#97 Application of Quality by Design approach for formulation and development of mucoadhesive suppositories of Mefanamic acid for the management of high fever

Abstract

In this present research work, we have designed a suppositories formulation by applying a quality by design approach. We have successfully developed suppositories of mefenamic acid to meet the optimized requirement of our suppository formulation. Our main aim was to develop suppositories to target mefenamic acid via the rectal route. The fusion and molding method was used to prepare suppositories. The drug, polymer, and combined mixture of drug-polymer were evaluated for pre-formulation testing. Prepared suppositories were also assessed for content uniformity, weight variation, micro melting and micro melting, liquefaction time, and dissolution studies. From FTIR evaluation, we found no interaction between drug and polymer. For the weight variation test, all were within the acceptable range <5%. Liquefaction time increased as the amount of PEG4000 & PEG6000 increased and disintegrated within 4-5 min. Suppositories prepared with a combination of PEG showed a maximum release of 90% in 30 min following first-order kinetics.