Veera Venkata Satyanarayana Reddy Karri, Int. J. Res. Pharm. Sci., 2020, 11(1), 403-410 ORIGINAL ARTICLE INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACEUTICAL SCIENCES Published by JK Welfare & Pharmascope Foundation Journal Home Page: www.pharmascope.org/ijrps Development, characterization and solubility enhancement of BCS class II drug phenytoin by solid phospholipid dispersion technique Veera Venkata Satyanarayana Reddy Karri * , Sathish Ananthan, Lavanya Mude Department of Pharmaceutics, JSS College of Pharmacy, Ooty, JSS Academy of Higher Education & Research, India Article History: Received on: 09.07.2019 Revised on: 10.10.2019 Accepted on: 17.10.2019 Keywords: Phenytoin, Solid lipid nano particles, BCS class, SEM, FTIR ABSTRACT The poor aqueous solubility acts as a core challenge in oral dosage form devel- opment for BCS class II drugs. Phenytoin is taking as a model drug; the present study adopted an innovative solid phospholipid nanoparticle (SPLN) line of attack, and it is parallelly equated with the industrialized methods (freeze- drying) which are used for the boosting of solubility and dissolution of Pheny- toin. Phenytoin was articulated along with phospholipid and mannitol at a diverse ratio of phenytoin, PL, mannitol, in which 1:12:18 was the correct ratio for ideal preparation. Freeze-drying helps to prepare SPLNs in orbicu- lar shape, which is amorphous in nature with ≤ 1μm diameter on average. While the amorphous matrix-like structure of solid phospholipid dispersion with larger particle size is obtained by freeze-drying technique. Formulating the formulation from this method improved the dissolution rate in a remark- able way. Tris buffer with pH 7.4acts as an apparent solubility dissolved con- centration of phenytoin. The poor aqueous solubility acts as a core challenge in oral dosage form development for BCS class II drugs. The decrease in the particle size or cumulating the drug surface area is the widely used practices to proliferate the solubility. The target of the present work was improvisa- tion in solubility, dissolution of a poorly water-soluble drug, and its release by using solid phospholipid nanoparticles. Phenytoin is taking as a model drug. The solid phospholipid nanoparticles were primed by freeze-drying technique along with phospholipid and mannitol in diverse drug to excipients ratios (1:1, 1:2w: w). These preparations were assessed for compatibility study using FTIR, solubility enhancement study by XRD, entrapment efϑiciency, surface morphology by SEM, and in-vitro release study. As per the results, there is no inϑluence of the excipients on the drug used. The solubility was increased by folds compared to in house prepared formulation. * Corresponding Author Name: Veera Venkata Satyanarayana Reddy Karri Phone: Email: ksnreddy87@gmail.com ISSN: 0975-7538 DOI: https://doi.org/10.26452/ijrps.v11i1.1834 Production and Hosted by Pharmascope.org © 2020 | All rights reserved. INTRODUCTION The biggest challenges of API are its poor aque- ous solubility and its dissolution rate (Sharma et al., 2015) in pharmaceutical development, and in past twin decades, this is the most common issue in new drug candidates due to the use of large data and combinatorial screening tools at the phase of drug discovery and selection. As per the pharmaceuti- cal classiϑication system (Buckley et al., 2013). The maximum dose power is not soluble in the aque- ous vehicle over the PH ranges at 37° C results in a drug compound is poorly soluble and most prob- © International Journal of Research in Pharmaceutical Sciences 403