oro dispersible films

05/02/2023 vignan pharmacy college , dep. of pharmaceutics

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ORO-DISPERSIBLE FILMS:A MODERN

EXPANSION IN FAST DISSOLVING DOSAGE

FORMSPrepared & Presented by:

S.Lakshmi sravanthiM.Pharm, IV semester

Dept.of Pharmaceutics

VIGNAN PHARMACY COLLEGE (Approved by AICTE, PCI-New Delhi & Affiliated to JNTUK- Kakinada)

Vadlamudi (V), Chebrolu (M), Guntur (Dt.) – 522 213

Introduction

Applications

Formulation development

Evaluation

Market potential

FDA approved drugs

Commercially available marketed products

Conclusion

References05/02/2023vignan pharmacy college , dep. of

pharmaceutics2

CONTENTS .

vignan pharmacy college , dep. of pharmaceutics

05/02/20233

INTRODUCTION

Oro-dispersible film drug-delivery systems were first

developed in the late 1970s as based on the technology of the

transdermal patch.

An alternative to tablets, capsules, and syrups for paediatric and

geriatric patients who experienced difficulties in swallowing

traditional oral solid-dosage forms.


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A solid dosage form that dissolves or disintegrates quickly in the oral

cavity, resulting in solution or suspension without need for the

administration of water, is known as Oral Fast-dispersing dosage form.

These are also called as:

Orally dissolving films

Flash release wafer

Wafer

Quick dissolving film

Soluble or Buccal film- Preferred by FDA

European Medicines Agency using Oro-Dispersible films

Definition:

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ADHESIVE LAYER

INTERMEDIATE LAYER

BACKING LAYER

Contains API OrAdhesion purpose only

Contains APIDrug dissolution OrShielded between layers

Permanent Or Dissolvable

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• 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

SPECIAL FEATURES


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• Thickness ranges from 2-500mm & it’s surface area is 1-20 cm².

• Its low dry tack allows for ease of handling & application.

• Its rapid hydration rate facilitates fast softening & absorption.

• 2mm thickness of film will take 5-10sec to start its disintegration.

GENERAL PROPERTIES


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ADVANTAGES:

1. Improved oral absorption

2. Faster onset of action

3. Minimized first – pass effect

4. Improved bio availability

5. Accurate dosing

6. No special training is required for administration

7. Reduced gastrointestinal irritation

DISADVANTAGES:

8. High dose can't be incorporated

9. Drug unstable in buccal pH can’t be administrated

10. Need special packing has they must be protected from water

11. Drugs with obnoxious odor can not be given


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APPLICATIONS OF ORAL STRIPS

Topical application:Feasible in delivery of active agents like analgesics or anti-microbial agents

Gastro retentive dosage systems: Poorly water soluble and high molecular weight molecules incorporated

into films, dissolution triggered by PH or enzymatic secretions

Diagnostic devices:Multiple agents can be incorporated in the film for timed release in

diagnostic device


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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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1. Flash release wafers

2. Mucoadhesive melt away wafers

3. Mucoadhesive sustained release wafers

PROPERTIES FLASH RELEASE WAFERS

MUCO-ADHESIVE MELT AWAY WAFERS

MUCO-ADHESIVE SUSTAINED WAFERS

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

Classification of Oral thin films:


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Category Conc(%) Examples

Drug 1-25 NSAIDS, Antiemetic, Anti asthmatic, Snoring agents, Erectile dysfunction drugs

Hydrophilic Polymers

40-50 Pullulan, Gelatin, Starch, Sodium alginate,Pectin, Maltodextrin, HPMC, HPC, PEO, Kollicoat, PVA, PVP.Novel film forming polymer: Rosin

Plasticizer 25-35 PEG,PG, PHTHALATE Derivatives

Saliva secreting agents

2-6 Citric acid, Malic acid, Tartaric acid

Sweetener 2-10 Sucrose, Glucose,FructoseAspartame, Sucralose

Flavor 2-5 Peppermint, vanilla,cofee, chocalate, Strawberry, Lemon

Formulation development


• Mouth dissolving film can be prepared by five methods:

1. Solvent casting method

2. Semisolid casting method

3. Hot melt extrusion

4. Solid dispersion technique.

5. Rolling method

• Generally Solvent casting method is most preferred for

the manufacture of mouth dissolving film.13

METHOD OF PREPARATION


SOLVENT CASTING METHOD

1.• In solvent casting method excipients

are dissolved in water. Then water soluble polymers and in last drug is added.

2.• Solutions are stirred with the help of

magnetic stirrer for 5 mins. to form a homogenous solution

3. • Finally casted in to the Petri plate and dried at 40°C temp in hot air oven.

