An optimized commercially feasible milling technique for molecular encapsulation of meloxicam in β-cyclodextrin

Drug Development and Industrial Pharmacy

Volumn 37, Issue 11, 2011, Pages 1318-1328

  Bandarkar, Farzana S ^a   Vavia, Pradeep R ^b  

^a KUWAIT UNIVERSITY   (Kuwait)

^b INSTITUTE OF CHEMICAL TECHNOLOGY   (India)

Author keywords

Ball milling; Dissolution; Industrial scale up; Solubility; Tablets

Indexed keywords

BETA CYCLODEXTRIN; MELOXICAM; WATER;

AQUEOUS SOLUTION; ARTICLE; COMPLEX FORMATION; DIFFERENTIAL SCANNING CALORIMETRY; DISPERSION; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; DRUG STABILITY; DRUG SYNTHESIS; ENCAPSULATION; FEASIBILITY STUDY; IN VITRO STUDY; INFRARED SPECTROSCOPY; PHYSICAL CHEMISTRY; PROTON NUCLEAR MAGNETIC RESONANCE; TABLET; X RAY DIFFRACTION;

ANALYSIS OF VARIANCE; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; BETA-CYCLODEXTRINS; BIOLOGICAL AVAILABILITY; DRUG CARRIERS; DRUG COMPOUNDING; SOLUBILITY; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; TABLETS; THIAZINES; THIAZOLES;

EID: 80053982552     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2011.572285     Document Type: Article

References (39)

