Development and evaluation of Fast Dissolving oral film


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Development and evaluation of Fast Dissolving oral film


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Development and evaluation of Fast Dissolving oral film:

Development and evaluation of Fast Dissolving oral film Prepared & Presented by : Mr. Swapnil L. Patil M.Pharm , III semester Dept.of Pharmaceutics FDF Pad. Dr. D. Y. Patil College of Pharmacy Akurdi , Pune .

Contents : :

Introduction Objectives Plan of work Literature survey Materials And Methods Evaluation References Contents : 12/17/2011 2

Introduction ::

Defination :- Oral film It is relatively a new dosage form in which thin film is prepared using hydrophilic polymers rapidly dissolves on tongue or buccal cavity. Rapid onset of action and improved bioavailability. Useful for pediatric, geriatric patients. Introduction : FDF 12/17/2011 3

Advantage of MDF ::

Advantage of MDF : 12/17/2011 4


Drugs which are unstable at buccal pH cannot be administered. Drugs which irritate the mucosa or an obnoxious odor cannot be administered by this route. Drug with small dose requirement can only be administered . Disadvantages 12/17/2011 5

Plan of work …..:

Plan of work ….. 12/17/2011 6

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AUTHOR TOPIC STUDY 1 S. Kunte et al Fast dissolving strips: A novel approach for the delivery of verapami l oral strips formulated with different concentrations of HPMC E6 and maltodextrin found to disintegrate in less than 30 seconds. 2 Aditya Dinge et al Formulation and Evaluation of Fast Dissolving Films for Delivery of Triclosan to the Oral Cavity HPMC and xanthan gum successfully taste masked by the use of poloxamer 407 and eugenol (HPBCD ) to improve solubility of TC 3 Prabhakara Prabhu et al Formulation and evaluation of fast dissolving films of levocitirizine di hydrochloride marked increase in the dissolution rate was exhibited by FDF of levocetirizine dihydrochloride containing HPMC as a polymer, when compared to conventional tablets. Literature survey 12/17/2011 7

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AUTHOR TOPIC STUDY 4 Renuka Mishra et al Formulation and Development of Taste-Masked Rapidly Dissolving Films of Cetirizine Hydrochloride The various grades of HPMC (E3/5/15) LV highly affected the in vitro disintegration time and in vitro dissolution profiles. (HPMC E3 LV) Flavors and sweeteners were incorporated in the film formulation 5 Cilurzo F. et al Diclofenac fast-dissolving film: suppression of bitterness by a taste-sensing system. The ' mint ' and ' licorice ' flavors and sucralose mixture resulted appropriate to mask DS bitterness TMAs did not significantly affect the film disintegration time and dissolution rate 6 Reinhart Martin et al Pivotal Bioequivalence study for Ondansetron Rapidfilm ® successfully completed On the basis of bioequivalence assessed in this pivotal study, therapeutic equivalence between Ondansetron RapidFilm ™ and Zofran ODT® could successfully be demonstrated Literature survey ………. 12/17/2011 8

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AUTHOR TOPIC STUDY 7 Francesco Cilurzo et al Nicotine Fast Dissolving Films Made of Maltodextrins : A Feasibility Study To develop a fast-dissolving film made of low dextrose equivalent maltodextrins the milk and mint flavours resulted particularly suitable to mask the taste 8 Mashru et al Development and Evaluation of Fast Dissolving Film of Salbutamol Sulphate polyvinyl alcohol had positive effect on tensile strength and mannitol had negative effect on tensile strength. 9 Sandeep Saini et al Fast dissolving film of levocetrizine dihydrochloride prepared by solvent casting method by using Maltodextrin & HPMC E15 Literature survey ………. 12/17/2011 9

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AUTHOR TOPIC STUDY 10 S. Raju et al Flash release oral films of metoclopramide hydrochloride for pediatric use: formulation and in-vitro evaluation HPMC , CMC This case study showed that hydroxypropyl methyl cellulose was the most suitable film-forming material for metoclopramide -loaded films, providing fast dissolution films that were not sticky and were easy to handle. 11 Avani Amin et al Development and Evaluation of Fast Dissolving Film of Salbutamol Sulphate Pullulan Solvent casting was the method used for formation of rapidly dissolving films. taste masking was achieved by use of sweeteners, flavours and citric acid. Literature survey ………. 12/17/2011 10

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AUTHOR TOPIC STUDY 11 S. Raju et al Design and development of sublingual fast dissolving films for an Antiasthmatic drug HPMC , HPC , Sodium alginate taste masking was achieved by use of sweeteners, Aspartame Literature survey ………. 12/17/2011 11

Justification :

Justification FDF 12/17/2011 12

Objective ::

To develop analytical method for estimation of ……….drug by UV spectrophotometer To study compatibility of ……drug with excipients To formulate mouth dissolving film of …….. To study the effect of polymers on release pattern of ………drug Objective : 12/17/2011 13

