Diluent performance of a three component co-processed excipient for formulating ibuprofen tablets by wet granulation

Abstract

Pharmaceutical tablets ingested orally remain the most popular dosage form in drug delivery, while the most frequently used route for administration of therapeutic agents remains the oral route. Recently, excipient development comprising a mixture of two or more materials assembled in a single frame by means of particle engineering, known as co-processed excipients, has gained enormous popularity. To prepare ibuprofen tablets by co-processing and wet granulation method and evaluate its diluent property. From the design of experiment (DOE), the optimized composition was obtained and ibuprofen granules were prepared for the newly developed co-processed excipient (lactose, mucin and corn starch BP) and starlac®, cellactose® and lactose as standards. The granules were evaluated for their micromeritic properties and compressed into tablets. Evaluation of the ibuprofen tablets for their physical properties and dissolution studies were done using British Pharmacopoeia methods. The results obtained showed that ibuprofen granules were flowable and compressible. The compressed ibuprofen tablets had good physical properties: minimal weight variation (495±9.46 – 501mg ±23.15), hardness (5.50 ±0.55 – 6.50±1.05 KgF), disintegration “time” < 15 min±0.37 and “friability” < 1.0 % ±0.00 - >1.0±0.07. The dissolution of ibuprofen tablets complied with British Pharmacopoeia criteria. The data obtained from the different evaluation parameters containing the co-processed excipient compared well with starlac, cellactose and lactose used as comparing standard. The co-processed excipient which performed better than starlac in terms of friability and lactose in terms of disintegration can serve as a good diluent in ibuprofen tablets.