Fast Dissolving Oral Film Of Donepezil Hydrochloride FDF Swapnil Patil

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Fast Dissolving Oral Film Of Donepezil Hydrochloride

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You Guided Me When I Was Lost…. You Supported Me When I Was Weak…. You Have Enlightened me all through….. “Happy … Teachers…. Day”…… Sir, 9/05/2012 1 5 sept,2012

Fast Dissolving oral film OF DONEPEZIL HYDROCHLORIDE: 

Fast Dissolving oral film OF DONEPEZIL HYDROCHLORIDE Guided by: Prof. P.R.Mahaparale Prepared & Presented by : Mr. Swapnil L. Patil M.Pharm , IV semester Dept.of Pharmaceutics FDF Pad. Dr. D. Y. Patil College of Pharmacy Akurdi , Pune

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Introduction Literature survey Objectives Plan of work Materials And Methods Result and Discussions Conclusion References 9/05/2012 3 CONTENTS .

Definition :- 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 geriatric patients. FDF 9/05/2012 4 INTRODUCTION

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9/05/2012 5 ADVANTAGES OF FDF .

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9/05/2012 Grittiness Fragile / Brittle Fear Choking Pain / infection/inflammation Large Dose Dosing accuracy Stability Microbial Cont. Water Dysphagia,Travelling 6

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9/05/2012 Alzheimers Disease Is an irreversible , progressive brain disease that slowly destroys memory & thinking skills and ability to carry out simple task. Symptoms: serious memory loss, Confusion, Behavioral Changes, Difficulty in Speaking/Walking Treatment: Mild to Moderate : Donepezil, Galantamine,rivastigmine Severe : Donepezil , Memantamine Cause problems with memory, thinking,& Behavior 7

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9/05/2012 Alzheimers Disease Occurs to Geriatric Patients So, Patient compliance is the Key parameter while designing the DDS Each and every day Patients has to take Dosage 8

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9/05/2012 Problems with DDS Conventional Tab/Cap D.T Liquids ( Emulsion /Susp./Syrup) MDT FDF Water Needed X X X Swallow/Coughing X X X Choking Fear X X X Dosing Accuracy X X X X Vomisis X X Dysphagia X X X Travelling X X X Mechanical Strength X X X Grittiness X X X X Stability X X X X Microbial Contamination X X X X Patient Compliance : FDF >MDT> Conventional TAB/CAP and Liquids X = No problems….DDS 9

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9/05/2012 Alzheimer's Disease 26.5 millions patients in 2006 Market $ 6 Billions in 2011 in 7 major markets Molecule available for mild to severe Alzheimer So, DONEPEZ Il is the undisputed market leader 10

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9/05/2012 Donepezil Hydrochloride Tab/MDT-Available in India FDF- Not available in India 11

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Sr AUTHOR TOPIC STUDY 1. Aggarwal J. et al 1 A Comparative investigation on different polymers employed in the formulation of oral fast dissolving films Polymers : HPMC E15; Gelatin, Sodium alginate and polyvinyl alcohol , pullulan Higher concentration of polymer and plasticizer resulted in increased disintegration time 2 Kunte S et al 7 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. 3 Dinge A. et al 5 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 9/05/2012 12 LITERATURE SURVEY

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Sr AUTHOR TOPIC STUDY 4 Raju S et al 19 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. 5 Saini S et al 20 Fast dissolving film of levocetrizine dihydrochloride 2 2 factorial design prepared by solvent casting method by using Maltodextrin & HPMC E15 6 Cilurzo F. et al 4 Nicotine Fast Dissolving Films Made of Maltodextrins 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 Literature survey ………. 9/05/2012 13

