Omeprazole, a benzimidazole derivative, suppresses gastric acid secretion by inhibiting H+/K+ ATPase in gastric parietals cells, and by reducing H+ concentration. It is effective regardless of the stimulation. The product of esomeprazole magnesium enteric-coated dosage form, in the market, is compos...
Omeprazole, a benzimidazole derivative, suppresses gastric acid secretion by inhibiting H+/K+ ATPase in gastric parietals cells, and by reducing H+ concentration. It is effective regardless of the stimulation. The product of esomeprazole magnesium enteric-coated dosage form, in the market, is composed of enteric – coated pellets of esomeprazole magnesium trihydrate. The purpose of this study is to develop a Stability improved enteric-coated form of esomeprazole magnesium dehydrate, to avoid existing patents, By creating a protection layer and coating the tablet, including alkalinizing agents, with enteric polymer like methacrylate copolymer. also to achieve direct compression, making it easier for the manufacturer, improving economic feasibility and productivity. The Stability of combination, with different kinds of alkalinizing agents and of composition ratio, with alkalinizing agents was checked by observing physical properties and ingredient decreasing progress. The combination with magnesium oxide had the best stability among all the ones with alkaline agent, and it maintains it when the alkaline is more than 10%. Dissolution rate of the enteric-coating was influenced by the rate of enteric-coated layer and the amount of disintegrants and binders. We confirmed the pharmacokinetic equivalence by dissolution testing, with NexiumⓇ as a comparator. Also high-density polyethylene was checked as the best packing material for enteric-coated table, by photostability testing. Active ingredients of manufactured test drug decreased less than 5 % under the accelerating conditions for 6 months. this period of time is relevant with 3 year under normal conditions, so it showed that the medicine could have been stable for use-by date.
Omeprazole, a benzimidazole derivative, suppresses gastric acid secretion by inhibiting H+/K+ ATPase in gastric parietals cells, and by reducing H+ concentration. It is effective regardless of the stimulation. The product of esomeprazole magnesium enteric-coated dosage form, in the market, is composed of enteric – coated pellets of esomeprazole magnesium trihydrate. The purpose of this study is to develop a Stability improved enteric-coated form of esomeprazole magnesium dehydrate, to avoid existing patents, By creating a protection layer and coating the tablet, including alkalinizing agents, with enteric polymer like methacrylate copolymer. also to achieve direct compression, making it easier for the manufacturer, improving economic feasibility and productivity. The Stability of combination, with different kinds of alkalinizing agents and of composition ratio, with alkalinizing agents was checked by observing physical properties and ingredient decreasing progress. The combination with magnesium oxide had the best stability among all the ones with alkaline agent, and it maintains it when the alkaline is more than 10%. Dissolution rate of the enteric-coating was influenced by the rate of enteric-coated layer and the amount of disintegrants and binders. We confirmed the pharmacokinetic equivalence by dissolution testing, with NexiumⓇ as a comparator. Also high-density polyethylene was checked as the best packing material for enteric-coated table, by photostability testing. Active ingredients of manufactured test drug decreased less than 5 % under the accelerating conditions for 6 months. this period of time is relevant with 3 year under normal conditions, so it showed that the medicine could have been stable for use-by date.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.