INTRODUCTION:

In present time the demand of new dosage form are increasingly specially in the case of pediatrics and geriatrics patients and the oral route are most preferred route for drug delivery because of ease of handling versatility, ease of administration and invasive method. The film is prepared by using polymer and dissolves in the mouth within a few minutes, it were developed in the late 1970 as an alternative of capsules, tablets and syrups for that patients who have difficulties in swallowing and chewing^(1,2,3). Orally fast dissolving film is new drug delivery system for the oral delivery of the drugs. It was developed on the basis of technology of the transdarmal patch. The delivery system consists of very thin oral strips, which is simply placed on the patients tongue or any oral mucosal tissue, instantly wet by saliva the film rapidly hydrates and adheres onto the sites of application.

It then rapidly disintegrates and dissolves to release the medication for oromucosal and intragastric absorption. Technology catalysts forecasts the market for drug products in oral thin formulations was valued of $500 million in 2007 and could reach $2 billion in 2012. Based on upward global growth trends of the past decade, the fast dissolving dosage market could produce revenues of $13 billion by 2015^(4,5).

Features of Oral Films⁽^6-8):-

1. Available in different size and shape.

2. Improved patient compliance.

3. It is thin and elegant.

4. It is compatible with taste masking.

5. It leaves less or no residue in the mouth.

6. It is improves bioavailability, especially in the cases of insoluble and hydrophobic drugs, due to rapid disintegration and dissolution of these tablets.

7. It is useful in case of rapid onset of action required such as sudden episodes of allergic attack or coughing, in motion sickness, bronchitis or asthma.

8. Water not required to swallowing.

9. Mucoadhesion is excellent.

10. Fast releasing and disintegration within minutes in the mouth.

Disadvantages:-

1. Drugs which are not stable at buccal pH cannot be administered.

2. It takes special packaging due to fragile in nature and must be protected from water.

3. Drugs in large dose cannot be administered.

4. Some drugs have bitter taste, and need taste masking.

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

Ideal charecteristics for oral film⁽^9,10):-

· The drug should have pleasant taste.

· The drug should be unionized at the pH of Buccal cavity.

· The drug should not be more than 40 mg.

· It should be permeate oral mucosal tissues.

· The drug should be stable and soluble in water like saliva.

Oral film formulation⁽^11-13):-

· Drug

· Film forming agent

· Plasticizers

· Flavoring and sweetening agent

· Surfactant

· Saliva stimulating agent

· Thickener and stabilizers.

Film forming agent:

It is used as carrier for drug. Cellulose derivative like hydroxypropyl methyl cellulose, hydroxyl propyl cellulose, and sodium carboxy methyl cellulose in different grade and other i.e, sodium alginate, polyvinyl pyrrolidine, polyethylene glycol. Mainly hydrophilic polymers are used as film former.

Plasticizers:-

It improves flexibility of film and decrease the britaleness of polymer film.

Ex .propylene glycol, castor oil, citrates derivatives

Flavoring and sweetening agent:-

The flavor enhance the acceptance of the formulation and enhance the elegance properties of film.

Ex. Menthol, peppermint, essential oils such as methyl salicylates, eucalyptol, thymol, vanilla, cinnamon etc.

Sweeters use to mask bad odour and brittal taste of the drugs. Natural and synthetic sweeter are used.

Ex. Galactose glucose, mannose, fructose, xylose, ribose, maltose, sucrose, sugar, sorbitol, mannitol, aspartame etc.

Surfactant:-

These are used to enhance solubility and wettinmg property of film to release within minutes the drug.

Ex. Benzalkoniumchoride, sodium lauryl sulfate, benzalconium chloride tween, and polaxomer.

Thickner and stabilizers:-

These are stabilize and enhance the viscosity i.exanthan gum, carrageenan and derivatives of cellulose.

Saliva stimulating agent:-

These activates the salivary gland to produce the saliva which helps in rapid disintegration of the film.

Ex. Citric acid, ascorbic acid, lactic acid, tartaric acid.

Techniques use in film preparation⁽^14-17):-

1. Hot melt extrusion method:-

In this method only thermostable drug is used. The API and other excipients are mixed in dry state and heated at high temperature then extruded it. The mass is used to forming of the film and cut it in desire size. These Sare dried at very low temperature. The whole process performs without using of the solvent.

2. Solvent casting method:-

The film prepare by dissolving the polymer and API in suitable solvent and stirrer up to 4 hrs. By using magnetic stirrer and keep it for remove the air bubbles entrapped in solution. The solution is poured over suitable casting mould, the film is air dried or dried under oven and carefully removed.

3. Semisolid casting method:-

The water soluble polymers are dissolved in water and added acid insoluble polymer which was prepared in ammonium and sodium hydroxide and plasticizer and form gel mass and cast into film.

4. Roller method :-

In this method suspension or solution of drug and polymers are prepared by using of solvent mostly water and alcohol. The suspension or solution should have specific rheological property. These are rolled with the help of and prepared film dried and cut in desired size.

Evaluation parameters for oral films⁽^12,18,19):

Mechanical properties

· Thickness

· Dryness

· Tensile strength

· Percent elongation

· Young’s modulus

· Tear resistance

· Folding Endurance

Organoleptic test

Swelling test

Surface pH test

Contact Angle

Transparency

Assay/Content Uniformity

Disintegration test

In-Vitro Dissolution test

1. Content uniformity:-

The one square inch of film cut and dissolves it in methanol in 100 ml volumetric flask and make up the volume. Solution suitably dilutes and measure absorption.