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Sr AUTHOR TOPIC STUDY 7 Choudhry et al 3 Formulation and evaluation of quick dissolving Film of levocetirizine dihydrochloride solvent casting technique carboxy methyl cellulose, hydroxy propyl methyl cellulose and hydroxy propyl cellulose . Neotame masked the bitter taste of levocetirizine dihydrochloride 8 Prabhu P. et al 26 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. 9 Amin A et L 25 Formulation and characterization of rapidly dissolving films of cetirizine hydrochloride using pullulan as a film forming agent Pullulan Solvent casting bitter taste masking was achieved by use of sweeteners- Aspartame, sucralose dissolution media namely 0.1N HCl and simulated saliva (500ml) Literature survey ………. 9/05/2012 14

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Sr AUTHOR TOPIC STUDY 10 Mashru et al 24 Development and Evaluation of Fast Dissolving Film of Salbutamol Sulphate salbutamol sulphate and polyvinyl alcohol 3 3 factorial design Simulated saliva (300 mL) using USP Apparatus 2 (paddles). 11 Reinhart Martin et al 9 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 9/05/2012 15

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To formulate and evaluate oral fast dissolving films of Donepezil HCl To study compatibility of Donepezil HCl with excipients To study the effect of different polymers on film forming capacity and plasticizers on the release of Donepezil HCl To prepare the optimized oral fast dissolving film formulation of Donepezil HCl by response surface methodology, Design Expert software 9/05/2012 16 OBJECTIVE .

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FDF 9/05/2012 17 JUSTIFICATION .

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Novelty No Marketed film of Donepezil HCl available in India Less excipients requirements Administered without water, anywhere, any time Ease of formulation by solvent casting method Patients not feel bitter taste of drug (by Obscuration Tech.) Immediate action due to rapid absorption 9/05/2012 18 .

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Usefulness Useful for geriatric patients Useful for uncooperative and admitted patients In travelling cases, Patients suffering from vomisis, Dysphagia patients : FDF is better than conventional tablets 9/05/2012 19

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Literature survey Selection and procurement of drug and excipients Preformulation study including characterization of drugs Identification of the drug Melting point UV spectrum FTIR spectrum DSC study Calibration curve of Donepezil Hydrochloride in 0.1 N HCl and in Simulated saliva pH 6.8 by UV spectrophotometer Drug - excipients compatibility study 9/05/2012 20 PLAN OF WORK .

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Formulation development of fast dissolving film Formulation design for selection and optimization of film forming polymer concentration Use of Factorial design for the formulation optimization of fast dissolving film of Donepezil Hydrochloride Evaluation of fast dissolving film Analysis of Factorial design results by Design Expert software 9/05/2012 21 PLAN OF WORK….

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Name: (RS)-2-[(1-benzyl-4-piperidyl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one Molecular weight: 415.95 Melting Point : 231-232 0 C Bioavailability: 100 % Solubility: soluble in water MoA: centrally acting reversible acetyl cholinesterase inhibitor Use: in the treatment of Alzheimer’s disease where it is used to increase cortical acetylcholine Dose : 5 -10mg , Maximum dose : 23 mg . HCL 9/05/2012 22 DRUG PROFILE : DONEPEZIL HYDROCHLORIDE .

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9/05/2012 23 PREFORMULATION STUDY .

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9/05/2012 U.V spectrum of Donepezil Hydrochloride 24 U.V SPECTRUM

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Sr. No Concentration (  g/ml) Absorbance * 1 … … 2 … … 3 … … 4 … … 5 … … 6 … … 7 … … 8 … … Calibration curve of Donepezil HCl in 0.1 N HCl Parameter Range Wave Length ……. Coefficient of Correlation 0.999 Intercept 0.0336 Equation Y= 0.0336x+0.024 9/05/2012 * Represents mean value 25

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Sr. No Concentration (  g/ml) Absorbance* 1 … … 2 … … 3 … … 4 … … 5 … … 6 … … 7 … … 8 … … Calibration curve of Donepezil HCl in Simulated saliva pH 6.8 Parameter Range Wave Length …. nm Coefficient of Correlation 0.9989 Intercept 0.031 Equation Y= 0.031x+0.0178 9/05/2012 * Represents mean value 26

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Drug Drug with excipients 9/05/2012 27 DRUG- EXCIPIENTS COMPATIBILITY STUDY BY DSC .

