Insights into Polymers: Film Formers in Mouth Dissolving Films

Drug Invention Today ISSN: 0975-7619 Review Article

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Corresponding Author:

Mohd Yasir, Department of Pharmaceutics, ITS Pharmacy College, Muradnagar, Ghaziabad- 201206 (UP), India Received 27-09-2011; Accepted 21-11-2011

December, 2011 Drug Invention Today, 2011, 3(12), 280-289 280

Insights into Polymers: Film Formers in Mouth Dissolving Films Priyanka Nagar, Iti Chauhan, Mohd Yasir* Department of Pharmaceutics, ITS Pharmacy College, Muradnagar, Ghaziabad- 201206 (UP), India

INTRODUCTION

Oral route is the most preferred and acceptable route due to ease of ingestion, pain avoidance, versatility and most importantly, the patient compliance [1]. Mouth dissolving

films, a new drug delivery system for the oral route, was developed based on the technology of the transdermal patch. This delivery system consists of a very thin oral strip, which is

simply placed on the patients tongue or any oral mucosal tissue, instantly wet by saliva, film rapidly hydrates and then disintegrates and/or dissolve to release the medication [2].

Oral film includes various ingredients for its formulation

which includes polymers, active pharmaceutical ingredient, film stabilizing agents, sweeteners, flavors, colors, saliva stimulating agents, preservatives, surfactants etc but the first

and far most a very essential ingredient which helps in film formation is a Polymer.

Film is prepared using hydrophilic polymers that rapidly dissolves on the tongue or buccal cavity, delivering the drug to the systemic circulation via dissolution when contact with

liquid is made [3]. A variety of polymers are available for preparation of fast

dissolving oral films. The use of film forming polymers in oral films has attracted considerable attention in medical and

nutraceutical applications. The selection of polymer, is one of the most important and critical parameter for the successful development of the film formulation. The polymers can be

used alone or in combination to obtain the desired film properties. The film obtained should be tough enough so that there won't be any damage while handling or during

transportation. The robustness of the strip depends on the type and amount of polymer in the formulation [4]. As the strip forming polymer (which forms the platform for the oral

film) is the most essential and major component of the film, at least 45%w/w of polymer should generally be present based

on the total weight of dry film [5] but typically 60 to 65%w/w of polymer is preferred to obtain desired properties [6].

The polymers employed in the oral film preparation should be: [7]

1. Non-Toxic and Non-Irritant

2. Devoid of leachable impurities 3. Should not retard disintegration time of film 4. Tasteless

5. Should have good wetting and spread ability property

6. Should exhibit sufficient peel, shear and tensile strength

7. Readily available

8. Inexpensive 9. Should have sufficient shelf life 10. Should not aid in causing secondary infections in

the oral mucosa or dental regions Presently, both natural and synthetic polymers are used for

preparation of fast dissolving oral film. Table 1 represents various natural & synthetic polymers which are nowadays used in MDF preparation. Table 4 and 5 represents quality

parameters of different natural and synthetic polymers respectively. Table 6 represents a patent review on different

polymers used for the preparation of MDF. Table: 1 Polymer Available Preparation of MDF

S.No. Polymer Examples Reference

1. Natural

Polymers Pullulan, Starch, Gelatin,

Pectin, Sodium alginate, Maltodextrins, Polymerized

Rosin

[7]

2. Synthetic Polymers

Hydroxy propyl methyl

cellulose, Sodium Carboxy

methyl cellulose, Poly

ethylene oxide, Hydroxy

propyl cellulose, Poly vinyl

pyrrolidone, Poly vinyl

alcohol

[7]

NATURAL POLYMERS 1. Pullulan Pullulan is a unique biopolymer with many useful traits and hundreds of patented applications. It is a water soluble,

neutral linear polysaccharide consisting of α–1, 6-linked maltotriose residues. It is a fungal exopolysaccharide produced from starch by Aureobasidium pullulan. [8]

Commercially pullulan is made from fermentation process. Other microbial sources of pullulan include Tremella

mesenterica [9], Cytaria harioti [9], Cytaria darwinii [9], Cryphonectria parasitica [10], Teloschistes flavicans [11], Rhodototula bacarum [12].

