SOLUBILITY AND DISSOLUTION ENHANCEMENT OF PIOGLITAZONE USING SOLID DISPERSION TECHNIQUE
Objective: To design the study to improve the solubility and hence enhance the dissolution of hydrophobic drug Pioglitazone in order to increase its bioavailability.
Methods: Solid dispersion of Pioglitazone using carriers Poloxomer 188 and HPÎ²CD was formulated in different ratios by microwave induced fusion method. In particular, the Microwave technology has been considered in order to prepare an enhanced release dosage form for poorly water soluble drug Pioglitazone. Statistical Analysis: Their physicochemical characteristics and solubility were compared to the corresponding dispersions and marketed drug. Drug and polymer were further characterized by FTIR.
Results: The results of FTIR revealed that no chemical interaction between the drug and the polymer exist.
Conclusion: All the formulations showed a marked increase in drug release with the increase in the concentration of Poloxomer 188 and HPÎ²CD.
1. Kumar A, Sahoo SK. Review on solubility enhancement techniques for hydrophobic drugs. Pharm Globale 2011;3:1-7.
2. Urbanetz NA, Lippold BC. Solid dispersions of nimodipine and polyethylene glycol 2000:dissolution properties and physicochemical characterization. Eur J Pharm Biopharm 2005;59:107â€“18.
3. Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 2000;50:47-60.
4. Amidon GL, Lennernas H, Shah, Crison VP JR. A theoretical basis for a biopharmaceutics drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413â€“20.
5. FDA. Guidance for Industry, Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system; 2000. Available from: http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf. [Last accessed on 10 Apr 2017]
6. EMEA. Guideline on the investigation of bioequivalence; 2010. Avaiable from: http://www.ema.europa.eu/docs/enGB/ documentlibrary/Scientificguideline/201 0/01/WC500070039.pdf. [Last accessed on 10 Apr 2017]
7. WHO. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Annex. 7, WHO Technical Report Series 937; 2006. Available from: http://whqlibdoc.who.int/trs/WHO TRS 937 eng.pdf. [Last accessed on 10 Apr 2017]
8. Yohei K, Koichi W. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications. Int J Pharm 2011;420:1-10.
9. Jaydeep N Dusane. Solubility Enhancement of glipizide by using microwave assisted solid dispersion method; 2016. p. 68â€“80.
10. Horter D, Dressman JB. Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract. Adv Drug Delivery Rev 2001;46:75â€“87.
11. Indian Pharmacopoeia. Government of ministry of health and family welfare. Indian Pharmacopoeia Commission, Ghaziabad 2010;3:147, 185-198, 1219-1220.
12. United State Pharmacopoeia. Water-Solid interaction of pharmaceutical systems, the official compendia of the standard; 2008. p. 710.
13. British Pharmacopoeia. London The stationary office, Published by the Stationary office on behalf of the medicines and healthcare products. Solubility Definition; 2009. p. 2208.
14. Sanjay Batra. Formulation and evaluation of sustain release matrix tablets of pioglitazone. Int J Pharm Sci Lett 2015;4:1-22.
15. Patrick J Sinko. Solubility and Distribution Phenomenon, Martinâ€Ÿs Physical Pharmacy and Pharmaceutical Sciences. Sixth Edition; 2011. p. 182-96.
16. Remington. The Science and Practice of Pharmacy. 21st edition. Vol. Iâ€“II. Published by Wolters Kuwar (India) Pvt. Ltd: New Delhi; 2015. p. 223, 903-914.
17. James Swarbrick. Encyclopedia of Pharmaceutical Technology. 2nd edition. Vol. 1,3; 717-28, 2458-65, 2701-12.
18. Qiu. Developing Solid oral dosage form, Pharmaceutical Theory and Practice. Academic Press: Part I, II, III; 2006. p. 3-22, 87-124, 125-46, 319-40, 501-18.
19. Patel N. Techniques to improve the solubility of poorly soluble drugs. Int J Pharm Life Sci Rev 2012;3:1459-69.
20. Sarmento B, Vasconcelose T. Solid dispersion as a strategy to improve oral bioavailability of poorly water soluble drugs. Adv Drug Delivery Rev 2007;12:1068-75.
