Abstract
The objective of the study is to formulate an extended release matrix tablet dosage form containing acetaminophen and caffeine by applying polymer technology which will relieve all kinds of pain for about 12 hours. Considering the fact that there is no such formulation available in the pharmaceutical market, it is expected that this drug could be an effective introduction. Hydrophobic polymers have a great application in pharmaceutical sciences as they retard the release of water-soluble drugs and give prolonged effect. Eudragit RS 30D was used to prepare 3 formulations (EF1, EF2, and EF3) containing varying concentrations of polymer, through the wet granulation method. Each tablet contained 1000 mg of acetaminophen and 130 mg of caffeine including other suitable excipients. All pharmacopeial and nonpharmacopeial tests were conducted to determine the quality of dosage form and to identify optimized formulation among EF1-EF3. Dissolution was conducted on similar gastric conditions through which different kinetic models were applied using DDSolver. For 12 hrs of dissolution, caffeine was released from EF1, EF2, and EF3 with the percentage release in the range from 99.85% to 100.65%, 99.32% to 100.28%, and 98.09% to 100.77%, respectively. For acetaminophen, the percent release was from 99.81% to 100.91%, 100.24% to 100.91%, and 86.81% to 95.73% for EF1-EF3, respectively. Results concluded that EF2 is the most optimized drug having all physicochemical quality control tests within the specified limits. On applying different models like zero-order, Hixson-Crowell, Higuchi, and Korsmeyer-Peppas upon use, it is concluded that the formulation follows Korsmeyer-Peppas as it was the best-fitted model with the r2 value closest to 0.999. EF2 is considered as a potential drug to be manufactured that will give prolonged relief against pain and will decrease compliance issues related to dosing frequency.
Highlights
Modified oral drug delivery systems are considered as a new approach towards the development of drugs [1]
Controlled release formulations are prepared with the intention to control the release of the drug over the period of time with the maintenance of effective drug concentration within the blood or plasma, for which different mathematical models are applied for the prediction of the release kinetics of the controlled release dosage form [3, 4]
It is a hydrophobic polymer used to control the release rate of the drug; structural and physicochemical characteristics of polymers play an important role while selecting them for a particular chemical and release time and pattern [5, 7]
Summary
Modified oral drug delivery systems are considered as a new approach towards the development of drugs [1]. Physicochemical parameters affecting the performance of a drug are being studied extensively; pharmaceutical companies are focusing on the modification and development of available drugs in the market such that they will have better safety and efficacy that will lead to increased patient compliance due to low dosing and improved efficacy [2]. Controlled release formulations are prepared with the intention to control the release of the drug over the period of time with the maintenance of effective drug concentration within the blood or plasma, for which different mathematical models are applied for the prediction of the release kinetics of the controlled release dosage form [3, 4]. Eudragit RS 30D is extensively used for the formulation of sustained release
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