Mouth dissolving films is a new drug delivery system for oral route. This delivery system consists of a very thin oral strip, which is simply placed on the patients tongue or any oral mucosal tissue, instantly wet by saliva, film rapidly hydrates and then disintegrates and/or dissolve to release the medication. In the formulation of oral film, the most important ingredient is

polymer which helps in film formation. Mainly hydrophilic polymers are used in mouth dissolving films. The present article highlights various natural and synthetic polymers, their properties and applications in oral film delivery system. Keywords: Fast dissolving oral film, polymers, patient compliance, disintegrates, strip etc.

Priyanka Nagar, et al. : Insights into Polymers: Film Formers in Mouth Dissolving Films


Pullulan has following properties [13]

It is impermeable to oxygen, non-hygroscopic and

non-reducing.

It is easily soluble in hot and cold water to make clear and viscous solution and also has high

adhesion and film forming abilities.

The principal advantages of pullulan are that it is a

nonionic polysaccharide and is blood compatible,

biodegradable, non-toxic, non immunogenic, non-mutagenic and non carcinogenic.

Bender et al. (1959) studied the novel glucan and named it "pullulan." During the 1960s, the basic structure of pullulan was resolved [14]. The unique linkage pattern of pullulan

endows the polymer with distinctive physical traits, including adhesive properties and the capacity to form fibers, compression moldings, and strong oxygen impermeable

films. Fig. 1 depicts the chemical structure of pullulan.

Fig. 1: Chemical structure of pullulan

Bender and Wallenfels (1961) discovered the enzyme

pullulanase, which specifically hydrolyzes a (1, 6) linkages in pullulan and converts the polysaccharide almost quantitatively to maltotriose. Pullulan can be considered to

be a polymer of panose or isopanose subunits, which may reflect more accurately the biosynthetic origins of the molecule. Catley and coworkers subsequently established the

occurrence of a minor percentage of randomly distributed maltotetraose subunits in pullulan [15].

The regular occurrence of alpha-(l, 6) linkages in pullulan interrupts what would otherwise be a linear amylase chain.

This unique linkage pattern is believed to be responsible for the structural flexibility and solubility of pullulan, resulting in distinct film and fiber-forming characteristics which is not

exhibited by other polysaccharides. Pullulan films are thermally stable and possess anti-static and

elastic properties and can be developed into compression mouldings [16]. Films made from pullulan are highly water

soluble, colorless, tasteless, odorless, transparent, flexible and heat sealable. Films made up of pullulan are clear and highly oxygen-impermeable with excellent mechanical properties.

The oxygen resistance of pullulan films is suitable for protection of readily oxidized fats and vitamins in food. Pullulan film has 300 times stronger oxygen barrier than

HPMC film and 9 times stronger than gelatin film of the same thickness [17]. 2. Starch / Modified Starches Starch is the major carbohydrate reserve in plant tubers and

seed endosperm where it is found as granules, each typically containing several million amylopectin molecules accompanied by a much larger number of smaller amylose

molecules. Amylose is responsible for the film-forming capacity of starch [18]. The largest source of starch is corn (maize) with other commonly used sources being wheat,

potato, tapioca and rice. Genetic modification of starch crops has recently led to the development of starches with

improved and targeted functionality. Starch is used to produce biodegradable films to partially or entirely replace plastic polymer. The films are transparent or translucent,

flavorless, tasteless and colorless [19]. However, starch film application is limited by poor mechanical strength and its

efficient barrier against low polarity compound. Many research reported that film forming conditions have an effect on crystallinity of the starch films and, therefore, their

properties [20]. Films of high-amylose corn starch or potato starch was more stable during aging, lost little of their elongation and had not or a slight increase in tensile strength

[20]. Films from cassava starch were found to have good flexibility and low water permeability, indicating the potential application as edible film former [21]. Plasticizer is

generally required for starch-based edible films to overcome film brittleness. The most commonly used plasticizers for starch films are glycerol and sorbitol [21].

