A DESIGN OF EXPERIMENT APPROACH FOR OPTIMIZATION AND CHARACTERIZATION OF ETODOLAC TERNARY SYSTEM USING SPRAY DRYING


Amir A. Shaikh, Praveen D. Chaudhari, Sagar S. Holkar

Abstract


Objective: The objective of the present investigation was to prepare and characterize Etodolac (ETO), Polyvinyl pyrrolidone K30 (PVP K30) and Hydroxypropyl β-cyclodextrin (HPB) ternary system in order to study the effect of complexation on solubility of ETO.

Methods: Physical mixtures of a drug and polymers in different weight ratios (1:1, 1:2, 1:4) were prepared to study the effect of individual polymers on solubility of ETO. Spray drying method was used to investigate the combined effect of PVP K30 and HPB on saturation solubility (SS), Dissolution efficiency (DE) and mean dissolution time (MDT) of ETO. Design of experiment (DoE) was used for preparation and optimization of ternary system. Drug polymer interactions were analyzed with Fourier transform infrared spectroscopy (FTIR), Differential scanning calorimetry (DSC), Scanning electron microscopy (SEM), Xray diffraction (XRD) and particle size analysis.

Results: Results of solubility study suggested that there was significant increase in solubility of ETO with increase in the concentration of PVP K30, Polyvinyl pyrrolidone K 90 (PVP K90) and HPB (*p<0.05). This might be due to the solubilizing effect of PVP K30, PVPK90 and complex formation of ETO with HPB. Various combinations of PVP K30 and HPB prepared using DoE approach by spray drying method showed greater solubility of ETO than its physical mixtures (*p<0.05). Results of FTIR, DSC, SEM, XRD and particle size analysis revealed the interaction between ETO, PVP K30 and HPB. This suggested formation of amorphous ternary system with mean particle diameter in the range of 763±1.35 nm.

Conclusion: Combine use of PVP K30 and HPB with DoE approach was an effective tool for formulating ternary system of ETO.


Keywords


Etodolac, Spray drying, Polyvinyl pyrrolidone K30, Hydroxypropyl β-cyclodextrin, Design of experiments, Ternary system

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References


Manimaran V, Damodharan N, Mothilal M, Rajkumar K, Chalackal RM. Enhancement of dissolution rate of glibenclamide by solid dispersion technology. Int J Curr Pharm Res 2010;2:14-7.

Kurmi R, Mishra DK, Jain DK. Solid dispersion: a novel means of solubility enhancement. J Crit Rev 2015;3:1-8.

Brewster ME, Loftsson T. Cyclodextrins as pharmaceutical solubilizers. Adv Drug Delivery Rev 2007;59:645-66.

Parmar SS, Mishra R, Shirolkar SV. Spherical agglomeration a novel approach for solubility and dissolution enhancement of simvastatin. Asian J Pharm Clin Res 2016;9:65-72.

Duchene D, Wouessidjewe D, Ponchel G. Cyclodextrins and carrier systems. J Controlled Release 1999;62:263-8.

Mendhe AA, Kharwade RS, Mahajan UN. Dissolution enhancement of poorly water-soluble drug by cyclodextrins inclusion complexation. Int J Appl Pharm 2016;8:60-5.

Shuang S, Choi MM. Retention behaviour and fluorimetric detection of procaine hydrochloride using carboxymethyl b-cyclodextrin as an additive in reversed-phase liquid chromatography. J Chromatogr 2001;A919:321-9.

Irie E, Uekama K. Cyclodextrins in drug delivery: an updated review. J Pharm Sci 1997;86:147-62.

Rajewski RA, Stella VJ. Pharmaceutical applications of cyclodextrins. 2. In vivo drug delivery. J Pharm Sci 1996;85:1142-69.

Carrier RL, Miller LA, Ahmed I. The utility of cyclodextrins for enhancing oral bioavailability. J Controlled Release 2007; 127:78-99.

Balfour JA, Buckley MM. Etodolac-A reappraisal of its pharmacology and therapeutic use in rheumatic diseases and pain states. Drugs 1991;42:274-99.

Reynolds JE. Martindale, the extra pharmacopoeia. 31st ed. London; Royal Pharmaceutical Society; 1996.

Vane JR, Botting RM. New insights into the mode of action of anti-inflammatory drugs. Inflamm Res 1995;44:1-10.

Fayez SM, Gad S, Khafagy EA, Abdeljaleel GA, Ghorab MM, El-nahhas SA. Formulation and evaluation of etodolac lecithin organogel transdermal delivery systems. Int J Pharm Pharm Sci 2015;7:325-34.

