Biodegradable injectable in situ implants and microparticles for sustained release of montelukast: In vitro release, pharmacokinetics, and stability

AAPS PharmSciTech

Volumn 15, Issue 3, 2014, Pages 772-780

  Ahmed, Tarek A ^a,b   Ibrahim, Hany M ^b   Samy, Ahmed M ^b   Kaseem, Alaa ^b   Nutan, Mohammad T H ^c   Hussain, Muhammad Delwar ^d  

^a KING ABDULAZIZ UNIVERSITY   (Saudi Arabia)

^b Al Azhar University   (Egypt)

^c TEXAS A AND M HEALTH SCIENCE CENTER   (United States)

^d California Health Sciences University   (United States)

Author keywords

controlled release; in vitro studies; in vivo studies; leukotriene receptor antagonist; polymeric drug delivery

Indexed keywords

1 METHYL 2 PYRROLIDINONE; ACETIC ACID ETHYL ESTER; DIMETHYL SULFOXIDE; MONTELUKAST; POLYGLACTIN; TRIACETIN; 2 PYRROLIDONE DERIVATIVE; ACETIC ACID DERIVATIVE; DRUG IMPLANT; LACTIC ACID; LEUKOTRIENE RECEPTOR BLOCKING AGENT; N-METHYLPYRROLIDONE; POLYGLYCOLIC ACID; POLYLACTIC ACID-POLYGLYCOLIC ACID COPOLYMER; QUINOLINE DERIVATIVE; SOLVENT;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IN VITRO STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PRIORITY JOURNAL; RAT; SHELF LIFE; SUSTAINED DRUG RELEASE; TIME TO MAXIMUM PLASMA CONCENTRATION; ANIMAL; BIODEGRADABLE IMPLANT; BLOOD; CHEMISTRY; COMPARATIVE STUDY; DRUG IMPLANT; INTRAMUSCULAR DRUG ADMINISTRATION; MEDICINAL CHEMISTRY; PARTICLE SIZE; PHARMACEUTICS; PROCEDURES; SOLUBILITY; SPRAGUE DAWLEY RAT; TEMPERATURE;

ABSORBABLE IMPLANTS; ACETATES; ANIMALS; CHEMISTRY, PHARMACEUTICAL; DIMETHYL SULFOXIDE; DRUG IMPLANTS; DRUG STABILITY; INJECTIONS, INTRAMUSCULAR; LACTIC ACID; LEUKOTRIENE ANTAGONISTS; MALE; PARTICLE SIZE; POLYGLYCOLIC ACID; PYRROLIDINONES; QUINOLINES; RATS, SPRAGUE-DAWLEY; SOLUBILITY; SOLVENTS; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; TRIACETIN;

EID: 84902003439     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-014-0101-3     Document Type: Article

References (46)