Recently, Hu et al have developed starch films from oxidized

potato starch (OPS) with glycerol as a plasticizer. The OPS films were transparent and flexible with interesting mechanical properties. Starches used in forming oral films

are: 1. Pre gelatinized starch includes lycoat 2. Modified starch

3. Amylase rich starch Modified starch is also used for preparation of oral film. Due

to low cost of this excipient it is used in combination of pullulan to decrease the overall cost of the product. Fig. 2

depicts the chemical structure of starch.

Fig. 2: Chemical structure of starch New film-forming polymer Lycoat NG 73 Lycoat NG 73 is an excellent film forming polymer from pea starch prepared by chemical and physical treatments [22].

Lycoat is a novel granular hydroxypropyl starch polymer that has been designed especially for orodispersible films. Lycoat disperses easily in cold water without formation of lumps.

Simple cooking by heating will develop its film-forming ability. It gives a homogenous solution as viscosity develops progressively by cooking thus preventing formation of lumps

and agglomerates. It can be used as the sole film forming polymer to formulate ODF with excellent functionality

without the need of additional film forming agent [22]. 3. Sodium Alginate

Chiefly sodium alginate consists of sodium salt of alginic acid, which is a mixture of polyuronic acids composed of residues of D-mannuronic acid and L-guluronic acid.

Alginate is an indigestible biomaterial produced by brown seaweeds (Phaeophyceae, mainly Laminaria). It is present in the



cell walls of brown algae as the calcium, magnesium and sodium salts of alginic acid [23]. Fig. 3 depicts the chemical

structure of sodium alginate.

Fig. 3: Chemical structure of sodium alginate

Alginate has a potential to form biopolymer film or coating

component because of its unique colloidal properties, which include thickening, stabilizing, suspending, film forming, gel producing, and emulsion stabilizing property [23]. Edible

films prepared from alginate are strong and exhibit poor water resistance because of their hydrophilic nature. The water permeability and mechanical attributes can be

considered as moderate compared to synthetic films. Mechanical properties of alginate film can be improved by

addition of starch [24]. 4. Pectin Pectin is a high-molecular-weight, complex anionic polysaccharide composed of β-1, 4-linked d-galacturonic acid residues, wherein the uronic acid carboxyls are either fully

(HMP, high methoxy pectin) or partially (LMP, low methoxy pectin) methyl esterified. Pectin is found in fruit and

vegetables and mainly prepared from citrus peel and apple pomace [25].

Fig. 4: Chemical structure of pectin

Pectins are good film formers with good capacity to carry

drugs and are particularly suitable for low pH applications. Solubility of the films depends on molecular weight of the polymer, but generally it dissolves slowly in the oral cavity.

In a study, it was found that degradation of pectin reduces its intrinsic viscosity from 4.9dl/g to 2.5dl/g making it more

suitable for use in oral films [25]. Fig. 4 shows the chemical structure of pectin. 5. Gelatin Gelatin is a generic term for a mixture of purified protein fractions obtained either by partial acid hydrolysis (type A

gelatin) or by partial alkaline hydrolysis (type B gelatin) of animal collagen and/ or may also be a mixture of both. The

protein fractions consist almost entirely of amino acids joined together by amide linkages to form linear polymers. Gelatin is prepared by the thermal denaturation of collagen, isolated

from animal skin, bones and fish skins [26]. It is readily soluble in water at temperatures above 40ºC, forming a viscous solution of random-coiled linear polypeptide chains.

Mammalian gelatins commonly have better physical properties and thermo stability than most fish and this has

been related mainly to their higher amino acid content [26]. The use of mammalian gelatin in the elaboration of edible film or coatings was very well studied until the sixties, which

resulted in many patents mainly in the pharmaceutical area [27]. The properties and film forming ability of gelatin is

directly related to the molecular weight, i.e., the higher the average molecular weight, the better the quality of the film. The molecular weight distribution depends mainly on the

degree of collagen cross-linking and the extraction procedure [27]. However, in the year 2000, the gelatin films formed principally with fish gelatin have returned to the attention of

researcher. Gelatin films were found to dissolve rapidly, excellent carriers for flavors and produce a smooth mouth feel [27]. Fig. 5 depicts the chemical structure of gelatin.

