ABSTRACT
Introduction: There were 36 medicine manufacturers and only two of them manufactured antibiotic capsules in 2010. In last year number of manufacturing capsule has been increasing. 2574 medicines and active pharmaceutical ingredients were registered in 2011 and 488 of them were antibiotics. Aim: The main aim of this investigation was to define items of imported and manufactured capsules and do comparative analysis of some capsules. Material and methods: Registered medicine list of Mongolia and questionnaire with 22 questions, and capsules of 2 domestic and 3 foreign manufacturers were used for this investigation. Results, conclusion: 10.84% of registered medicines is capsules, of which and 16.33% from India, 7.82% from China, 5.78% from Indonesia, 8.5% from Slovenia, and other countries. 3.4% of registered capsules are manufactured in Mongolia. All medicine manufacturers import hard gelatin capsules from China and use for the manufacturing. 71.4% of domestic manufacturers use technological parameters, 57.1% stability and dissolution, 28.5% chemical properties and interaction with active pharmaceutical ingredients and excepients as the main criteria for the capsule selection used for the manufacturing. 40.0% of capsules used for the manufacturing is 0 size capsule. 72.2% of manufactured capsules are antibiotics. Quality parameters of imported and manufactured Ampicilline capsule were determined in the frame of this investigation. Conclusion: Items of imported and manufactured capsules, selection criteria of capsules used for the manufacturing were determined. Comparative quality analysis of Ampicilline capsule was done and some quality parameters of imported and manufactured Ampicilline capsule were in accordance of MNS 5097:2007. Key words: Ampicillin trihydrate 500 mg, dissolution test