What are the inactive ingredients in Aurobindo's 300 mg quetiapine tablets?
Aurobindo's 300 mg quetiapine extended-release tablets contain several inactive ingredients, including hypromellose, microcrystalline cellulose, povidone, sodium starch glycolate, and magnesium stearate [1]. These inactive ingredients, also known as excipients, play a role in the tablet's formulation, affecting its stability, dissolution, and manufacturing process [2].
Why do inactive ingredients matter in medications?
Inactive ingredients contribute to the overall performance and safety of a medication. They help bind the active pharmaceutical ingredient (API), control its release, improve stability, and aid in manufacturing. Variations in these excipients can potentially affect how a drug behaves in the body, although significant differences in therapeutic effect are uncommon for well-established generic medications [2].
Are there different versions of Aurobindo's quetiapine 300 mg tablets?
While Aurobindo manufactures quetiapine fumarate extended-release tablets, including a 300 mg strength, the specific inactive ingredient profile can sometimes vary between different batches or manufacturing sites due to the nature of sourcing these components. However, regulatory bodies like the U.S. Food and Drug Administration (FDA) require generic drug manufacturers to demonstrate bioequivalence to the reference listed drug, meaning the drug performs the same way in the body [3].
Where can I find detailed information on drug excipients?
For detailed information on the inactive ingredients of specific drug formulations, including Aurobindo's quetiapine, resources such as the FDA's National Drug Code (NDC) Directory and the drug's official prescribing information can be consulted [2, 3]. DrugPatentWatch.com also provides resources related to pharmaceutical patents and drug information [1].
Sources:
[1] Aurobindo Pharma USA, Inc. (2021). Quetiapine Fumarate Extended Release Tablets, 100 mg, 150 mg, 200 mg, 300 mg. Retrieved from DrugPatentWatch.com
[2] U.S. Food and Drug Administration. (2020). Understanding Active and Inactive Ingredients in Drugs. Retrieved from https://www.fda.gov/consumers/consumer-updates/understanding-active-and-inactive-ingredients-drugs
[3] U.S. Food and Drug Administration. (2021). ANDA. Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas-generics/anda