Fig. 5: Chemical structure of gelatin

6. Polymerized Rosin

Rosin, formerly called colophony or Greek pitch (Pixgraeca), is a solid form of resin obtained from pines and some other plants, mostly conifers, produced by heating fresh liquid resin

to vaporize the volatile liquid terpene components [28]. Rosin and its esters are reported to have excellent film

forming properties and can be used for enteric coating and delayed release of drugs [29]. Being natural in origin, rosin and its derivatives are expected to be biodegradable In-vivo.

Polymerized rosin is made from gum rosin by polymerization via catalyst. It has many excellent properties including high softening point, anti-oxidation, non-crystallizing and good

compatibility with film-forming agent [29]. 7. Maltodextrin

It is a non-sweet nutritive saccharide polymer. It is produced from starch by partial hydrolysis and is usually found as a

creamy-white hygroscopic spray dried powder. Maltodextrin consists of D-glucose units connected in chains of variable length. The glucose units are primarily linked with α (1→4)

glycosidic bond. Maltodextrin is typically composed of a mixture of chains that vary from three to nineteen glucose units [30]. Maltodextrins are classified by DE (dextrose

equivalent) and have DE between 3-20. Higher the DE value, shorter the glucose chains, higher the sweetness and higher the solubility. It is used as film forming agent. Table 2

represents a brief review on natural polymers which are used for preparation of mouth dissolving film. Table 2 represents

literature review on natural polymers used for the preparation of MDF.



Table 2: Literature Review on Natural Polymers Used for Preparation of MDF

S.No. Polymer Drug Description Reference

1. Pullulan Cetrizine HCl Used as film forming polymer in order to

formulate the oral film and the film shows satisfactory thickness, good mechanical

properties, good disintegration time, even

distribution and uniformity in the film.

[31]

Pilocarpine HCL Used as film forming material and film was

easy to swell and quickly disintegrate.

[32]

2. Starch Benzocaine Lycoat RS720 (25%w/w) was used to formulate

oral film. This form offered dose homogeneity with fast dissolution. It allowed hydrophilic,

hydrophobic as well as temperature sensitive API’s incorporation.

[22]

Tianeptine Sodium Lycoat NG73 was used as new film forming agent and its various physico- mechanical

properties were compare with HPC, HPMC,

HEC, and PVA. Lycoat NG73 showed greatest

dissolution, satisfactory disintegration and

desired physico-mechanical properties.

[33]

3. Sodium

alginate

Medicinal carbon Used as film base material. The addition of

sorbitol or manitol in it caused improvement in

adsorption ability of medicinal carbon film as compared to its powder form along with

sufficient strength and disintegration time.

[34]

Levocetrizine HCl Sodium alginate used as film forming polymer [35]

Salbutamol Sulfate Sodium alginate used in formulation of film [36] 4. Gelatin Montelukast

sodium

Montelukast sodium fast dissolving film was

prepared by solvent casting method using gelatin as film base with different

concentrations of superdisintegrants like

microcrystalline cellulose and crospovidone

using PEG 400 as plasticizer. It was

demonstrated that 4% crospovidone and 10%

MCC with 4% gelatin as a film base was

suitable for developing fast dissolving films of

Montelukast sodium

[37]

5. Maltodextrin Piroxicam Maltodextrin with a low dextrose equivalent as

film forming material was used to formulate oral film by both casting and extrusion method.

Homogenous film was obtained by loading a

large amount of water insoluble powders more than 15%w/w.

[38]

Nicotine Two different dextrose equivalents namely DE 6 and DE12 were selected in order to evaluate

the effect of polymer molecular weight on film tensile properties. It shows that decreasing the

DE value of Maltodextrin the tenacity of the film improved.

