World Journal of
Pharmaceutical and Life Sciences

FORMULATION AND IN-VIVO CLINICAL STUDY OF DULOXETINE HYDROCHLORIDE DELAYED RELEASE CAPSULE BASED ON MUPS TECHNOLOGY AS PER QUALITY BASED DESIGN

Chengzhi Yao, Zhenjiang Yao and *Sunil Kumar Panda

ABSTRACT

Duloxetine Hydrochloride delayed release capsule is indicated to treat depression and anxiety. In addition, duloxetine is used to help relieve nerve pain (peripheral neuropathy) in people with diabetes or ongoing pain due to medical conditions such as arthritis, chronic back pain, or fibromyalgia (a condition that causes widespread pain)[1] The reference listed drug for Duloxetine capsule is 20 mg, 30 mg and 60 mg. We used Quality by Design (QBD) to develop generic Duloxetine Hydrochloride capsule is 20 mg, 30 mg and 60 mg that are therapeutically equivalent to the RLD. Initially, the quality target product profile (QTPP) was defined based on the properties of the drug substance, characterization of the RLD product, and consideration of the RLD label and intended patient population. Identification of critical quality attributed (CQAs) was based on the severity of harm to a patient (safety and efficacy) resulting from failure to meet the quality attribute of the drug product. Our investigation during pharmaceutical development focused on those CQAs that could be impacted by a realistic change to the drug product formulation or manufacturing process. For generic duloxetine hydrochloride capsule, these CQAs included % Assay, Acid resistance, Dissolution, Ethanol Dose Dumping, % Drug released and Degradation products. We have done a clinical Bioequivalence study on both fasting and fed study and had bioequivalence with the innovator.

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