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 Table of Contents  
ORIGINAL/BRIEF
Year : 2012  |  Volume : 4  |  Issue : 5  |  Page : 19-20  

Formulation development and optimization of polyox based quick dissolving film of quetiapine


1 Department of Pharmaceutics, Arihant School of Pharmacy, Adalaj, Ahmedabad, India
2 Department of Pharmaceutical Analysis, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, India
3 Department of Pharmaceutics, Institute of Pharmacy, Nirma University, India

Date of Web Publication21-Mar-2012

Correspondence Address:
A Sunita Chaudhary
Department of Pharmaceutics, Arihant School of Pharmacy, Adalaj, Ahmedabad
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0975-7406.94123

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   Abstract 

Quick dissolving film prepared by various grades of polyox like Polyox N10,N80, N750 and N205. Polyox having excellent film forming capacity with rapid hydration power which leads to rapid disintegration of film upon contact with saliva. Film is optimized for concentration of polymer and plasticizer using CCD design. The tensile Strength, folding Endurance, % drug released at 10 min (Y10) and disintegration time were selected as dependent variables. The data revealed that 2% of polyox N 750 and 15% of PEG 400 showed excellent film forming property with rapid drug release profile.

Keywords: Solvent casting, psychotic, immediate release, central composite design


How to cite this article:
Chaudhary A S, Chaudhary B A, Mehta A T. Formulation development and optimization of polyox based quick dissolving film of quetiapine. J Pharm Bioall Sci 2012;4, Suppl S1:19-20

How to cite this URL:
Chaudhary A S, Chaudhary B A, Mehta A T. Formulation development and optimization of polyox based quick dissolving film of quetiapine. J Pharm Bioall Sci [serial online] 2012 [cited 2020 Jan 23];4, Suppl S1:19-20. Available from: http://www.jpbsonline.org/text.asp?2012/4/5/19/94123

QDT is most successful dosage form in tablet but film possesses more benefits than tablet due to availability of larger surface area which leads to rapid disintegrating and thereby dissolution in the oral cavity. [1] Fast dissolving film prepared using different grades of polyox is an innovative idea for rapid and fast release of drug for immediate treatment of psychotic disease. Quetiapine (QT) is used to treat schizophrenia attack and bipolar disorder having half-life of 6 hours. QT is rapidly absorbed and well tolerated drug. QT has tendency of minimum extrapyramidal symptoms. [2] This indicates a need to prepare the quick dissolving film of QT which provides rapid relief from psychotic symptoms and also minimize adverse effects.


   Materials and Methods Top


QT was received as gifted by Torrent Pharmaceuticals Pvt. Ltd., Polyox N 10, Polyox N 80, Polyox N 750 and Polyox N 205 were gifted by Dow chemicals Pvt. Ltd. Mumbai, PEG 400, Di- butyl phthalate and PG were purchased from S.D. Fine Chem Ltd., Aspartame and sucralose were obtained from Himedia lab, Bombay.

Formulation

Film was prepared by solvent casting method. [3] Preliminary trials were carried out for selection of appropriate grades of Polyox from different grades mentioned above. Concentration of polymer and plasticizers were optimized by central composite design. In this design 2 factors were evaluated, each at 3 levels. Experimental trials were performed at all 9 possible combinations with 5 replication batches. The amount of Polyox N750 (X1) and PEG 400 (X2) were selected as independent variables. The Tensile Strength, [4] folding Endurance, % drug released at 10 min (Y10) and disintegration time were selected as dependent variables.


