between 5.4 and 7.0, which may be converted to a gel. It is partially soluble in water at normal temperature and soluble in hot water. It requires heating to above 85°C for 10 min for complete solubility.³⁰

 

13. Mangiferaindica Gum (MIG):

Synonym for Mangiferaindicais mango, and it belongs to Anacardiaceae family. It is nontoxic and used as disintegrant, binder, suspending agent, and emulsifying agent in different formulations. The gum powder is white to off white in colour, and the powder was soluble in water and virtually insoluble in acetone chloroform, ether, methanol, and ethanol. It is facilely available, and gum is devoid of toxicity, and each and every component of the tree has pharmacological activity like diuretic, astringent, diabetes, asthma, diarrhea, urethritis, and scabies.³¹

 

14.Hibiscus Rosa Sinensis Mucilage:

Itis also called shoe flower plant, China rose, and Chinesehibiscus; it belongs to the family Malvaceae. Mucilagesare used as thickeners, suspending agent, water retentionagent, and disintegrants. The plant is facilely available and its leaves contain mucilage. The constituents of mucilagesare L-rhamnose, D-galactose, D-galacturonic acid, and D-glucuronic acid. The percentage yield of mucilage is varies from 15-20%. Other physicochemical parameters of mucilage are also evaluated. The results of swelling ratio, angle of repose, bulk density and compressibility index are observed as 9, 26.5oC, 0.65g/cc, 16% respectively.^{32, 33}

15. Dehydrated Banana Powder (DBP):

Banana is additionally called plantain. DBP is belongs to the family Musaceae. It contains vitamin A, so it is used in the treatment of gastric ulcer and diarrhea. It also contains vitamin B6, which used in reducing the stress and solicitousness. It is a very good source of energy due to highcarbohydrate content, and it contains potassium, which is responsible for more preponderant brain functioning.^{34, 35}

 

16. Cassia fistula gum:

Cassia fistula is also referred as golden shower, purging cassia, or Indian laburnum. It belongs to family Fabaceae. Gum obtained from the seeds of Cassia fistula tree. Cassia fistula gum comprises of β-(1→4) linked d-mannopyranose units with random distributions of α (1→6) linked d-galactopyranose units as its side chain is having mannose: galactose ratio of 3:0. As compared to native gumCarbamoylethylation and Carboxymethylation of Cassia gum is reported to improve cold water solubility, improve viscosity and increase microbial resistance. Fistula gum is utilized as superdisintegrant in the formulation development of FDT.³⁶

 

17. Cucurbita maxima pulp powder:

Cucurbita is genus of herbaceous vines, which belongs to the family, Cucurbitaceae 0. To obtain the cucurbita maxima pulp powder, first clean the fruit with water to remove the dust, and then peel from peel was removed. The seeds were removed and pulp was put into mixer to produce viscous liquid. This liquid was further lyophilized to get solid porous mass, size reduced and powder was collected. The collected powder was screened through 80# sieve, and stored properly. Naturally obtained Cucurbita maxima pulp powder utilized as a good tablet disintegrant., and also acts as pharmaceutical adjuvant.³⁷

 

18.Ocimumamericanum seed mucilage:

Patel et al prepared the propanolal hydrochloride tablets using ocimumamericanum seed mucilage using various concentrations like 2, 4, 6, 8, 10% the optimum concentration of mucilate for rapid dissolution is shown at 10% and the same concentration with starch and propanaolal hydrochloride is prepared and shows disintegration time of 269 seconds while ocimum shows the disintegration in 154 seconds. The hardness friability drug content is within limit.³⁸

 

19. Pullulan:

Pullulanis naturalwater-soluble polysaccharide, produced from starch by fungus aureobasidiumpullulans fermentation. It is maltotriosetrimer made up of α-(1 → 6)-linked (1 → 4)-α-d-triglucosides with a chemical formula of c₆h₁₀o_5. The dry powder of pullulan is white in color, tasteless and odorless. The compound is nontoxic, nonmutagenic, noncarcinogenic, biodegradable, and edible. It is nonhygroscopic in nature; decomposes at high temperatures of 250-280°^c. Pullulan forms transparent, water-soluble, fat-resistant, antistatic films. Films are of low oxygen and moisture permeability and have excellent mechanical properties³⁹

 

20. Rosin:

Rosin is also called as colophony or Greek pitch. It is a solid form of resin obtained from pines and some other plants, mostly conifers. It is semi-transparent and varies in color mainly consists of various resin acids, especially abietic acid. Rosin derivatives have an excellent film forming and coating properties. Rosin is brittle and friable in nature, having a faint piney odor. It is typically a glassy solid, when brought into solution they form crystals. It is soluble in alcohol, ether, benzene and chloroform. Rosin film is prepared by casting or solvent evaporation method.⁴⁰

 

21.Ocimumbasilicum seeds:

