Oral thin film

Oral thin film overview

1. ORAL THIN FILM TECNOLOGY BY KH.HUSSAN REZA Asst. Professor , BENGAL SCHOOL OF TECHNOLOGY

2. 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.

3. 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.

4. LIMITATIONS Drugs 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).

5. Process over view Weighing Mixing of slurry Layering mother roll formation Slitting of mother rolls to daughter rolls Packaging

6. Market potential With the reference to Research and Market : Oral Thin Films Market ,2015-2025:jan 2015 As per the market projection study for 2015-2025, owns a good prospective of growth as a upcoming technology of drug delivery. 10 oral films are in market and another 29 are in the stage of various clinical and pre clinical trials. Around 10 proprietary technologies like Pharm Film,RapidFilm,Bio -FX, ect are coming up which has 38% of the market. Thus there is a potential ground of research in this technology.

7. List of brands in world :

8. Ground research works Extensive 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.

9. Patent Survey

10. Pantoprazole oral film Method involved: Solvent casting Excipients used: Hydroxy propyl methyl cellulose LV Hydroxy propyl methyl cellulose E-15 Aspartame Sodium hydroxide   Saffranine Glycerine Pottasium di hydrogen pthalate

11. Plan of work Determination of calibration curves Design and formulation of the ODF Evaluation of the selected ODF Folding endurance Drug content uniformity Drug disintrigation study Invitro dissolution study

12. Conclusion of the work The 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.