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HOT – MELT EXTRUSION


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SOLID DISPERSION EXTRUSION


In 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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ROLLING METHOD


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MORPHOLOGY STUDY Scanning electron microscopeVisual inspection

THICKNESS Micrometer screw gauge WEIGHT VARIATION Digital vernier callipers

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TENSILE STRENGTH

(Load at failure * 100)

FOLDING ENDURANCE A typical folding endurance for a film is 100 – 150

TRANSPARENCY Transperancy=(logT600)/b=-€c

(Strip thickness * Strip width)

Evaluation


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PERCENTAGE ELONGATION

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

SWELLING PROPERTY (Wt – W0) / W0

SURFACE PH OF FILM PH meterMOISTURE CONTENT Karl Fischer titration method

or weight variation(Wt – W0) / W0

PERMEATION STUDIES Franz diffusion cellDISINTEGRATION TIME Typical disintegration time

for film is 30sTests: Slide frame method Petri dish method

CONTACT ANGLE GoniometerDISSOLUTION USP Type I or Type II


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Packaging for oral thin films includes foil paper or plastic pouches,

single pouch, aluminum pouch, blister packaging with multiple units

and barrier films.

Barrier films are most commonly used for those drugs which are

extremely moisture sensitive .

The films are manufactured by Rapid film technology developed by

Labtec GmbH describes primary packaging made of a sealing pouch

affords enough space for logos, codes, instructions or other

information.

Barrier films were prepared by a laminating process and packaging

costs are comparable to tablets

Packaging of orally disintegrating films


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• With the reference to Research and Market : Oral Thin Films

Market ,2015-2025:jan 2015

1. As per the market projection study for 2015-2025, owns a good

prospective of growth as a upcoming technology of drug delivery.

2. 10 oral films are in market and another 29 are in the stage of various

clinical and pre clinical trials.

3. Around 10 proprietary technologies like PharmFilm, RapidFilm, Bio-

FX, etc are coming up which has 38% of the market.

4. Thus there is a potential ground of research in this technology.

Market potential

FDF


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Drug Year Company

Versafilm(Rizatriptan) Feb /4 /2014 IntelGenx and RedHill Biopharma

Suboxone (Buprinorphine or

Naloxone)

31/08/2010 Reckitt Benckiser Pharmaceuticals Inc.

Zulpenz January 2010 Pharmfilm technology

Ondansetron 23rd march 2010 APR Applied Pharma research s.a (“APR”)

and Labtech GmbH(“Labtech”)

Zelapar October 2005 Valent Pharmaceuticals

Interanational Inc

FDA Approved ODF


EXAMPLES OF MARKETED ODFs FOR SYSTEMIC DRUG DELIVERY

Brand Distributor Drug

BenadrylR Allergy quick dissolve strips

McNeil-PPC Diphenhydramine HCL

Gas –XR thin strips Novartis consumer health

Simethicone

Risperidon HEXALR

SF SchmelzfilmHexal AG Risperidone

SudafedR quick dissolve strips

McNeil-PPC Phenylephrine HCL

TherafluR Thin strips long acting cough

Novartis consumer health

Dextromethorphan HBr

ZulpenzTM Sativa Pharmaceuticals Ondansetron


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EXAMPLES OF MARKETED ODFs FOR LOCAL DRUG DELIVERY

Brand Distributor Drug

ChlorasepticR Sore

Throat Relief Strips

Prestige brands Benzocaine

OrajelR Kids Sore

Throat Relief Strips

Church & Dwight Co. Pectin

Snoreez Oral Strips Passion For Life

Healthcare

Peppermint oil,

vitamin E, sodium

hyaluronate, guar gum


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The 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.

CONCLUSION


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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 technology is growing in fast pace challenging most of the

pharmaceutical companies to develop oral films for a wide range

of active pharmaceutical ingredients.


REFERENCES

Arya A, Chandra A, Sharma V, (2010). Fast Dissolving Oral Films: An Innovative Drug.

International Journal of ChemTech Research. 2 (1), 576-583.

Varma S N, Sharma P K, (2014). Buccal Film: An Advance Technology for Oral Drug

Delivery. Advances in Biological Research. 8 (6),260-267.

Jain N.K., (2005). Controlled and Novel Drug Delivery. 1st ed. New Delhi: CBS Publishers

and Distributers. pp- 52-56.

Tarjani et.al,(2014)Evaluation of mouth dissolving films:physical and chemical

methods.Eijppr 4(1):62-65.

Chonkar ankita D. Et al,(2015) an overview on fast dissolving oral

films.www.asiapharmaonline.org,5(3):129-137.

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FDF


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Eva maria et al.,(2011), Advances in orodispersible films for drug delivery.informa

health care 8(3):299-316

Alpesh R.Patel et al.,(2010), fast dissolving films as new venture in fast dissolving

dosage forms.International journal of drug development and research , 2(2):232-246

Muhammad irfan et al.,(2015),orally disintegrating films A modern expansion in

drug delivery systems.Saudi pharmaceutical journal

Udhan ravindra radha kisan et ai.,(2012),Mouth dissolving films and their

overview.International research journal of pharmacy,3(9):39-42

Yogyata S. Pathare ew al., (2013), Polymers used for Fast Disintegrating Oral Films:

Review, International Journal Of Pharmaceutical Sciences Review And

Research.,21(1):169-178

FDF


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oro dispersible films

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