2. Thickness:-

Film thickness is measured by micrometer screw gauge these are insure the accuracy of dose in film strip.

3. pH value:-

pH are measured by the dissolving one oral film in 10 ml distilled water and measuring the pH of the obtained solution should have nearly uniform pH value.

4. Folding endurance :-

This is determine by repeating folding of film at same point till the film strip breaks and the number of times of folding without breaking is counted.

5. Morphology study:-

These are predicted by using scanning electron microscopy.

6. In vitro dissolution studies:-

In vitro dissolution test is carried out according to the standers dissolution apparatus. 900 ml of fresh deionised water taken as dissolution media maintain the temperature. five ml aliquots of samples are taken at regular intervals.

7. Stability Studies:-

A stability study on the optimized oral fast dissolving film is carried out for determination of effect of temperature and humidity on the stability of the drug. The film are stored in an aluminum foil and subjected to stability at room temperature. The sample can withdraw at 3 months and 6 months and subjected for cumulative %drug release and in vitro dissolution studies to determine disintegration time and disintegration test.

CONCLUSION:

The oral fast dissolving films have better patient compliance in the case of geriatrics and pediatrics patients. It has proved and accepted method for the systemic fast drug delivery of active pharmaceuticals ingredients than other dosage forms, like nitroglycerin are absorb sublingually fast. The film is an elegant, stable and effective vehicle for delivery of different drugs for example neutraceuticals, antiallergics, antiasthmatic for immediate onset action of drug. This have greater stability method combine form of the solid and liquid dosage form by making a bridge between two ideas, incorporating of API and excipients in both forms solid and liquid. The manufacturing of these are very inexpensive for any pharmaceuticals industry. Due to immediate release and ease of manufacturing it will be taken attention and increased business of pharmaceuticals industry in future.

REFERENCES:

1. Jadhav, SD; Kalambe, NR; Jadhav, MC; Tekade, WB and Patil, RV(2012),”Formulation and evaluation of fast dissolving oral films of levocetrizine dihydrochloride”, Int J Phar Sci, Vol. 4 Suppl 1,337-341.

2. Sakuda, Y.; Ito,A.; Sasatsu, M.; Machida, Y,2010 ,”Preparation and evaluation of medical carbon oral films”, Chem. Pharm. Bull. 2010, 58,454-457.

3. Lindgren S, Janzon L. Dysphagia: Prevalence of swallowing complaints and clinical findings. Medical Clinics of North America,(1993); 77:3-5.

4. Joseph F Standing, Catherine Tuleu, Paediatric Formulations-Getting to the heart of the problem. International Journal of Pharmaceutics, 300:2005: 56-66.

5. Goel Honey, RaiParshuram, Rana Vikas, Tiwary K Ashok, Orally Disintegration systems: Innovations in Formulation and Technology. Recent patent on Drug Delivery and Formulation. 2: 2008:258-274.

6. Arya A, Chandra A, Sharma V, Phathakk. Fast dissolving films: an innovative drug delivery system and dosage form. Int J Chem Tech 2010, 576-583.

7. Prajapati, BP and Ratnakar, N (2009), “A Review on recent patents on fast dissolving drug delivery system”, International Journal of Pharmatech Research, Vol.1 (3), 790-798.

8. Nandy, BC; Mazumder, B; Pathak, K and Saxena, N (2011), “An overview on fast dissolving drug delivery system”, AJPSR, Vol.1 (2), 2249-4898.

9. Neelam, S; Vipin, S and Summet, G (2012), “ Recent advances in novel mouth dissolving tablets”, Novel Science International Journal of Pharmaceutical Science, Vol. (3), 1204-211.

10. Bhowmik, D; Chiranjib, B; Krishnakanth, Pankaj and Chandra, RM (2009), “Fast Dissolving Tablet: An Overview”, Journal of Chemical and Pharmaceutical Research, Vol.1 (1), 163-177.

11. Bhyan B, Jangra S, Kaur M and Singh H: Orally Fast Dissolving Films: innovations in formulation and technology. International Journal of Pharmaceutical Sciences Review and Research 2011; 9(2): 50-57.

12. Puthil SP and R P Dixit: Oral strip technology: overview and future potential. Journal of Controlled Release 2009; 139: 94-107.

13. Gavaskar B, Vijaykumar S, Sharma G and Rao YM: Overview on fast dissolving films. International Journal of Pharmacy and Pharmaceutical Sciences 2010; 2(3):29-33.

14. Siddiquinehal, M. D., G. Garg and P.A. Sharma, 2011. Short review on A novel approach in oral fast dissolving drug delivery system and their patents. Advances in Biological Research, pp:291-303.

15. Nagar,P. and Y. Chauhaniti, 2011. Asirmohd, Insights into Polymers: Films Drug Invention Today 3(12); 280-289.

16. Frey 2006. Film strips and pharmaceuticals. Pharmaceutical Manufacturing and Packaging Resourcer 4: 92-93.

17. Deshmane SV Joshi UM Channawar MA, Design and Characterization of Carbopol-HPMC based Buccal compact containing propranolol hydrochloride. Indian Journal of Pharmaceutical Education and Research 44(3): 20S10: 67-78.

18. Khairnar A., Jain P., Baviskar R D, Development of mucoadhesive Buccal patch containing aceclofenac: in vitro evaluation. International Journal of PharmTech Res. 1(4): 2009:34-42.

Received on 18.02.2016 Accepted on 05.03.2016

Asian J. Pharm. Res. 6(1): January -March, 2016; Page 56-58

DOI: 10.5958/2231-5691.2016.00010.1