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Drug+Pullulan Drug+HPMC E Drug Drug+PVA 9/05/2012 28 DRUG- EXCIPIENTS COMPATIBILITY STUDY BY FTIR .

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9/05/2012 Sr. No. Name of the Ingredient Category Name of Manufacturer Company 1 Donepezil Hydrochloride Drug …………… 2 Pullulan Polymer ……………. 3 HPMC E3,E5,E6,E15 Polymer ……………. 4 Polyvinyl Alcohol Polymer …………… 5 Glycerol Plasticizer ……………. 6 Sucralose Sweetener ……………. MATERIALS 29

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Sr. No. Instrument 1 UV Visible spectrophotometer 2 FTIR spectrophotometer 3 Magnetic Stirrer 4 Dissolution apparatus 5 Micrometer Screw Gauge 6 Stability Chamber 9/05/2012 30 EQUIPMENTS

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Sr. no. Ingredients Percentage amount (%) Examples 1 Drug 1-23 Antialzheimers etc 2 Polymer 40-50 HPMC,Pullulan, Maltodextinn, Carbopol etc 3 Plasticizer 25-35 PG,PEG , Sorbitol 4 Sweetener 2-10 Sucralose, Aspartame 5 Flavor 2-5 Peppermint , Vanilla,Coffee,Chocalate 9/05/2012 31 GENERALIZED FORMULATION DESIGN .

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9/05/2012 11 Polymers Screening of polymers Chitosan Pullulan HPMC (E3,E5,E6,E15) PVA ………….. X ……. X (.:…………….) E (.:….) PVA Evaluated on the basis of Transparency Film Forming Capacity HPMC E + PVA ……….. ……….. HPMC E3 HPMC E5 HPMC E6 HPMC E15 PULLULAN POLYOX WSR 1105 PVA SODIUM ALGINATE PVP CHITOSAN GELATIN 32 Polymers

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9/05/2012 Plasticizer Glycerol …PEG…… PG …….. ………. …….. Glycerol Final Formulation: HPMC E + PVA + Glycerol 33

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9/05/2012 Polymer (2% W/V) E1 E2 E3 E4 E5 E6 E7 E8 E9 E10 E11 HPMC E3 √ HPMC E5 √ HPMC E6 √ HPMC E15 √ PULLULAN √ POLYOX WSR 1105 √ PVA √ SODIUM ALGINATE √ PVP √ CHITOSAN √ GELATIN √ D.W. (…ml ) √ √ √ √ √ √ √ √ √ (0.1N HCL) √ Table 1: Effect of the Different polymers on film forming capacity of film 34

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9/05/2012 Sr No. Polymers Used *Film forming capacity Appearance 1 HPMC E3 +++ Transparent 2 HPMC E5 +++ Transparent 3 HPMC E6 ++++ Transparent 4 HPMC E15 +++ Transparent 5 PULLULAN +++++ Very Transparent 6 POLYOX WSR 1105 - ---- 7 PVA +++ Transparent 8 SODIUM ALGINATE - --- 9 PVP K30 + Semitransparent 10 CHITOSAN +++ Transparent 11 GELATIN - ---- Table 2: Evaluation of Films prepared by using Explored polymers 35

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9/05/2012 Sr.No. Components P1 P2 P3 P4 1 Donepezil HCl (mg) … … … … 2 Pullulan (mg) … … … … 3 Glycerol (ml) … … … … 4 PEG 400 (ml) … … … … 5 PG (ml) … … … … 6 D.W. (ml) … … … … Table 3: Preparation of Trial batches with Pullulan Table 4: Preparation of Trial batches with Chitosan Sr.No. Components C1 C2 C3 C4 1 Donepezil HCl (mg) 2 Chitosan (mg) 3 Glycerol (ml) 4 PEG 400 (ml) 5 PG (ml) 6 0.1N HCl (ml) Table 5: Preparation of Trial batches with PVA Sr.No Components V1 V2 V3 V4 1 Donepezil HCl (mg) … … … … 2 PVA (mg) … … … … 3 Glycerol (ml) … … … … 4 PEG 400 (ml) … … … … 5 PG (ml) … … … … 6 D.W. (ml) … … … … Table 6: Preparation of Trial Batches with HPMC E series polymer Sr.No. Components E1 E2 E3 E4 1 Donepezil HCl (mg) … … … … 2 HPMC E3(mg) … … … … 3 HPMC E5(mg) … … … … 4 HPMC E6(mg) … … … … 5 HPMC E15(mg) … … … … 6 D.W.(ml) … … … … 36