[39]

SYNTHETIC POLYMERS 1. Hydroxypropyl Cellulose

Hydroxypropyl cellulose (HPC) is non-ionic water soluble thermoplastic polymer. Hydroxypropyl cellulose as partially

substituted poly (hydroxypropyl) ether of cellulose. It may contain NMT 0.6% of silica or another suitable anticaking agent. HPC is commercially available in a number of different

grades that have various solution viscosities [40]. It is known that films formed with polymers having very high

glass transition temperature values are stiff. Because of relatively high glass transition temperatures (compared to other film forming polymers) of HPC [41], the formed films

were shown to exhibit brittle fracture and were found to be stiff, with a high elastic modulus and a very low percent elongation (less than 5%). Typically slow dissolving, the films

have good carrying capacity and reasonable clarity. HPC has

a good film forming property. It was chosen as the primary matrix-forming polymer since it is the only water soluble cellulose derivative that is thermoplastic. HPC has a softening

temperature in the range of 100–1500C, depending on its molecular weight. It imparts low surface and interfacial tension to its solution and thus can be used for the

preparation of flexible films alone or in combination with Hypromellose [41]. Fig. 6 depicts the chemical structure of hydroxypropyl cellulose.

R is H or [CH2CH(CH3)O]nH

Fig. 6: Chemical structure of hydroxypropyl cellulose



2. Hydroxypropyl Methyl Cellulose Hydroxypropyl Methyl Cellulose (HPMC) or hypromellose is

a partly O- methylated and O-(2-hydroxypropylated) cellulose. It is known for its good film forming properties and has excellent acceptability. Lower grades of HPMC like

Methocel E3, E5, and E15 are particularly used for film formation because of their low viscosity. Fig. 7 depicts the

chemical structure of hydroxypropyl methyl cellulose.

Fig. 7: Chemical structure of hydroxypropyl methyl cellulose

HPMC polymer has a high glass transition temperature and is classified according to the content of substituent’s and its viscosity which affects the solubility– temperature

relationship. HPMC forms transparent, tough and flexible films from aqueous solutions [42]. Additives are often incorporated to improve specific properties of formulated

films. Several studies have been focused on the influence of additives on physico-chemical properties of HPMC films. It is

known that lipid compounds such as waxes, triglycerides (e.g., tristearin), fatty acids (e.g., Stearic and palmitic acid), frequently incorporated into HPMC films, lead to a decrease

the water affinity and moisture transfer due to their high hydrophobic properties caused by their high content of long-chain fatty alcohols and alkanes.

3. Sodium Carboxy Methyl Cellulose Sodium carboxy methyl cellulose (Na CMC) is prepared from

cellulose by treatment with alkali and mono-chloro-acetic acid or its sodium salt. Na CMC is non-ionic cellulose ether

commonly used in controlled release hydrophilic matrix systems. It is non-toxic and has the ability to accommodate high drug loadings [43]. Na CMC is also a good film former.

Formulations comprising Na CMC or other hydrophilic polymers such as HPMC and xanthan have great potential for delivery of drugs to moist surfaces. The enzymatically

modified carboxymethyl cellulose has good film forming property. It is reported for use in combination with other film forming polymers for preparation of oral films [43]. Fig. 8

depicts the chemical structure of Sodium carboxy methyl cellulose.

Fig. 8: Chemical structure of Sodium carboxy methyl cellulose

The oral films made of CMC were only castable when the polymer was initially dissolved in distilled water and alcohol was added in final step. When a mixture of alcohol and water

or pure alcohol was used, the polymer rapidly precipitated [44].

4. Polyvinyl Alcohol Polyvinyl alcohol is produced by the polymerization of vinyl

acetate to poly vinyl acetate followed by hydrolysis of poly vinyl acetate to poly vinyl alcohol. Commercial PVA grades are available with high degree of hydrolysis [45]. Fig. 9

depicts the chemical structure of polyvinyl alcohol.

