Abstract
This study describes the development of a new Esomeprazole delayed release gastro-resistant formulation with improved storage stability. A three-step:Drug, Sub (seal),Enteric Coating. Coating process was employed using a fluid bed coater. Various formulation factors (namely- size and quantity of starting sugar spheres, binder quantity during drug-layering, sub (seal)-coating polymer type, and quantity and enteric coating quantity) were evaluated and the whole process was modeled with the aid of Fluid bed equipment (FBE). Results showed that the selection of small-sized pellets (45/60 mesh size) can lead to agglomeration, while weight gain due to Sub (seal)-coating increases the dissolution rate of Esomeprazole. The enteric-coating applied showed good gastro-resistant performance in both 0.1 N HCl and pH 4.5 media. The effect of cellulose-based sub(seal)-coating polymers, (namely, hydroxypropyl cellulose and hydroxypropyl methyl cellulose) on formulation's storage stability at 40 ± 2 °C/75 ± 5%RH indicated that only hydroxypropyl methyl cellulose was able to stabilize ESO delayed-release formulations in terms of assay, dissolution, and gastro-resistance performance. Esomeprazole magnesium is formulated as delayed release pellets to provide desired effect at certain time in maintained drug concentration without any unwanted effect with patient compliance also to improve its bioavailability by decreasing its expose to gastric acid.
Developing any new drug molecule is pretty pricey and time eating process. Betterment of protection and efficacy ratio of the preceding pills has been tried via one-of-a-kind techniques such as drug therapy, dose titration, and healing drug monitoring. Delivering drug at a regular and managed rate, sluggish and focused transport are different very appealing techniques and were used vigorously. It could be very exciting to notice that the significant paintings and lots of guides from USA, Europe are authored with the aid of using the Indian researchers..[1–3] Controlled drug delivery systems (CDDS) may include the maintenance of the drug levels within a desired range, the need for lesser administrations, appropriate use of the drug in question, and increased patient compliance. While these advantages can be significant, the disadvantages cannot be ignored like the possibility of toxicity or non-biocompatibility of the materials being used, undesirable by-products from degradation, any surgery required to implant or remove the system, the chances of patient discomfort from the delivery device, and the higher cost of controlled-release systems when compared with the traditional pharmaceutical formulations.
Keywords: CDDS, Esomeprazole, Pellets, fluid bed equipment