   Results and Discussion Top


Different grades of polyox were used for film formation like N10, N80, N750 and N205. Initially, preliminary trials were carried out to select ideal grade of polymer used for film formation and then used for optimization of other parameters of film. Different mentioned grades were tried between 1-4% concentrations. From the result, it was observed that by increasing the concentration of polymer up to 2%, thickness and strength of film was improved. But by increasing concentration more than 2%, folding endurance of film was improved but increase in disintegration time more than limit. Thus, 2% concentration of polymer was used for further optimization of plasticiser and sweeteners. Plasticizer tried were Glycerin, PEG 400, and Propylene glycol in 15% concentration each. Glycerin and propylene glycol showed more sticky film which was unable to detach from surface. Poly ethylene glycol showed good film forming property with good flexibility. Polyox N750 was selected for further optimization of film property due to its excellent film forming nature with optimum viscosity for rapid dissolving film [Figure 1], [Figure 2].
Figure 1: Comparison of % elongation of design batches

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Figure 2: Comparison of film thickness of design batches

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Optimization of concentration of Polyox N750 and % of PEG as plasticisers was optimized systematically using with central composite design (CCD). [5] Optimization was carried out by preparing R1-R13 batches in CCD. From the results it was observed that disintegration time of all the batches ranges between 6-30 sec, tensile strength between 0.106 - 0.760 Kg/cm 2 , Folding endurance between 10-89 and drug release profile with in 10 min 80%-99%. % elongation was increased by increasing the concentration of plasticizers.

All the batches showed more than 80% drug release profile in initial 10 min. From all evaluation parameter, R10 batch with 2% polyox 750 and 15% of PEG 400 was considered as promising batch with all satisfactory parameters. For validation of optimum formulation, check point R14 was prepared and evaluated for all the response. Check point batch was compared for predicted value with observed value. Observed value was found close to the predicted value, which indicated good correlation of results.

Optimized film was analyzed by DSC spectra and compared with DSC spectra of pure drug. Spectra showed presence of drug peak at same energy of enthalpy as that of pure QT. Drug interaction was confirmed by FTIR spectra. FTIR spectra indicated that no interaction between drug and excipients. Stability study was carried out for 3 months in final optimized formulation. Formulation was stored at 65% relative humidity and 37°C temperature in the humidity oven. After 3 months film was again evaluated for all parameters. So, it was found that polyox was sensitive to moisture and humidity. Some predictable changes were observed in film property like decrease in disintegration time and more softness of film due to higher amount of moisture. Film texture was evaluated after 3 months of storage which indicates increase in stickiness of film at higher relative humidity. Other parameters remain unaltered after 3 months of storage.


   Conclusion Top


The results of central composite design revealed that the entire factor significantly influences the dependent variable. Thus, it can be concluded that by adopting a systematic formulation approaches, an optimum point can be reached in the shortest time with minimum effort. Thus, developed film can be useful for curing the emergency condition like schizophrenia which gives rapid relief within short time. Stability study data shows need of proper storage condition for film to protect from effect of moisture.


   Acknowledgement Top


Authors acknowledge the Institute of Pharmacy, Nirma university and Saraswati institute of pharmaceutical sciences, Dhanap, Gandhinagar for providing the research facilities. Authors are thankful to Dow chemicals for providing samples of Polyox.

 
   References Top

1.Suresh B, Halloran D, James L. Quick dissolving films: A novel approach to drug delivery, Drug Development Technology. 2006;1-7.  Back to cited text no. 1
    
2.Small JG., Steven RH., Arvamitis LB., Quetiapine In patients of Schizophrenia. A high and low dose double blind comparison with placebo, Archive Journal of Psychiatry., 1997, 54, 549-557.  Back to cited text no. 2
    
3.Corniello C, Quick dissolving strips: From concept to commercialization. Drug Delivery Technology. 2006; 6, 68-71.  Back to cited text no. 3
    
4.Radebaugh GW, Murtha JL, Julian TN, Bondi JN, Methods for evaluating the puncture and shear properties of pharmaceutical polymeric films. International Journal of Pharmaceutics. 1988; 45, 39-46  Back to cited text no. 4
    
5.Mendenhall W., Sincich T., Multiple regression: A Second Course in Business Statistics, Regression Analysis, 3 rd ed. San Francisco, CA: Dellen Publishing Co, 1989.  Back to cited text no. 5
    


    Figures

  [Figure 1], [Figure 2]



 

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