Fig. 9: Chemical structure of polyvinyl alcohol

5. Polyethylene Oxide Polyethylene oxide (PEO) or POLYOX is a synthetic polyether

or water soluble resins that is readily available in a wide range of molecular weights. Materials with MW <100,000 are

usually called PEGs, while higher molecular weight polymers are classified as Poly ethylene oxides. Poly ethylene oxides are white, free-flowing hydrophilic crystalline powders with

an average particle size of around 150 μm. It is a biocompatible polymer [46]. The interesting properties of PEO are its relatively high melting point, good structural

integrity, low glass transition temperature, low toxicity and biocompatibility. It is a non-ionic, water soluble resin, highly hydrophilic with good lubricating, binding and film forming

properties. Fig. 10 depicts the chemical structure of polyethylene oxide.

Fig. 10: Chemical structure of polyethylene oxide

6. Kollicoat Kollicoat, a polyvinyl alcohol – polyethylene glycol graft

copolymer is a new pharmaceutical excipient that was specially developed as a coating polymer for instant release tablets. The molecule is hydrophilic and thus readily soluble

in water. The polyvinyl alcohol moiety provides good film-forming properties and the polyethylene glycol part acts as an internal plasticizer leading to excellent flexibility. In contrast

to other film formulations, the plasticizer cannot migrate because it is covalently bound in the molecule. In contrast to pure polyvinyl alcohol films, the flexibility is maintained in

storage because rearrangement of the molecules to a high level of order (“crystallization”) is prohibited. Relative

humidity in the range of 30–75 % has practically no influence on the mechanical properties of the Kollicoat films [47]. Film formed of kollicoat is transparent in nature. Fig. 11 depicts the

chemical structure of kollicoat.

Fig. 11: Chemical structure of kollicoat



7. Poly Vinyl Pyrrolidone (PVP) Polyvinyl pyrrolidone (PVP), also commonly called

Polyvidone or Povidone, is a water soluble polymer made from the monomer N-vinyl pyrrolidone [48]. In solution, it has excellent wetting properties and readily forms films. It is

physiologically compatible, non-toxic, essentially chemically inert, temperature resistant, pH-stable, non-ionic, and

colorless. Fig. 12 depicts the chemical structure of polyvinyl pyrrolidone. Polyvinyl pyrrolidone films are brittle in nature and therefore co-povidone is mixed with poly vinyl

pyrrolidone for preparation of flexible fast disintegrating

Fig. 12: Chemical structure of polyvinyl pyrrolidone

strips [49]. Table 3 represents a review on synthetic polymers

used for preparation of mouth dissolving films.

Table 3: Literature Review on Synthetic Polymers Used for Preparation of MDF

S.No Polymer Drug Description Reference

1. HPC Salbutamol sulfate HPC was used as film forming agent [50] Cetrizine

hydrochloride

Blend of HPMC E-3 and HPC in combination was used and then taste

masking of the formed film was done by using ion exchange resin Tulison 335

[51]

2. HPMC Rizatriptan benzoate

Low viscosity hydrophilic polymer, HPMC E5 LV (1-5%) used in the preparation. Batch with higher amount of polymer had high

disintegration time.

[52]

Prochlorperazine Use of hypermellose (7.4%) in combination with low substituted HPC

(1.3%). Film revealed excellent stability and dissolution profile.

[53]

Dexamethasone Use of hypermellose (7.4%) in combination with low substituted HPC

(1.3%). Approx. 90% of dexamethasone was found to be dissolved

within 5 minutes.

[54]

Verapamil Formulation containing 2% HPMC E6 in combination with 3.5% maltodextrin was found to be optimized. Thickness of strip was found

to be increased with increased concentration of HPMC E6 in contrary to maltodextrin.

[55]

Ondansetron Low viscosity grade of HPMC (HPMC E 15) were used due to its excellent film forming property and palatable taste. Formulation

containing 20% w/w HPMC E 15 was found to show optimum performance; higher concentrations lead to a sticky film.