1. Chenite A, Chaput C, Wang D, Combes C, Buschmann MD, Hoemann CD, et al. Novel injectable neutral solutions of chitosan form biodegradable gels in situ. Biomaterials. 2000;21:2155-61. (Pubitemid 30612386)
2. Packhaeuser CB, Schnieders J, Oster CG, Kissel T. In situ forming parenteral drug delivery systems: an overview. Eur J Pharm Biopharm. 2004;58:445-55. (Pubitemid 39037247)
3. Heller J. Polymers for controlled parenteral delivery of peptides and proteins. Adv Drug Deliv Rev. 1993;10:163-204. (Pubitemid 23172581)
4. Langer R. Newmethods of drug delivery. Science. 1990;249:1527-33.
5. Reddy KR. Controlled release, pegylation, liposomal formulations: new mechanisms in the delivery of injectable drugs. Ann Pharmacother. 2000;34:915-22.
6. Kranz H, Yilmaz E, Brazeau GA, Bodmeier R. In vitro and in vivo drug release from a novel in situ forming drug delivery system. Pharm Res. 2008;25(6):1347-54. (Pubitemid 351624356)
7. Couffin-Hoarau AC, Motulsky A, Delmas P, Leroux JC. In situ-forming pharmaceutical organogels based on the self-assembly of L-alanine derivatives. Pharm Res. 2004;21:454-7. (Pubitemid 38338981)
8. He C, Kim SW, Lee DS. In situ gelling stimuli-sensitive block copolymer hydrogels for drug delivery. J Control Release. 2008;127:189-207.
9. Talasaz AHH, Ghahremankhani AA, Moghadam SH, Malekshahi MR, Atyabi F, Dinarvand R. In situ gel forming systems of poloxamer 407 and hydroxypropyl cellulose or hydroxypropyl methyl cellulose mixtures for controlled delivery of vancomycin. J Appl Polym Sci. 2008;109:2369-74.
10. Kranz H, Bodmeier R. A novel in situ forming drug delivery system for controlled parenteral drug delivery. Int J Pharm. 2007;332:107-14. (Pubitemid 46227772)
11. Martindale. The complete drug reference. 35th ed. London: Pharmaceutical; 2005.
12. Huang CK, Handel N. Effects of singulair (montelukast) treatment for capsular contracture. Aesthet Surg J. 2010;30:404-8.
13. Goldbart AD, Greenberg-Dotan S, Tal A. Montelukast for children with obstructive sleep apnea: a double-blind. Placebo-controlled study. Pediatrics. 2012;130(3):e575-80.
14. Zhao JJ, Rogers JD, Holland SD, Larson P, Amin RD, Haesen R, et al. Pharmacokinetics and bioavailability of montelukast sodium (MK-0476) in healthy young and elderly volunteers. Biopharm Drug Dispos. 1997;18:769-77. (Pubitemid 27517566)
15. Yu-hua H, Naijia HH, Lewis E, Holly B, Alan C, Carma M, et al. Pharmacokinetic comparisons of tail-bleeding with cannula- or retro-orbital bleeding techniques in rats using six marketed drugs. J Pharmacol Toxicol Methods. 2007;56:256-64.
16. Sharma G, Italia JL, Sonaje K, Tikoo K, Ravi K. Biodegradable in situ gelling system for subcutaneous administration of ellagic acid and ellagic acid loaded nanoparticles: evaluation of their antioxidant potential against cyclosporine induced nephrotoxicity in rats. J Control Release. 2007;118:27-37.
17. Sripalakit P, Kongthong B, Saraphanchotiwitthaya A. A simple bioanalytical assay for determination of montelukast in human plasma: application to a pharmacokinetic study. J Chromatogr B. 2008;869:38-44.
18. Rothen-Weinhold A, Besseghir K, Vuaridel E, Sublet E, Oudry N, Gurny R. Stability studies of a somatostatin analogue in biodegradable implants. Int J Pharm. 1999;178:213-21. (Pubitemid 29078575)
19. Fredenberg S, Wahlgren M, Reslow M, Axelsson A. The mechanisms of drug release in poly(lactic-co-glycolic acid)-based drug delivery systems - a review. Int J Pharm. 2011;415:34-52.
20. Jain RA. The manufacturing techniques of various drug loaded biodegradable poly (lactide-co-glycolide) devices. Biomaterials. 2000;21:2475-90.
21. Lambert WJ, Peck KD. Development of an in situ forming biodegradable poly-lactide-co-glycolide system for the controlled release of proteins. J Control Release. 1995;33:189-95.
22. Bailey JW, Haymond MW, Miles JM. Triacetin: a potential parenteral nutrient, JPEN J Parenter Enteral Nutr. 1991;15:32-6.
23. Frederic L, Pascal R, Nathalie F, Guillaume N, Annie C, Joel R, et al. Baclofen-loaded microspheres: preparation and efficacy testing in a new rabbit model. Eur J Pharm Biopharm. 2005;59:449-59.
24. The Merck Index. An encyclopedia of chemicals, drugs and biologics. Whitehouse Station: Merck; 1996.