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Sr. No Category Con. (%) Examples 1 Drug 1-25 Antiemetic , Insomenia , NSAIDS, etc 2 Polymer 40-50 HPMC,Pullulan , Maltodextinn , Carbopol etc 4 Plasticizer 25-35 PG,PEG, Phthalate derivatives 5 Sweetener 2-10 Sucrose , Aspartame 6 Flavor 2-5 Peppermint , Vanilla,Coffee,Chocalate Formulation of Fast dissolving film 12/17/2011 14

Candidate drugs :

Candidate drugs . 12/17/2011 15

Drug profile:

................ Molecular Formula:........ Molecular Weight:- Appearance :- ,,,,…… Dose:-………. Half life:- 5.7 hrs Water solubility:-……. Category :-………. Treatment for : …………. Drug profile FDF 12/17/2011 16


Excipients Plasticizers polymers Sweetener Colour Flavor Saliva stimulants 12/17/2011 17

Selection of Polymers:

Selection of Polymers Hydroxyl propyl methyl cellulose Hydroxy Propyl cellulose Starch and modified starch Pullunan Pectin Gelatin Carboxy methyl cellulose PVP + Cross linked PVP 12/17/2011 18

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MATERIALS Sr. No. Material Source 1 Drug Gift Sample from……… 2 Polymer Gift Sample from………. 3 Excp . Gift Sample from……… 4 Excp . Gift Sample from ………… 12/17/2011 19

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Sr. No. Instrument 1 UV Visible spectrophotometer 2 IR spectrophotometer 3 Magnetic Stirrer 4 Dissolution apparatus 5 Micrometer Screw Gauge 6 Stability Chamber EQUIPMENTS 12/17/2011 20

Manufacturing of FDF ::

1.HOT MELT EXTRUSION METHOD- In the extrusion process the API and other ingredients are mixed in dry state, subjected to heating process and then extruded out in molten state. In this process, solvents are completely eliminated. The films are further cooled and cut to the desired size. The high temperature used in this process may degrade thermolabile APIs. Manufacturing of FDF : 12/17/2011 21

2 : Solving Casting:

Preparation of the casting solution, Deareation of the solution, Transfer of the appropriate volume of solution into a mold, Drying the casting solution, Cutting the final dosage form to contain the desired amount of drug, Packaging. 2 : Solving Casting 12/17/2011 22

3. Semisolid casting:

Water soluble polymers are dissolved in water Solution added to solution of acid insoluble polymer which was prepared in NH4OH,NaOH. Plasticizer is added to obtain gel mass. The prepared gel mass is cast into films. Thickness : 0.015-0.05 inch 3. Semisolid casting 12/17/2011 23

4. 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. 4. Rolling method 12/17/2011 24

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Sr. No Concentration (  g/ml) Absorbance 1 0 0 2 1 0.05 3 2 0.1 4 3 0.14 5 4 0.191 6 5 0.237 7 6 0.283 8 7 0.338 9 8 0.385 10 9 0.419 11 10 0.483 Preformulation Studies and Calibration Curve of drug………… Parameter Range Wave Length …….nm Coefficient of Correlation 0.9992 Intercept 0.1122 12/17/2011 25

Evaluation of FDF ::

1.Thickness 2.Tensile strength = load at failure × 100 strip thickness × strip width 3.Percent elongation 4.Tear resistance 5. Folding endurance 6.Dissolution test 7.Content uniformity 8.Disintegration time Evaluation of FDF : 12/17/2011 26


1.THICKNESS The thickness of strip can be measured by micrometer screw gauge at different strategic locations. This is essential to assure uniformity in the thickness of the film as this is directly related to the accuracy of dose. Evaluation of FDF : . 12/17/2011 27


Tensile strength is the maximum stress applied to a point at which the strip specimen breaks. It is calculated by the applied load at rupture divided by the cross-sectional area of the strip as given in the equation below: Load at failure × 100 Strip thickness × Strip width 2.TENSILE STRENGTH Tensile strength = 12/17/2011 28


When stress is applied, a strip sample stretches and this is referred to as strain. Strain is basically the deformation of strip divided by original dimension of the sample. Generally elongation of strip increases as the plasticizer content increases Increase in length of strip × 100 Initial length of strip 3.PERCENT ELONGATION % elongation = 12/17/2011 29


Tear resistance of plastic film or sheet is a complex function of its resistance to rupture. Basically very low rate of loading 51 mm (2 in.)/min is employed and is designed to measure the force to initiate tearing. The maximum stress or force (that is generally found near the onset of tearing) required to tear the specimen is recorded as the tear resistance value in Newton (or pounds-force). 4.TEAR RESISTANCE 12/17/2011 30


