Applications of complementary polymers in HPMC hydrophilic extended release matrices

Drug Delivery Technology

Volumn 9, Issue 7, 2009, Pages 20-27

  Tiwari, Sandip B ^a   Rajabi Siahboomi, Ali R ^b  

^a Colorcon Inc ^*  (United States)

^b Colorcon ^*

Author keywords

[No Author keywords available]

Indexed keywords

ALGINIC ACID; ALPRENOLOL; ANION; CARBOMER; CARBOXYMETHYLCELLULOSE; CATION; CELLULOSE; CIPROFLOXACIN; ETHYL CELLULOSE; EXCIPIENT; FATTY ACID DERIVATIVE; GLYCEROL BEHENATE; GLYCEROL STEARATE; GUAIFENESIN; HEXADECANOL; HYDROXYPROPYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; MACROGOL; METHYLCELLULOSE; METOPROLOL TARTRATE; OXPRENOLOL; PHTHALIC ACID DERIVATIVE; POLYMER; POLYMETHACRYLIC ACID; POLYVINYL ACETATE; PROPRANOLOL; UNINDEXED DRUG; VALPROATE SEMISODIUM; VERAPAMIL; XANTHAN;

CHEMICAL COMPOSITION; CHEMICAL STRUCTURE; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG RELEASE; DRUG RESEARCH; DRUG SOLUBILITY; HYDRODYNAMICS; HYDROPHILICITY; MOLECULAR WEIGHT; PARTICLE SIZE; PHYSICAL CHEMISTRY; REVIEW; STOMACH PH; TABLET FORMULATION; VISCOSITY;

EID: 70449394012     PISSN: 15372898     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (57)

