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 Table of Contents  
ORIGINAL/BRIEF
Year : 2012  |  Volume : 4  |  Issue : 5  |  Page : 108-109  

Formulation development and evaluation of mouth dissolving film of domperidone


1 A. R. College of Pharmacy and G. H. Patel Institute of Pharmacy, P. B. No. 19, Vallabh Vidyanagar, Anand, Gujarat, India
2 Indukaka Ipcowala College of Pharmacy, New V. V. Nagar, Anand, Gujarat, India

Date of Web Publication21-Mar-2012

Correspondence Address:
Pratikkumar Joshi
A. R. College of Pharmacy and G. H. Patel Institute of Pharmacy, P. B. No. 19, Vallabh Vidyanagar, Anand, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0975-7406.94159

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   Abstract 

The present investigation was undertaken with the objective of formulating mouth dissolving film(s) of the antiemetic drug Domperidone to enhance the convenience and compliance by the elderly and pediatric patients. Domperidone is a drug of choice in case of nausea and vomiting produced by chemotherapy, migraine headaches, food poisoning and viral infections. It causes dopamine (D2 and D3) receptor blockage both at the chemoreceptor trigger zone and at the gastric level. It shows high first pass metabolism which results in poor bioavailability (10-15%). In view of high first pass metabolism and short plasma half-life it is an ideal candidate for rapid release drug delivery system. The solid dispersions of Domperidone were prepared with the use β-cyclodextrin in various ratios (1:1, 1:2, 1:3) and solubility study was performed to determine the ratio in which solubility of Domperidone was highest (1:3). The selected solid dispersions were then utilized for the preparation of film by solvent casting method utilizing HPMC E15 as a film forming agent and PEG-400 as plasticizer. Five formulae were prepared and were evaluated for their in vitro dissolution characteristics, in vitro disintegration time, and their physico-mechanical properties. The promising film (F1) showed the greatest drug dissolution (more than 75% within 15 min), satisfactory in vitro disintegration time (45 sec) and physico-mechanical properties that are suitable for mouth dissolving films.

Keywords: Mouth dissolving film, domperidone, β-cyclodextrin


How to cite this article:
Joshi P, Patel H, Patel V, Panchal R. Formulation development and evaluation of mouth dissolving film of domperidone. J Pharm Bioall Sci 2012;4, Suppl S1:108-9

How to cite this URL:
Joshi P, Patel H, Patel V, Panchal R. Formulation development and evaluation of mouth dissolving film of domperidone. J Pharm Bioall Sci [serial online] 2012 [cited 2020 Aug 9];4, Suppl S1:108-9. Available from: http://www.jpbsonline.org/text.asp?2012/4/5/108/94159

Domperidone is specific blocker of dopamine receptors (D2 and D3) and is widely used to treat emesis. It causes dopamine receptor blockage both at the chemoreceptor trigger zone and at the gastric level. It shows high first pass metabolism which results in poor bioavailability (10-15%). In view of high first pass metabolism and short plasma half-life it is an ideal candidate for rapid release drug delivery system.


   Materials and Methods Top


Preparation of solid dispersion of Domperidone : Domperidone inclusion complexes were prepared with β-CD in different ratio (1:1, 1:2 and 1:3) by kneading method.

Preparation of fast dissolving films : Solid dispersion of Domperidone and β-cyclodextrin (1:3) was selected and dispersed in half quantity of water and to it methanol is added along with Tween-80 and heated at 60°C. In other half quantity of water, HPMC E15 is dissolved and PEG-400 is added. Both the solutions are sonicated and then casted in petridish. It is dried in oven at 60°C for 5 hrs to obtain the film.

Evaluation of films

  1. Morphological properties: Properties such as homogeneity, color, transparency and surface of the oral films were evaluated by visual inspection.
  2. Film mass: The mass of three films were determined by an analytical balance and mean±S.D was calculated.
  3. Film thickness: Film thicknesses were measured at five positions (central and the four corners) using the Digital Vernier Caliper and the mean thickness was calculated.
  4. Folding endurance study: It was measured manually by repeatedly folding a film at the same place till it broke.
  5. In vitro disintegration studies: The film as per the dimensions (3 × 2 cm) required for dose delivery was placed on a stainless steel wire mesh placed in a petridish containing 10 ml phosphate buffer pH 6.8. Time required for the film to break was noted as in vitro disintegration time.
  6. Dissolution and Drug release: Dissolution test of films was performed using (900 ml; phosphate buffer pH 6.8 with USP dissolution apparatus II at 50 rpm and 37±0.5°C temperature. The drug release was analyzed spectrophotometrically at λmax 286.5 nm using ultraviolet (UV) spectrophotometer (Shimadzu model no: 1800).
[Table 1] and [Table 2].
Table 1: Formulation of mouth dissolving film of domperidone


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Table 2: Evaluation of mouth dissolving film of domperidone

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   Results and Discussions Top


All the films were non-sticky, soft and semi-transparent. Surface of all the films were smooth except F1 formulation. The weight of each film was found to be uniform. All the formulation contained varied amount of polymer and hence thickness of each film was varied between the ranges of 0.14 mm-0.36 mm.

When the concentration of HPMC E15 is increased from 5%-10%, thickness of the strip increased. Folding endurance was measured manually and it was found to decrease with increase in the concentration of film forming polymer HPMC E15. The surface pH of all the formulation was found to be in the range of 6.8-7.2 and hence will not cause any irritation to oral mucosa. F1 formulation found to give minimum disintegration time (45 sec) as compared to other formulations. The drug release rate decreases as the concentration of the film forming agent HPMC E15 increases in the formulation. After 15 min interval more than 75% of drug was released from batches as defined in the Guidances such as USP30.


   Conclusion Top


Films were prepared of Domperidone-β-cyclodextrin solid dispersion by the use of HPMC E15 as a film forming agent and PEG-400 as a plasticizer. All the films were found to disintegrate within 70 sec. Among the prepared formulations F1, formulation showed minimum disintegration time of seconds. Domperidone mouth dissolving films were prepared successfully by the use of solid dispersion of Domperidone with β-cyclodextrin and it can be used to treat emesis caused by various conditions in geriatric, bedridden and non-cooperative patients due to its ease of production. [1]

 
   References Top

1.Choudhary DR, Patel VA, Patel HV, Kundawala AJ. Formulation and evaluation of quick dissolving film of levocetirizine dihydrochloride. Int. J. Pharmacy and Techno. 2011; 3(1): 1740-49.  Back to cited text no. 1
    



 
 
    Tables

  [Table 1], [Table 2]


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