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9/05/2012 Sr No. Formulations Film forming capacity Appearance Disintegration Time *(sec) Remark 1 P1 Best Transparent++ … … 2 P2 Best Transparent++ … … 3 P3 Best Transparent++ … … 4 P4 Good Transparent++ … … Table 7: Evaluation of Trial Batches of Pullulan/Chitosan/PVA/HPMC E Series Films *All values are mean ± SD, (n=3) Sr No. Formulations Film forming capacity Appearance Disintegration Time (sec)* Remark 1 C1 Average 2 C2 Average 3 C3 Average 4 C4 Average Sr No. Formulations Film forming capacity Appearance Disintegration Time (sec)* 1 V1 Good … … 2 V2 Good … … 3 V3 Average … … 4 V4 Average … … Sr No. Formulations HPMC grades used Film forming capacity Appearance Disintegration Time (sec)* 1 E1 E3 2 E2 E5 3 E3 E6 4 E4 E15 37

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9/05/2012 Figure 1: The comparative study of M1 to M5 formulation Figure 2: Dissolution profiles of formulations containing HPMC E and PVA 38 Formulations Sr.No. Components M1 M2 M3 M4 M5 1 Donepezil HCl (mg) … … … … … 2 HPMC E(mg ) … … … … … 3 PVA(mg) … … … … … 4 D.W.(ml) … … … … … Table 8: Preparation of Trial Films using combinations of HPMC E and PVA

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9/05/2012 Sr.No. Components R1 R2 R3 R4 R5 R6 R7 R8 1 Donepezil HCl(mg) … … … … … … … … 2 HPMC E…(mg ) … … … … … … … … 3 PVA(mg) … … … … … … … … 4 Glycerol (ml) … … … … … … … … 5 PEG 400 (ml) … … … … … … … … 6 PG (ml) … … … … … … … … 7 D.W.(ml) … … … … … … … … Table 10: Preparation of trial films using combinations of HPMC E and PVA with different plasticizer 39 Sr No. Formulations Appearance Disintegration time (sec)* Thickness (mm)* Folding endurance* 1 R1 Transparent … … … 2 R2 Transparent … … … 3 R3 Transparent … … … 4 R4 Difficult to remove … … … 5 R5 Transparent … … … 6 R6 Transparent … … … 7 R7 Transparent … … … 8 R8 Difficult to remove … … … Table 11: Evaluation of Trial Films of HPMC E and PVA with different plasticizer

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9/05/2012 40 Formulations Formulations Figure 3: Effect of Plasticizer on Folding Endurance Figure 4: Effect of Plasticizer on DT

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9/05/2012 Figure 6: Films of Different batches 41 Plasticizers

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Coded Values Actual Values ( mg) X 1 X 2 -1 … … 0 … … +1 … … Formulation Code Variable Level X 1 X 2 S1 -1 -1 S 2 -1 0 S 3 -1 +1 S 4 0 -1 S 5 0 0 S 6 0 +1 S 7 +1 -1 S 8 +1 0 S 9 +1 +1 9/05/2012 42 3 2 Factorial design .

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Components S1 S2 S3 S4 S5 S6 S7 S8 S9 Donepezil HCl (mg) … … … … … … … … … HPMC (mg ) … … … … … … … … … PVA(mg) … … … … … … … … … Glycerol (ml) … … … … … … … … … Sucralose (mg) … … … … … … … … … D.W.(ml) … … … … … … … … … ** Area of the Final film- 2cm X 2cm *** Dose of drug per film- 5 mg 9/05/2012 43 FORMULATION OF FACTORIAL BATCHES .