1. Higuchi T. Mechanism of sustained-action medication: theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci. 1963;52:1145-1149.
2. Inactive ingredient search for approved drug products. Website visited: www.accessdata.fda.gov/scripts/cder/iig/index.cfm. Date accessed: May 31, 2009.
3. Alderman D. A review of cellulose ethers in hydrophilic matrices for oral controlled-release dosage forms. Int J Pharm Tech Prod Mfr. 1984;5(3):1-9. (Pubitemid 15105124)
4. Li CL, Martini LG, Ford JL, Roberts M. The use of hypromellose in oral drug delivery. J Pharm Pharmacol. 2005;57(5):533-546. (Pubitemid 40562392)
5. Tiwari SB, Rajabi-Siahboomi AR. Extended-release oral drug delivery technologies: monolithic matrix systems. In: Jain KK, ed. Methods Mol Biol. Vol.437. Humana Press: Totowa, NJ;2008:217-243.
6. Tiwari SB, Murthy TK, Pai MR, Mehta PR, Chowdary PB. Controlled release formulation of tramadol hydrochloride using hydrophilic and hydrophobic matrix system. AAPS PharmSciTech. 2003;4(3):E31.
7. Rajabi-Siahboomi AR, Bowtell RW, Mansfield P, Davies MC, Melia CD. Structure and behavior in hydrophilic matrix sustained release dosage forms: part 4, studies of water mobility and diffusion coefficients in the gel layer of HPMC tablets using NMR imaging. Pharm Res. 1996;13(3):376-380. (Pubitemid 26114727)
8. Streubel A, Siepmann J, Dashevsky A, Bodmeier R. pH-independent release of a weakly basic drug from water-insoluble and-soluble matrix tablets. J Control Release. 2000;67(1):101-110. (Pubitemid 30201685)
9. Tatavarti A, Hoag S. Microenvironmental pH modulation based release enhancement of a weakly basic drug from hydrophilic matrices. J Pharm Sci. 2006;95(7):1459-1468. (Pubitemid 44049115)
10. Tatavarti A, Mehta K, Augsburger L, Hoag S. Influence of methacrylic and acrylic acid polymers on the release performance of weakly basic drugs from sustained release hydrophilic matrices. J Pharm Sci. 2004;93(9):2319-2331. (Pubitemid 39129629)
11. Gabr K. Effect of organic acids on the release patterns of weakly basic drugs from inert sustained release matrix tablets. Eur J Pharm Biopharm. 1992;38(6):199-202. (Pubitemid 23034728)
12. Gohel M, Parikh R, Nagori S, Jena D. Fabrication of modified release tablet formulation of metoprolol succinate using hydroxypropyl methylcellulose and xanthan gum. AAPS PharmSciTech . 2009;10(1):62-68.
13. Dias V, Gothoskar A, Fegely K, Rajabi-Siahboomi A. Modulation of drug release from hypromellose (HPMC) matrices: suppression of the initial burst effect. Paper presented at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition. San Antonio, TX; 2006.
14. Huang X, Brazel C. On the importance and mechanisms of burst release in matrix-controlled drug delivery systems. J Control Release. 2001;73(2-3):121- 136. (Pubitemid 32539245)
15. US Patent No. 6,368,628. Seth P. Sustained release pharmaceutical composition free of food effect; 2002.
16. Davis J, Burton J, Connor A, MacRae R, Wilding I. Scintigraphic study to investigate the effect of food on a HPMC modified release formulation of UK-294,315. J Pharm Sci. 2009;98(4):1568-1576.
17. Steinberg M, Borzelleca J, Enters E, Kinoshita F, Loper A, Mitchell D, Tamulinas C, Weiner M. A new approach to the safety assessment of pharmaceutical excipients. The Safety Committee of the International Pharmaceutical Excipients Council. Regul Toxicol Pharmacol. 1996;24(2, Pt 1):149.
18. Uchiyama M. Regulatory status of excipients in Japan. Drug Infor J. 1999;33(1):27-32.
19. Baldrick P. Pharmaceutical excipient development: the need for preclinical guidance. Regul Toxicol Pharmacol. 2000;32(2):210. (Pubitemid 30841077)
20. Siepmann J, Kranz H, Bodmeier R, Peppas NA. HPMC-matrices for controlled drug delivery: a new model combining diffusion, swelling, and dissolution mechanisms and predicting the release kinetics. Pharm Res. 1999;16(11):1748- 1756. (Pubitemid 29530409)
21. Siepmann J, Peppas NA. Modeling of drug release from delivery systems based on hydroxypropyl methylcellulose (HPMC). Adv Drug Deliv Rev. 2001;48(2-3):139-157. (Pubitemid 32434400)
22. Siepmann J, Peppas NA. Hydrophilic matrices for controlled drug delivery: an improved mathematical model to predict the resulting drug release kinetics (the "sequential layer" model). Pharm Res. 2000;17(10):1290-1298.
23. Hogan J. Hydroxypropylmethylcellulose sustained release technology. Drug Dev Ind Pharm.1989;15(6):975-999.
24. METHOCEL™ Cellulose Ethers (Controlled Release). Website visited: www.colorcon.com. Date accessed: May 31, 2009.
25. Dow Excipients. Technical Presentations. Website visited: www.dow.com/dowexcipients/resources/product/methocel/meth-presentations.htm. Date accessed: May 31, 2009.
26. Gothoskar A, Dias V, Rajabi-Siahboomi A. Controlling the release of nifedipine (a practically insoluble drug) using hypromellose matrices. Paper presented at the Controlled Release Society 33rd Annual Meeting and Exposition. Vienna, Austria; 2006.
