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Fast Dissolving Oral Films:

Fast Dissolving Oral Films Presented By Anupama.M M PHARMACY PHARMACEUTICS Cmr college


CONTENTS Fast dissolving oral films Overview of oral mucosa Comparision between fast dissolving tablet & film Special features Classification of oral films Advantages & disadvantages Formulation New technologies Storage & packing Evaluation parameters Commercially available fims CONCLUSION REFERENCES Fast dissolving oral films Overview of oral mucosa Comparision between fast dissolving tablet & film Special features Classification of oral films Advantages & disadvantages Formulation New technologies Storage & packing Evaluation parameters Commercially available fims CONCLUSION REFERENCES

Fast dissolving oral films:

Fast dissolving oral films These are solid dosage forms which is a thin polymeric strip incorporating and delivering pharmaceutical active ingredients & once placed in the mouth dissolves in a short period of time without drinking water or chewing. These are also called as: Oral thin films Buccal films/strips Oral strips

Overview of oral mucosa:

Overview of oral mucosa

PowerPoint Presentation:

ADHESIVE LAYER INTERMEDIATE LAYER BACKING LAYER Contains API OR Adhesion purpose only Contains API Drug dissolution OR Shielded between layers Permanent or Dissolvable

Special features:

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

Comparision between Fast dissolvinng tablet & film:

Fa st Disso l ving Tablets Fa st Disso l ving F i l ms L e s s e r dissolut i on due to less sur fa c e a r e a G rea t e r dissolut i on due to la r g e r su r f a c e a r e a L e ss d u r a ble a s comp a re d with or a l fi l ms B e t t e r d u r a ble th a n o r a l d is i nte g r a t i n g tabl e ts L e ss p a t i e nt compl i a n c e t h a n fil m s More p a t i e nt compl i a n c e Hi g h dose ca n b e inco r p o r a ted L ow do s e ca n on l y b e inco r por a t e d I t has a f e a r of c ho c ki n g No r isk of c ho c ki n g Comparision between Fast dissolvinng tablet & film

Classification of oral Films:

Classification of oral Films Three types: Flash release Mucoadhesive melt away wafer Mucoadhesive sustained release wafers

Properties of film:

Sub ty pe F l a s h re l ea s e w afe r M u c o a dh e s i v e m e l t - a w a y w a fe r M u c o a dh e s i v e s u s ta in e d re l e a s e w afe r A re a ( c m 2) 2 - 8 2 - 7 2 - 4 T hi c kn e s s ( µ m ) 20 - 7 50 - 50 0 50 - 25 0 S tr u ct u r e Fi l m : s i n g le l a y e r Si n g le o r mu ltil a y e r S y s t e m M u lti l a y e r s ys t e m Ex c i pi e n t s S o l u b l e , h i g h l y h y drop h ilic po l ym er s S o l u b l e , h y drop h i l ic P o l ym er s L o w /N on- s o l u b le P o l ym er s D r ug ph a s e S o lid s o l u ti o n S o lid s o l u ti o n o r s u s pe n de d dr u g par ti c l e s S us p e ns i o n a n d / o r s o lid S o l u ti o n Appli cat i o n T o ngu e( u ppe r pa l a t e ) Gi n g i v a l o r b u cca l R e g i o n Gi n g i v a l , (o t h e r re g i o n in t h e ora l cav i t y ) Di ss o lu t i o n Ma x i m u m 6 0 s eco n d s Di s i n t e g ra ti o n in a few minutes , f o r m i n g g e l Ma x i m u m 8 - 1 0 h o u r s Si t e o f act i o n S y s t e m ic o r l oca l S y s t e m ic o r l oca l S y s t e m ic o r l oca l Properties of film


PRODUCT APPLICATION Edible Oral Films : Fast dissolve in the mouth within 3-10 Sec Fully Dissolving Dental/ Buccal Films : 5-10 mins Controlled release into the oral cavity or onto the teeth/gums Dental Films Buccal Films Sublingual/Mucosal Absorption this film is commercially marketed as snore- eze,an anti snoring agent controlled release directly into the bloodstream with rapid absorption snoring device e.g . teeth- whitening strips, teeth re- mineralising films


Disadvantages Hygroscopic in nature High dose cannot be incorporated Drugs unstable in buccal pH cannot be administered. Eating and drinking may be restricted

Formulation development:

C ate g o r y concentration (%) Examples D r u g 1 - 2 5 NSAIDS, Antiemetic, Anti asthmatic P ol y m e r 40 - 5 0 HPMC, Pullunan , Carbapol P l a s t i c i z e r 25 - 3 5 PEG,PG,PHTHALATE derivatives S w ee t e n e r 2 - 1 0 Sucrose,Aspartane F l a v o r 2 -5 Peppermint,Vanilla,Cofee,Chocalate Formulation development

Manufacturing Methods:

Manufacturing Methods There are various methods: Solvent casting Semisolid casting Hot-melt extrusion Rolling Solvent casting

Solvent Casting Method:

Solvent Casting Method Water soluble ingredients are dissolved in water and API and other agents are dissolved in suitable solvent to form a clear viscous solution. Both the solutions are mixed Resulting solution is cast as a film Film is collected Drugs formulated by solvent casting method : 1. Ondansetron 2. Maltodextrin 3. Salbutamol

