Research Article Subacute Toxicity Profile of Lacidipine Nanoformulation in Wistar Rats Rupesh Shirodkar, 1 Chandrasekhar Misra, 2 Chethan GH, 2 Pallavi Shetty, 1 Zenab Attari, 1 Srinivas Mutalik, 1 and Shaila Lewis 1 1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka 576104, India 2 Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka 576104, India Correspondence should be addressed to Shaila Lewis; s.lewis@manipal.edu Received 6 March 2015; Accepted 25 April 2015 Academic Editor: Tao Sun Copyright © 2015 Rupesh Shirodkar et al. Tis is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Te present study was aimed at investigating the safety of Lacidipine (LCDP) loaded nanostructured lipid carriers (NLCs) in Wistar rats. NLCs were formulated using ultrasound dispersion technique. Animals were orally treated once daily with NLCs containing 0.140 mg, 0.350 mg, and 0.875 mg of LCDP as low, medium, and high dose per kg body weight, respectively, during 28 days along with blank formulation and pure LCDP. Control rats were fed with water. Animals were observed throughout experiment period and their body weight was recorded once weekly. Overnight fasted rats were sacrifced on the 29th day. Study revealed no signs or symptoms of toxicity or morbidity. No signifcant changes in the body weight were observed between treated and control group. Signifcant increase in lef testis weight and liver weight was observed in male and female rats, respectively. Haematological estimation revealed signifcant decrease in haemoglobin count in male rats while female rats showed signifcant increase in granulocyte count. All the serum clinical parameters were within the normal range and no gross histopathological changes were observed. No delayed efect was noted in satellite group. Te results indicate that developed LCDP loaded NLCs are safe when administered orally in rats. 1. Introduction Recent trend is focused on nanotechnology based drug delivery system with the aim either to improve solubility or to enhance bioavailability in order to achieve satisfactory therapeutic efcacy [1]. However, the research involving the toxicological impact and hazards of nanoparticles is still in its initial stage [2]. Among various nanoparticulate drug deliv- ery systems, nanostructured lipid carriers (NLCs) were devel- oped to overcome the disadvantages of solid lipid nanopar- ticles, namely, lower loading capacity and drug expulsion during storage [3]. Lacidipine (LCDP) was classifed as per Biopharmaceutics Classifcation System (BCS) as class II drug [4]. LCDP is a dihydropyridine calcium channel blocker used in the treatment of hypertension with more pronounced vascular selectivity [5]. Upon oral administration, LCDP is poorly absorbed from gastrointestinal tract and undergoes extensive frst pass metabolism in the liver by CYP3A4 enzymes, resulting in 2 to 9% bioavailability [6, 7]. Literature survey revealed development of NLCs for improving the bioavailability of lipophilic and low bioavailable drugs [1, 8]. To enhance the bioavailability of LCDP, it was formulated into NLCs. Earlier studies however indicated slight increase in alkaline phosphatase (ALP) level which gets normalized on long term administration [9]. LCDP was also tested in normotensive rats and results obtained from chemistry anal- ysis revealed slight variations in the levels of creatinine kinase (CK), serum glutamate oxaloacetic transaminase (SGOT), and alanine transaminase (ALT) levels. Te variations were however found to be within normal biologic limits [10]. For- mulating LCDP into NLCs may improve its pharmacological activity. To evaluate whether such incorporation has any toxic Hindawi Publishing Corporation e Scientific World Journal Volume 2015, Article ID 947623, 12 pages http://dx.doi.org/10.1155/2015/947623