Domperidone 10 mg Tablet | Comparative Dissolution Study

Dissolution testing has emerged in the pharmaceutical field as a very important tool to characterize drug product performance. Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilization of the drug under physiological conditions, and the permeability across the gastrointestinal tract.

Domperidone is a dopamine antagonist medication that is used to treat nausea and vomiting and certain gastrointestinal problems like gastroparesis (delayed gastric emptying). It raises the level of prolactin in the human body and is used to induce and promote breast milk production. It may be taken by mouth or rectally.

Domperidone was discovered in 1974 and was introduced for medical use in 1979. It was developed by Janssen Pharmaceutica. Domperidone is available over-the-counter in many countries, for instance in Europe and elsewhere throughout the world. It is not approved for use in the United States. However, it is available in the United States for people with severe and treatment-refractory gastrointestinal motility problems under an expanded access individual-patient investigational new drug application.

There are several dosage forms and strengths available with Domperidone. The most common of which is Domperidone 10 mg Tablet.

Each film-coated tablet contains Domperidone 10 mg as Domperidone Maleate BP. The comparative dissolution study between Domperidone 10 mg Tablet from Pharmaceuticals-1 and Domperidone 10 mg Tablet from Pharmaceuticals-2 are as below:

Apparatus Condition:

Apparatus: Type 2 (Paddle)

Medium: 0.1N Hydrochloric Acid

Quantity: 900 ml

RPM: 50

Time: 45 minutes

Temperature: 37⁰c ± 0.5⁰c

Range: NLT 80% of the labeled amount of Domperidone is dissolved within 45 minutes.

Preparation of Standard Solution:                                    

Weigh accurately about 55 mg WS of Domperidone Maleate & transfer quantitively into a 1000 ml volumetric flask. Add 10 ml dimethylformamide to dissolve. Make volume up to the mark with the 0.1N Hydrochloric Acid & mix well. Transfer 10 ml of this solution to another 100 ml volumetric flask & make volume up to the mark with the 0.1N Hydrochloric Acid & mix well.

Preparation of Sample Solution:

Take 900 ml 0.1N Hydrochloric Acid media in each dissolution vessel. Assemble the apparatus & warm the media to 37⁰c ± 0.5⁰C. Place six tablets into the six individual dissolution vessels. Start the apparatus according to the mentioned condition & transfer about 70 ml solutions after 45 minutes from each vessel & filter. Transfer 50 ml of this solution into a 100 ml volumetric flask & make the volume up to the mark with the 0.1N Hydrochloric Acid & mix well.

Procedure:

Measure the absorbance of both standard & sample solution in a 1 cm cell at 286 nm with a suitable Spectrophotometer using 0.1N Hydrochloric Acid as a blank.

Calculation:

Domperidone dissolves after 45 minutes

Where,

At = Absorbance of Test Sample

Ws = Weight of Working Standard

P = Potency of Working Standard

Wt = Label Claim

As = Absorbance of Working Standard

Results:

Domperidone 10 mg Tablet from Pharmaceuticals-1:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.352	99.78%	0.445	98.25%	97.44%
2			0.440	97.15%
3			0.438	96.71%
4			0.447	98.70%
5			0.443	96.49%
6			0.441	97.35%

Domperidone 10 mg Tablet from Pharmaceuticals-2:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.352	99.78%	0.444	98.78%	97.92%
2			0.447	97.37%
3			0.438	97.09%
4			0.450	97.94%
05			0.443	98.22 %
6			0.445	96.25%

Conclusion:

The active substance and strength of Domperidone 10 mg Tablet from Pharmaceuticals-1 is the same as that of Domperidone 10 mg Tablet from Pharmaceuticals-2; the pharmaceutical form is the same. The dissolution results of both tablets in the dissolution medium are nearly the same. So, it is concluded that Domperidone 10 mg Tablet from Pharmaceuticals-1 & Domperidone 10 mg Tablet from Pharmaceuticals-1 contain the same active ingredients.