Abdul Karim Ahammad, Nihar Ranjan Pani


The hypothesis of the present investigation is the eutectic interaction between a therapeutic entity and a eutectic agent could be utilized to prepare and formulate superior lipid based and solid-state self-emulsified dosage forms (SEDF). In the present study, Simvastatin was employed as a model drug (mg) and essential oils (Lineloic acid) were evaluated as the eutectic agents. A conventional tablet of Simvastatin was developed and optimized through 23 factorial designs by incorporating drug into solid lipid based self- emulsified formulation to enhance the bioavailability of drug. The objective of current research is to enhanced the bioavailability of lipophilic model drug, simvastatin by the developing the SEDF. The tablet of SEDF was intended to develop and to increase the   stability of the formulation. The formulae of SEDF tablet of Simvastatin were optimized through 23factorial design by using concentration of, Cross carmelose sodium (CCS), Maltose and microcrystalline cellulose (MCC) as three independent variables and drug release at 5min (DR5), drug release at 30min (DR30), drug release at 60min (DR60) as three dependent variables. The tablets were evaluated for weight variation, thickness, hardness, friability, disintegration test, dissolution test. The in vitro dissolution study  of F6 containing 70mg/tab, 100mg/Tab, 30mg/tab amount of c.c.s, maltose, MCC respectively, reveals the desired dissolution profile  according to pharmacopeia consideration.(>85 % of drug release at 30min).


Simvastatin, Selfemusified tablet, Optimization, Drug release

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Acharya, S., Patra, S., and Pani, N.R. (2014). Optimization of HPMC and carbopol concentrations in non-effervescent floating tablet through factorial design. Carbohyd Polym, 102, 360– 368.

Aungst, B.J. (1993). Novel formulation strategies for improving oral bioavailability of drugs with poor membrane permeation or presystemic metabolism. J Pharm Sci, 82, 979–987.

Biswal, P. K., Bharadwaj, R., Kundu, P., (2016): Effect of polacriline pattasium on the physicochemical properties of carvedilol immediate release tablet, Biopharm J., 2(2), 46-54.

Bolton, S. (1990). Pharmaceutical statistics (2nd ed.). NY, USA: Marcel Decker Inc.

Carr, R.L. (1965). Evaluating flow properties of solids. Chem. Eng, 18, 163–168.

Constantinides, P.P. (1985). Lipid micro emulsions for improving drug dissolution and oral absorption. Physical and biopharmaceutical aspects. Pharm Res, 12, 161-172.

Craig, D.Q.M., Lievens, H.S.R., Pitt, K.G., and Storey, D.E. (1993). An investigation into the physico-chemical properties of self-emulsifying systems using low frequency dielectric spectroscopy, surface tension measurements and article size analysis. Int J Pharm , 96, 147–155.

Lachman, L., Lieberman, H., and Kanig, J. (1987). The theory and practice of industrial pharmacy (3rd ed). Varghese publication house.

Lipinski, C.A. (2000). Drug-like properties and causes of poor solubility and permeability. J Pharmacol Toxicol, 44, 235-249.

Nazzal, S., Nutan, M., Palamakula, A., Shah, R., Zaghloul, A.A., and Khan, M.A. (2002). Optimization of a self-nanoemulsified tablet dosage form of ubiquinone using response surface methodology, effect of formulation ingredients. Int. J. Pharm, 240, 103- 114.

Nazzal, S., Smalyukh II, Lavrentovich OD., and Khan, MA. (2002). Preparation and in vitro characterization of a eutectic based semisolid self-nanoemulsified drug delivery system (SNEDDS) of Ubiquinone: Mechanism and progress of emulsion formation. Int J Pharm, 235, 247-265.

O’Neil, M.J., Smith, A., and Heckelman, P.E. (1989). The Merck Index (11th ed). Whitehouse Station, NJ, USA: Merck and Co., Inc.

Pani, N,R., Nath, L.K., and Acharya, S. (2011). Compatibility studies of nateglinide with the excipients of immediate release tablets. Acta Pharmaceut, 61, 237–247.

Pani, N.R., Nath, L.K., and Bhunia, B. (2010). Formulation, development, and optimization of immediate release nateglinide tablets by factorial design. Drug Discov Therap, 46, 453-458.

Patel, A., Modasiya, M., Shah, D., and Patel, V. (2009). Development and in vivo floating behavior of verapamil HCl intragastric floating tablets. AAPS Pharm Sci Tech, 10, 310–315.

Pout on, C.W. (2000). Lipid formulations for oral administration of drugs: non-emulsifying, self-emulsifying and ‘self-microemulsifying’ drug delivery systems. Eur J Pharm Sci, 2, S93–S98.

Robinson, J.R. (1996). Introduction: Semi-solid formulations for oral drug delivery. B Tech Gattefosse, 89, 11-13.

Singh, SK., Reddy, IK., and Khan, MA. (1996). Optimization and characterization of controlled release pellets coated with an experimental latex: II. Cationic drug. Int J Pharm, 141, 179–195.

Spireas, S., and Sadu, S. (1998). Enhancement of prednisolone dissolution properties using liquisolid compacts. Int J Pharm, 166, 177–188.

Stability testing of new drug substances and products.ICH harmonized tripartite guideline. 2003. (accessed Aug 14, 2007).

United State, Pharmacopoeia., National Formulary. (USP, 2004.).

SP, 2004.).


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