Tarnawski AS, Jones MK. Inhibition of angiogenesis by NSAIDs: molecular mechanisms and clinical implications. J Mol Med 2003;81:627-36.

Steinmeyer J. Pharmacological basis for the therapy of pain and inflammation with nonsteroidal anti-inflammatory drugs. Arthritis Res 2000;2:379-85.

Karatas A, Yuksel N, Baykara T. Improved solubility and dissolution rate of piroxicam using gelucire 44/14 and labrasol. Farmaco 2005;60:777-82.

Yazdanian M, Briggs K, Jankovsky C, Hawi A. The "high solubility" definition of the current FDA Guidance on Biopharmaceutical classification system may be too strict for acidic drugs. Pharm Res 2004;21:293-9.

Remington. The Science and practice of pharmacy. 21 ed. Philadelphia: University of the Sciences; 2005.

Insel PA. Analgesic-antipyretic and anti-inflammatory agents and drugs employed in the treatment of gout. In: Hardman JG, Goodman SL, Gilman A, Limbird LE. editors. The pharmacological basis of therapeutics. 9th ed. New York: Mc Graw-Hill. 1996. p. 635.

Percy SR. Improvement in drying and concentrating liquid substances by atomizing. United States Patent and Trademark Office, US125; 1872. p. 406.

Fogler BB, Kleninschmidt RV. Spray drying. Ind Eng Chem Res 1938;30:1372-84.

Miller DA, Gill M. Spray-drying technology. In: Williams III RO, Watts AB, Miller DA, Gill M. editors. Formulating Poorly Water Soluble Drugs. Series: AAPS Advances in the Pharmaceutical Sciences Series 3. New York; Springer; 2012. p. 363-72.

Corrigan OI. Thermal analysis of spray dried products. Thermochim Acta 1995;248:245-58.

Singh B, Kumar R, Ahuja N. Optimizing drug delivery systems using systematic “Design of Experiments.”Part I: Fundamental Aspects Critical Reviews™ in Therapeutic. Drug Carrier Systems 2004;22:27-105.

Singh B, Dahiya M, Saharan V, Ahuja N. Optimizing drug delivery systems using systematic “Design of Experiments.”Part II: Retrospect and Prospects Critical Reviews™ in Therapeutic. Drug Carrier Systems 2005;22:215-93.

Al-Hamidi H, Edward AA, Mohammad MA, Nokhodchi A. To enhance the dissolution rate of poorly water-soluble drugs: glucosamine hydrochloride as a potential carrier in solid dispersion formulations. Colloids surf B 2010;76:170-8.

Costa FO, Souse JJ, Pais AA, Fomosinho SJ. Comparision of dissolution profile of ibuprofen pellets. J Controlled Release 2003;89:199-212.

Brittain HG. Analytical profiles of drug substances and excipients. Vol 29. San Diego: Academic Press; 2002. p. 111.

Herzfeldi C, Kummel R. Dissociation constants, solubilities and dissolution rates of some selected nonsteroidal anti inflammatories. Drug Dev Ind Pharm 1983;9:767-93.

Gupta VR, Mutalik S, Patel MM, Jani GK. Spherical crystals of celecoxib to improve solubility, dissolution rate and micromeritic properties. Acta Pharm 2007;57:173-84.

Nandiyanto AB, Okuyama K. Progress in developing spray-drying methods for the production of controlled morphology particles: from the nanometer to submicrometer size ranges. Adv Powder Technol 2011;22:1-19.

Chadha R, Arora P, Gupta S, Jain DS. Complexation of nevirapine with beta cyclodextrins in the presence and absence of tween 80: characterization, thermodynamic parameters and permeability flux. J Therm Anal Calorim 2011;105:1049-59.




About this article

Title

A DESIGN OF EXPERIMENT APPROACH FOR OPTIMIZATION AND CHARACTERIZATION OF ETODOLAC TERNARY SYSTEM USING SPRAY DRYING

Keywords

Etodolac, Spray drying, Polyvinyl pyrrolidone K30, Hydroxypropyl β-cyclodextrin, Design of experiments, Ternary system

DOI

10.22159/ijpps.2017v9i2.16087

Date

01-02-2017

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 9, Issue 2, 2017 Page: 233-240

Online ISSN

0975-1491

Statistics

96 Views | 308 Downloads

Authors & Affiliations

Amir A. Shaikh
CRD, PRIST University, Vallam, Thanjavur, T.N., India
India

Praveen D. Chaudhari
PES’s Modern College of Pharmacy, Pune, M.S., India
India

Sagar S. Holkar
Dept. of Pharmaceutics, SCES’s Indira College of Pharmacy, Pune, M.S. India
India


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