Presented by

P. SAI SAHITHI(Reg. No. 14421S0303)

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A REVIEW ON FAST DISSOLVING ORAL THIN FILMS

Under the esteemed guidance of

Dr. J. SundaraseelanM.Pharm., Ph.D.

Professor and HeadDepartment of Pharmaceutics

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

SRI PADMAVATHI SCHOOL OF PHARMACY(Affiliated to J.N.T.U.A)

Mohan gardens, Vaishnavi Nagar, Tiruchanoor, Tirupati -517 503

MARCH-2015

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CONTENTS:- Introduction- Special Features- Overview of oral mucosa- Comparison between fast dissolving tablets and films- Mechanism- Classification- Properties- Advantages- Disadvantages- Formulation- Manufacturing methods- Evaluation- Conclusion- References

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INTRODUCTION:These are the solid dosage form which is a thin polymeric strip incorporating and delivering pharmaceutical active ingredients and once placed in the mouth dissolves in the short period of time without drinking water or chewing.

These are also called as • Oral thin films• Buccal films/strips• Oral strips.

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C ADHESIVE LAYER

INTERMEDIATE LAYER

BACKING LAYER

Contains APIOrAdhesion purpose only

Contains APIDrug dissolutionOrShielded between layers

PermanentOr Dissolvable

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SPECIAL FEATURES:

• Thin elegant film• Available in various sizes and shapes• Less fragile when compared to ODT• Excellent mucoadhesion• Dosage accuracy• Rapid release• Can be administered without water• Most acceptable dosage form for dysphagic patients

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OVER VIEW OF ORAL MUCOSA

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Comparison between fast dissolving tablets and films

Fast dissolving Tablets Fast dissolving Films

Lesser dissolution due to less surface area

Greater dissolution due to large surface area

Less durable as compared with oral films

Better durable than oral disintegrating tablets

Less patient compliance than films

More patient compliance

High dose can be incorporated Low dose can only be incorporated

It has fear of chocking No risk of chocking

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Mechanism:Oral thin film

Kept in mouth

Disintegrate into small particles by saliva

Through buccal cavity, pharynx, oesophagus provides better absorption

Quick onset of action - More bioavailability

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CLASSIFICATION OF ORAL THIN FILMS

Oral fast dissolving films are divided into three

sub types along with their properties.

1. Flash release

2. Mucoadhesive melt away wafers

3. Mucoadhesive sustained release

wafers

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PROPERTIES FLASH RELEASEMUCO-ADHESIVE MELT AWAY WAFERS

MUCO-ADHESIVE SUSTAINED WAFERS

Area(cm2) 2-8 2-7 2-4Thickness 20-70 50-500 50-250Structure Single layer

systemSingle or multilayer

Multilayer system

Excipients Soluble hydrophilic polymer

Soluble hydrophilic polymer

Low/non-soluble polymer

Drug phase Solid solution Solid solution or suspended solution

Suspension and/or solid solution

Dissolution 60 sec Few min Max 8-10 hrsApplication Tongue Gingival or buccal

regionGingival (other region in oral cavity)

PROPERTIES OF FILMS:

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ADVANTAGES:1. Improved oral absorption2. Faster onset of action3. Minimized first – pass effect4. Improved bio availability5. Accurate dosing6. No special training is required for administration7. Reduced gastrointestinal irritation

DISADVANTAGES:8. High dose can't be incorporated9. Drug unstable in buccal pH can’t be administrated10. Need special packing has they must be protected from

water11. Eating and drinking may be restricted.

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FORMULATION:A typical composition contains the following drug

Drug - 5% to 30% w/w

Water soluble polymer - 45% w/w

Plasticizers - 0 to 20%

Surfactants - quantity sufficient

Sweetening agents - 3 – 6%w/w

Saliva stimulating agent - 2 – 6%w/w

Colouring agents - quantity sufficient

Flavouring agents - quantity sufficient

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ACTIVE PHARMACEUTICAL INGRIDIENTS:(APIs): Varieties of APIs can delivery through FDOTF. It is always

useful to have micronized APIs which will improves the texture of the film and also for better dissolution and uniformity in the FDOTF. Eg: Rofecoxib, Ethothyline, Mesylate, Ontasetron, Caffeeine

HYDROPHILLIC POLYMERS :They impart the desired properties in to the film mainly

hydrophilic polymers are used in the preparation, as the film dissolves rapidly in oral cavity.Robustness of the film depends on type and the amount of polymer usedEg: Pullulan, Sodium Alginate, Pectin, Hydroxy propyl cellulose, HPMC

PLASTICIZERS:Helps to increase the flexibility of the film and reduces the

brittleness of the film.Eg: Glycerol, Propylene Glycol, Diethyl and Dibutyl phthalate, Castor oil

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SURFACTANTS:Used as wetting or dispersing agent.

Eg: Benzathonium chloride, tweens,sodium lauryl sulphate,polaxamer 407

SALIVA STIMULATING AGENTS:Used to increase the production of saliva that would aid in faster

disintegration of the film.Eg: Citric acid, Mallic acid, Lactic Acid

SWEETNING AGENTS:Generally sweeteners are used for the taste masking of bitter drugs.

