Pharma Jogot
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:
| SL | NAME OF THE INGREDIENT(S) | SPECIFICATION | QUANTITY | FUNCTION |
| Active Ingredient(s) | ||||
| 1 | Domperidone Maleate | BP | 12.726 mg (Equivalent to Domperidone 10.000 mg) | |
| Excipient(s) | ||||
| 2 | Microcrystalline Cellulose 101 | BP | 56.250 mg | |
| 3 | Lactose Monohydrate | BP | 40.000 mg | |
| 4 | Povidone K-30 | BP | 4.511 mg | |
| 5 | Maize Starch | BP | 52.766 mg | |
| 6 | Purified Talc | BP | 3.500 mg | |
| 7 | Magnesium Stearate | BP | 1.500 mg | |
| Coating Material(s) | ||||
| 10 | Hypromellose 15 CPS | BP | 4.200 mg | |
| 11 | Polyethylene Glycol – 6000 | USP | 0.150 mg | |
| 12 | Purified Talc | BP | 0.200 mg | |
| 13 | Titanium Dioxide | BP | 0.240 mg | |
| 14 | Carnauba Wax | BP | 0.040 mg | |
| 15 | * Methanol | BP | 34.000 mg | |
| 16 | * Methylene Chloride | USP | 50.000 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.