[56]

Rofecoxib HPMC 15cps (3%w/w) was used to formulate oral film by casting

method and it shows that with increasing the concentration of polymer

mechanical properties of the film increases due to increase in the

elasticity nature of the polymer and release of the drug occurs with in

30 sec.

[57]

3. Sodium CMC Medicinal carbon CMC was used as film base material. The addition of sorbitol or

manitol in it causes hardly any improvement in adsorption ability of

medicinal carbon to Brilliant blue FCF.

[58]

4. Polyvinyl

alcohol

Rofecoxib PVA (4%w/w) was used to formulate oral film by casting method and

it shows that with increasing the concentration of polymer mechanical

properties of the film increases due to increase in the elasticity nature of the polymer and release of the drug occurs within 1 min.

[59]

Salbutamol sulfate Combination of HPMC and PVA was used in formulating the oral film. It showed acceptable characteristics and desirable mechanical

properties.

[60]

Ondansetron HCl PVA and PVP were used in different ratios along with carbopol in

order to formulate oral film. The film formed showed good flexibility, smooth and better mechanical properties.

[61]

Levocetrizine

di hydrochloride

Blend of HPMC and PVA either single or in combination was used to

formulate oral film by solvent casting method. Fast dissolving film

showed fast onset of action as compared to conventional tablet.

[62]

5. Polyethylene

oxide

Ondansetron HCl Methocel E-15 was used along with PEO N-10. Incorporation of PEO

helps in faster disintegration along with good elegance to the film.

[63]

6. PVP Indomethacin Three grades of PVP K 10, 25, 40 were used. Indomethacin was seen to

crystallize from all PVP grades over 24-48 hrs at two study temperatures 25 and 37 ºC

[64]



Table 4: Quality Parameters of Different Natural Polymers

S.No Polymer

Quality parameters

Reference Appearance

Water solubility (25 ºC)

pH Moisture (%

loss on drying,)

Molecular weight ( kDa)

1. Pullulan White or yellowish-

white powder

Easily soluble 5–7 Maximum 6 100–250 [65]

2. Sodium alginate

White to pale yellowish-brown colored powder.

Slowly soluble in water, forming a viscous colloidal

solution

7.2 Maximum 15 [66]

3. Pectin

Yellowish white, odorless powder

Soluble in water 6.0-7.2

Maximum 10 30,000–100,000

[67]

4. Gelatin

Amber to faintly yellow colored,

vitreous, brittle solid

Swells in water and softens. It is soluble

in hot water

3.8-6.0

(type A) 5.0-

7.4 (type B)

Maximum 10 15,000–250,000

[68]

5. Maltodextrin

White powder or granules

Swells in water and softens. It is soluble

in hot water

4-7

Maximum 6 variable [69]

Table 5: Quality Parameters of Different Synthetic Polymers

S.No.

Polymer Quality parameters Reference

Appearance Water solubility (25 ºC)

pH Moisture (% loss on drying)

Molecular weight ( kDa)

1. Hydroxy propyl

cellulose

White to slightly yellow colored,

odorless and tasteless powder

Easily soluble in water

5-8 Maximum 1.6 50 000–1 250 000

[68]

2. Hydroxy

propyl methyl

cellulose

Odorless and tasteless,

white or creamy white fibrous or granular

powder

Soluble in cold

water, forming a viscous colloidal

solution

5-8 Maximum 1.6 50 000–1

250 000

[69]

3. Sodium

carboxy methyl cellulose

It is white, odorless

powder

Easily soluble 6–8 Maximum 10 90,000–

700,000

[69]

4. Poly vinyl alcohol

White to cream-colored granular powder.

Easily soluble 5–8 Maximum 5 20000-200000

[69]

5. Poly ethylene oxide

Off-white powder

8-10

<1 Variable [68]

6. Kollicoat

Free flowing powder >50% in water 6.7 About

45000

[68]



Table 6: Patent Reviews on MDF

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Source of support: Nil, Conflict of interest: None Declared

Insights into Polymers: Film Formers in Mouth Dissolving Films

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