Formulation and Evaluation of Enteric Coated Tablets of Duloxetine Hydrochloride

摘要

Duloxetine hydrochloride is an acid labile antidepressant drug which degrades in acidic environment. The study was aimed toformulate enteric coated tablets of Duloxetine hydrochloride using (Protectab enteric M1) to avoid degradation in the stomach andto improve the therapeutic efficiency. Five formulations (F-I to F-V) were prepared by direct compression method, without & withaddition of calcium carbonate as an alkalizing agent. Prepared tablets were evaluated for various post compression parameters.Among the formulations, the drug release of F-I formulated without addition of calcium carbonate, F-II & F-III prepared with 5mg &15mg of calcium carbonate were not within the I.P limit. So in F-IV and F-V, calcium carbonate concentration was increased to 25 mg& 30 mg which showed drug release of 95.78% and 100.67% at 45 min which was within the I.P limit. Hence F-IV & F-V formulationswere selected for enteric coating and F-IV formulation was coated with 4% Protectab enteric M1 polymer(E-IV), and F-V was coatedwith 8% Protectab enteric M1 polymer(E-V). Formulation E-IV fails in the disintegration test and Formulation E-V passed thedisintegration test of the enteric coated tablets. Hence E-V was selected as a best formulation which showed better drug releasecompared to marketed drug and stability study revealed, E-V formulation was stable even after stored at 25±2°C/60%±5%RH and40±2oC/75%±5%RH for a period of 3 months. Hence the study concluded that formulation E-V satisfied all the criteria for entericcoated tablets.