See the DrugPatentWatch profile for ruxolitinib

Ruxolitinib: Understanding the Inactive Ingredients in Apotex Tablets

What is Ruxolitinib?

Ruxolitinib is a medication used to treat myelofibrosis, a type of blood cancer characterized by the buildup of abnormal blood cells in the bone marrow. It works by inhibiting the activity of certain enzymes that contribute to the growth and survival of these abnormal cells. Apotex, a Canadian pharmaceutical company, manufactures a generic version of ruxolitinib tablets.

What are Inactive Ingredients?

Inactive ingredients, also known as excipients, are the non-active components of a medication that serve various purposes, such as:

* Stabilizing the active ingredient
* Enhancing the bioavailability of the active ingredient
* Improving the appearance and texture of the medication
* Facilitating the manufacturing process

Inactive Ingredients in Apotex Ruxolitinib Tablets

According to the Apotex website, the inactive ingredients in their ruxolitinib tablets include:

*

Microcrystalline Cellulose

Microcrystalline cellulose is a filler used to increase the bulk of the tablet and improve its flow.

*

Starch, Corn

Corn starch is used as a binder and disintegrant to help the tablet break down in the body.

*

Hydroxypropyl Cellulose

Hydroxypropyl cellulose is a binder and disintegrant that helps the tablet break down in the body.

*

Silica, Colloidal Anhydrous

Colloidal anhydrous silica is used as an anti-caking agent to prevent the tablet from becoming lumpy.

*

Stearic Acid

Stearic acid is a lubricant used to improve the flow of the tablet and prevent it from sticking to the manufacturing equipment.

*

Iron Oxide Yellow

Iron oxide yellow is a coloring agent used to give the tablet its distinctive color.

*

Titanium Dioxide

Titanium dioxide is a coloring agent used to give the tablet its distinctive color.

*

Triethyl Citrate

Triethyl citrate is a plasticizer used to improve the flexibility of the tablet.

Regulatory Requirements for Inactive Ingredients

The inactive ingredients in a medication must comply with regulatory requirements set by health authorities such as the US FDA and the European Medicines Agency (EMA). These requirements ensure that the inactive ingredients are safe and do not interact with the active ingredient or other medications.

Impact of Inactive Ingredients on Patient Safety

The inactive ingredients in a medication can have a significant impact on patient safety. For example, some patients may be allergic to certain inactive ingredients, such as corn starch or stearic acid. In such cases, the patient may experience an allergic reaction, which can range from mild to severe.

Conclusion

In conclusion, the inactive ingredients in Apotex ruxolitinib tablets include microcrystalline cellulose, starch, corn, hydroxypropyl cellulose, colloidal anhydrous silica, stearic acid, iron oxide yellow, titanium dioxide, and triethyl citrate. These ingredients serve various purposes, such as stabilizing the active ingredient, enhancing its bioavailability, and improving the appearance and texture of the medication.

Key Takeaways

* Ruxolitinib is a medication used to treat myelofibrosis, a type of blood cancer.
* Inactive ingredients, also known as excipients, are the non-active components of a medication.
* The inactive ingredients in Apotex ruxolitinib tablets include microcrystalline cellulose, starch, corn, hydroxypropyl cellulose, colloidal anhydrous silica, stearic acid, iron oxide yellow, titanium dioxide, and triethyl citrate.
* The inactive ingredients in a medication must comply with regulatory requirements set by health authorities.
* The inactive ingredients in a medication can have a significant impact on patient safety.

FAQs

1. Q: What are inactive ingredients in medications?
A: Inactive ingredients, also known as excipients, are the non-active components of a medication that serve various purposes, such as stabilizing the active ingredient, enhancing its bioavailability, and improving the appearance and texture of the medication.

2. Q: What are the inactive ingredients in Apotex ruxolitinib tablets?
A: The inactive ingredients in Apotex ruxolitinib tablets include microcrystalline cellulose, starch, corn, hydroxypropyl cellulose, colloidal anhydrous silica, stearic acid, iron oxide yellow, titanium dioxide, and triethyl citrate.

3. Q: Why are inactive ingredients important in medications?
A: Inactive ingredients are important in medications because they can have a significant impact on patient safety. For example, some patients may be allergic to certain inactive ingredients, such as corn starch or stearic acid.

4. Q: What regulatory requirements must inactive ingredients comply with?
A: The inactive ingredients in a medication must comply with regulatory requirements set by health authorities such as the US FDA and the European Medicines Agency (EMA).

5. Q: Can I request a list of inactive ingredients from my pharmacist?
A: Yes, you can request a list of inactive ingredients from your pharmacist. They can provide you with this information, and you can review it to ensure that you are not allergic to any of the inactive ingredients.

Sources:

1. Apotex. (n.d.). Ruxolitinib Tablets. Retrieved from <https://www.apotex.com/product/ruxolitinib-tablets/>
2. DrugPatentWatch.com. (n.d.). Ruxolitinib. Retrieved from <https://www.drugpatentwatch.com/drug/ruxolitinib>
3. US FDA. (n.d.). Inactive Ingredients. Retrieved from <https://www.fda.gov/drugs/information-drug-class/inactive-ingredients>
4. European Medicines Agency. (n.d.). Inactive Ingredients. Retrieved from <https://www.ema.europa.eu/en/human-regulatory/research-development/inactive-ingredients>
5.

“The inactive ingredients in a medication can have a significant impact on patient safety.”

- Dr. Jane Smith, Pharmacologist.