Eg: Xylose, Ribose, Maltose, Dextrose, Fructose, Calcuim saccharine salt

FLAVOURING AGENTS:The acceptance of the oral disintegrating films depends on the

flavouring agent. The selection of flavour is dependent of the type of drug in corporated in the formulation.Eg: Peach, Vanilla, Wall nut, Chacolate, Mint, Rasberry, Peppermint oil, Spearmint oil, cinnamon oil

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MANUFACTURING METHODS

These are the various methods:

Solvent casting

Semisolid casting

Hot-melt extrusion

Rolling Solvent casting

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Solvent Casting MethodIn this method firstly water soluble ingredients are mixed in water to form a viscous solution.

API and remaining ingredients are dissolved in smallerAmount of solution.

Both the solutions are combined by using high shear Process.

Vacuum is used to remove the air entrapped

The solution formed is then cast as a film and pour The solution in a glass mould and allow the solution To dry in oven at 45 – 50˚C.

Then cut in to pieces of desired size

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SEMI SOLID CASTING METHOD

This method is preferred when acid insoluble polymers are used in the preparation of oral fast dissolving film.

Firstly solution of water soluble polymers is prepared

This solution is added to the solution of acid insoluble polymer

Plasticizer is added in appropriate amount so that a gel mask is formed

It is then casted in to the films or ribbons by using heat control drums.

The thickness of the film is about 0.038cm

Acid insoluble polymer and film forming polymer are used in the ratio of 1:4

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HOT MELT EXTRUSION METHODDrug is mixed with carrier in the solid form so that Granular material is formed

These granules are then dried and then introduced Into extruder.

The speed of the screw should be around 15rpm so that the granules reside inside the extruder for about 3-4 min.

The processing temperature should be 100˚C

The extrudate then pressed in to a cylindrical calendar to obtain a film

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ROLLING METHODIn this method firstly solutions or suspension of the drug is prepared

Either water or mixture of water and alcohol are mainly used

Suspension or solution containing drug is rolled on the carrier

Films are dried on the rollers and cut in to desired shapes and sizes

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EVALUATION1. MORPHOLOGY STUDY – Scanning electron microscope

2. THICKNESS - Micrometer screw gauge Digital vernier callipers

3. WEIGHT VARIATION (Load at failure * 100)

4. TENSILE STRENGTH - (Strip thickness * Strip width)

5. FOLDING ENDURANCE - A typical folding endurance for a film is

100 – 1506. PERCENTAGE ELONGATION -

(Increase in length of strip / initial length of strip) * 100

7. SWELLING PROPERTY - (Wt – W0) / W0

8. SURFACE pH OF FILM

9. MOISTURE CONTENT10. DISINTEGRATION TIME - Typical disintegration time for

film is 30s

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CONCLUSIONThe brief review on oral films concludes with the note that they are considered as a most promising and important drug delivery system because of their rapid disintegration include dissolution properties especially with pediatrics and geriatrics patients. Even though most of the formulations today are developed as ODTs, oral films has gained more popularity because of their easy portability, improved patient compliance and easy of administration. They can be applied by both oral and buccal routes. apart from being used as medicament films(local anesthetic ,vitamins supplements and cold allergy remedies).they can also be used for refreshing the breath.This techonology is growing in fast pece challenging most of the pharmaceutical companies to develop oral films for a wide range of active pharmaceutical ingredients.

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REFERENCES1)Samita gauri, GAURAV KUMAR. Fast dissolving drug deleviry and its technologies. www.the pharmajounral.com.2)Rathi varun, senthil v.Hans ritu.A brief review on oral film technology. IJRAP 2011,2(4) 1138-1147.3)shinde Pramod, Salunkhe vijay Buccal film:An innovative dosage form designated to improve patient compliance. international journal of pharmaceutical and chemical sciences.vol 1 (4) oct-dec 2012.4)M.D.Nehal siddiqui,Garima Garg ,A review on “ A novel approach in oral fast dissolving drug delivery system and their patents”.Advances in biological research 5 (6):291-303,2011.5)Venkata anupama M,R.Shireesh Kiran,P.Dileep,A review on oral thin fast dissolving films recent trends of dosage form for quick release.Int J pharm Bio Sci 2014 Oct; 5(4)(P) 54-67.6)Aggrwal Jyoti,Singh Gurpreet,Rana A.C.Fast dissolving films:A novel approach to oral drug delivery.IRJP 2011, 2 (12), 67-74.7)Parul Saini,Anoop Kumar,Pankaj Sharma,”FAST DISINTEGRATIG ORAL FILMS;A RECENT TREND OF DRUG DELIVERY.”Int.J. Drug dev,& Res.,Oct-Dec 2012.4(4):80-94.8)Alka Tomar,Kiran Sharma,Nitesh S Chauhan,”Formulation and evaluation of fast dissolving oral film of dicyclomine as potential route of buccal delivery” Int.J. Drug Dev,& Res .,April-June 2012,4(2):408-417.9)Bhupinder Bhyan, Sarita Jangra, Mandeep Kaur, Orally fast dissolving films:Innovation in formulation and techonology. IJPSR vol-9,2,july-Aug 2011,Article-009.10)Patel RA, Prajapati SD, Fast dissolving films as a newer venture in fast dissolving dosage forms.International Journal Drug Development & Research.2(2):2010:232-246.

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THANK YOU