ORAL THIN FILM TECNOLOGY

BYKH.HUSSAN REZA

Asst. Professor , BENGAL SCHOOL OF TECHNOLOGY

INTRODUCTION Oral dissolving film or oral drug strip

is a dosage form administer drugs via mouth (buccal or sublingually).

Fast dissolving films or rapidly dissolving dosage forms have great importance in the pharmaceutical industry.

They undergo rapid disintegration in the salivary fluids of the oral cavity in seconds.

Referred by various names like quick disintegrating, orally disintegrating, rapidly disintegrating, mouth dissolve or melt in mouth dosage forms.

BENEFITS Quick onset of action and enhance

efficacy.

Avoidance/ reduction of fast pass metabolism.

Improve patient compliance. Pain free administration.

No need of water , no risk of chocking.

Best for pediatrics, geriatrics, trend for young-generations

Films can be produced by easily industrially feasible and scalable methods.

LIMITATIONSDrugs which are unstable at

buccal pH cannot be administered.

Drugs which irritate the mucosa cannot be administered by this route.

Drug with small dose requirement can only be administered.

Special packaging method needed (pouch or cassette packing).

Process over view1. Weighing2. Mixing of slurry3. Layering 4. mother roll formation5. Slitting of mother rolls to daughter rolls6. Packaging

Market potentialWith the reference to Research and Market : Oral

Thin Films Market ,2015-2025:jan 20151. 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 Pharm Film,RapidFilm,Bio-FX, ect are coming up which has 38% of the market.

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

List of brands in world :

Ground research worksExtensive literature survey mostly based on

patents of various ODF from USPTO,WIPO,EPA.

Targeting of drugs yet to be covered under this technology

Presently worked out intial works on drugs like Pantoprazole and Azitromycine .

The Pantoprazole study report anexed gave a good support for the positivity of the work carried out.

Patent Survey

Pantoprazole oral filmMethod involved: Solvent

castingExcipients used: Hydroxy propyl methyl cellulose LV Hydroxy propyl methyl cellulose E-15 Aspartame Sodium hydroxide  Saffranine Glycerine Pottasium di hydrogen pthalate

Plan of workDetermination of calibration

curvesDesign and formulation of the

ODFEvaluation of the selected ODF Folding endurance Drug content uniformity Drug disintrigation study Invitro dissolution study

Conclusion of the workThe polymer concentration

was found to be a major factor affecting the drug release and the mechanical strength of the patch.

It was concluded that HPMC LV was found to be effective polymer in the rapid film disintegration and dissolution compared to HPMC E 15 probably due its low viscosity.

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