25. Berchane NS, Carson KH, Rice-Ficht AC, Andrews MJ. Effect of mean diameter and polydispersity of PLG microspheres on drug release: experiment and theory. Int J Pharm. 2007;337:118-26. (Pubitemid 46756043)
26. Sansdrap P, Moës AJ. In vitro evaluation of the hydrolytic degradation of dispersed and aggregated poly(d, l-lactide-co-glycolide) microspheres. J Control Release. 1997;43:47-58. (Pubitemid 26393607)
27. Husmann M, Schenderlein S, Lück M, Lindner H, Kleinebudde P. Polymer erosion in PLGA microparticles produced by phase separation method. Int J Pharm. 2002;242:277-80.
28. Pekarek KJ, Jacob JS, Mathiowitz E. Double-walled microspheres for drug delivery. Mater Res Soc Symp Proc. 1994;331:97-101.
29. Mallapragada SK, Peppas NA, Colombo P. Crystal dissolution controlled release systems. II. Metronidazole release from semicrystalline poly(vinyl alcohol) systems. J Biomed Mater Res. 1997;36:125-30. (Pubitemid 27271006)
30. Kishida A, Murakami K, Goto H, Akashi M, Kubita H, Endo T. Polymer drugs and polymeric drugs. X. Slow release of 5-fluorouracil from biodegradable poly(g-glutamic acid) and its benzyl ester matrices. J Bioact Compat Polym. 1998;13:270-8. (Pubitemid 28461647)
31. Ahmed TA, Ibrahim HM, Ibrahim F, Samy AM, Kaseem A, Nutan MT, et al. Development of biodegradable in situ implant and microparticle injectable formulations for sustained delivery of haloperidol. J Pharm Sci. 2012;101:3753-62.
32. Hatefi A, Amsden B. Biodegradable injectable in situ forming drug delivery systems. J Control Release. 2002;80:9-28. (Pubitemid 34273745)
33. Soni R, Sagar GV, Sharma P. Formulation, development and in-vitro evaluation of mucoadhesive bilayered buccal patches of montelukast sodium. Int J Pharm Pharm Sci. 2012;4(2):484-97.
34. Jain RA, Rhodes CT, Railkar AM, Malick W, Shah NH. Controlled release of drugs from injectable in situ formed biodegradable PLGA microspheres: effect of various formulation variables. Eur J Pharm Biopharm. 2000;50:257-62.
35. Kim HK, Park TG. Microencapsulation of dissociable human growth hormone aggregates within poly(D, L-lactic-co-glycolic acid) microparticles for sustained release. Int J Pharm. 2001;229:107-16. (Pubitemid 32972086)
36. Brodbeck KJ, DesNoyer JR, McHugh AJ. Phase inversion dynamics of PLGA solutions related to drug delivery. Part II. The role of solution thermodynamics and bath-side mass transfer. J Control Release. 1999;62:333-44. (Pubitemid 29476581)
37. Kim S, Jang KS, Choi HD, et al. Porous polyimide membranes prepared by wet phase inversion for use in low dielectric applications. Int J Mol Sci. 2013;14:8698-707.
38. Wang L, Venkatraman S, Kleiner L. Drug release from injectable depots: two different in vitro mechanisms. J Control Release. 2004;99:207-16. (Pubitemid 39222107)
39. Siegel SJ, Kahn JB, Metzger K, Winey KI, Werner K, Dan N. Effect of drug type on the degradation rate of PLGA matrices. Eur J Pharm Biopharm. 2006;6:287-93. (Pubitemid 44585214)
40. Bodmeier R, McGinity JW. Solvent selection in the preparation of poly(d, l-lactide) microspheres prepared by the solvent evaporation method. Int J Pharm. 1988;43:179-86. (Pubitemid 18097541)
41. Kranz H, Bodmeier R. Structure formation and characterization of injectable drug loaded biodegradable devices: In situ implants versus in situ microparticles. Eur J Pharm Sci. 2008;34:164-72.
42. Kranz H, Brazeau GA, Napaporn J, Martin RL, Millard W, Bodmeier R. Myotoxicity studies of injectable biodegradable in situ forming drug delivery systems. Int J Pharm. 2001;212:11-8. (Pubitemid 32121946)
43. Khan HA. CalcDose: a software for drug dosage conversion using metabolically activemass of animals. Drug Chem Toxicol. 2003;26:53-60.
44. Laurence DR, Bacharach AL. Evaluation of drug activities: pharmacometrics. London: Academic; 1964.
45. Michael EB, Leslie MS, Jerome JS, William EE. Applied pharmacokinetics & pharmacodynamics: principles of therapeutic drug monitoring. 4th ed. Baltimore: Lippincott Williams & Wilkins; 2006.
46. Magdalena C, Irina-Draga C, Ofelia P, Bogdan S, Luminita J, Eduard C, et al. The protective effect of montelukast sodium on carbon tetrachloride induced hepatopathy in rat. Prostaglandins Other Lipid Mediat. 2009;88:82-8.