Formulation and Stabilization of Duloxetine Hydrochloride Delayed Release Pellets with the Aid Non Ionic Barrier Layer
Journal Title: IOSR Journal of Pharmacy (IOSRPHR) - Year 2013, Vol 3, Issue 7
Abstract
The main objective of the present study is to formulate a stable Duloxetine HCl delayed release pellets with the aid of non ionic protective layer between drug layer and enteric layer. Duloxetine HCl is highly unstable at acidic environment. The preformulation study reveals, Duloxetine HCl is incompatible with enteric polymers, due to the presence of free acid in the enteric polymer. Duloxetine HCl is also unstable at alkaline pH. Hence, a nonionic polymer is selected in barrier coating. Duloxetine hydrochloride enteric coated pellets were formulated using fluidized bed process with different levels of barrier coating. Three separate layers, the drug layer, the barrier layer and the enteric layer, were coated on to the inert core pellets, sugar spheres. The enteric coated pellets were top coated using film coating material and encapsulated in hard gelatin capsule shell. The probability of interaction of enteric polymer with duloxetine is very high during shelf life. The filled capsules were evaluated for description, Assay, Acid resistance and Drug release in pH 6.8 Phosphate buffer at initial and 6 months accelerated condition (40 ± 2°C/75± 5%RH), to conclude the % build up of barrier coating required to avoid the interaction between duloxetine hydrochloride and enteric polymer. The formulation with 10% & 15% barrier coating are failed to control the interaction between duloxetine hydrochloride and enteric polymer. The formulation with 20% barrier coating was found to be stable, and the interaction between duloxetine hydrochloride and enteric polymer was controlled.
Authors and Affiliations
Raja Subburayalu, Dr. Janakiraman Kunchithapatham
Keywords
Related Articles
- EP ID EP93580
- DOI -
- Views 162
- Downloads 0
[b] Hepatoprotective and antioxidants activity of ethanolic extract of Cuscutta reflexa roxb[/b]
Estimation Of Reference Intervals For Plasma Amylase In Apparently Healthy Adults Of Southern Nigeria
There is need for locally derived age-sex specific laboratory Reference Ranges (RR) for healthy Africans in southern Nigeria. Reference values from American and European population are used for African subje...
OSA: An awaking disorder!
OSA is characterized by repeated narrowing or collapse of the upper airway during sleep. It is the most common sleep disordered breathing seen among general population and contributes to increased morbidity and mor...
Anemia and Iron Deficiency Anemia in Egypt
Blood hemoglobin and serum ferritin analysis were used to identify the extent of anemia and iron deficiency anemia in Egypt. The study conducted in 2010/11, among 4526 households from eleven governorates and...
An Ecological Journey to Pandam through Mulgaon Areas of Darjeeling Himalaya with Special Reference to Monitoring Of Vegetation in West Bengal, India
The paper reflects the ecological dynamics of vegetation with special reference to burning problems that are increasing day by day in villages of Darjeeling Himalaya of West Bengal, India. It includes floras (Ro...