Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF ROFLUMILAST SOLID DISPERSION

Panasa Harish Kumar* and Dr. D.V.R.N. Bikshapathi

ABSTRACT

The present investigation carried out on Roflumilast fast dissolving tablets by employing solid dispersion technique. Roflumilast solid dispersion were prepared by solvent evaporation and fusion method. Roflumilast is a drug that acts as a selective, long acting inhibitor of the enzyme PDE-4. It has anti-inflammatory effects and is used as an orally administered drug for the treatment of inflammatory conditions of the lungs such as chronic obstructive pulmonary disease (COPD). Roflumilast belongs to BCS Class II drugs which is low solubility and high permeability. The main objective of this study is to improve the aqueous solubility of Roflumilast by employing the solid dispersion and enhance the dissolution rate. Based on solubility studies pH 6.8 selected as dissolution medium. Invitro dissolution data revealed that, Formulations prepared with solvent evaporation method, majority of formulations were shown maximum drug release within 10 minutes only. Formulations prepared with Fusion method F2, F8 and F9 formulations were shown maximum drug release at 10 min. Invitro dissolution data revealed that formulations containing PEG 4000 and Kolliphor P 188 was shown good results in both methods. Based on invitro drug release solid dispersion blend with PEG 4000 and Kolliphor P 188 were taken for DSC studies. DSC studies revealed that incompatability between Drug and PEG 4000. Hence Kolliphor P 188 Solid dispersion blend of fusion method and solvent evaporation method were taken XRD studies. XRD studies revealed that instability of dispersion by solvent evaporation method. By considering the XRD results Roflumilast with Kolliphor P 188 solid dispersion by fusion method was taken for SEM studies. SEM studies revealed that the particle size was 10 μm and 20 μm.

Keywords: Roflumilast, Solid dispersion, Solvent evaporation method, Fusion method, Fast dissolving tablets.