Ocimumbasilicum is also referred as great basil or saint-joseph's-wort. This is an herb, which belongs to the family lamiaceae. The mucilage is present in the pericarp of ocimumbasilicum seed (sweet basil seed), this mucilage is utilized as a natural superdisintegrant in the fast dissolving tablet. O. Basilicum mucilage was found to be soluble in distilled water and insoluble in other solvents. The mucilage mainly consisted of some high molecular weight polysaccharides (2320 kDa), which was composed of glucose, galactose, mannose, arabinose, xylose and rhamnose.^{41,42, 43}

 

22. Xanthan gum:

Xanthan Gum is a high molecular weight polysaccharide derived from bacteria, Xanthomonascampestris through a process of fermentation. Xanthan gum is having highhydrophilicity and low gelling tendency. It has low water solubility and extensive swelling properties which helps in faster disintegration. Xanthan gum viscosity has excellent stability over a wide range of pH and temperature. Xanthan gum is resistant to enzymatic degradation.⁴⁴

 

23. Maltodextrin:

Maltodextrin is an oligosaccharide which produced from starch by partial hydrolysis. It is usually a hygroscopic spray-dried powder, white in color, easily digestible, being absorbed rapidly and moderately sweet or almost flavorless. Maltodextrin is mainly composed of a mixture of chains that vary from three to seventeen glucose units long. Maltodextrin is non-toxic, edible and is available in powdered form.⁴⁵

 

 

24. Sodium alginate:

Alginate is an indigestible biomaterial produced by brown seaweeds. It is a source of dietary fibre. chieflysodium alginate consists of sodium salt of alginicacid; it is a mixture of polyuronic acids composed of residues of D-mannuronic acid and L-guluronic acid. Alginate has colloidal properties, it helps to form biopolymer film or coating component, which include thickening, stabilizing, suspending, film forming, gel producing, and emulsion stabilizing. An alginate solution has the gelling capacity in presence of Calcium. Edible films prepared from alginate form strong films and due to their hydrophillicnature they exhibit poor water resistance. A mixture of starch and alginate to form edible film improve the mechanical properties of film.⁴⁶

 

25 Gum acacia:

Gum acacia, also known as Arabic gum, acacia, Senegal gum and Indian gum, belonging to Leguminosae family. It is made of hardened sap of acacia tree. The main constituent of gum acacia is arabinogalactan, a biopolymer consisting of arabinose and galactosemonosaccharides. Gum Acacia has wide industrial uses as a stabilizer, thickening agent, emulsifying and suspending agent, as well as tablet binder. The Gum acacia having light orange to pale white in color also it is water soluble.⁴⁷

 

26. Gum tragacanth:

Tragacanth gum is a plant-derived molecule obtained from the stems and branches of Astragalus, having a molecular weight of about 840 kDa. It is a viscous, odorless, tasteless, and water-soluble. It is a branched and anionic carbohydrate composed of a complex mixture of polysaccharides. Tragacanth gum is composed of two major fractions: one water soluble -tragacanthin and another that is not soluble but instead water swellable–bassorin. Tragacanth is used as a suspending agent, emulsifying agent, thickener, and stabilizer. Tragacanth is stable at a pH 4-8.^48,49

 

27. Gum Carrageenan:

Carrageenan is an anionic, high molecular weight above 100 kDapolysaccharide, obtained from certain species of red seaweed. It is composed of alternate units of β-D-galactose and 3, 6-anhydro-α-Dgalactose, linked by α-(1, 3) and β-(1, 4) glycosidic unions. carrageenans can be obtained, are kappa (κ), iota (ι), and lambda (λ). Carrageenan is composed of sulfated polygalactan which contain 15 to 40% of ester-sulfate content. It is mainly formed by alternate units of d-galactose and 3, 6-anhydro-galactose (3, 6-AG) joined by α-1, 3 and β-1, 4-glycosidic linkage. Carrageenans are used as gelling, thickening, and stabilising agents.⁵⁰

 

 

List Of Natural Polymers And Drugs With Their Effect

Table No. 1

 

Table No. 2

 

CONCLUSION:

Fast dissolving tablets offer numerous significant advantages over conventional dosage forms because of improved efficacy, enhanced bioavailability, rapid onset of action along with better patient compliance and acceptance. Use of natural polymers has considerable outcome in the design of Fast dissolving tablets as compared to synthetic polymers. Natural polymers incremented the drug release rate from the tablet and decremented the dissolution and disintegration time. Natural polymers are preferred over synthetic ones as they are non-toxic, facilely available at low cost, utilized in low concentration and are naturally extracted. Natural polymers exhibit faster drug dissolution and increased bioavailability, thereby, resulting in efficacious therapy and improved patient compliance.

 

ACKNOWLEDGEMENT:

I would like to thanks our Principle sir Dr. M. J. Patil and Dr. Avinash R. Tekade, Dean and HOD of Pharmaceutics, Dr. Mukesh P. Ratnaparkhi, HOD of D. Pharm. Also our college member be like librarian, computer experts, and all other persons.

 

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Received on 18.12.2019          Modified on 20.03.2020

Accepted on 28.05.2020         © RJPT All right reserved