Young's modulus or elastic modulus is the measure of stiffness of strip. It is represented as the ratio of applied stress over strain in the region of elastic deformation Slope of stress-strain curve × 100 Strip thickness × cross-head speed 5.YOUNG'S MODULUS Young’s modulus = 12/17/2011 31


Folding endurance is determined by repeated folding of the strip at the same place till the strip breaks. The number of times the film is folded without breaking is computed as the folding endurance value. 6. FOLDING ENDURANCE 12/17/2011 32


Dissolution testing can be performed using the standard basket or paddle apparatus described in any of the pharmacopoeia. The dissolution medium will essentially be selected as per the sink conditions. Many times the dissolution test can be difficult due to tendency of the strip to float on to the dissolution medium when the paddle apparatus is employed . 7.DISSOLUTION TEST 12/17/2011 33

Evaluation of FDF ::

8.DISINTEGRATION TIME Although, no official guidance is available for films strips. Pharmacopoeial disintegrating test apparatus may be used for this study. Typical disintegration time for strips is 5–30 s 9.CONTENT UNIFORMITY- Determined by any standard assay method of API in any standard pharmacopoeia. Limit of content uniformity is 85–115 percent Evaluation of FDF : 12/17/2011 34

Pending Work :

… ….. …….. ………. ………… …………… Thesis submission. Pending Work 12/17/2011 35

Expected Outcome :

Development of Fast Dissolving Film with :- Expected Outcome FDF 12/17/2011 36

References :

References FDT . Choudhary DR, patel VA , kundawala AJ, Formulation and evaluation of quick dissolving Film of levocetirizine dihydrochloride , Int J Pharma Tech ,2011;3 (1) :1740-1749 Saini S , NandaA ., Dhari J., Formulation, development & evaluation of oral fast dissolving anti-allergic film of levocetrizine dihydrochloride , J. Pharm. Sci. & Res., 2011;3(7):1322-1325 Raju S., Reddy P., Kumar V., flash release oral films of metoclopramide hydrochloride for pediatric use: formulation and in-vitro evaluation, j. Chem. Pharm. Res., 2011;3(4):636-646 Patil SB.,Shahi SR., Formulation and evaluation of quick dispersible tablet of Olanzapine , Int J Pharma . Res.Dev.,2009; 7(!),30-34 12/17/2011 37


Mishra R and Amin A., Formulation and Characterization of Rapidly Dissolving Films of Cetirizine hydrochloride using Pullulan as a Film Forming Agent ,Ind J Pharm Edu Res, 2011; 45(1) :75-76 Dixit RP.,Puthli SP., Oral strip technology: Overview and future potential , J of Cont Release 2009 ;139: 94–107 Kunte S.,and Tandale P., Fast dissolving strips: A novel approach for the delivery of verapamil , J Pharm Bioallied Sci. , 2010 Oct-Dec; 2(4): 325–328 Arya A, Chandra A, Sharma V, Pathak K., Fast dissolving oral films: An innovative drug delivery system and dosage form, Int J ChemTech Res., 2010;2:576–83. Reference….. 12/17/2011 38

Reference….. :

Prabhu P., Malli R., Koland M., Formulation and evaluation of fast dissolving films of levocitirizine di hydrochloride , Int J of Pharma Investigation, 2011 ; 1(2) : 99-104 Mishra R., Amin A., Formulation Development of Taste-Masked Rapidly Dissolving Films of Cetirizine Hydrochloride, Pharma. Technology , 2009; 33(2): 48-56 . Mashru RC.,Development and Evaluation of Fast Dissolving Film of Salbutamol Sulphate, Drug Dev. Ind. Pharm., 2005 ; 31 (1) : 25–34 Cilurzo F., Minghetti P., Diclofenac fast-dissolving film: suppression of bitterness by a taste-sensing system, Drug Dev Ind Pharm., 2011 Mar, 7(3):252-9. Reference….. 12/17/2011 39


Dinge A and Nagarsenker M., Formulation and Evaluation of Fast Dissolving Films for Delivery of Triclosan to the Oral Cavity, Ame. Asso. of Pharma Scientists PharmSciTech. 2008 June; 9(2): 349–356. Pharmaceutical manufacturing encyclopedia, William Andrew Publishing, East-West Press Pvt. Ltd.,3 rd ed, 2512 Dahiya M., Saha S., Shahiwala A., A review on mouth dissolving films, Curr. Drug Deliv. , 2009 Oct ; 6(5):469-76. Reinhart Martin , : Pivotal Bioequivalence study for Ondansetron Rapidfilm® successfully completed , Labtec_Press Release_Dummy.rtf dated on 01/14/08 Francesco C., Cupone IE, Minghetti P., Nicotine Fast Dissolving Films Made of Maltodextrins: A Feasibility Study;AAPS PharmSci Tech,2010 ;11(4):1511-1517 Reference….. 12/17/2011 40

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Thank You ! 12/17/2011 41

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