BUDESONIDE COMPATIBILITY STUDY WITH EXCIPIENTS FOR PREPARATION OF NANOPARTICLE
DOI:
https://doi.org/10.22159/ijcpr.2021v13i2.41553Keywords:
Budesonide, Nanoparticles, Surfactant, Poloxamer, Glycerol Monostearate, Stability, QualityAbstract
Objective: As a condition of acceptance and approval of any pharmaceutical product, stability studies ensuring the durability of the consistency, stability and efficacy of the product during the shelf life are taken into consideration. These studies should be conducted according to the guidelines provided by ICH, WHO and other agencies as intended.
Methods: The aim of this research was to evaluate the stability of the budesonide solution in some solutions and excipients and to further study the production of budesonide nanoparticles. In order to study the Budesonide stability mixture of solvent and polymers were used. To study the effect of temperature and relative humidity on the stability of budesonide preparations, prepared mixtures were stored under Accelerated (40 °C±2 °C/75 percent RH±5 percent RH), Intermediate (30 °C±2 °C/65 percent RH±5 percent RH), Long-term (25 °C±2 °C/60 percent RH±5 percent RH) and at 2-8 °C.
Results: Budesonide showed good compatibility at defined stability conditions in one month. Such type of preformulation compatibility study is necessary in preparation of nanoparticles.
Conclusion: It would be helpful in screening and identifying a suitable solvent, polymer and mixture at a desired concentration.
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References
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2. O’Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, et al. Inhaled Combined Budesonide–Formoterol as Needed in Mild Asthma. N Engl J Med. 2018;378:1865–76.
3. Ali HSM, York P, Blagden N, Soltanpour S, Acree WE, Jouyban A. Solubility of budesonide, hydrocortisone, and prednisolone in ethanol+water mixtures at 298.2 K. J Chem Eng Data. 2010;55:578–82.
4. Abbasalipourkabir R, Salehzadeh A, Abdullah R. Characterization and stability of nanostructured lipid carriers as drug delivery system. Pakistan J Biol Sci. 2012;15:141–6.
5. Bajaj S, Singla D, Sakhuja N. Stability testing of pharmaceutical products. J Appl Pharm Sci 2012;2:129–38.
6. Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs-a review. J Pharm Anal 2014;4:159–65.
7. Yoshioka S, Stella VJ. Stability of drugs and dosage forms [Internet]. Stability of Drugs and Dosage Forms. Springer, Boston MA; 2002. Available from: https://link.springer.com/ book/10.1007/b114443#authorsandaffiliationsbook. [Last accessed on 02 Oct 2020].
8. Rajashi B Pharate, Suneela S Dhaneshwar. Stability-indicating high-performance thin-layer chromatography method for simultaneous estimation of formoterol fumarate dihydrate and fluticasone propionate in bulk drug and pharmaceutical dosage form. Asian J Pharm Clin Res 2019;12:149–55.
9. Carr AG, Branch A, Mammucari R, Foster NR. The solubility and solubility modelling of budesonide in pure and modified subcritical water solutions. J Supercrit Fluids 2010;55:37–42.
10. Jouyban A, Acree WE, Martínez F. Preferential solvation of some corticosteroids in {ethanol +water } mixtures at 298.2 K. J Mol Liq 2020;312:113249.
11. Shen Y, Lu F, Hou J, Shen Y, Guo S. Incorporation of paclitaxel solid dispersions with poloxamer188 or polyethylene glycol to tune drug release from poly(?-caprolactone) films. Drug Dev Ind Pharm 2013;39:1187–96.
12. Lin X, Shi Y, Yu SS, Li S, Li W, Li M, et al. Preparation of poloxamer188-b-PCL and study on in vitro radioprotection activity of curcumin-loaded nanoparticles. Front Chem. 2020;8:212.
13. Yan F, Zhang C, Zheng Y, Mei L, Tang L, Song C, et al. The effect of poloxamer 188 on nanoparticle morphology, size, cancer cell uptake, and cytotoxicity. Nanomed Nanotechnol Biol Med 2010;6:170–8.
14. Moghimi SM, Hunter AC, Dadswell CM, Savay S, Alving CR, Szebeni J. Causative factors behind poloxamer 188 (Pluronic F68, FlocorTM)-induced complement activation in human sera. A protective role against poloxamer-mediated complement activation by elevated serum lipoprotein levels. Biochim Biophys Acta Mol Basis Dis 2004;1689:103–13.
