CAPSULE IN CAPSULE DOSAGE FORM WITH MINI TABLETS FOR THE TREATMENT OF HELICOBACTER PYLORI

Abstract

The current investigation involves proton pump inhibitor based therapy (Lansoprazole + Clarithromycin + Amoxicillin) combining three drugs with Capsule in capsule technology for the treatment of Helicobacter pylori improving patient convenience and compliance.

For delivery of Amoxicillin and Clarithromycin in stomach, combination mini tablets were formulated by direct compression method of the two drugs. Evaluation of the blend flow properties were carried out on powder blends and subsequently compressed to formulate mini tablets and evaluated for physicochemical properties, drug content and in vitro release study. The optimized formulation was subjected to short term stability study at accelerated conditions of temperature and relative humidity of 40ºC ± 2ºC and 75% ± 5% RH and evaluated at required time intervals for physical appearance and drug content. All evaluation results were found to be within the acceptable range. Lansoprazole being acid labile was filled in size 5 capsules and capsules were enteric coated with Eudragit S 100 for intestinal delivery. For final delivery of combination doses, the mini tablets were filled into the 00 size capsules and an enteric coated Lansoprazole capsule was placed in it implementing capsule in capsule technology. These capsules were evaluated as the final dosage forms for the drug content and in vitro release profile. All the tests exhibited results within an acceptable range. Hence capsule in capsule dosage form can be a good alternative for the delivery of three drugs for the treatment of H.pylori infection for better patient compliance.