EFFECT OF LACTOSE, L-HPC GRADES ON FLOW PROPERTIES OF MICRONIZED TADALAFIL FORMULATED AS SOLID DOSAGE FORM

Tadalafil belongs to BCS class IV and recommended for treatment of erectile dysfunction. Micronization technique is used by researchers to improve its solubilization and dissolution rate. The conventional tabletting excipients pose challenge especially with micronized drug particles. The current research work aimed to study the effect of some speciality excipients on flow properties of micronized Tadalafil formulated wet granulation approach. Different grades of L-HPC and Lactose were studied. L-HPC grades included L-HPC NBD 21, L-HPC 21 and HPC – LM. The lactose grades included Milled lactose (Pharmatose 200M) and Granulated lactose (Supertab GR and Supertab SD 11). Milled lactose was used in formulation using wet granulation process whereas granulated lactose was used as directly compressible excipient. PVP k-30 added intra-granularly in concentration range of 1 – 3% w/w. All the formulation batches were evaluated for its micromeritics and dissolution. The batch with L-HPC NBD 21 showed ‘Excellent’ flow properties as compared to L-HPC LM and L-HPC 21. Both grades of granulated lactose showed ‘Excellent’ flow of granules but slightly greater angle of repose values (30 – 35°) indicating ‘Good to Fair flow’. Batches with PVP k-30 gave compressibility index in range of 17 – 20% indicating fair flow of granules. These intra – granular excipient improved granule characteristics, in wet granulation process for formulation using micronized Tadalafil.