15. G Moloughney J, Weisleder N. Poloxamer 188 (P188) as a membrane resealing reagent in biomedical applications. Recent Pat Biotechnol 2013;6:200–11.
16. Tian JL, Zhao YZ, Jin Z, Lu CT, Tang QQ, Xiang Q, et al. Synthesis and characterization of poloxamer 188-grafted heparin copolymer. Drug Dev Ind Pharm 2010;36:832–8.
17. Passerini N, Albertini B, Gonzalez Rodriguez ML, Cavallari C, Rodriguez L. Preparation and characterisation of ibuprofen-poloxamer 188 granules obtained by melt granulation. Eur J Pharm Sci 2002;15:71–8.
18. Gibbs WJ, Hagemann TM. Purified poloxamer 188 for sickle cell vaso-occlusive crisis. Ann Pharmacother 2004;38:320–4.
19. Kim M, Haman KJ, Houang EM, Zhang W, Yannopoulos D, Metzger JM, et al. PEO-PPO diblock copolymers protect myoblasts from hypo-osmotic stress in vitro dependent on copolymer size, composition, and architecture. Biomacromolecules 2017;18:2090–101.
20. Barroso NG, Okuro PK, Ribeiro APB, Cunha RL. Tailoring properties of mixed-component oleogels: wax and monoglyceride interactions towards flaxseed oil structuring. Gels 2020;6:5.
21. Borges A, de Freitas V, Mateus N, Fernandes I, Oliveira J. Solid lipid nanoparticles as carriers of natural phenolic compounds. Antioxidants 2020;9:1-24.
22. Emami J, Mohiti H, Hamishehkar H, Varshosaz J. Formulation and optimization of solid lipid nanoparticle formulation for pulmonary delivery of budesonide using taguchi and box-behnken design. Res Pharm Sci 2015;10:17–33.
23. Gardouh A, Ghorab M, Abdel Rahman S. Effect of viscosity, method of preparation and homogenization speed on physical characteristics of solid lipid nanoparticles. ARPN J Sci Technol 2011;2:996–1006.
24. Xia D, Cui F, Gan Y, Mu H, Yang M. Design of lipid matrix particles for fenofibrate: effect of polymorphism of glycerol monostearate on drug incorporation and release. J Pharm Sci 2014;103:697–705.
25. Talele P, Sahu S, Mishra AK. Physicochemical characterization of solid lipid nanoparticles comprised of glycerol monostearate and bile salts. Colloids Surf B 2018;172:517–25.
26. Ortega Toro R, Jimenez A, Talens P, Chiralt A. Effect of the incorporation of surfactants on the physical properties of corn starch films. Food Hydrocoll 2014;38:66–75.
27. Shah M, Pathak K. Development and statistical optimization of solid lipid nanoparticles of simvastatin by using 23 full-factorial design. AAPS PharmSciTech 2010;11:489–96.
28. Kuchekar AB, Pawar AP. Screening of factors using plackett burman design in the preparation of capecitabine-loaded nano polymeric micelles. Int J Pharm Pharm Sci 2014;6:489–96.
29. Carr AG, Mammucari R, Foster NR. Solubility, solubility modeling, and precipitation of naproxen from subcritical water solutions. Ind Eng Chem Res 2010;49:9385–93.
30. Sondari D, Tursiloadi S. The effect of surfactan on formulation and stability of nanoemulsion using extract of Centella Asiatica and Zingiber Officinale. In: AIP Conference Proceedings; 2018.
31. Yuan H, Wang LL, Du YZ, You J, Hu FQ, Zeng S. Preparation and characteristics of nanostructured lipid carriers for control-releasing progesterone by melt-emulsification. Colloids Surf B 2007;60:174–9.
32. Duong VA, Nguyen TTL, Maeng HJ. Preparation of solid lipid nanoparticles and nanostructured lipid carriers for drug delivery and the effects of preparation parameters of the solvent injection method. Molecules 2020;25:4781.
33. Gawade AR, Boldhane. Solid dosage form development of dabigatran etexilate mesylate with increased solubility and dissolution using co-crystallization. Int J Pharm Sci Res 2020;11:2899-905.
Published
15-03-2021
How to Cite
KUCHEKAR, A., J. JATHAR, and A. GAWADE. “BUDESONIDE COMPATIBILITY STUDY WITH EXCIPIENTS FOR PREPARATION OF NANOPARTICLE”. International Journal of Current Pharmaceutical Research, vol. 13, no. 2, Mar. 2021, pp. 39-42, doi:10.22159/ijcpr.2021v13i2.41553.
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