Dissolution Profile of Theophylline Extended Release Caplets Based On Metolose 90 SH – 4000SR With Accelerated Stability Study

Abstract

To avoid consume theophylline oftenly, we need an extended release dosage form to maintain the therapeutic dose on the blood plasma for a long interval time. The most common dosage form in the market is coated tablet, but that needs a long procedure and quite expensive to be produced. Recently, there is a brand new polymer derived from Hydroxypropylmethyl cellulose is Metolose 90SH-4000SR. This kind of polymer is able to form  high viscosity hydro gel with a suitable solvent. Gel which is formed from the polymer physically restrain the active ingredient released on a short period. Through this study, presented practically easy to use metolose as the matrix of a binder in wet granulation method. The study found that efficient solution consistency for binder solution of the matrix gel of Metolose is 10%. In the manufacturing process of the caplets, metolose as gel is used on low concentration at 4,5-5% (18-20 mg of 400 mg total weight of caplet).  Both caplets shows similiar quality in terms of physical properties and dissolution rate profile. After 6 months storage at 40OC and humidity 75% (accelerated stability condition storage) the dissolution profile and theophylline contents not change or decrease significantly.