Wednesday , November 6 2024

Domperidone 10 mg Tablet | Formulation & Manufacturing Process

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 formulation & manufacturing process of Domperidone 10 mg Tablet is as below:

Formulation:

Each tablet contains:

SLNAME OF THE INGREDIENT(S)SPECIFICATIONQUANTITYFUNCTION
Active Ingredient(s)
1Domperidone MaleateBP12.726 mg
(Equivalent to
Domperidone
10.000 mg)
 
Excipient(s)
2Microcrystalline Cellulose 101BP56.250 mg 
3Lactose MonohydrateBP40.000 mg 
4Povidone K-30BP4.511 mg 
5Maize StarchBP52.766 mg 
6Purified TalcBP3.500 mg 
7Magnesium StearateBP1.500 mg 
Coating Material(s)
10Hypromellose 15 CPSBP4.200 mg 
11Polyethylene Glycol – 6000USP0.150 mg 
12Purified TalcBP0.200 mg 
13Titanium DioxideBP0.240 mg 
14Carnauba WaxBP0.040 mg 
15* MethanolBP34.000 mg 
16* Methylene ChlorideUSP50.000 mg 
* Does not appear in the final product.
** The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Manufacturing Process:

The process consists of sieving the active ingredient & excipients through a Vibration Shifter and granules preparation by rapid mixture/granulator & blending that a Drum Blender follows. The tablets will be compressed by the compression machine and coating will be carried out by Auto coater. Tablets will be blistered by the Blister machine.

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