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Authors
Affiliations
1 Department of Pharmaceutics, College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, 395, Sarojini Naidu Road, New Sidhapudur, Coimbatore-641044, Tamilnadu, IN
2 College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, 395, Sarojini Naidu Road, New Sidhapudur, Coimbatore- 641044, Tamilnadu, IN
3 Department of Pharmaceutics, K.M. College of Pharmacy, Uthangudi, Madurai, Tamilnadu, IN
4 Formulation Development Department, Medopharm Pvt. Ltd.,
Kayirambedu, Chennai, Tamilnadu, IN
5 Department of Pharmaceutics, K.K College of Pharmacy, Gerugambakam, Chennai, IN
Source
Research Journal of Pharmaceutical Dosage Form and Technology, Vol 2, No 3 (2010), Pagination: 241-246
Abstract
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 RPHPLC 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.
Keywords
Antibiotics, Probiotic, Enteric Coating, Capsule.