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9/05/2012 Table 12: Evaluation Parameter of Factorial Batches of Fast Dissolving Oral Films Formulation Code Appearance Weight of the film (mg)* Thickness (mm)# Surface pH* Folding Endurance* S1 … … … … … S2 … … … … … S3 … … … … … S4 … … … … … S5 … … … … … S6 … … … … … S7 … … … … … S8 … … … … … S9 … … … … … 44

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9/05/2012 Formulation Code Tensile strength (N/mm 2 ) Disintegration Time (sec) Drug content per film (2 x 2cm) (mg) S1 … … … S2 … … … S3 … … … S4 … … … S5 … … … S6 … … … S7 … … … S8 … … … S9 … … … Table 13 : Evaluation of Factorial Batches of Fast Dissolving Oral Films 45

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Time (min) Cumulative % drug release* 0.1 N HCl Simulated saliva (pH6.8) 1 … … 2 … … 3 … … 4 … … 5 … … 9/05/2012 Figure 5: Dissolution profiles of S4 formulations in 0.1 N HCl and in simulated saliva. 46 DISSOLUTION DATA OF S4 FORMULATION IN DIFFERENT DISSOLUTION MEDIUM .

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9/05/2012 Table 14: Dissolution data of factorial batches of fast dissolving oral films TIME (Min) Cumulative % Drug Release S1 S2 S3 S4 S5 S6 S7 S8 S9 1 … … … … … … … … … 2 … … … … … … … … … 3 … … … … … … … … … 4 … … … … … … … … … 5 … … … … … … … … … 7 … … … … … … … … … 10 … … … … … … … … … 15 … … … … … … … … … 47

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9/05/2012 Figure 6: Dissolution profiles of formulations S1 TO S9 48

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Factor Name Unit Type Low Actual High Actual Low Coded High Coded Mean Std. Dev. A … mg Numeric … … -1 1 … … B … mg Numeric … … -1 1 … … Response Name Units Obser . Analysis Min. Max. Mean Y1 %DR % 9 Polynomial … … … Y2 DT sec 9 Polynomial … … … Y3 FE Num. 9 Polynomial … … … 9/05/2012 49

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9/05/2012 Response F-value P-value Inference %DR 16.98 0.0208 Significant DT 159.00 0.0008 Significant FE 39.87 0.0060 Significant 50

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9/05/2012 % D R at 5 min = +92.38 -… * X 1 – …* X 2 – …. X 1 * X 2 – 0….. *X 1 2 + 0…..* X 2 2 (R 2 = 0.9659) 51 RESPONSE SURFACE PLOT .

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9/05/2012 52 . RESPONSE SURFACE PLOT

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9/05/2012 53

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The FTIR and DSC study revealed that, polymers and excipients used were compatible with drug. The Fast dissolving films were formulated using solvent casting technique. Amongst all the formulations, formulation containing HPMC E combine with PVA as film forming polymer has shown excellent in vitro disintegration time and in vitro cumulative percent drug release , compared to other formulations. Formulation……………………………………………………………………………………….was considered as the best formulation. From above discussion, it can be concluded that the successful formation and optimization of fast dissolving films of Donepezil HCl using HPMC E and PVA. Hence Donepezil Hydrochloride can be conveniently administered orally in the form of films 9/05/2012 54 CONCLUSION