27. Abrahamsson B, Roos K, Sjogren J. Investigation of prandial effects on hydrophilic matrix tablets. Drug Dev Ind Pharm. 1999;25(6):765-771. (Pubitemid 29239406)
28. Scholz A, Kostewicz E, Abrahamsson B, Dressman J. Can the USP paddle method be used to represent in-vivo hydrodynamics? J Pharm Pharmacol. 2003;55(4):443-451.
29. US Patent No. 5009895. Lui C. Sustained release with high and low viscosity HPMC; 1991.
30. Joshi M, Gat G, Mehta S. Sustained Release Formulation of Alprazolam; 2007. WO/2007/010369.
31. Rao V, Engh K, Qiu Y. Design of pH-independent controlled release matrix tablets for acidic drugs. Int J Pharm. 2003;252(1-2):81-86.
32. US Patent No. 2007/0048377. A1.Rajabi-Siahboomi A, Fegely K, Young C, Rege P. Drug compositions containing controlled release hypromellose matrices; 2006.
33. US Patent No. 4792452. Howard J, Timmins P. Controlled release formulation; 1988.
34. Timmins P, Delargy A, Howard J. Optimization and characterization of a pH-independent extended-release hydrophilic matrix tablet. Pharm Dev Technol. 1997;2(1):25-31.
35. Calan® SR. Website visited: www.media.pfizer.com/files/products/uspi- calan-sr.pdf. Date accessed: May 31, 2009.
36. Conti S, Maggi L, Segale L, Machiste EO, Conte U, Grenier P, Vergnault G. Matrices containing NaCMC and HPMC: part 1, dissolution performance characterization. Int J Pharm. 2007;333(1-2):136-142. (Pubitemid 46283280)
37. Conti S, Maggi L, Segale L, Machiste EO, Conte U, Grenier P, Vergnault G. Matrices containing NaCMC and HPMC: part 2, swelling and release mechanism study. Int J Pharm. 2007;333(1-2):143-151. (Pubitemid 46283282)
38. Devi KP, Rao KV, Baveja S, Fathi M, Roth M. Zero-order release formulation of oxprenolol hydrochloride with swelling and erosion control. Pharm Res. 1989;6(4):313-317. (Pubitemid 19134608)
39. Baveja S, Rao KR, Devi KP. Zero-order release hydrophilic matrix tablets of beta-adrenergic blockers. Int J Pharm. 1987;39(1-2):39-45.
40. Dabbagh MA, Ford JL, Rubinstein MH, Hogan JE, Rajabi-Siahboomi AR. Release of propranolol hydrochloride from matrix tablets containing sodium carboxymethylcellulose and hydroxypropylmethylcellulose. Pharm Dev Technol. 1999;4(3):313-324.
41. Glucophage®. Website visited: http://packageinserts.bms.com/pi/pi- glucophage-xr.pdf. Date accessed: May 31, 2009.
42. Varshosaz J, Tavakoli N, Kheirolahi F. Use of hydrophilic natural gums in formulation of sustained-release matrix tablets of tramadol hydrochloride. AAPS PharmSciTech. 2006;7(1):168-174.
43. US Patent No. 6261601. Talwar N, Sen H, Staniforth J. Orally administered controlled drug delivery system providing temporal and spatial control; 2001.
44. Pharmaceutical polymers for oral solid dosage forms. Website visited: www.lubrizol.com/Pharmaceutical/Brochures.html. Date accessed: May 31, 2009.
45. Samani S, Montaseri H, Kazemi A. The effect of polymer blends on release profiles of diclofenac sodium from matrices. Eur J Pharm Biopharm. 2003;55(3):351-355.
46. Tiwari S, Martin L, Rajabi-Siahboomi A. The influence of anionic polymers on hydrochlorothiazide extended release hypromellose matrices. Paper presented at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition. San Diego, CA; 2007.
47. Modulation of drug release from matrices consisting of hydrophilic polymer blends. Website visited: www.excipientfest.net/americas/presentations/ EFA17A-5SandipTiwariColorcon.pdf. Date accessed: May 31, 2009.
48. Martin L, Tiwari S, Rajabi-Siahboomi A. The influence of hydrodynamic conditions on verapamil hydrochloride release from hydrophilic matrices using ionic and non-ionic polymers. Paper presented at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition. Atlanta, GA; 2008.
49. Lohray B, Tiwari S. A controlled release delivery system for metformin. 2005;WO/2005/123134.
50. Hossain M, Rashid M, Hossain A. Effect of waxy materials on the release kinetics of ibuprofen from HPMC based sustained release matrix tablet. Pak J Biol Sci. 2004;7(5):772-776.
51. US Patent No. 5403593. Royce A. Melt granulated compositions for preparing sustained release dosage forms; 1995.
52. Macrae R. Pharmaceutical formulations. 1997;WO/1997/018814.
53. US Patent No. 2003/0104053 A1. Gusler G, Berner B, Chau M, Padua A. Optimal polymer mixtures for gastric retentive tablets; 2001.
54. Glumetza®. Website visited: www.glumetzaxr.com/prescribing-info.asp. Date accessed: May 31, 2009.
55. US Patent No. 5948440. Arora J, Jain G, Sen H. Modified release matrix formulation of cefaclor and cephalexin; 1999.
56. Vueba ML, L.A. Batista de CLA, Veiga F, Sousa JJ, Pina ME. Role of cellulose ether polymers on ibuprofen release from matrix tablets. Drug Dev Ind Pharm. 2005;31(7):653-665. (Pubitemid 41356208)
57. Ebube NK, Hikal AH, Wyandt CM, Beer DC, Miller LG, Jones AB. Sustained release of acetaminophen from heterogeneous matrix tablets: influence of polymer ratio, polymer loading, and co-active on drug release. Pharm Dev Technol. 1997;2(2):161-170.