21. Beom Jin Lee. Current trends and future perspectives of a solid dispersion containing poorly water soluble drugs. Eur J Pharm Biopharm Rev 2013;85:799-813.
22. Jared AB, Taylor SL. Evaluation of amorphous solid dispersion properties using thermal analysis techniques. Advance Drug Delivery Review 2012;64:396-421.
23. Van Drooge DJ. Characterization of the molecular distribution of drugs in glassy solid dispersions at the nanometer scale, using differential scanning calorimetry and gravimetric water vapour sorption techniques. Int J Pharm 2006;310:220â€“9.
24. Dressman J. Drug solubility: how to measure it, how to improve it. Adv Drug Delivery Rev 2007;59:531-2.
25. Taral Mayur N. Solubility enhancement of atorvastatin calcium by using microwave assisted solid dispersion preparation method. Int J Pharm Res Allied Sci 2015;4:51-6.
26. Taylor SL, Baird JA. Evaluation of amorphous solid dispersion properties using the thermal analytical technique. Adv Drug Delivery Rev 2012;64:396-421.
27. Chiou WL, Riegelman S. Preparation and dissolution characteristics of several fast-release solid dispersions of griseofulvin. J Pharm Sci 1969;58:1505â€“10.
28. Sajid M, Choudhary V. Solubility enhancement methods with the importance of hydrotropy. J Drug Delivery Thera 2012;6:96-101.
29. Kogermann K, Penkina A. Dissolution testing of amorphous solid dispersion. Int J Pharm 2013;444:40-6.
30. Arun Kumar Dash, Suchismita Jena, Sudhir Kumar Sahoo. Study of the effect of pH on pioglitazone by UV spectroscopy and its estimation in bulk and pharmaceutical dosage forms. Reference ID: PHARMATUTOR-ART-1040.
31. S Sayed, A Thomas. RP-HPLC method development for determination of Pioglitazone hydrochloride from tablets. J Pharm Res 2009;2:1479-80.
32. Jedlieka, J Klime, Grafnetterova T. Reversed-phase HPLC methods for purity test and assay of pioglitazone hydrochloride in tablets. Pharmazie 2004;59:178-82.
33. Radhakrishna T, Sreenivas RD. Determination of poglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods. J Pharma Biomed Anal 2002;29:593.
34. Pradeepthi J, Masthanamma SK. A validated spectrophotometric method for determination of determination of Azilsartan medoxomil in pharmaceutical dosage form. J Sci Res Pharm 2013;4:7-10.
35. Takeda Pharmaceuticals, Azilsartan Medoxomil (TAK 491), NDA 200-796. Center for drug evaluation and research. Application number 200796Orig1s000, Chemistry Review(s); 2011.
36. Amar. The Modified natural carrier in solid dispersion for enhancement of solublity of poorly water soluble drugs. J Drug Delivery Thera 2014;4:111-6.
37. Kathy Z, Cheng WM. Azilsartan medoxomil a new angiotensin receptor blocker. Clin Thera 2011;33:1577-89.
38. Yasir M, Asif M. Biopharmaceutical classification system: an account. Int J Reprod BioMed 2010;2:1681-90.
39. Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 2000;50:47â€“60.
40. Sarmento B, Vasconcelose T. Solid dispersion as strategy to improve oral bioavailability of poorly water soluble drugs. Adv Drug Delivery Rev 2007;12:1068-75.
41. Laxmikant Zawar. Microwave induced solid dispersion as a novel technique for enhancing the dissolution rate of repaglinide. Adv Pharmacol Pharm 2013;1:95-10.
42. Craig QM. The mechanisms of drug release from solid dispersions in water soluble polymers. Int J Pharm 2002; 231:131-44.
43. Serajuddin TM. Solid dispersion of poorly water soluble drug: early promises. Subsequent Problems Recent Breakthroughs 1999;88:1058-67.
44. Gines J, Arias M. Thermal investigation of crystallization of polyethylene glycols in solid dispersion containing oxazepam. Int J Pharm 1996;143:247-53.