The Study For The Liquid-filled Capsules Of Lansoprazole

The drug of Lansoprazole was prepared for the liquid-filled capsules to enhance its chemical stability and bioavailability. The major research contents were as follows:⑴The basic physico-chemical properties of the drug include saturated solubility and partition coefficient were determined. The result indicated that Lansoprazole is scarcely dissolve in water and possesses higher liposolubility.⑵The methods of the high efficiency liquid chromatography (HPLC) were established to analyze the content, relevant substances and dissolution. The consequences manifested the methods were reliable and accurate, and could satisfy the needs of analysis.⑶This paper investigated the approach of the dissolution according to the characteristic of the liquid-filled capsules of Lansoprazole, and the best one was that stirring with oar, and the dissolution medium whose auxiliary solvent was Tween-80.⑷First of all, the initial formulation was definited by investigating the interaction between the excipient and drug. And then the formulation was optimized by using orthogonal design. The optimum formulation was Lansoprazole– CrRH– poloxamer– magnesium oxide– soybean oil (30∶30∶20∶10∶160).⑸The approach of trituration by a mortar,a high speed homogenizer and colloid mill was studied. The result showed that the best one for small trial was the mortar.⑹The validation test for the optimum formulation and technology was researched. The results showed each index was up to standard, which indicated the success of the optimization for the formulation and technology.⑺The long test of three months was studied, the consequences demonstrated that the releasing in vitro was good, the content and relevant substances were both up to standard, which manifested that the liquid-filled capsules of Lansoprazole had higher chemical stability.⑻This study assessed the bioavailability of the liquid-filled capsules of Lansoprazole, comparing with Lansoprazole capsule produced by national industrial. The result was that relative bioavailability was (115.4±44.6) percent. All these investigations revealed that the liquid-filled capsule of Lansoprazole possessed good chemical stability and higher bioavailability. The liquid-filled capsule was the ideal dosage form for Lansoprazole.