Formulation Development and Evaluation of Capsule Containing Fluclaxacillin Sodium and Amoxicillin Trihydrate with Enteric Coated Granules of Lactic Acid Bacillus

This work presents the preparation of capsule formulation containing ethyl cellulose coated Flucloxacillin sodium, Amoxicillin trihydrate with enteric coated Lactic acid bacillus granules. Preformulation studies were carried out for active ingredients and excipients using DSC, FTIR and exposing them into different temperature. Preparation of enteric coated Lactic acid bacillus granules was optimized using two enteric polymers cellulose acetate phthalate and hydoxy propyl methyl cellulose acetate phthalate (HP-55) using enteric test and microbial assay. Optimized one was utilized in the capsule formulation. Formulation was optimized by changing the excipients. Flow properties of the formulation were evaluated then they were filled into hard gelatin capsules by hand operated capsule filling machine. The capsules were evaluated for their thickness, weight variation, Net content and disintegration. In-vitro drug release and drug content analysis were also carried out by RP-HPLC method using isocratic and gradient elution method. Microbial assay method is used for the spore count of Lactic acid bacillus. The packaging optimization also carried out by packing the capsules in three different packaging systems and by conducting the accelerated stability testing studies. In conclusion the capsule formulation in strip packing is stable in accelerated condition for a period of two months.