1. Vippagunta SR, Wang Z, Hornung S, Krill SL. (2007). Factors affecting the formation of eutectic solid dispersions and their dissolution behavior. J Pharm Sci, 96:294-304. (Pubitemid 46363560)
2. Christian L, Jennifer D. (2000). Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm, 50:47-60.
3. Serajuddin AT. (1999). Solid dispersion of poorly water-soluble drugs: early promises, subsequent problems, and recent breakthroughs. J Pharm Sci, 88:1058-1066.
4. Amidon GL, Lennernas H, Shah VP, Crison JR. (1995). A theoretical basis for biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res, 12:413-420.
5. Pinnamaneni S, Das NG, Das SK. (2002). Formulation approaches for orally administered poorly soluble drugs. Pharmazie, 57:291-300. (Pubitemid 34517296)
6. James K. (1986). Solubility and related properties. Vol 28. New York: Marcel Dekker Inc., 355-395.
7. Chaumeil JC. (1998). Micronization: a method of improving the bioavailability of poorly soluble drugs. Methods Find Exp Clin Pharmacol, 20:211-215. (Pubitemid 28255411)
8. Perrut M, Jung J, Leboeuf F. (2005). Enhancement of dissolution rate of poorly soluble active ingredients by supercritical fluid processes. Part II: Preparation of composite particles. Int J Pharm, 288:11-16. (Pubitemid 39656450)
9. Forster A, Hempenstall J, Rades T. (2001). Characterization of glass solutions of poorly water-soluble drugs produced by melt extrusion with hydrophilic amorphous polymers. J Pharm Pharmacol, 53:303-315. (Pubitemid 32229189)
10. Paradkar A, Ambike AA, Jadhav BK, Mahadik KR. (2004). Characterization of curcumin-PVP solid dispersion obtained by spray drying. Int J Pharm, 271:281-286. (Pubitemid 38210105)
11. Breitenbach J. (2002). Melt extrusion: from process to drug delivery technology. Eur J Pharm Biopharm, 54:107-117. (Pubitemid 34919382)
12. Hamsaraj K, Vikram S, Rayasa R. (2006). Industrially Feasible Alternative Approaches in the Manufacture of Solid Dispersions: A Technical Report. AAPS Pharm Sci Tech, 7:87.
13. Mallick S, Pattnaik S, Swain K, De PK, Saha A, Ghoshal G et al. (2008). Formation of physically stable amorphous phase of ibuprofen by solid state milling with kaolin. Eur J Pharm Biopharm, 68:346-351.
14. Descamps M, Willart JF, Dudognon E, Caron V. (2007). Transformation of pharmaceutical compounds upon milling and comilling: the role of T(g). J Pharm Sci, 96:1398-1407. (Pubitemid 46797497)
15. Sethia S, Squillante E. (2003). Solid dispersions: revival with greater possibilities and applications in oral drug delivery. Crit Rev Ther Drug Carrier Syst, 20:215-247. (Pubitemid 37237280)
16. Vasconcelos T, Sarmento B, Costa P. (2007). Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs. Drug Discov Today, 12:1068-1075. (Pubitemid 350186132)
17. Loftsson T. (1998). Increasing the cyclodextrin complexation of drugs and drug biovailability through addition of water-soluble polymers. Pharmazie, 53:733-740. (Pubitemid 28535551)
18. Loftsson T, Brewster ME. (1996). Pharmaceutical applications of cyclodextrins. 1. Drug solubilization and stabilization. J Pharm Sci, 85:1017-1025. (Pubitemid 26338912)
19. Miro A, Quaglia F, Giannini L, Cappello B, La Rotonda M. (2006). Drug/cyclodextrin solid systems in designing hydrophilic matrices: A strategy to modulate drug delivery rate. Curr Drug Deliv, 3:373-378. (Pubitemid 44534049)
20. Duchene D, Wouessidjewe D. (1990). Pharmaceutical uses of cyclodextrins and derivatives. Drug Dev Ind Pharm, 16:2487-2499.
21. Bekers O, Uijtendal EV, Beijnen JH, Bult A, Underberg WJ. (1991). Cyclodextrins in pharmaceutical field. Drug Dev Ind Pharm, 17:1503-1549.
22. El-Maradny HA, Mortada SA, Kamel OA, Hikal AH. (2008). Characterization of ternary complexes of meloxicam-HPbetaCD and PVP or L-arginine prepared by the spray-drying technique. Acta Pharm, 58:455-466.
23. Buchi N, Nalluri KP, Chowdary KV, Murthy R, Becket G, Crooks P. (2007). Tablet formulation studies on nimesulide and meloxicamcyclodextrin binary systems. AAPS Pharm Sci Tech, 8:36.
24. Mosher G, Thompson D. (2002) Complexation and cyclodextrins. In: Encyclopedia of Pharmaceutical Technology. 2nd edition. New York: Marcel Dekker Inc, 531-558.
25. Kaneto U, Fumitoshi H, Tetsumi I. (1998). Cyclodextrin Drug Carrier Systems. Chem Rev, 98:2045-2076.
26. Noble S, Balfour JA. (1996). Meloxicam. Drugs, 51:424-30; discussion 431. (Pubitemid 26091352)
27. Türck D, Roth W, Busch U. (1996). A review of the clinical pharmacokinetics of meloxicam. Br J Rheumatol, 35(Suppl 1):13-16.
28. Gates BJ, Nguyen TT, Setter SM, Davies NM. (2005). Meloxicam: a reappraisal of pharmacokinetics, efficacy and safety. Expert Opin Pharmacother, 6:2117-2140. (Pubitemid 41600587)
29. Kumar SG, Mishra DN. (2006). Preparation, characterization and in vitro dissolution studies of solid dispersion of meloxicam with PEG. J Pharm Soc Jpn, 126:657-664. (Pubitemid 44180773)
30. Baboota S, Agarwal SP. (2002). Inclusion complexation of meloxicam with β-cyclodextrin. Ind J Pharm Sci, 64:408-411.
31. Nath BS, Shiva Kumar HN. (2000). A 2(3) factorial studies on factors influencing meloxicam β-cyclodextrin complexation for better solubility. Ind J Pharm Sci, 62:129-132. (Pubitemid 30488975)
32. Naidu NB, Chowdary KP, Murthy KV, Satyanarayana V, Hayman AR, Becket G. (2004). Physicochemical characterization and dissolution properties of meloxicam-cyclodextrin binary systems. J Pharm Biomed Anal, 35:75-86. (Pubitemid 38368862)
33. Ghorab MM, Abdel-Salam HM, El-Sayad MA, Mekhel MM. (2004). Tablet formulation containing meloxicam and beta-cyclodextrin: mechanical characterization and bioavailability evaluation. AAPS Pharmscitech, 5:e59.
34. Inamdar N, Bhise K, Memon S. (2008). Solubility enhancement and development of dispersible tablet of meloxicam. Asian J Pharm, 2:128-132.
35. Yu L. (2001). Amorphous pharmaceutical solids: preparation, characterization and stabilization. Adv Drug Deliv Rev, 48:27-42. (Pubitemid 32454482)
36. Kaushal AM, Gupta P, Bansal AK. (2004). Amorphous drug delivery systems: molecular aspects, design, and performance. Crit Rev Ther Drug Carrier Syst, 21:133-193. (Pubitemid 41647581)
37. Willart JF, Descamps M. (2008). Solid state amorphization of pharmaceuticals. Mol Pharm, 5:905-920.
38. Higuchi T, Connors KA. (1965). Advances in Analytical Chemistry and Instrumentation, Chapter 4. Phase Solubility Studies; Interscience: New York, pp.,117-212.
39. ICH Q1C and Q1A: "Stability Testing of New Dosage Forms" . http://www.ikev.org/haber/stabilite/kitap/StabilityWorkshop/ICH.pdf