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Aggarwal J, Singh G, Saini S., Fast dissolving films: A novel approach to oral drug delivery. Int Res J of Pharm, 2011; 2(12): 69-74. Arya A, Chandra A, Sharma V, Pathak K, Fast Dissolving Oral Films: An Innovative DrugDelivery System and Dosage Form, Int J of ChemTech Research, 2010; 2(1):576-583. Choudhary D.R., Patel V.A. , Kundawala A.J., Formulation and evaluation of quick dissolving Film of levocetirizine dihydrochloride , Int J Pharma Tech ,2011;3 (1) :1740-1749 Cilurzo F., Minghetti P., Buratti S., Selmin F., Chiara G.. Gennari , Montanari L., Nicotine Fast Dissolving Films Made of Maltodextrins: A Feasibility Study, AAPS PharmSciTech,2010. 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; 9(2): 349–356. Dixit R.P.,Puthli S.P., Oral strip technology: Overview and future potential , J of Cont Release, 2009 ;139: 94–107 Kunte S., Tandale P., Fast dissolving strips: A novel approach for the delivery of verapamil , J Pharm Bioallied Sci. , 2010; 2(4): 325–328 Margareth R. C. , Raimar L., May A., Simulated biological fluids with possible application in dissolution testing, Dissolution Technologies 18(3):15–28 Reinhart M. , Pivotal Bioequivalence study for Drug Rapidfilm® successfully completed , Labtec_Press Release_Dummy.rtf dated on 01/14/08 9/05/2012 . 55 REFERENCES

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Tripathi K.D. , Essentials of medical pharmacology, 5th ed., Jaypee Brothers Medical Publishers ,2009:84,337-340 www.accessdata.fda.gov/scripts/cder/dissolution/dsp_SearchResults_Dissolutions.cfm?PrintAll=1 www.aricept.com/ www.drugbank.ca/drugs/DB00843 www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/donepezilhydrochloride.pdf www.mims.com/USA/drug/info/Donepezil%20Hydrochloride/Donepezil%20Hydrochloride%20Tablet,%20Film%20Coated?type=full Sau-hung S., Robert D., Lori, Fast dissolving orally consumable films, U.S. Patent 6,596,298, July 22, 2003. Rowe R., Sheskey P., Owen S., Handbook of Pharmaceutical Excipients, 5 th ed. The Pharmaceutical Press, Grayslake, American Pharmacists Association, Washington 2006, 5th ed, 301-303 ,346-349, 592-593, 742-743. Ozaki Y ,Nomoura T., Pullulan binder and its uses., U.S. Patent 5411945, May2, 1995. 9/05/2012 Reference….. 56

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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 Saini S., Nanda A., Dhari J., Formulation, development & evaluation of oral fast dissolving anti-allergic film of levocetrizine dihydrochloride , J. Pharm. Sci. & Res., 2011;3(7):1322-1325 Samita G., Kumar G., Fast dissolving drug delivery and its technologies. The Pharma Innovation ,2012; 1(2): 34-39. Sapkal N., Kilor V., Daud A., Development of fast dissolving oral thin films of ambroxol hydrochloride: Effect of formulation variables., J of Adv Pharma Res, 2011; 2(2): 102-109 Gupta M, Patel M. Enhancement of Dissolution Rate of Rapidly Dissolving Film of Meclizine hydrochloride By Complexation of Meclizine Hydrochloride with beta Cyclodextrine.J of Applied Pharma Sci,2011;1(9):150-153. Mashru R.C., Sutariya V.B., Sankalia M.G., Parikh P.P,. Development and evaluation of fast dissolving film of salbutamol sulphate, Drug Dev Ind Pharm 2005 ; 31 (1) : 25–34 Mishra R, 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): 71-77. Prabhu P., Malli R., Koland M., Formulation and evaluation of fast dissolving films of levocitirizine 9/05/2012 Reference….. 57

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1 . Patil S. L*., Mahaparale P. R. , Fast Dissolving Oral Films: An Innovative Drug Delivery System, published in International Journal of drug discovery and medical research , 2012; 1 (1): 39-43. 2 Patil S.L*., . Mahaparale P.R., Screening of the polymers for formulation of oral fast dissolving film, published in Inventi Rapid Pharm Tech , 2012 ; 1 :1,3 3.……………………………………………………………………………………communicated to AAPS PharmSciTech. 9/05/2012 58 PUB LIC AT IO NS .

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9/05/2012 Now…..May be Donepezil is available in FD Films Th a nk Y ou . . . . 59