Semisolid Casting Method:

Semisolid Casting Method Solution of water soluble film forming polymer is prepared. Resulting solution is added to a solution of acid insoluble polymer Appropriate amount of polymer is added so that gels mass is obtained. Finally the gel mass is casted into the films or ribbons using heat controlled drums. The thickness of the film should be about 0.015-0.05 inc

Hot melt extrusion Method:

Hot melt extrusion Method The drug is mixed with carriers in solid form. Extruders having heaters melts the mixture Finally the melt is shaped in films by the dies  

Rolling Method:

Rolling Method A solution or suspension containing the drug is rolled on a carrier. Solvent : water or water and alcohol The film is dried on the rollers and cut into desired size

New Technology used in Film formulation:

New Technology used in Film formulation Soluleaves : This technique is used to formulate the quick dissolving films by adding with active ingredient, flavor and colour to fill pleasant and easy acceptable form. Foam burst : This method gives effect like the melt in moth like sensation because at time of preparation of film gas is blown on the film due to this films gives honey comb like structure and this void are empty or filled with other material to acquire the specific test or odour . Wafertab : In this system drug load in film after casting.   Micap : Micap plc signed an option agreement in 2004 to combine its expertise in micro encapsulation technology with the BioProgress water-soluble films. Aim of this company to make the smoke sensation product.

Storage and Packaging:

Storage and Packaging variety of packaging options are available Single packaging is mandatory for film - an aluminum pouch is the most commonly used APR- Labtec has developed the Rapid card- specially designed patented size as a credit card holds three raid films on each side Materials usually used for packaging : Foil, paper or plastic pouches Single pouch and Aluminum pouch Blister card with multiple units Barrier Films

Evaluation parameters:

Evaluation parameters Weight of film to ensure that the film contains proper amount of excipients and API   Film Thickness micrometer screw guage Ph Value   Folding endurance gives an indication of brittleness Disintegration test In Vitro Dissolution Studies

PowerPoint Presentation:

Disintegration Time testing Slide frame method Petri dish method

PowerPoint Presentation:

Test Procedure Fill a clean beaker deionized water. Test the conductivity of the water to establish the background value.- Adhere the film inside the dry, clean 800ml beaker so that the centre section is even with or slightly below the 100 ml line of the beaker. Arrange the Conductivity probe and the impeller in the beaker. As quickly as possible pour the 300 ml of the water in the beaker containing the film, impeller and the conductivity probe. When the water completely covers the film, start the timer (approx 3sec). Then restart the impeller stirring at 250rpm. Take a data point at every 10 sec for the first minute.

Application of fast dissolving film :

Application of fast dissolving film Manage pain Allergies Sleep difficulties Cns disorders Delivering vitamins and personal care products Wound care etc

Marketed OTF:

Marketed OTF

FDA approved OTF:

FDA approved OTF DRUG YEAR COMPANY SUBOXONE ( Bupreonorphine & Naloxone ) 2012 Reckitt Benckiser Pharmaceuticals inc ZULPENZ 2010 Pharmafilm Technology ONDANSETRON 2010 APR Applied Pharma research and Labtech ZELAPAR 2005 Valeant Pharmaceuticals International inc


Conclusion Pharmaceutical industries have recognized the potential for delivering medicinal products through OTF and have launched several products for the OTC market using this technology. Recently RDFs have gained popularity as dosage forms for the mouth fresheners Gaining importance as they are ideal dosage form for use in young children, as well as genatric patients. Also, many industries have pipelines of molecules of shifting their existing tablets preparation to oral strips.  


REFERENCES 1 Panchal MS, Patel H, Bhavani A, Dr.Vadalia KR. Formulation and Evaluation of Mouth Dissolving Film of Ropinirole Hydrochloride by Using Pullulan Polymers. Int J Pharm Res Allied Sci 2012; Volume 1, issue 3: 60-72. Bhupinder B, kirti J. Formulation and evaluation of fast dissolving sublingual films Rizatriptan Benzoate. Int J Drug Develop Res, January-March 2012; Vol. 4, Issue 1: 133-43.  Kaza R, Arun Kumar R. Design and Characterization of Fast Dissolving Films of Valsartan . Int J Innovative Pharm Res 2012; 3(2): 212-9. 4 Londhe VY, Umalkar KB. Formulation Development and Evaluation of Fast Dissolving film of Telmisartan . Indian J Pharm Sci March-April 2012; 74(2): 122-6.  5 Sumitha Ch, Dileep MV, Srinivas K. Development of Taste Masked Fast Dissolving Orally Consumable Films of Sildenafil Citrate. J Pharm Cosmetol 2011; Vol 1: 1-6. El- Setouhy DA,El-Malak NSA. Formulation of Novel Tianeptine Sodium Orodispersible Film. PharmSciTech September 2010; Vol. 11, No. 3: 1018-25.  Dinge A, Nagarsenker M. Formulation and Evaluation of Fast Dissolving Films for Delivery of Triclosan to the Oral Cavity. PharmSciTech June 2008; Vol. 9, No. 2: 349-56. Mishra R, Amin A. Formulation and Characterization of Rapidly Dissolving Films of Cetirizine hydrochloride using Pullulan as a Film Forming Agent. Indian J Pharm Edu Res, Jan-Mar, 2011; Vol 45, Issue 1: 71-7.

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